( f C ^ 2 J . ^ 20mg, +30mg€¦ · 1) ß+® ¥ &9Ú") ú ã ê9Ú &"n 2003; 85 (7): 2042-7. 2) ã Ä&g é" G ³',4ø9Ú$| G" n æ n à Ê&g é" .;"n < \ f9Ú%Y3 9Ú ° ï t; 2010

$Page 1: ( f C ^ 2 J . ^ 20mg, +30mg€¦ · 1) ß+® ¥ &9Ú") ú ã ê9Ú &"n 2003; 85 (7): 2042-7. 2) ã Ä&g é" G ³',4ø9Ú$| G" n æ n à Ê&g é" .;"n < \ f9Ú%Y3 9Ú ° ï t; 2010$
20mg, 30mg

2 ( 2) : CTD ( )

2.7.5

2.7.5

2.7.5 ............................................................................................................................................... 3

- 2 -

2.7.5

(1)

(2)

1) Relling MV, Lin JS, Ayers GD, Evans WE. Racial and gender differences in N-acetyltransferase,

xanthine oxidase, and CYP1A2 activities. Clin Pharmacol Ther 1992; 52: 643-58.

2) Sesardic D, Boobis AR, Edwards RJ, Davies DS. A form of cytochrome P450 in man, orthologous

to form d in the rat, catalyses the O-deethylation of phenacetin and is inducible by cigarette

smoking. Br J Clin Pharmacol 1988; 26: 363-72.

3) Meyer JH, Wilson AA, Ginovart N, Goulding V, Hussey D, Hood K. Occupancy of serotonin

transporters by paroxetine and citalopram during treatment of depression: a [11C]DASB PET

imaging study. Am J Psychiatry 2001; 158: 1843-9.

4) Meyer JH, Wilson AA, Sagrati S, Hussey D, Carella A, Potter WZ. Serotonin transporter occupancy

of five selective serotonin reuptake inhibitors at different doses: an [11C]DASB positron emission

tomography study. Am J Psychiatry 2004; 161: 826-35.

5) Takano A, Suhara T, Ichiyama T, Yasuno F, Suzuki K. Time course of in vivo 5-HTT transporter

occupancy by fluvoxamine. J Clin Psychopharmacol 2006;26:188-91.

(3)

1) 2003; 85 (7): 2042-7.

2) 3 ; 2010.

p.103-114.

3) Backonja M, Beydoun A, Edwards KR, Schwartz SL, Fonseca V, Hes M, et al. Gabapentin for the

symptomatic treatment of painful neuropathy in patients with diabetes mellitus. A randomized

controlled trial. JAMA 1998; 280 (21): 1831-6.

4) CHMP (Committee for medicinal products for human use). Guideline on clinical investigation of

medicinal products intended for treatment of neuropathic pain. November 2004.

5) Mallinckrodt CH, Kaiser CJ, Watkin JG, Molenberghs G, Carroll RJ. The effect of correlation

structure on treatment contrasts estimated from incomplete clinical trial data with likelihood-based

repeated measures compared with last observation carried forward ANOVA. Clinical Trials 2004; 1:

477-89.

6) 2002; 17 (2):

125-38.

7) (distal symmetric polyneuropathy)

2003; 14 (2): 225-7.

8) Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step

quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic

- 3 -

neuropathy. Diabetes care 1994; 17: 1281-9.

9) Meyer JH, Wilson AA, Ginovart N, Goulding V, Hussey D, Hood K, et al. Occupancy of serotonin

transporters by paroxetine and citalopram during treatment of depression: a [11C]DASB PET

imaging study. Am J Psychiatry 2001; 158: 1843-9.

10) Meyer JH, Wilson AA, Sagrati S, Hussey D, Carella A, Potter WZ, et al. Serotonin transporter

occupancy of five selective serotonin reuptake inhibitors at different doses: an [11C]DASB positron

emission tomography study. Am J Psychiatry 2004; 161: 826-35.

11) Depression Frontier 2005; 3: 72-7.

(4)

1) Friedman RA, Leon AC. Expanding the black box — depression, antidepressants, and the risk of

suicide. N Engl J Med 2007; 356: 2343-6.

2) Relling MV, Lin JS, Ayers GD, Evans WE. Racial and gender differences in N-acetyltransferase,

xanthine oxidase, and CYP1A2 activities. Clin Pharmacol Ther 1992; 52: 643-58.

- 4 -

20mg, 30mg

2 ( 2) : CTD ( )

2.7.6

2.7.6

2.7.6 ........................................................................................................................... 5

2.7.6.1 ................................................................................................ 7

2.7.6.1.1 ......................................................................................................................... 7

2.7.6.1.2 ............................................................................................................................... 76

2.7.6.1.3 2 ..................................................................................................... 159

2.7.6.1.4 3 ..................................................................................................... 183

2.7.6.2 ................................................................................................ 206

2.7.6.2.1 2 ............................................................................................................. 206

2.7.6.2.2 3 ............................................................................................................. 280

2.7.6.2.3 2 ................................................................. 395

2.7.6.2.4 ............................................................................................................. 416

- 2 -

BAI Beck

BDI-II Beck -II

BID 1 2

BMI Body Mass Index

BPI

CGI-

DSM-IV 4

EQ-5D Euro QOL EQ-5D

FAS

HAM-D17 Hamilton 17 01 02 03

04 05 06 07 08

09 10 11 12

13 14 15

16 17

ITT

LOCF Last observation carried forward

MAO

M.I.N.I.

MNSI

MNSS

NOS

NRS Numerical Rating Scale

PGI-

PPS

QD 1 1

SFMPQ McGill

SF-36 QOL

5-HT

- 3 -

MedDRA ALT AST -GTP

CK

ALP LDH

BUN

HbA1c

- 4 -

2.7.

6

2.7.

6-1

2.7

.6-1

a)

2.7.

6

12N

0821

5.3.

5.1-

01

11

20

mg

112

20 m

g13

40

mg

120

mg

212

40 m

g13

13

20 m

g4

760

mg

120

mg

240

mg

312

60 m

g13

13

40 m

g4

720

mg

113

218

20 m

g54

40

mg

54

60 m

g55

55

12 1

2.7.

6.1.

1

15

N08

315.

3.5.

1-02

11

40

mg

120

mg

212

40 m

g13

13

20 m

g4

760

mg

120

mg

240

mg

312

60 m

g13

13

40 m

g4

720

mg

113

339

40 m

g86

60

mg

86 16

7

12 1

2.7.

6.1.

2

2

F1J-

MC

- H

MAW

5.

3.5.

1-03

60 m

g B

ID

12

()

20

mg

QD

112

20 m

g Q

D

60 m

g Q

D1

1260

mg

QD

60

mg

BID

13

40 m

g B

ID4

1260

mg

BID

457

20 m

g Q

D11

560

mg

QD

114

60 m

g B

ID11

311

5

12

2.7.

6.1.

3

3

F1J-

MC

- H

MAV

(a)

5.3.

5.1-

04

60 m

g B

ID

12

()

60

mg

QD

112

60 m

g Q

D13

30 m

g Q

D

60 m

g B

ID1

360

mg

QD

412

60 m

g B

ID13

60 m

g Q

D1

13

334

60 m

g Q

D11

460

mg

BID

112

108

12 1

2.7.

6.1.

4

- 5 -

2.7

.6-1

()

a)

2.7.

6

2

13

N08

225.

3.5.

2-01

1

1

40 m

g1

20 m

g2~

5040

mg

60 m

g1

20 m

g2

40 m

g3

40 m

g60

mg

4~50

60 m

g51

40 m

g52

20 m

g

149

40 m

g12

60

mg

137

50 2

2.7.

6.2.

1

3

16

N08

325.

3.5.

2-02

1

1

40 m

g1

20 m

g2~

5140

mg

5220

mg

60 m

g1

20 m

g2

40 m

g3~

5060

mg

5140

mg

5220

mg

258

40 m

g12

9 60

mg

129

50 51 1

2

2.7.

6.2.

2

2

F1J-

MC

- H

MAW

- Ex

tens

ion

5.3.

5.2-

03

60 m

g B

ID

1

2 (

)

60 m

g B

ID1

340

mg

BID

452

60 m

g B

ID

152

337

60 m

g B

ID22

211

5

522.

7.6.

2.3

F1J-

MC

- H

MB

T 5.

3.5.

2-04

60

mg

BID

1

2 (

)

160

mg

QD

2860

mg

QD

60

mg

BID

227

60 m

g B

ID

120

mg

QD

227

120

mg

QD

449

60 m

g B

ID33

412

0 m

g Q

D11

5

282.

7.6.

2.4

a)

20

mg

QD

120

mg

11

60 m

g Q

D1

60 m

g 1

160

mg

BID

160

mg

12

120

mg

QD

112

0 m

g 1

1

- 6 -

2.7.6.1

2.7.6.1.1

2.7.6.1.1.1

2.7.6.1.1-1

2.7.6.1.1-1

[ 5.3.5.1-01 ] 12N0821

( )

20 40 60 mg1 1 3

15 16 1 2 12 11 4 12

14 24 ( )

1 1 40 mg 20 mg1 40 mg 60 mg 20 mg 1

40 mg 1 60 mg

20 mg

P

P

20 mg 40 mg

20 mg P

40 mg60 mg

40 mg 20 mg

Visit

0 1 2 3 4 6 8 10 12 13

2 ( ) 31 4 5 6 7 8 9

20 mg

40 mg

60 mg 20 mg

a)

14-2 -1

a) 2 P

- 7 -

1) 20 75 2) 1 2 *

6 *

2

2

1 2

3 2 1 2 3

1

1) 2)

2

2 3 C128 10 4

[ (distal symmetric polyneuropathy) ( 2002 1 18 ) ]

3)

1) Visit1 HbA1c 9% 2) Visit2 7 24

4 3) Visit1 Visit2 80%

1) Visit1 7 MAO (Monoamine oxidase) 2)

()

3) 4) 5) 6)

7)

8) ( )

- 8 -

9) 10) Visit1 30 11) 1 12) ( )

1) Visit1 ALT 100 U/L 2) Visit1 2.0 mg/dL 3) Visit2 74) Visit2 1 Beck -II

( BDI-II) 20 2

1. 2 1

2. 2

( MINI (Mini international neuropsychiatric interview) )

5) Visit1 45 75 HbA1c Visit1±1.0%

6) ( )

200 ( 50 ) 218

(20 mg 54 40 mg 54 60 mg 55 55 )

Full Analysis Set (FAS) 216 (20 mg 54 40 mg 54 60 mg 55 53 )

Per Protocol Set (PPS) 188 (20 mg 49 40 mg 44 60 mg 45 50 )

218 (20 mg 54 40 mg 54 60 mg 55 55 )

( ) 1 50 (4 200 )

[ 5.3.5.1-03 ]

( ± ) -1.64±2.18 20 mg1 1 -2.16±2.45 60 mg 1 1 -2.70±2.54

40 mg 20 mg 60 mg2.5 1 50

60.8% 60 mg54.3% 60 mg

2 50.8%

1 20 mg

- 9 -

1 1 3

13

3 4 1

( A) 2

( B) 3 12

( C) ( D) ( E)

20 mg 20 mg 20 mg 20 mg 0 mg 0 mg 40 mg 20 mg 40 mg 40 mg 20 mg 0 mg 60 mg 20 mg 40 mg 60 mg 40 mg 20 mg

0 mg 0 mg 0 mg 0 mg 0 mg

A B C D E 1

13 ( 12 1 )

Visit2 7

1) (1 1.5 g

) 2) ( ®) 3) 4) ( ) 5) ( ) 6) 7) 2 ( ) 8) /

( ® ) (

®) ( ® ) 5-HT3 (® ) 5-HT4 ( ® ) 5-HT1B/1D (

® ) ( ® ) 9) 10) MAO ( ®) 11) ( ®) 12)

1) 2) 3) 4) 5) 6) 7)

Visit1 2

1)

- 10 -

2) 3) ( ) 4) ( ® ) 5) ( ® ) 6) ( ® ) 7) E1

( ® ) ( )

1) 9)

(BPI)

(PGI- ) Beck -II (BDI-II)

24 24 BPI-

PGI- BDI-II

/

(FAS)

(PPS) 1 ( )

15% Freeman-Halton Kruskal-Wallis

4

24 Last observation carried forward

(LOCF) ( -) 0.05

( 0.025) ( 0.025) 2

95%

Fisher (0.05)

54

20 20

- 11 -

Visit 1 2 - 3 - 4 5 6 7 8 9 - -2 -1 0 1 2 3 4 6 8 10 12

13/ 14

BPI PGI- BDI-II

b)

b)

a) b) BPI PGI- BDI Beck a) Visit2 b)

2.7.6.1.1.2

(1)

2.7.6.1.1-1

264 218 (20 mg 54 40 mg 54 60 mg

55 55 ) 218

40 (20 mg 9 40 mg 11 60 mg 11 9 )

178 (20 mg 45 40 mg 43 60 mg 44 46 )

264

46 42 4

218 20 mg 54 40 mg 54 60 mg 55 55

40 20 mg 9 40 mg 11 60 mg 11 9

178 20 mg 45 40 mg 43 60 mg 44 46

2.7.6.1.1-1

[ 5.3.5.1-01 10-1 ]

- 12 -

2.7.6.1.1-2

32 (20 mg 7 40 mg 10 60 mg

9 6 ) 3 (60 mg 1 2 )

2 (20 mg 1 1 ) 3 (20 mg 1 40 mg 1

60 mg 1 )

2.7.6.1.1-2

20 mg 40 mg 60 mg % % % % %

9 16.7 11 20.4 11 20.0 9 16.4 40 18.3 7 13.0 10 18.5 9 16.4 6 10.9 32 14.7 1 2 4 2 1 9 1 -2 1 1 3 5 3 -6 1 4 2 4 11 7 -12 3 1 2 1 7 12 0 0 0.0 0 0.0 1 1.8 2 3.6 3 1.4 1 0 1 -2 1 1 3 -6 0 7 -12 2 2 12 0 1 1.9 0 0.0 0 0.0 1 1.8 2 0.9 1 1 1 1 -2 1 1 3 -6 0 7 -12 0 12 0 1 1.9 1 1.9 1 1.8 0 0.0 3 1.4 1 0 1 -2 0 3 -6 1 1 7 -12 1 1 2 12 0 %

( ) 1 7 1 -2 8-14 3 -6 15-42 7 -12 43-84 12 85

[ 5.3.5.1-01 10-1 ]

2.7.6.1.1-2 2.7.6.1.1-3

218 (20 mg 54 40 mg 54 60 mg 55 55

) FAS 2 (

2 ) 216 (20 mg 54 40 mg 54 60 mg 55

53 ) PPS FAS 6 (20 mg 1 40 mg 1 60 mg

3 1 ) 22 (20 mg 4 40 mg 9 60 mg

- 13 -

7 2 ) 188 (20 mg 49 40 mg 44 60 mg

45 50 ) PPS

(13 ) (4 )

FAS PPS

218

20 mg 54 40 mg 54 60 mg 55 55

218 20 mg 54 40 mg 54 60 mg 55 55

2 2

FAS 216 20 mg 54 40 mg 54 60 mg 55 53

6 20 mg 1 40 mg 1 60 mg 3 1

22 20 mg 4 40 mg 9 60 mg 7 2

PPS 188 20 mg 49 40 mg 44 60 mg 45 50

2.7.6.1.1-2

[ 5.3.5.1-01 11-1 12-1 ]

2.7.6.1.1-3

FAS PPS

0158 × 0214 × 0228 ( ) × 0292 ×

20 mg

0371 × 0152 × 0283 × 0287 × 0326 × 0345 × 0423 × 0466 × 0592 × 0611 Visit1 2 1 3 ×

40 mg

0746 80% ( 1 )

×

- 14 -

2.7.6.1.1-3 ( )

FAS PPS

0071 × 0151 × 0156 × 0223 × 0314 × 0401 × 0453 Visit3 64.3%

Visit4 50.0% 42.9%

×

0575 × 0581 ×

60 mg

0745 × 0114 ( ) × 0298 Visit3

× ×

0468 × × 0582 ×

0616 × [ 5.3.5.1-01 11-2 ]

2.7.6.1.1-4

FAS 70.4% (152/216 ) 29.6% (64/216 ) (

± ) 60.2±9.4 4.78±4.25

(p=0.0856)

2.7.6.1.1-4 (FAS)

20 mg 40 mg 60 mg % % % % %

a)

216 100.0 54 100.0 54 100.0 55 100.0 53 100.0 Pe=0.2775

152 70.4 34 63.0 43 79.6 39 70.9 36 67.9 64 29.6 20 37.0 11 20.4 16 29.1 17 32.1

( ) Pk=0.2855 20 30 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 30 40 8 3.7 4 7.4 1 1.9 1 1.8 2 3.8 40 50 18 8.3 3 5.6 8 14.8 2 3.6 5 9.4 50 65 106 49.1 26 48.1 25 46.3 26 47.3 29 54.7 65 75 84 38.9 21 38.9 20 37.0 26 47.3 17 32.1 60.2 59.9 59.4 61.5 60.1 9.4 9.4 9.1 8.9 10.1 30 37 37 37 30 61.0 62.0 60.0 62.0 60.0 75 73 74 75 74

- 15 -

2.7.6.1.1-4 (FAS)( )

20 mg 40 mg 60 mg % % % % %

a)

216 100.0 54 100.0 54 100.0 55 100.0 53 100.0 (cm) Pk=0.1755

150 15 6.9 3 5.6 3 5.6 6 10.9 3 5.7 150 160 58 26.9 15 27.8 11 20.4 16 29.1 16 30.2 160 170 102 47.2 25 46.3 25 46.3 26 47.3 26 49.1 170 41 19.0 11 20.4 15 27.8 7 12.7 8 15.1 162.78 162.39 164.19 161.92 162.62 8.36 8.16 8.72 8.52 8.09 142.2 143.0 142.2 146.2 148.5 163.70 163.60 165.30 162.40 162.70 188.8 177.0 182.2 185.0 188.8

(kg) Pk=0.5722 50 26 12.0 9 16.7 6 11.1 5 9.1 6 11.3 50 60 64 29.6 13 24.1 16 29.6 22 40.0 13 24.5 60 70 72 33.3 17 31.5 17 31.5 19 34.5 19 35.8 70 54 25.0 15 27.8 15 27.8 9 16.4 15 28.3 62.81 63.34 62.59 60.84 64.54 12.00 13.57 11.40 8.70 13.73 36.1 38.3 38.0 36.1 42.6 62.75 62.55 62.45 60.00 64.00 109.0 101.0 87.0 76.1 109.0 BMI (kg/m2) Pk=0.6719 18.5 15 6.9 4 7.4 3 5.6 3 5.5 5 9.4 18.5 25.0 132 61.1 29 53.7 34 63.0 38 69.1 31 58.5 25.0 30.0 61 28.2 19 35.2 17 31.5 14 25.5 11 20.8 30.0 35.0 6 2.8 2 3.7 0 0.0 0 0.0 4 7.5 35.0 40.0 2 0.9 0 0.0 0 0.0 0 0.0 2 3.8 40.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 23.64 23.88 23.13 23.17 24.39 3.75 4.04 3.31 2.63 4.70 15.8 16.4 15.9 15.8 16.2 23.35 23.36 23.30 23.25 23.49 37.9 34.9 30.0 29.0 37.9

Pe=1.0000

7 173 80.1 43 79.6 43 79.6 44 80.0 43 81.1 7 43 19.9 11 20.4 11 20.4 11 20.0 10 18.9

Pe=0.9689 1 9 4.2 2 3.7 3 5.6 2 3.6 2 3.8 2 207 95.8 52 96.3 51 94.4 53 96.4 51 96.2

( ) Pk=0.9518 5 41 19.0 8 14.8 10 18.5 14 25.5 9 17.0 5 10 51 23.6 16 29.6 14 25.9 9 16.4 12 22.6 10 124 57.4 30 55.6 30 55.6 32 58.2 32 60.4 12.52 11.49 13.21 12.10 13.30 8.12 7.48 8.47 7.82 8.75 0.7 0.9 0.8 0.7 0.7 10.88 10.36 11.46 10.56 13.47 41.6 41.6 33.2 29.7 35.9

- 16 -

2.7.6.1.1-4 (FAS)( )

20 mg 40 mg 60 mg % % % % %

a)

216 100.0 54 100.0 54 100.0 55 100.0 53 100.0

( ) Pe=0.9928

2 56 25.9 14 25.9 13 24.1 15 27.3 14 26.4 2 160 74.1 40 74.1 41 75.9 40 72.7 39 73.6 4.78 4.22 4.58 4.91 5.44 4.25 3.60 3.97 3.90 5.35 0.5 0.6 0.7 0.5 0.6 3.56 3.28 3.27 3.84 4.59 30.9 21.2 21.8 15.9 30.9

Pe=0.5253 179 82.9 45 83.3 45 83.3 48 87.3 41 77.4 27 12.5 7 13.0 5 9.3 4 7.3 11 20.8 8 3.7 2 3.7 3 5.6 2 3.6 1 1.9 2 0.9 0 0.0 1 1.9 1 1.8 0 0.0

Pk=0.0856

0 179 82.9 39 72.2 47 87.0 48 87.3 45 84.9 1 2 4 1.9 1 1.9 0 0.0 2 3.6 1 1.9 3 5 6 2.8 2 3.7 2 3.7 1 1.8 1 1.9 6 10 10 4.6 3 5.6 3 5.6 2 3.6 2 3.8 11 17 7.9 9 16.7 2 3.7 2 3.6 4 7.5 2.5 4.7 1.5 1.3 2.3 7.3 10.0 5.4 5.0 7.2 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 42 42 35 33 35

Pe=0.5812 81 37.5 20 37.0 23 42.6 22 40.0 16 30.2 135 62.5 34 63.0 31 57.4 33 60.0 37 69.8

Pe=0.4285 6 2.8 3 5.6 0 0.0 2 3.6 1 1.9 210 97.2 51 94.4 54 100.0 53 96.4 52 98.1

Pe=0.3838 5 2.3 0 0.0 1 1.9 3 5.5 1 1.9 211 97.7 54 100.0 53 98.1 52 94.5 52 98.1

Pe=0.9412

117 54.2 28 51.9 31 57.4 29 52.7 29 54.7 99 45.8 26 48.1 23 42.6 26 47.3 24 45.3

Pe=0.2096 56 25.9 9 16.7 17 31.5 13 23.6 17 32.1 160 74.1 45 83.3 37 68.5 42 76.4 36 67.9

Pe=0.7442

214 99.1 53 98.1 53 98.1 55 100.0 53 100.0 2 0.9 1 1.9 1 1.9 0 0.0 0 0.0

- 17 -

2.7.6.1.1-4 (FAS)( )

20 mg 40 mg 60 mg % % % % %

a)

216 100.0 54 100.0 54 100.0 55 100.0 53 100.0

Pe=0.8224

90 mL/min 106 49.1 25 46.3 26 48.1 26 47.3 29 54.7 90 mL/min 110 50.9 29 53.7 28 51.9 29 52.7 24 45.3 94.17 96.32 93.94 89.86 96.70 31.76 29.88 36.39 27.04 33.49 28.8 45.5 28.8 41.6 49.0 89.22 87.31 87.55 88.08 96.62 237.9 159.3 196.9 155.4 237.9 a) Pe Freeman-Halton Pk Kruskal-Wallis p 0.15

[ 5.3.5.1-01 11-4 ]

(4)

(A)

(a)

2.7.6.1.1-5

(p=0.0004)

2.7.6.1.1-5 (FAS)

t a)

0.2268 0.5746 211 0.39 Pr=0.6935 0.0036 0.0054 211 0.65 Pr=0.5143

-0.3453 0.0952 211 -3.63 Pr=0.0004 1 0.3653 0.6097 211 0.60 Pr=0.5497 2 0.0000 2 -0.2384 0.2783 211 -0.86 Pr=0.3925 2 0.0000

a) Pr p

[ 5.3.5.1-01 11-7 ]

(b)

(LOCF) 2.7.6.1.1-6

(LOCF)

- 18 -

( ± ) 20 mg -1.80±0.38 40 mg

-1.80±0.37 60 mg -1.24±0.38 -1.50±0.38

2.7.6.1.1-6 (LOCF) (FAS)

95%

a)

20 mg 54 -1.80 0.38 -2.55 -1.06 - 40 mg 54 -1.80 0.37 -2.53 -1.07 - 60 mg 55 -1.24 0.38 -1.99 -0.50 -

53 -1.50 0.38 -2.24 -0.75 - 20 mg- - -0.31 0.33 -0.96 0.34 Pac=0.3504 40 mg- - -0.31 0.33 -0.96 0.35 Pac=0.3570 60 mg- - 0.25 0.33 -0.40 0.90 Pac=0.4484 a) Pac p

[ 5.3.5.1-01 11-8 ]

2.7.6.1.1-7

× ×

20 mg

1 4 (p=0.0011 0.0473) 12 ( ±

) 20 mg -2.04±0.30 40 mg -2.20±0.30 60 mg -1.50±0.30 -1.70±0.30

2.7.6.1.1-7 (FAS)

1 2 3 4 5 6 7 8 9 10 11 1220 mg

54 52 50 50 50 50 47 46 45 45 45 45

a) -0.87 ±0.20

-1.09 ±0.22

-1.30 ±0.24

-1.42±0.25

-1.59±0.26

-1.67±0.26

-1.87±0.28

-1.85±0.28

-1.85 ±0.28

-1.93 ±0.29

-2.04 ±0.29

-2.04±0.30

95% -0.48 -0.67 -0.83 -0.93 -1.09 -1.15 -1.33 -1.30 -1.30 -1.36 -1.47 -1.4695% -1.25 -1.52 -1.78 -1.91 -2.09 -2.18 -2.41 -2.40 -2.40 -2.49 -2.62 -2.62

(Pm) b) 0.0011 0.0261 0.0473 0.0465 0.0687 0.1618 0.1430 0.1881 0.2871 0.2723 0.1534 0.341040 mg

54 50 49 47 47 45 45 45 43 43 43 43

a) -0.46 ±0.19

-0.78 ±0.22

-1.09 ±0.24

-1.34±0.25

-1.57±0.25

-1.70±0.26

-1.92±0.28

-2.04±0.28

-2.14 ±0.28

-2.12 ±0.29

-2.19 ±0.29

-2.20±0.30

95% -0.08 -0.36 -0.62 -0.85 -1.07 -1.18 -1.38 -1.49 -1.58 -1.55 -1.61 -1.6195% -0.83 -1.21 -1.56 -1.83 -2.06 -2.21 -2.46 -2.59 -2.69 -2.69 -2.76 -2.78

(Pm) b) 0.2880 0.3897 0.2284 0.0893 0.0825 0.1381 0.1082 0.0605 0.0589 0.0996 0.0701 0.1694

- 19 -

2.7.6.1.1-7 (FAS)( )

1 2 3 4 5 6 7 8 9 10 11 1260 mg

55 53 48 48 46 46 45 45 45 45 45 44

a) -0.57 ±0.20

-0.82 ±0.22

-0.94 ±0.24

-1.04±0.25

-1.21±0.26

-1.23±0.26

-1.34±0.28

-1.30±0.28

-1.30 ±0.28

-1.37 ±0.29

-1.47 ±0.29

-1.50±0.30

95% -0.19 -0.39 -0.47 -0.55 -0.71 -0.71 -0.79 -0.75 -0.75 -0.80 -0.90 -0.9295% -0.96 -1.24 -1.42 -1.53 -1.72 -1.75 -1.88 -1.85 -1.85 -1.94 -2.05 -2.08

(Pm) b) 0.0906 0.3112 0.5129 0.4940 0.5785 0.9815 0.8799 0.7554 0.5661 0.6308 0.8580 0.5909

53 53 53 53 51 50 49 49 47 47 46 46

a) -0.26 ±0.20

-0.59 ±0.22

-0.77 ±0.24

-0.85±0.25

-1.05±0.26

-1.24±0.26

-1.39±0.28

-1.41±0.28

-1.49 ±0.28

-1.54 ±0.29

-1.54 ±0.29

-1.70±0.30

95% 0.13 -0.16 -0.29 -0.35 -0.55 -0.72 -0.85 -0.86 -0.95 -0.97 -0.97 -1.1295% -0.65 -1.02 -1.24 -1.34 -1.55 -1.75 -1.93 -1.95 -2.04 -2.11 -2.11 -2.27a) ± b) Pm p

× × [ 5.3.5.1-01 14.2-2 ]

2.7.6.1.1-8 2.7.6.1.1-9

30% 30%

30% 30% (50% 75% 100%

) 30%

2 30% 2

20%

Fisher Cochran-armitage

30% 41.5% 40 mg

51.9% 50% 24.5% 40 mg 40.7% 10 15%

- 20 -

2.7.6.1.1-8 (FAS) a)

20 mg 40 mg 60 mg 20 mg 40 mg 60 mg

b)

54 54 55 53 30% 25 28 23 22 30% (%) 46.3 51.9 41.8 41.5

Pe=0.6981 Pe=0.3346 Pe=1.0000 Pca=0.8412

50% 16 22 10 13 50% (%) 29.6 40.7 18.2 24.5

Pe=0.6646 Pe=0.0993 Pe=0.4851 Pca=0.7510

75% 7 7 5 5 75% (%) 13.0 13.0 9.1 9.4

Pe=0.7608 Pe=0.7608 Pe=1.0000 Pca=0.9485

100% 2 1 1 0 Pe=0.4953 Pe=1.0000 Pe=1.0000 Pca=0.6698100% (%) 3.7 1.9 1.8 0.0 a) Pe Fisher p b) Pca Cochran-Armitage p

[ 5.3.5.1-01 11-13 ]

2.7.6.1.1-9 (FAS) a)

20 mg 40 mg 60 mg 20 mg 40 mg 60 mg

b)

54 54 55 53 24 26 19 19 Pe=0.4319 Pe=0.2414 Pe=1.0000 Pca=0.9780 (%) 44.4 48.1 34.5 35.8

a) Pe Fisher p b) Pca Cochran-Armitage p

[ 5.3.5.1-01 11-14 ]

30% 2.7.6.1.1-10

2.7.6.1.1-11

30% 30%

30%

2.7.6.1.1-10 30% (FAS)

a)

( )

( ) b)

20 mg 54 27 1 6.5 Pl=0.6224 40 mg 54 25 1 4.5 Pl=0.2586 60 mg 55 28 1 5.0 Pl=0.5347

53 27 1 9.0 - a) b) Pl p

[ 5.3.5.1-01 11-15 ]

- 21 -

2.7.6.1.1-11 (FAS)

a)

( )

( ) b)

20 mg 54 30 1 8.5 Pl=0.2189 40 mg 54 28 1 4.5 Pl=0.0571 60 mg 55 36 1 10.0 Pl=0.7965

53 34 1 12.0 - a) b) Pl p

[ 5.3.5.1-01 11-16 ]

2.7.6.1.1-12

2.7.6.1.1-13

( )

( ) 2

1

BDI-II 2 BDI-II

1 (0.0018)

BDI-II (p=0.0102)

BDI-II

100%

100%

2.7.6.1.1-12 (FAS)

t a) 1 -1.6163 0.2189 205 -7.38 Pr 0.0001

0.0018 0.0056 205 0.32 Pr=0.7472 BDI-II

0.0631 0.0244 205 2.59 Pr=0.0102

2 -2.3419 0.6048 206 -3.87 Pr=0.0001 -0.0020 0.0160 206 -0.13 Pr=0.8986 a) Pr p

[ 5.3.5.1-01 11-19 ]

2.7.6.1.1-13 (FAS)

107.7% -7.7%

[ 5.3.5.1-01 11-20 ]

- 22 -

(B)

(a)

(LOCF)

2.7.6.1.1-14

PGI- (p=<0.0001

0.0005)

2.7.6.1.1-14 (LOCF) (FAS)

t a)

0.0051 0.0058 211 0.87 Pr=0.3846 0.0037 0.0057 211 0.65 Pr=0.5157

0.0063 0.0063 206 1.00 Pr=0.3202 BPI- 0.0022 0.0059 206 0.36 Pr=0.7162

0.0053 0.0058 206 0.91 Pr=0.3626 0.0020 0.0061 206 0.32 Pr=0.7471

0.0010 0.0064 206 0.15 Pr=0.8789 BPI- -0.0046 0.0063 206 -0.73 Pr=0.4637

0.0064 0.0065 206 0.99 Pr=0.3254 -0.0065 0.0066 206 -0.98 Pr=0.3277 -0.0007 0.0062 206 -0.11 Pr=0.9156 0.0023 0.0063 206 0.37 Pr=0.7105 -0.0064 0.0068 206 -0.94 Pr=0.3472 7 -0.0006 0.0057 206 -0.10 Pr=0.9214 PGI- 0.0036 0.0035 204 1.05 Pr=0.2933 BDI-II -0.0026 0.0148 203 -0.18 Pr=0.8592

-0.0005 0.0022 206 -0.21 Pr=0.8334 -0.0002 0.0019 206 -0.09 Pr=0.9278 -0.0042 0.0023 206 -1.85 Pr=0.0663 0.0004 0.0016 206 0.24 Pr=0.8130 BPI PGI- BDI Beck a) Pr p

[ 5.3.5.1-01 11-11 ]

(b)

(LOCF) 2.7.6.1.1-15

20 mg BPI-

(p=0.0013) (p=0.0320) (p=0.0058)

(p=0.0066) (p=0.0065) (p=0.0344) (p=0.0022) 7

(p=0.0020) 40 mg BPI-

(p=0.0373) (p=0.0448) 60 mg

- 23 -

2.7.6.1.1-15 (LOCF)(FAS) a)

20 mg 54 -1.80 0.41 Pac=0.6259 40 mg 54 -1.64 0.40 Pac=0.9748 60 mg 55 -1.32 0.41 Pac=0.3746 53 -1.63 0.41 -

20 mg 54 -1.75 0.40 Pac=0.6903 40 mg 54 -1.73 0.39 Pac=0.7355 60 mg 55 -1.35 0.40 Pac=0.4726 53 -1.61 0.40 - BPI- 20 mg 53 -1.8 0.4 Pac=0.6940 40 mg 51 -1.7 0.4 Pac=0.9228 60 mg 54 -1.2 0.4 Pac=0.2969 53 -1.6 0.4 - 20 mg 53 -1.2 0.4 Pac=0.8488 40 mg 51 -1.6 0.4 Pac=0.4829 60 mg 54 -1.0 0.4 Pac=0.4601 53 -1.3 0.4 - 20 mg 53 -1.7 0.4 Pac=0.4308 40 mg 51 -1.8 0.4 Pac=0.3597 60 mg 54 -1.1 0.4 Pac=0.2938 53 -1.4 0.4 - 20 mg 53 -1.2 0.4 Pac=0.7324 40 mg 51 -1.6 0.4 Pac=0.2475 60 mg 54 -0.9 0.4 Pac=0.4981 53 -1.1 0.4 - BPI- 20 mg 53 -2.3 0.4 Pac=0.0013 40 mg 51 -1.7 0.4 Pac=0.0822 60 mg 54 -1.1 0.4 Pac=0.7408 53 -1.0 0.4 - 20 mg 53 -2.1 0.4 Pac=0.0320 40 mg 51 -1.8 0.4 Pac=0.1846 60 mg 54 -1.7 0.4 Pac=0.3038 53 -1.3 0.4 - 20 mg 53 -2.0 0.5 Pac=0.0058 40 mg 51 -1.4 0.5 Pac=0.2042 60 mg 54 -0.6 0.4 Pac=0.5677 53 -0.9 0.4 - 20 mg 53 -1.9 0.5 Pac=0.0066 40 mg 51 -1.6 0.5 Pac=0.0373 60 mg 54 -1.3 0.5 Pac=0.1803 53 -0.8 0.5 - 20 mg 53 -1.4 0.4 Pac=0.0065 40 mg 51 -0.9 0.4 Pac=0.1435 60 mg 54 -0.6 0.4 Pac=0.5772 53 -0.4 0.4 - 20 mg 53 -2.2 0.4 Pac=0.0344 40 mg 51 -1.8 0.4 Pac=0.2530 60 mg 54 -1.4 0.4 Pac=0.9764 53 -1.4 0.4 -

- 24 -

2.7.6.1.1-15 (LOCF)(FAS)( )

a)

20 mg 53 -2.0 0.5 Pac=0.0022 40 mg 51 -1.6 0.5 Pac=0.0448 60 mg 54 -1.3 0.5 Pac=0.1586 53 -0.7 0.5 - 7 20 mg 53 -2.03 0.40 Pac=0.0020 40 mg 51 -1.56 0.40 Pac=0.0844 60 mg 54 -1.16 0.39 Pac=0.5525 53 -0.96 0.40 - PGI- 20 mg 52 2.9 0.2 Pac=0.8669 40 mg 51 2.9 0.2 Pac=0.9828 60 mg 54 3.1 0.2 Pac=0.1994 52 2.9 0.2 - BDI-II 20 mg 51 -3.4 1.1 Pac=0.8319 40 mg 51 -3.1 1.1 Pac=0.9264 60 mg 54 -3.4 1.0 Pac=0.7766 52 -3.2 1.1 -

20 mg 53 -0.6 0.2 Pac=0.1777 40 mg 51 -0.4 0.2 Pac=0.9463 60 mg 54 -0.5 0.2 Pac=0.5421 53 -0.4 0.2 - 20 mg 53 -0.4 0.1 Pac=0.7331 40 mg 51 -0.4 0.1 Pac=0.8552 60 mg 54 -0.3 0.1 Pac=0.9910 53 -0.3 0.1 - 20 mg 53 -0.4 0.2 Pac=0.4242 40 mg 51 -0.5 0.2 Pac=0.1395 60 mg 54 -0.5 0.2 Pac=0.0885 53 -0.2 0.2 - 20 mg 53 -0.2 0.1 Pac=0.9868 40 mg 51 -0.3 0.1 Pac=0.3182 60 mg 54 -0.2 0.1 Pac=0.5127 53 -0.2 0.1 - BPI PGI- BDI Beck a) Pac p

[ 5.3.5.1-01 11-12 ]

12 2.7.6.1.1-16

× ×

12 20 mg BPI-

(p=0.0007) (p=0.0277)

(p=0.0025) (p=0.0079) (p=0.0058) (p=0.0228)

(p=0.0019) 7 (p=0.0011) 40 mg

- 25 -

60 mg BPI- (p=0.0256)

2.7.6.1.1-16 12 (FAS) a)

20 mg 45 -2.25 0.31 Pm=0.6840 40 mg 43 -2.34 0.32 Pm=0.4979 60 mg 44 -1.90 0.31 Pm=0.4732 46 -2.12 0.31 -

20 mg 45 -2.10 0.33 Pm=0.6128 40 mg 43 -2.22 0.33 Pm=0.4265 60 mg 44 -1.73 0.33 Pm=0.6334 46 -1.91 0.32 - BPI- 20 mg 43 -2.0 0.4 Pm=0.5122 40 mg 42 -2.0 0.4 Pm=0.5095 60 mg 43 -1.5 0.4 Pm=0.6567 46 -1.7 0.4 - 20 mg 43 -1.2 0.4 Pm=0.9068 40 mg 42 -1.5 0.4 Pm=0.4498 60 mg 43 -1.1 0.4 Pm=0.8370 46 -1.2 0.4 - 20 mg 43 -1.9 0.4 Pm=0.3807 40 mg 42 -2.0 0.4 Pm=0.2886 60 mg 43 -1.4 0.4 Pm=0.6062 46 -1.6 0.4 - 20 mg 43 -1.2 0.4 Pm=0.7087 40 mg 42 -1.6 0.4 Pm=0.1651 60 mg 43 -1.0 0.4 Pm=0.9174 46 -1.1 0.4 - BPI- 20 mg 43 -2.4 0.4 Pm=0.0007 40 mg 42 -1.7 0.4 Pm=0.1056 60 mg 43 -1.5 0.4 Pm=0.3490 46 -1.1 0.4 - 20 mg 43 -2.2 0.4 Pm=0.0277 40 mg 42 -1.9 0.4 Pm=0.1373 60 mg 43 -2.0 0.4 Pm=0.0800 46 -1.4 0.4 - 20 mg 43 -2.2 0.4 Pm=0.0025 40 mg 42 -1.6 0.4 Pm=0.1220 60 mg 43 -1.1 0.4 Pm=0.7533 46 -1.0 0.4 - 20 mg 43 -1.7 0.4 Pm=0.0079 40 mg 42 -1.4 0.5 Pm=0.0701 60 mg 43 -1.4 0.4 Pm=0.0660 46 -0.6 0.4 - 20 mg 43 -1.4 0.4 Pm=0.0058 40 mg 42 -0.8 0.4 Pm=0.2572 60 mg 43 -0.9 0.4 Pm=0.1450 46 -0.4 0.4 -

- 26 -

2.7.6.1.1-16 12 (FAS)( )

a)

20 mg 43 -2.5 0.4 Pm=0.0228 40 mg 42 -2.1 0.4 Pm=0.1910 60 mg 43 -1.8 0.4 Pm=0.5690 46 -1.6 0.4 - 20 mg 43 -1.7 0.4 Pm=0.0019 40 mg 42 -1.2 0.4 Pm=0.0591 60 mg 43 -1.4 0.4 Pm=0.0256 46 -0.4 0.4 - 7 20 mg 43 -2.11 0.35 Pm=0.0011 40 mg 42 -1.57 0.37 Pm=0.0921 60 mg 43 -1.45 0.35 Pm=0.1770 46 -0.98 0.35 - PGI- 20 mg 43 2.9 0.2 Pm=0.8030 40 mg 42 2.6 0.2 Pm=0.4125 60 mg 43 3.0 0.2 Pm=0.4245 46 2.8 0.2 - BDI-II 20 mg 43 -2.8 1.0 Pm=0.9330 40 mg 42 -3.1 1.0 Pm=0.8286 60 mg 43 -3.7 1.0 Pm=0.3563 46 -2.9 1.0 -

20 mg 43 -0.7 0.1 Pm=0.1669 40 mg 42 -0.6 0.2 Pm=0.6965 60 mg 43 -0.7 0.1 Pm=0.2594 46 -0.5 0.1 - 20 mg 43 -0.4 0.1 Pm=0.5747 40 mg 42 -0.4 0.1 Pm=0.6316 60 mg 43 -0.4 0.1 Pm=0.7967 46 -0.3 0.1 - 20 mg 43 -0.4 0.1 Pm=0.4965 40 mg 42 -0.6 0.1 Pm=0.1088 60 mg 43 -0.6 0.1 Pm=0.0558 46 -0.3 0.1 - 20 mg 43 -0.2 0.1 Pm=0.9380 40 mg 42 -0.4 0.1 Pm=0.1458 60 mg 43 -0.2 0.1 Pm=0.9633 46 -0.2 0.1 - BPI PGI- BDI Beck a) Pm p

× × [ 5.3.5.1-01 14.2-43 ]

(5)

(A)

2.7.6.1.1-17

( ) 20 mg 47/54 (87.0%) 196 40 mg 47/54 (87.0%)

- 27 -

226 60 mg 47/55 (85.5%) 189 44/55 (80.0%) 140

( )

( ) 20 mg 45/54 (83.3%) 40 mg 46/54

(85.2%) 60 mg 45/55 (81.8%) 42/55 (76.4%)

( )

( ) 20 mg 19/54 (35.2%) 40 mg

18/54 (33.3%) 60 mg 19/55 (34.5%) 13/55 (23.6%)

( )

( ) 20 mg 32/54 (59.3%) 109 40 mg 42/54 (77.8%)

118 60 mg 38/55 (69.1%) 92 24/55 (43.6%) 52

( ) 40

mg (p=0.0004) 60 mg (p=0.0121) ( ) 20 mg 28/54

(51.9%) 40 mg 40/54 (74.1%) 60 mg 34/55 (61.8%)

22/55 (40.0%) ( )

40 mg (p=0.0005) 60 mg (p=0.0354) (

) 20 mg 14/54 (25.9%) 40 mg 7/54 (13.0%) 60 mg

11/55 (20.0%) 5/55 (9.1%) ( )

20 mg (p=0.0244)

2.7.6.1.1-17

20 mg 40 mg 60 mg 20 mg 40 mg 60 mg

54 54 55 55 54 54 55 55

47 47 47 44 32 42 38 24 (%) 87.0 87.0 85.5 80.0 59.3 77.8 69.1 43.6

95% (%) 94.6 94.6 93.5 89.6 72.4 88.0 80.9 57.7 95% (%) 75.1 75.1 73.3 67.0 45.0 64.4 55.2 30.3

p a) Pe=0.4402 Pe=0.4402 Pe=0.6148 - Pe=0.1265 Pe=0.0004 Pe=0.0121 -

45 46 45 42 28 40 34 22 (%) 83.3 85.2 81.8 76.4 51.9 74.1 61.8 40.0

95% (%) 92.1 93.4 90.9 86.8 65.7 85.0 74.6 54.1 95% (%) 70.7 72.9 69.1 63.0 37.8 60.3 47.7 27.0

p a) Pe=0.4752 Pe=0.3320 Pe=0.6398 - Pe=0.2512 Pe=0.0005 Pe=0.0354 -

19 18 19 13 14 7 11 5 (%) 35.2 33.3 34.5 23.6 25.9 13.0 20.0 9.1

95% (%) 49.4 47.5 48.6 37.0 39.7 24.9 33.0 20.0 95% (%) 22.7 21.1 22.2 13.2 15.0 5.4 10.4 3.0

p a) Pe=0.2116 Pe=0.2939 Pe=0.2939 - Pe=0.0244 Pe=0.5563 Pe=0.1751 - a) Fisher

[ 5.3.5.1-01 14.3-1 ]

- 28 -

(MedDRA )

2.7.6.1.1-18

5% 20 mg 15 (27.8%) 16 8

(14.8%) 8 6 (11.1%) 7 6 (11.1%) 6 CK

5 (9.3%) 6 5 (9.3%) 5 4 (7.4%) 6

ALT 4 (7.4%) 4

/ 3 (5.6%) 3 40 mg

16 (29.6%) 18 15 (27.8%) 15 7 (13.0%)

9 7 (13.0%) 7 -GTP 6 (11.1%) 6 5 (9.3%)

6 ALT AST HbA1c 4 (7.4%) 4 3 (5.6%) 7

CK

3 (5.6%) 3 60 mg

17 (30.9%) 19 10 (18.2%) 12 7 (12.7%) 8

7 (12.7%) 7 6 (10.9%) 6 -GTP

4 (7.3%) 4 3 (5.5%) 5 BUN

/ ALP 3 (5.5%) 3

8 (14.5%) 9 6 (10.9%) 6 5 (9.1%)

5 ALT AST 3 (5.5%) 3

(20 mg p=0.0139

40 mg p=0.0077) (40 mg p=0.0059)

20 mg 39 (72.2%) 122 29 (53.7%) 69

3 (5.6%) 5 40 mg 40 (74.1%) 144

33 (61.1%) 79 3 (5.6%) 3 60 mg 43 (78.2%) 122

26 (47.3%) 67 0 30 (54.5%)

72 31 (56.4%) 67 1 (1.8%) 1

24 2 6 20 mg

4 40 mg 8 60 mg 2 20 mg 1 60 mg 1

5% 20 mg 12 (22.2%) 13 8 (14.8%)

8 5 (9.3%) 5 ALT 4 (7.4%) 4 3 (5.6%)

4 / 3

(5.6%) 3 40 mg 15 (27.8%) 16 15 (27.8%) 15

6 (11.1%) 8 6 (11.1%) 6 3 (5.6%) 7

5 (9.3%) 5 -GTP HbA1c 3 (5.6%) 3

60 mg 17 (30.9%) 18 9 (16.4%) 10

6 (10.9%) 6 4 (7.3%) 4 -GTP ALP 3 (5.5%) 3

- 29 -

7 (12.7%) 8 5 (9.1%) 5 3

(5.5%) 3

(20 mg p=0.0271)

(20 mg p=0.0130 40 mg p=0.0018) (40 mg p=0.0128)

(60 mg p=0.0363)

20 mg 29 (53.7%) 80 11 (20.4%) 27

1 (1.9%) 2 40 mg 36 (66.7%) 87 18

(33.3%) 30 1 (1.9%) 1 60 mg 34 (61.8%) 68

14 (25.5%) 24 0 19 (34.5%) 33

13 (23.6%) 19 0

- 30 -

2.7

.6.1

.1-1

8

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

39(

122)

72.

2% 4

0(14

4) 7

4.1%

43(

122)

78.

2% 3

0 (7

2) 5

4.5%

29

(80)

53.

7% 3

6 (8

7) 6

6.7%

34

(68)

61.

8% 1

9 (3

3) 3

4.5%

29

(69)

53.

7% 3

3 (7

9) 6

1.1%

26

(67)

47.

3% 3

1 (6

7) 5

6.4%

11

(27)

20.

4% 1

8 (3

0) 3

3.3%

14

(24)

25.

5% 1

3 (1

9) 2

3.6%

3

(5)

5.6%

3

(3)

5.6%

0

(0)

0.0%

1

(1)

1.8%

1

(2)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

4

7(19

6) 8

7.0%

47(

226)

87.

0% 4

7(18

9) 8

5.5%

44(

140)

80.

0% 3

2(10

9) 5

9.3%

42(

118)

77.

8% 3

8 (9

2) 6

9.1%

24

(52)

43.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

3 (4

) 5.

6%

3 (3

) 5.

5%

1 (1

) 1.

8%

0

(0)

0.0%

3

(4)

5.6%

1

(1)

1.8%

1

(1)

1.8%

1

(1)

1.9%

2

(3)

3.7%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3 (3

) 5.

6%

4 (7

) 7.

4%

3 (3

) 5.

5%

1 (1

) 1.

8%

2

(2)

3.7%

3

(5)

5.6%

1

(1)

1.8%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 31 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.7%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

6%

2 (2

) 3.

6%

1 (1

) 1.

8%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.6%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

6 (6

) 11

.1%

2

(2)

3.6%

2

(2)

3.6%

0 (0

) 0.

0%

2 (2

) 3.

7%

2 (2

) 3.

6%

0 (0

) 0.

0%

- 32 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

3

(3)

5.5%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

1 (1

) 1.

9%

1 (1

) 1.

8%

5 (5

) 9.

1%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

- 33 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

1

9 (2

7) 3

5.2%

18

(27)

33.

3% 1

1 (1

6) 2

0.0%

6

(8)

10.9

%

13

(18)

24.

1% 1

7 (2

6) 3

1.5%

10

(13)

18.

2%

4 (6

) 7.

3%

9 (1

4) 1

6.7%

11

(14)

20.

4% 1

1 (1

7) 2

0.0%

10

(13)

18.

2%

6

(9)

11.1

%

8 (8

) 14

.8%

10

(14)

18.

2%

6 (6

) 10

.9%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

6 (4

2) 4

8.1%

27

(42)

50.

0% 1

9 (3

3) 3

4.5%

14

(21)

25.

5%

19

(28)

35.

2% 2

3 (3

4) 4

2.6%

17

(27)

30.

9% 1

0 (1

2) 1

8.2%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 34 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.6%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

6%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

3 (3

) 5.

6%

3 (3

) 5.

6%

3 (3

) 5.

5%

1 (1

) 1.

8%

3

(3)

5.6%

3

(3)

5.6%

3

(3)

5.5%

1

(1)

1.8%

2

(2)

3.7%

4

(4)

7.4%

3

(3)

5.5%

5

(5)

9.1%

2 (2

) 3.

7%

3 (3

) 5.

6%

3 (3

) 5.

5%

4 (4

) 7.

3%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

5 (5

) 9.

3%

7 (7

) 13

.0%

6

(6)

10.9

%

6 (6

) 10

.9%

5 (5

) 9.

3%

6 (6

) 11

.1%

6

(6)

10.9

%

5 (5

) 9.

1%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

5 (5

) 9.

3%

3 (7

) 5.

6%

1 (1

) 1.

8%

0 (0

) 0.

0%

4

(4)

7.4%

3

(7)

5.6%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

1

(2)

1.8%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6 (6

) 11

.1%

3

(7)

5.6%

2

(2)

3.6%

1

(2)

1.8%

5 (5

) 9.

3%

3 (7

) 5.

6%

2 (2

) 3.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

1

(2)

1.8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (2

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (2

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

2 (4

) 3.

6%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

2

(3)

3.6%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 35 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

9

(10)

16.

7% 1

1 (1

2) 2

0.4%

4

(5)

7.3%

3

(3)

5.5%

7 (8

) 13

.0%

11

(12)

20.

4%

4 (4

) 7.

3%

2 (2

) 3.

6%

5 (5

) 9.

3%

6 (6

) 11

.1%

7

(7)

12.7

%

2 (2

) 3.

6%

4

(4)

7.4%

4

(4)

7.4%

6

(6)

10.9

%

1 (1

) 1.

8%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

5 (1

6) 2

7.8%

16

(18)

29.

6% 1

0 (1

2) 1

8.2%

5

(5)

9.1%

1

2 (1

3) 2

2.2%

15

(16)

27.

8%

9 (1

0) 1

6.4%

3

(3)

5.5%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.7%

1

(2)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

2 (2

) 3.

7%

1 (2

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

3 (3

) 5.

6%

1 (2

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

2

(2)

3.7%

1

(2)

1.8%

0

(0)

0.0%

- 36 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

2 (2

) 3.

7%

0 (0

) 0.

0%

2 (2

) 3.

6%

1 (1

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

4

(4)

7.4%

2

(2)

3.7%

1

(1)

1.8%

0

(0)

0.0%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6 (6

) 11

.1%

2

(2)

3.7%

3

(3)

5.5%

1

(1)

1.8%

3 (3

) 5.

6%

1 (1

) 1.

9%

2 (2

) 3.

6%

0 (0

) 0.

0%

1

2 (1

6) 2

2.2%

8

(9)

14.8

%

7 (9

) 12

.7%

5

(7)

9.1%

8 (1

0) 1

4.8%

5

(5)

9.3%

5

(6)

9.1%

2

(3)

3.6%

3

(3)

5.6%

7

(9)

13.0

%

4 (8

) 7.

3%

1 (3

) 1.

8%

3

(3)

5.6%

5

(6)

9.3%

3

(3)

5.5%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

4 (1

9) 2

5.9%

12

(18)

22.

2% 1

0 (1

7) 1

8.2%

6

(10)

10.

9%

10

(13)

18.

5%

8 (1

1) 1

4.8%

7

(9)

12.7

%

2 (3

) 3.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

3 (3

) 5.

6%

0 (0

) 0.

0%

1 (1

) 1.

8%

1

(1)

1.9%

2

(2)

3.7%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

3 (3

) 5.

6%

0 (0

) 0.

0%

1 (1

) 1.

8%

1

(1)

1.9%

2

(2)

3.7%

0

(0)

0.0%

1

(1)

1.8%

- 37 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

4

(4)

7.4%

1

(1)

1.9%

4

(4)

7.3%

3

(3)

5.5%

2 (2

) 3.

7%

0 (0

) 0.

0%

3 (3

) 5.

5%

1 (1

) 1.

8%

0 (0

) 0.

0%

3 (3

) 5.

6%

3 (3

) 5.

5%

0 (0

) 0.

0%

0

(0)

0.0%

3

(3)

5.6%

3

(3)

5.5%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

4 (4

) 7.

4%

4 (4

) 7.

4%

7 (7

) 12

.7%

3

(3)

5.5%

2 (2

) 3.

7%

3 (3

) 5.

6%

6 (6

) 10

.9%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.9%

1

(1)

1.8%

1

(1)

1.8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (2

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

1 (1

) 1.

9%

1 (1

) 1.

8%

2 (3

) 3.

6%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(2)

1.9%

1

(5)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

2 (3

) 3.

7%

1 (5

) 1.

8%

0 (0

) 0.

0%

- -

- -

5 (5

) 9.

3%

2 (2

) 3.

7%

3 (3

) 5.

5%

2 (2

) 3.

6%

5

(5)

9.3%

2

(2)

3.7%

2

(2)

3.6%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

5 (5

) 9.

3%

3 (3

) 5.

6%

3 (3

) 5.

5%

2 (2

) 3.

6%

5

(5)

9.3%

3

(3)

5.6%

2

(2)

3.6%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

- 38 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

2

(2)

3.7%

6

(7)

11.1

%

4 (4

) 7.

3%

5 (6

) 9.

1%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

11

(14)

20.

4%

8 (1

1) 1

4.8%

11

(14)

20.

0% 1

3 (1

5) 2

3.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (3

) 3.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

2 (1

6) 2

2.2%

14

(18)

25.

9% 1

4 (1

8) 2

5.5%

19

(22)

34.

5%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(3)

3.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 39 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

2 (2

) 3.

7%

4 (5

) 7.

4%

2 (2

) 3.

6%

2 (3

) 3.

6%

- -

- -

4 (5

) 7.

4%

1 (1

) 1.

9%

5 (6

) 9.

1%

6 (6

) 10

.9%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

6 (7

) 11

.1%

5

(6)

9.3%

7

(8)

12.7

%

8 (9

) 14

.5%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

2 (2

) 3.

6%

0 (0

) 0.

0%

- -

- -

- 40 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(2)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (2

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

2

(2)

3.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

2 (2

) 3.

6%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 41 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (2

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (2

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (2

) 1.

8%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (3

) 1.

8%

1 (1

) 1.

8%

- -

- -

3 (4

) 5.

6%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

1 (1

) 1.

9%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

4 (5

) 7.

4%

3 (3

) 5.

6%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

3 (3

) 5.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

4 (4

) 7.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 42 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1

7 (3

6) 3

1.5%

16

(46)

29.

6% 2

1 (4

4) 3

8.2%

13

(19)

23.

6%

14

(31)

25.

9%

8 (1

6) 1

4.8%

12

(17)

21.

8%

6 (9

) 10

.9%

6

(13)

11.

1%

7 (1

2) 1

3.0%

1

(1)

1.8%

3

(10)

5.

5%

3

(8)

5.6%

2

(4)

3.7%

0

(0)

0.0%

2

(4)

3.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

0 (4

9) 3

7.0%

20

(58)

37.

0% 2

1 (4

5) 3

8.2%

15

(29)

27.

3%

15

(39)

27.

8%

9 (2

0) 1

6.7%

12

(17)

21.

8%

7 (1

3) 1

2.7%

4

(4)

7.4%

4

(4)

7.4%

2

(2)

3.6%

2

(2)

3.6%

4 (4

) 7.

4%

2 (2

) 3.

7%

1 (1

) 1.

8%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

ALT

4 (4

) 7.

4%

4 (4

) 7.

4%

2 (2

) 3.

6%

3 (3

) 5.

5%

4

(4)

7.4%

2

(2)

3.7%

1

(1)

1.8%

2

(2)

3.6%

2

(2)

3.7%

4

(4)

7.4%

1

(1)

1.8%

2

(2)

3.6%

2 (2

) 3.

7%

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

AST

2 (2

) 3.

7%

4 (4

) 7.

4%

1 (1

) 1.

8%

3 (3

) 5.

5%

2

(2)

3.7%

2

(2)

3.7%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

8%

- -

- -

- 43 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

5

(6)

9.3%

3

(3)

5.6%

2

(2)

3.6%

2

(2)

3.6%

2 (2

) 3.

7%

2 (2

) 3.

7%

0 (0

) 0.

0%

2 (2

) 3.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

CK

5 (6

) 9.

3%

3 (3

) 5.

6%

2 (2

) 3.

6%

2 (2

) 3.

6%

2

(2)

3.7%

2

(2)

3.7%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

2

(2)

3.7%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

3 (3

) 5.

6%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.9%

3

(3)

5.5%

1

(1)

1.8%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

3 (5

) 5.

6%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

4 (6

) 7.

4%

2 (2

) 3.

7%

3 (3

) 5.

5%

1 (1

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.7%

1

(1)

1.8%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

6%

1 (1

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

2

(2)

3.7%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

LDH

2 (2

) 3.

7%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

2

(2)

3.7%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

- 44 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

9%

2 (2

) 3.

6%

0 (0

) 0.

0%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

3

(3)

5.6%

1

(1)

1.8%

2

(2)

3.6%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

3 (3

) 5.

6%

1 (1

) 1.

8%

2 (2

) 3.

6%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.9%

3

(3)

5.5%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

BU

N

1 (1

) 1.

9%

1 (1

) 1.

9%

3 (3

) 5.

5%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

2

(2)

3.7%

0

(0)

0.0%

1

(1)

1.8%

2

(2)

3.6%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

6%

1 (1

) 1.

9%

1 (1

) 1.

8%

2 (2

) 3.

6%

3

(3)

5.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

C

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

- 45 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

2

(2)

3.7%

6

(6)

11.1

%

4 (4

) 7.

3%

0 (0

) 0.

0%

2

(2)

3.7%

3

(3)

5.6%

3

(3)

5.5%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-GTP

2 (2

) 3.

7%

6 (6

) 11

.1%

4

(4)

7.3%

1

(1)

1.8%

2 (2

) 3.

7%

3 (3

) 5.

6%

3 (3

) 5.

5%

1 (1

) 1.

8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

HbA

1c

0 (0

) 0.

0%

4 (4

) 7.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

3

(3)

5.6%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.7%

1

(1)

1.8%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

7%

1 (1

) 1.

8%

1 (1

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

3

(3)

5.6%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.7%

1

(1)

1.8%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

7%

1 (1

) 1.

8%

1 (1

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

8%

- -

- -

- 46 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.6%

1

(1)

1.9%

2

(2)

3.7%

1

(1)

1.8%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

7%

1 (1

) 1.

8%

1 (1

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

6%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

- 47 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

3 (3

) 5.

6%

0 (0

) 0.

0%

1 (1

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

T

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

1

(1)

1.9%

0

(0)

0.0%

3

(3)

5.5%

1

(1)

1.8%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

6%

0 (0

) 0.

0%

3 (3

) 5.

5%

1 (1

) 1.

8%

3

(3)

5.6%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

2

(2)

3.7%

1

(1)

1.9%

3

(3)

5.5%

0

(0)

0.0%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

/

3 (3

) 5.

6%

1 (1

) 1.

9%

3 (3

) 5.

5%

0 (0

) 0.

0%

3

(3)

5.6%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

U

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.9%

3

(3)

5.5%

0

(0)

0.0%

1 (1

) 1.

9%

1 (1

) 1.

9%

3 (3

) 5.

5%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

ALP

1 (1

) 1.

9%

1 (1

) 1.

9%

3 (3

) 5.

5%

0 (0

) 0.

0%

1

(1)

1.9%

1

(1)

1.9%

3

(3)

5.5%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

1 (1

) 1.

9%

2 (2

) 3.

7%

4 (4

) 7.

3%

1 (4

) 1.

8%

0

(0)

0.0%

2

(2)

3.7%

3

(3)

5.5%

0

(0)

0.0%

1

(1)

1.9%

4

(4)

7.4%

1

(1)

1.8%

3

(4)

5.5%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1 (2

) 1.

9%

7 (7

) 13

.0%

5

(5)

9.1%

4

(8)

7.3%

0 (0

) 0.

0%

5 (5

) 9.

3%

3 (3

) 5.

5%

1 (1

) 1.

8%

- 48 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.6%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

2

(2)

3.7%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

6%

2 (2

) 3.

6%

1 (1

) 1.

8%

0

(0)

0.0%

3

(3)

5.6%

2

(2)

3.6%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (4

) 1.

8%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

1 (1

) 1.

8%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (2

) 1.

9%

1 (1

) 1.

9%

2 (2

) 3.

6%

2 (5

) 3.

6%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

7

(8)

13.0

%

6 (6

) 11

.1%

3

(3)

5.5%

5

(5)

9.1%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

5 (7

) 9.

3%

4 (5

) 7.

4%

2 (2

) 3.

6%

5 (7

) 9.

1%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

1 (1

5) 2

0.4%

9

(11)

16.

7%

5 (5

) 9.

1% 1

0 (1

2) 1

8.2%

2 (2

) 3.

7%

1 (1

) 1.

9%

1 (1

) 1.

8%

1 (1

) 1.

8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 49 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

2

(2)

3.7%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

9%

1 (1

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

6%

2 (2

) 3.

7%

1 (1

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

8%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 50 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

3 (3

) 5.

6%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

- 51 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(2)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

1 (2

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

5%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

( )

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

1

1 (1

1) 2

0.4%

20

(28)

37.

0% 2

1 (2

8) 3

8.2%

9

(10)

16.

4%

10

(10)

18.

5% 1

9 (2

5) 3

5.2%

19

(24)

34.

5%

7 (8

) 12

.7%

3

(4)

5.6%

6

(7)

11.1

%

4 (4

) 7.

3%

2 (2

) 3.

6%

1

(2)

1.9%

4

(5)

7.4%

3

(3)

5.5%

1

(1)

1.8%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

4 (1

6) 2

5.9%

26

(35)

48.

1% 2

4 (3

2) 4

3.6%

11

(12)

20.

0%

11

(12)

20.

4% 2

3 (3

0) 4

2.6%

21

(27)

38.

2%

8 (9

) 14

.5%

- 52 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

4 (6

) 7.

4%

3 (3

) 5.

5%

0 (0

) 0.

0%

0

(0)

0.0%

3

(5)

5.6%

2

(2)

3.6%

0

(0)

0.0%

0

(0)

0.0%

3

(3)

5.6%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

3 (3

) 5.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

7 (9

) 13

.0%

4

(4)

7.3%

0

(0)

0.0%

0 (0

) 0.

0%

6 (8

) 11

.1%

2

(2)

3.6%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.6%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

6%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.6%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.7%

5

(5)

9.3%

4

(4)

7.3%

2

(2)

3.6%

2 (2

) 3.

7%

4 (4

) 7.

4%

4 (4

) 7.

3%

1 (1

) 1.

8%

3 (4

) 5.

6%

2 (2

) 3.

7%

0 (0

) 0.

0%

1 (1

) 1.

8%

1

(2)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

5 (6

) 9.

3%

7 (7

) 13

.0%

4

(4)

7.3%

3

(3)

5.5%

3 (4

) 5.

6%

5 (5

) 9.

3%

4 (4

) 7.

3%

1 (1

) 1.

8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

8 (8

) 14

.8%

14

(14)

25.

9% 1

6 (1

7) 2

9.1%

7

(8)

12.7

%

8

(8)

14.8

% 1

4 (1

4) 2

5.9%

16

(16)

29.

1%

6 (7

) 10

.9%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.6%

1

(1)

1.8%

0 (0

) 0.

0%

1 (1

) 1.

9%

2 (2

) 3.

6%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

8 (8

) 14

.8%

15

(15)

27.

8% 1

7 (1

9) 3

0.9%

8

(9)

14.5

%

8

(8)

14.8

% 1

5 (1

5) 2

7.8%

17

(18)

30.

9%

7 (8

) 12

.7%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

6%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

- 53 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

2 (2

) 3.

7%

2 (2

) 3.

6%

2 (2

) 3.

6%

0

(0)

0.0%

1

(1)

1.9%

2

(2)

3.6%

1

(1)

1.8%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

2 (2

) 3.

7%

2 (2

) 3.

6%

2 (2

) 3.

6%

1

(1)

1.9%

1

(1)

1.9%

2

(2)

3.6%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

9%

1 (1

) 1.

8%

1 (1

) 1.

8%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

1

(1)

1.8%

0

(0)

0.0%

3

(3)

5.6%

1

(1)

1.9%

2

(2)

3.6%

0

(0)

0.0%

2 (2

) 3.

7%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (2

) 1.

9%

2 (2

) 3.

6%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

4 (4

) 7.

4%

2 (3

) 3.

7%

4 (4

) 7.

3%

0 (0

) 0.

0%

2

(2)

3.7%

1

(1)

1.9%

2

(2)

3.6%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

- 54 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

- 55 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

2 (2

) 3.

7%

3 (3

) 5.

6%

2 (2

) 3.

6%

0 (0

) 0.

0%

2

(2)

3.7%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

3

(3)

5.6%

3

(3)

5.6%

4

(6)

7.3%

1

(2)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6 (6

) 11

.1%

6

(6)

11.1

%

6 (8

) 10

.9%

1

(2)

1.8%

2 (2

) 3.

7%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.7%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3 (3

) 5.

6%

1 (1

) 1.

9%

1 (1

) 1.

8%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.7%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

1 (1

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

- 56 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

3

(5)

5.5%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

1 (1

) 1.

9%

3 (5

) 5.

5%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

5 (5

) 9.

3%

2 (2

) 3.

7%

4 (4

) 7.

3%

5 (6

) 9.

1%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

4

(4)

7.3%

3

(3)

5.6%

4

(4)

7.4%

7

(9)

12.7

%

5 (5

) 9.

1%

1

(1)

1.9%

3

(3)

5.6%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

7 (8

) 13

.0%

6

(6)

11.1

% 1

0 (1

3) 1

8.2%

9

(11)

16.

4%

2

(2)

3.7%

3

(3)

5.6%

1

(1)

1.8%

5

(6)

9.1%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

2

(3)

3.6%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (4

) 3.

6%

1 (1

) 1.

8%

- -

- -

- 57 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

1 (1

) 1.

9%

0 (0

) 0.

0%

2 (2

) 3.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.6%

1

(1)

1.9%

2

(2)

3.7%

2

(2)

3.6%

1

(1)

1.8%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 3.

7%

3 (3

) 5.

6%

2 (2

) 3.

6%

3 (3

) 5.

5%

0

(0)

0.0%

2

(2)

3.7%

0

(0)

0.0%

2

(2)

3.6%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

1 (1

) 1.

8%

1 (2

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(2)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

- 58 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

1

(1)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

1 (1

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

4 (5

) 7.

4%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

3

(4)

5.6%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6 (7

) 11

.1%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

5 (6

) 9.

3%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

3.7%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 5.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3

(3)

5.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

-

- -

-

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

- -

- -

- 59 -

2.7

.6.1

.1-1

8 (

)

20

mg

(5

4)

40 m

g

(54

) 60

mg

(5

5)

(5

5)

20 m

g

(54

) 40

mg

(5

4)

60 m

g

(55

)

(55

)

2

(2)

3.7%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 3.

7%

1 (1

) 1.

9%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

3.7%

1

(1)

1.9%

0

(0)

0.0%

0

(0)

0.0%

(

)

[5.

3.5.

1-01

14

.3-9

14

.3-1

0 ]

- 60 -

(B)

2.7.6.1.1-19

1 20 mg 196 44

40 mg 226 71 60 mg 189 42 140 21

2 1

2.7.6.1.1-19

( )

(%) (%)

20 mg 54 47 196 87.0 32 109 59.3 0 1 54 22 44 40.7 19 38 35.2 1 2 52 9 12 17.3 3 4 5.8 2 4 50 16 28 32.0 9 16 18.0 4 8 50 26 58 52.0 13 27 26.0 8 12 46 19 26 41.3 5 6 10.9 12 45 14 28 31.1 7 18 15.6

40 mg 54 47 226 87.0 42 118 77.8 0 1 54 32 71 59.3 30 59 55.6 1 2 50 12 13 24.0 7 7 14.0 2 4 49 19 31 38.8 11 15 22.4 4 8 47 24 53 51.1 8 17 17.0 8 12 45 16 30 35.6 7 10 15.6 12 43 15 28 34.9 8 10 18.6

60 mg 55 47 189 85.5 38 92 69.1 0 1 55 23 42 41.8 21 38 38.2 1 2 53 12 17 22.6 7 10 13.2 2 4 49 19 28 38.8 11 16 22.4 4 8 47 27 68 57.4 11 17 23.4 8 12 45 15 20 33.3 6 7 13.3 12 44 10 14 22.7 4 4 9.1

55 44 140 80.0 24 52 43.6 0 1 55 12 21 21.8 9 15 16.4 1 2 53 6 8 11.3 3 3 5.7 2 4 53 17 30 32.1 9 14 17.0 4 8 52 28 48 53.8 8 9 15.4 8 12 48 16 21 33.3 5 6 10.4 12 46 11 12 23.9 4 5 8.7

0 1 7 1 2 8 14 2 4 15 28 4 8 29 568 12 57 84 12 85

[ 5.3.5.1-01 14.3-21 14.3-22 ]

(C)

2.7.6.1.1-20

20 mg 14/54 (25.9%) 21 40 mg 11/54

(20.4%) 16 60 mg 8/55 (14.5%) 12 11/55 (20.0%)

11 20 mg 4/54 (7.4%) 8 40 mg

6/54 (11.1%) 6 60 mg 3/55 (5.5%) 3 4/55 (7.3%)

4

- 61 -













(F)

20 mg 3 4 40 mg 7 13 60 mg 9 15

2 3

(G) ( )

( ) ±

LDH 20 mg

( )

60 mg 4

1+ 7 8 2

( ) ±

20 mg 1 (250 mmHg)

2.7.6.1.1.3

20 mg 40 mg 60 mg

20 60 mg

(LOCF) 20 mg 40 mg 60 mg

(LOCF)

12

20 mg 40 mg 60 mg

1 (20 mg ) 11 (20 mg 4

40 mg 3 4 ) 20 mg 87.0% (47/54

) 40 mg 87.0% (47/54 ) 60 mg 85.5% (47/55 ) 80.0% (44/55 )

10% 20 mg

- 74 -

40 mg -GTP

60 mg

20 mg 40 mg 60 mg

- 75 -

2.7.6.1.2

2.7.6.1.2.1

2.7.6.1.2-1

2.7.6.1.2-1

[ 5.3.5.1-02 ] 15N0831

( )

40 60 mg1 1 12 40 mg60 mg ( )

15 16 1 2 12 11 4 12

14 24 ( )

1 140 mg 20 mg 1 40 mg 60 mg

20 mg 1 40 mg 1 60 mg

20 mg40 mg

20 mg

40 mg60 mg

40 mg 20 mg

Visit

0 1 2 3 4 6 8 10 12 13

2 ( )

31 4 5 6 7

40 mg

60 mg 20 mg

-2 -1

a)

14

a) 3

- 76 -

1) 20 802) 1 2 *1

6*2

()

( ) (

) ( )

*12

*2 ( )

2 1 2

3 2 1 2 3

1

1) 2) *2

2

2 3 C128 10 4

[ (distal symmetric polyneuropathy) ( 2002 1 18 ) ]

3)

1) Visit1 HbA1c

*1 9.0% *1

2) Visit1 42 70 HbA1c Visit1*2 ±1.0%

*2 Visit1 42 70Visit1 42 70

3) Visit2 7 24

( ) 4 4) Visit1 Visit2 80%

- 77 -

1) *

* ( 4 6 29 80 )

3 2) 3) Visit1 70 (

) 4) 5)

6) 1

7)

() (

) ( )

8) 9) Visit1 42 70 HbA1c 10) ( ) 11) Visit1 90 12) 1 ( )

13) ( )

1) Visit2 14 Monoamine oxidase (MAO)

Visit2 14

2) ( 180 mmHg110 mmHg )

3) Visit1 ALT* AST* 100 U/L 4) Visit1 * 1.5 mg/dL 5) Visit1 * 2.0 mg/dL

* 6) Visit1

7) Visit1

8) Visit1 55 Visit1

9) Visit2 7 4 10) Visit2 1 Beck

-II (BDI-II) 20 2

1. 2 1

2. 2

( M.I.N.I. (Mini international neuropsychiatric interview) )11) ( )

- 78 -

300 (40 mg 75 60 mg 75 150 )

339 (40 mg 86 60 mg 86 167 )

Full Analysis Set (FAS) 338 (40 mg 85 60 mg 86 167 )

Per Protocol Set (PPS) 278 (40 mg 68 60 mg 70 140 )

338 (40 mg 85 60 mg 86 167 )

412 40 mg

2.07 1.41 -0.7140 mg 0.33 (0.7/2.1)

60 mg 40 mg 40 mg60 mg

0.33 0.025 t 20.80 1 143 286

150 (40 mg 7560 mg 75 ) 150 300

1 20 mg

1 1 3 1 1 1 2

C

A B C BC1 C2

1 2 3 12 3 3 4 40 mg 20 mg 40 mg 40 mg 20 mg 20 mg 0 mg 60 mg 20 mg 40 mg 60 mg 20 mg 40 mg 20 mg 0 mg 0 mg 0 mg 0 mg 0 mg 0 mg

A B B 3 C C 1

13 ( 12 1 )

Visit1 Visit7

1) [

( ) 1 1.5 g Visit2

Visit6 7 4]

2) ( ®) 3)

- 79 -

4) 5) 6) ( ) 7) (

) 8) ( ) 9) [

( ) ] 10) ( )11) [ (

) ] 12) 13) 14) 15) /

( ® ) (

®) ( ® ) 5-HT3 (® ) 5-HT4 ( ® ) 5-HT1B/1D (

® ) ( ® ) 16) 17) MAO ( ®) 18) ( ®) 19)

Visit1 Visit7

1) 2) 3) 4) 5) 6) 7)

Visit1 Visit7 Visit156 Visit1

1) 2) ( ) 3) ( ® ) 4) ( ® ) 5) E1 6) ( ® ) 7) ( ® ®

)

( ® ) 1 1.5 g

Visit2 Visit6 7 4

- 80 -

Visit1 Visit7

Visit1 Visit7

Visit1 Visit7

1) 16)

(BPI)

(PGI- ) BDI-II

24 24 BPI-

PGI- BDI-II

(FAS)

(PPS) 1 ( )

0.15 Fisher Wilcoxon

2

12 ( 12

- ) 0.025Last

Observation Carried Forward (LOCF)

95%

Fisher (0.05)

73

20 20

- 81 -

Visit 1 2 - 3 - 4 5 6 7 - -2 -1 0 1 2 3 4 8 12

13/ 14

BPI PGI- BDI-II

a)

a)

a) BPI PGI- BDI Beck a)

2.7.6.1.2.2

(1)

2.7.6.1.2-1

448 339 (40 mg 86 60 mg 86

167 ) 338 293 (40 mg

73 60 mg 70 150 ) 46 (40 mg 13 60 mg

16 17 )

( ) 448

109

( ) 339 40 mg 86

60 mg 86 167

293 46 a) 40 mg 73 60 mg 70

150

40 mg 13 60 mg 16

17

a) ( 1 )

2.7.6.1.2-1 ( )

[ 5.3.5.1-02 10-1 ]

- 82 -

2.7.6.1.2-2

28 (40 mg 9 60 mg 10

9 ) 5 (40 mg 2 60 mg 1 2 )

3 (60 mg 1 2 ) 2 (40 mg 1

1 ) 1 (60 mg 1 ) 5 (40 mg 1 60 mg 1

3 )

2.7.6.1.2-2

40 mg 60 mg

% % % % 172 100.0 86 100.0 86 100.0 167 100.0

122 70.9 61 70.9 61 70.9 136 81.4 50 29.1 25 29.1 25 29.1 31 18.6

1 0.6 0 0.0 1 1.2 2 1.2

19 11.0 9 10.5 10 11.6 9 5.4 3 1.7 2 2.3 1 1.2 2 1.2

1 0.6 0 0.0 1 1.2 0 0.0 1 0.6 1 1.2 0 0.0 1 0.6 2 1.2 1 1.2 1 1.2 3 1.8

27 15.7 13 15.1 14 16.3 17 10.2 a)

1 0 0.0 0 0.0 0 0.0 0 0.0 1 2 0 0.0 0 0.0 0 0.0 0 0.0 2 6 1 0.6 0 0.0 1 1.2 1 0.6 6 12 0 0.0 0 0.0 0 0.0 1 0.6 12 0 0.0 0 0.0 0 0.0 0 0.0

1 4 2.3 3 3.5 1 1.2 1 0.6 1 2 2 1.2 2 2.3 0 0.0 2 1.2 2 6 8 4.7 3 3.5 5 5.8 3 1.8 6 12 5 2.9 1 1.2 4 4.7 3 1.8 12 0 0.0 0 0.0 0 0.0 0 0.0

1 0 0.0 0 0.0 0 0.0 0 0.0 1 2 0 0.0 0 0.0 0 0.0 0 0.0

2 6 0 0.0 0 0.0 0 0.0 0 0.0 6 12 0 0.0 0 0.0 0 0.0 0 0.0 12 0 0.0 0 0.0 0 0.0 0 0.0

1 0 0.0 0 0.0 0 0.0 0 0.0 1 2 0 0.0 0 0.0 0 0.0 1 0.6

2 6 0 0.0 0 0.0 0 0.0 0 0.0 6 12 3 1.7 2 2.3 1 1.2 1 0.6 12 0 0.0 0 0.0 0 0.0 0 0.0

1 0 0.0 0 0.0 0 0.0 0 0.0 1 2 0 0.0 0 0.0 0 0.0 0 0.0 2 6 1 0.6 0 0.0 1 1.2 0 0.0 6 12 0 0.0 0 0.0 0 0.0 0 0.0 12 0 0.0 0 0.0 0 0.0 0 0.0

- 83 -

2.7.6.1.2-2 ( )

40 mg 60 mg

% % % % 1 1 0.6 1 1.2 0 0.0 0 0.0

1 2 0 0.0 0 0.0 0 0.0 0 0.0 2 6 0 0.0 0 0.0 0 0.0 1 0.6 6 12 0 0.0 0 0.0 0 0.0 0 0.0 12 0 0.0 0 0.0 0 0.0 0 0.0

1 0 0.0 0 0.0 0 0.0 0 0.0 1 2 1 0.6 0 0.0 1 1.2 1 0.6 2 6 1 0.6 1 1.2 0 0.0 0 0.0 6 12 0 0.0 0 0.0 0 0.0 2 1.2 12 0 0.0 0 0.0 0 0.0 0 0.0

0 0.0 0 0.0 0 0.0 0 0.0

2 1.2 0 0.0 2 2.3 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0

1 0.6 1 b) 1.2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 1 0.6 1 b) 1.2 0 0.0 0 0.0

4 2.3 2 2.3 2 2.3 0 0.0 a) 1 1 7 1 2 8 14 2 6 15 42 6 12

43 84 12 85 b)

[ 5.3.5.1-02 10-1 10-2 ]

(2)

2.7.6.1.2-2 2.7.6.1.2-3

339 (40 mg 86 60 mg 86

167 ) FAS (

) 1 (40 mg ) 338 (40 mg 85 60 mg 86

167 ) PPS FAS 5 (60 mg 1 4 )

55 (40 mg 17 60 mg 15 23 ) 278 (40 mg

68 60 mg 70 140 ) FAS

PPS

1 (40 mg ) 338

(40 mg 85 60 mg 86 167 )

- 84 -

[ ] ( ) 339

40 mg 86 60 mg 86 167

GCP 0 1

40 mg 1 60 mg 0 0 FAS 338

40 mg 85 60 mg 86 167

5

40 mg 0 60 mg 1 4 0 55

40 mg 17 60 mg 15 23 PPS 278

40 mg 68 60 mg 70 140

[ ] ( ) 339

40 mg 86 60 mg 86 167

GCP 0

40 mg 0 60 mg 0 0 1

40 mg 1 60 mg 0 0

338 40 mg 85 60 mg 86 167

2.7.6.1.2-2

[ 5.3.5.1-02 11-1 12-1 ]

2.7.6.1.2-3 a)

FAS PPS

40 mg 0073 0453 0523 80% 0554 0863 0953 1052 1063 1103 1123 1173 80% 1321 1363

- 85 -

2.7.6.1.2-3 ( ) a)

FAS PPS

40 mg 1422 ( ) 1503

1542 b) c)

[ ] [ ]

1571 1631

60 mg 0442 0522 0533 0561 0602

0753 Visit2 [ ] Visit2 [ ]

0861 0881 1163 1192 1211 1223 1282 1484 1533 80% 1641

0214 0361

0424 ( ) 0472

0482 Visit2 [ ] Visit2 [ ] Visit2 [ ]

0512 80% 0571 0574 0713

0751 Visit2 [ ] Visit2 [ ]

0883 Visit2 [ ] Visit2 [ ]

[ ]

0884 0934 0971 0972 1003 1071 1114 1152 1202 1214

- 86 -

2.7.6.1.2-3 ( ) a)

FAS PPS

1262 1292

( ) 1293 1334 1442 1611

a) b) c)

[ 5.3.5.1-02 10-3 11-2 ]

(3)

FAS 2.7.6.1.2-4

75.7% (256/338 ) 24.3% (82/338 ) ( ±

) 60.8±10.0 4.29±4.11

BMI

3 (p=0.1218 p=0.0708 p=0.1229)

2.7.6.1.2-4 (FAS)

a)

338

171 167 b)40 mg

85 60 mg

86 256 (75.7%) 127 (74.3%) 129 (77.2%) Pe=0.5291 65 (76.5%) 62 (72.1%)

82 (24.3%) 44 (25.7%) 38 (22.8%) 20 (23.5%) 24 (27.9%) ( ) 20 30 2 (0.6%) 1 (0.6%) 1 (0.6%) Pk=0.5212 0 (0.0%) 1 (1.2%)

30 40 12 (3.6%) 8 (4.7%) 4 (2.4%) 2 (2.4%) 6 (7.0%) 40 50 28 (8.3%) 16 (9.4%) 12 (7.2%) 4 (4.7%) 12 (14.0%) 50 65 162 (47.9%) 72 (42.1%) 90 (53.9%) 44 (51.8%) 28 (32.6%) 65 80 134 (39.6%) 74 (43.3%) 60 (35.9%) 35 (41.2%) 39 (45.3%) 60.8 60.9 60.8 62.1 59.7 10.0 10.8 9.2 9.3 12.1 22 22 28 35 22 62.0 63.0 62.0 62.0 63.0 79 79 76 79 79

(cm) 150 21 (6.2%) 10 (5.8%) 11 (6.6%) Pk=0.9537 7 (8.2%) 3 (3.5%) 150 160 78 (23.1%) 42 (24.6%) 36 (21.6%) 23 (27.1%) 19 (22.1%) 160 170 148 (43.8%) 71 (41.5%) 77 (46.1%) 29 (34.1%) 42 (48.8%) 170 91 (26.9%) 48 (28.1%) 43 (25.7%) 26 (30.6%) 22 (25.6%) 163.98 163.83 164.13 163.63 164.02 8.34 8.06 8.65 8.78 7.32 144.0 145.3 144.0 145.3 148.2 164.20 164.00 164.20 163.10 164.35 184.2 180.3 184.2 178.8 180.3

- 87 -

2.7.6.1.2-4 (FAS)( )

a)

338

171 167 b)40 mg

85 60 mg

86 (kg) 50 29 (8.6%) 15 (8.8%) 14 (8.4%) Pk=0.8699 10 (11.8%) 5 (5.8%)

50 60 104 (30.8%) 51 (29.8%) 53 (31.7%) 30 (35.3%) 21 (24.4%) 60 70 115 (34.0%) 62 (36.3%) 53 (31.7%) 24 (28.2%) 38 (44.2%) 70 90 (26.6%) 43 (25.1%) 47 (28.1%) 21 (24.7%) 22 (25.6%) 64.21 63.91 64.52 62.72 65.08 11.90 11.90 11.93 13.35 10.23 38.3 38.3 40.6 38.3 43.6 63.70 63.70 63.70 60.30 65.45 108.4 105.6 108.4 105.6 95.6 BMI (kg/m2) 18.5 17 (5.0%) 9 (5.3%) 8 (4.8%) Pk=0.1218* 5 (5.9%) 4 (4.7%) 18.5 25.0 209 (61.8%) 112 (65.5%) 97 (58.1%) 59 (69.4%) 53 (61.6%) 25.0 30.0 88 (26.0%) 41 (24.0%) 47 (28.1%) 17 (20.0%) 24 (27.9%) 30.0 35.0 21 (6.2%) 7 (4.1%) 14 (8.4%) 3 (3.5%) 4 (4.7%) 35.0 40.0 3 (0.9%) 2 (1.2%) 1 (0.6%) 1 (1.2%) 1 (1.2%) 40.0 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 23.82 23.74 23.90 23.27 24.20 3.65 3.60 3.70 3.67 3.50 16.0 16.5 16.0 16.8 16.5 23.45 23.40 23.50 23.10 23.65 37.4 35.5 37.4 35.5 35.5

6 187 (55.3%) 96 (56.1%) 91 (54.5%) Pe=0.8269 49 (57.6%) 47 (54.7%) 6 151 (44.7%) 75 (43.9%) 76 (45.5%) 36 (42.4%) 39 (45.3%)

1 17 (5.0%) 9 (5.3%) 8 (4.8%) Pe=1.0000 5 (5.9%) 4 (4.7%) 2 321 (95.0%) 162 (94.7%) 159 (95.2%) 80 (94.1%) 82 (95.3%)

5 69 (20.4%) 36 (21.1%) 33 (19.8%) Pk=0.9984 20 (23.5%) 16 (18.6%) ( ) 5 10 64 (18.9%) 32 (18.7%) 32 (19.2%) 18 (21.2%) 14 (16.3%) 10 200 (59.2%) 103 (60.2%) 97 (58.1%) 47 (55.3%) 56 (65.1%) 5 (1.5%) 0 (0.0%) 5 (3.0%) 0 (0.0%) 0 (0.0%)

2 104 (30.8%) 53 (31.0%) 51 (30.5%) Pe=1.0000 26 (30.6%) 27 (31.4%) ( ) 2 234 (69.2%) 118 (69.0%) 116 (69.5%) 59 (69.4%) 59 (68.6%)

4.29 4.37 4.21 4.58 4.16 4.11 3.78 4.44 3.90 3.67 0.3 0.3 0.6 0.3 0.6 3.30 3.30 3.20 3.50 3.15 41.3 23.1 41.3 17.8 23.1

295 (87.3%) 144 (84.2%) 151 (90.4%) Pe=0.1791 69 (81.2%) 75 (87.2%) 30 (8.9%) 20 (11.7%) 10 (6.0%) 9 (10.6%) 11 (12.8%) 13 (3.8%) 7 (4.1%) 6 (3.6%) 7 (8.2%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)

0 316 (93.5%) 163 (95.3%) 153 (91.6%) Pk=0.1620 80 (94.1%) 83 (96.5%)1 2 8 (2.4%) 3 (1.8%) 5 (3.0%) 3 (3.5%) 0 (0.0%)

( ) 3 5 3 (0.9%) 2 (1.2%) 1 (0.6%) 1 (1.2%) 1 (1.2%) 6 10 7 (2.1%) 2 (1.2%) 5 (3.0%) 1 (1.2%) 1 (1.2%) 11 4 (1.2%) 1 (0.6%) 3 (1.8%) 0 (0.0%) 1 (1.2%) 0.4 0.3 0.6 0.2 0.4 2.1 1.9 2.4 0.9 2.5 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 22 22 17 7 22

- 88 -

2.7.6.1.2-4 (FAS)( )

a)

338

171 167 b)40 mg

85 60 mg

86 123 (36.4%) 54 (31.6%) 69 (41.3%) Pe=0.0708* 29 (34.1%) 25 (29.1%)

215 (63.6%) 117 (68.4%) 98 (58.7%) 56 (65.9%) 61 (70.9%) 4 (1.2%) 1 (0.6%) 3 (1.8%) Pe=0.3669 1 (1.2%) 0 (0.0%)

334 (98.8%) 170 (99.4%) 164 (98.2%) 84 (98.8%) 86 (100.0%) 3 (0.9%) 2 (1.2%) 1 (0.6%) Pe=1.0000 2 (2.4%) 0 (0.0%)

335 (99.1%) 169 (98.8%) 166 (99.4%) 83 (97.6%) 86 (100.0%) 198 (58.6%) 93 (54.4%) 105 (62.9%) Pe=0.1229* 41 (48.2%) 52 (60.5%)

140 (41.4%) 78 (45.6%) 62 (37.1%) 44 (51.8%) 34 (39.5%) 62 (18.3%) 29 (17.0%) 33 (19.8%) Pe=0.5745 17 (20.0%) 12 (14.0%)

276 (81.7%) 142 (83.0%) 134 (80.2%) 68 (80.0%) 74 (86.0%) 338 (100.0%) 171 (100.0%) 167 (100.0%) - 85 (100.0%) 86 (100.0%)

0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 186 (55.0%) 95 (55.6%) 91 (54.5%) Pe=0.8176 45 (52.9%) 50 (58.1%)

( ) 78 (23.1%) 37 (21.6%) 41 (24.6%) 23 (27.1%) 14 (16.3%)

74 (21.9%) 39 (22.8%) 35 (21.0%) 17 (20.0%) 22 (25.6%) 113 (33.4%) 57 (33.3%) 56 (33.5%) Pe=0.9525 25 (29.4%) 32 (37.2%)

( ) 114 (33.7%) 59 (34.5%) 55 (32.9%) 33 (38.8%) 26 (30.2%)

111 (32.8%) 55 (32.2%) 56 (33.5%) 27 (31.8%) 28 (32.6%)90 186 (55.0%) 95 (55.6%) 91 (54.5%) Pe=0.9130 54 (63.5%) 41 (47.7%)90 152 (45.0%) 76 (44.4%) 76 (45.5%) 31 (36.5%) 45 (52.3%)

(mL/min) 92.26 91.70 92.84 86.61 96.73 32.81 33.40 32.29 32.28 33.92 32.9 32.9 37.6 32.9 33.5 86.55 87.00 85.90 82.20 91.30 220.4 220.4 203.6 197.4 220.4

(%) * (p<0.15) a) X Y X Y b) Pe Fisher Freeman-Halton p Pk Wilcoxon p

[ 5.3.5.1-02 11-4 ]

(4)

(A)

FAS 12

2.7.6.1.2-5 40 mg 60 mg

2.7.6.1.2-6

×

12 ( ± )

-2.47±0.18 -1.61±0.18

(p<0.0001)

- 89 -

(p=0.0001) 12

40 mg 60 mg 12 -2.41±0.21 -2.53±0.21

-1.61±0.19 40 mg 60 mg [

95% (-1.18 -0.43) (-1.30 -0.56)]

(p=0.0001)

2.7.6.1.2-5 12 (FAS)

95% ( )

t p a) 145 -2.47 0.18 -2.83 -2.11 - - -

150 -1.61 0.18 -1.97 -1.24 - - - - - -0.87 0.15 -1.17 -0.56 3412 -5.59 <0.0001*

[ ]

t p a)

-0.230 0.0596 3412 -3.86 0.0001* 1 -0.418 0.3162 3412 -1.32 0.1858

2 0.000 2 -0.289 0.1509 3412 -1.92 0.0554

2 0.000 * (p<0.05) a) p

×

[ 5.3.5.1-02 11-7 ]

- 90 -

2.7.6.1.2-6 12 (FAS)

95%

40 mg 73 -2.41 0.21 -2.83 -2.00 60 mg 72 -2.53 0.21 -2.95 -2.11

150 -1.61 0.19 -1.97 -1.24 40 mg- - -0.81 0.19 -1.18 -0.43 60 mg- - -0.93 0.19 -1.30 -0.56

[ ]

t p a)

-0.230 0.0597 3401 -3.85 0.0001* 1 -0.419 0.3168 3401 -1.32 0.1855

2 0.000 2 -0.289 0.1511 3401 -1.91 0.0561

2 0.000 * (p<0.05) a) p

×

[ 5.3.5.1-02 11-10 ]

(LOCF)

2.7.6.1.2-7 40 mg 60 mg

2.7.6.1.2-8

LOCF

(LOCF)( ± )

-2.38±0.24 -1.56±0.24

(p<0.0001)

2 ( p=0.0009 p=0.0355)

2

40 mg 60 mg (LOCF) -2.34±0.27 -2.43±0.27

40 mg 60 mg [ 95%

(-1.23 -0.33) (-1.31 -0.43)]

- 91 -

2.7.6.1.2-7 (LOCF)(FAS)

95%

a) ( )

171 -2.38 0.24 -2.85 -1.91 - 167 -1.56 0.24 -2.03 -1.08 -

- - -0.82 0.18 -1.19 -0.46 <0.0001*

[ ]

t p a)

0.416 0.4920 70 0.84 0.4012 -0.825 0.1846 263 -4.47 <0.0001*

0.000 -0.270 0.0805 263 -3.35 0.0009*

1 -0.395 0.4298 263 -0.92 0.3587 2 0.000

2 -0.432 0.2045 263 -2.11 0.0355* 2 0.000 * (p<0.05) a) p

[ 5.3.5.1-02 11-8 ]

2.7.6.1.2-8 (LOCF)(FAS)

95%

40 mg 85 -2.34 0.27 -2.87 -1.81 60 mg 86 -2.43 0.27 -2.96 -1.89

167 -1.56 0.24 -2.03 -1.09 40 mg- - -0.78 0.23 -1.23 -0.33 60 mg- - -0.87 0.23 -1.31 -0.43

[ 5.3.5.1-02 11-9 ]

40 mg 60 mg

2.7.6.1.2-9

( ± )

1 40 mg 2

60 mg 1

- 92 -

2.7.6.1.2-9 (FAS)

1 2 3 4 5 6 7 8 9 10 11 12

171 171 167 164 163 159 156 153 153 152 151 147 145

a)

5.77 ±1.20

5.22 ±1.33

4.80 ±1.50

4.50 ±1.61

4.23±1.60

4.08±1.63

3.98±1.66

3.80±1.69

3.74±1.82

3.68 ±1.78

3.68 ±1.78

3.58±1.74

3.48 ±1.81

b) -

-0.78 ±0.18

-1.20 ±0.18

-1.49 ±0.18

-1.74±0.18

-1.89±0.18

-1.97±0.18

-2.16±0.18

-2.21±0.18

-2.28 ±0.18

-2.28 ±0.18

-2.38±0.18

-2.47±0.18

p c) - 0.0299* 0.0003* 0.0001* <0.0001*<0.0001* 0.0001* <0.0001*<0.0001*<0.0001*<0.0001*<0.0001*<0.0001*40 mg

85 85 82 80 80 79 78 76 76 75 75 73 73

a) 5.79

±1.23 5.27

±1.39 4.80

±1.57 4.54

±1.75 4.26

±1.734.11

±1.814.02

±1.853.83

±1.853.80

±1.933.72

±1.83 3.73

±1.87 3.60

±1.773.54

±1.86 b)

- -0.74 ±0.21

-1.22 ±0.21

-1.49 ±0.21

-1.77±0.21

-1.92±0.21

-1.99±0.21

-2.17±0.21

-2.20±0.21

-2.28 ±0.21

-2.26 ±0.21

-2.36±0.21

-2.41±0.21

95% d) -

(-0.650.08)

(-0.93-0.20)

(-0.96-0.22)

(-1.10-0.36)

(-1.09-0.36)

(-0.98-0.24)

(-1.11-0.37)

(-1.09-0.34)

(-1.16-0.42)

(-1.10-0.36)

(-1.17-0.42)

(-1.18-0.43)

60 mg 86 86 85 84 83 80 78 77 77 77 76 74 72

a)

5.76 ±1.17

5.17 ±1.28

4.79 ±1.44

4.46 ±1.47

4.20±1.46

4.04±1.44

3.94±1.47

3.76±1.52

3.68±1.72

3.63 ±1.73

3.63 ±1.70

3.56±1.72

3.41 ±1.77

b) -

-0.83 ±0.21

-1.20 ±0.21

-1.50 ±0.21

-1.72±0.21

-1.87±0.21

-1.96±0.21

-2.15±0.21

-2.23±0.21

-2.28 ±0.21

-2.31 ±0.21

-2.41±0.21

-2.53±0.21

95% d) -

(-0.74-0.01)

(-0.91-0.18)

(-0.97-0.24)

(-1.05-0.32)

(-1.05-0.31)

(-0.95-0.22)

(-1.09-0.35)

(-1.11-0.37)

(-1.16-0.42)

(-1.14-0.40)

(-1.22-0.48)

(-1.30-0.56)

167 167 166 162 161 159 157 157 155 153 153 152 150

a)

5.78 ±1.17

5.56 ±1.28

5.35 ±1.41

5.11 ±1.46

4.98±1.59

4.83±1.69

4.64±1.77

4.58±1.81

4.53±1.91

4.52 ±1.92

4.47 ±1.92

4.44±1.95

4.38 ±1.99

b) -

-0.45 ±0.18

-0.65 ±0.18

-0.90 ±0.18

-1.03±0.18

-1.19±0.18

-1.38±0.18

-1.43±0.18

-1.48±0.18

-1.49 ±0.18

-1.54 ±0.18

-1.56±0.18

-1.61±0.18

* (p<0.05) a) ± b) ± c) p d) 40 mg 60 mg 95%

[ 5.3.5.1-02 11-11 11-12 14.2-1 ]

2.7.6.1.2-10 2.7.6.1.2-11

30% 30%

30% 30% (50% 75% 100%

) 30%

2 30% 2

20%

Fisher

30% 57.3% 35.3%

- 93 -

(p<0.0001) 50%

39.2% 19.8% 30%

(p=0.0001)

48.5% 32.3%

(p=0.0028)

40 mg 60 mg 30% 55.3% 59.3% 40 mg 60 mg

[ 95% (7.1 32.8) (11.3

36.6)] 50% 40 mg 60 mg 37.6% 40.7% 30%

40 mg 60 mg [ 95%

(5.9 29.8) (8.9 32.9)] 40 mg 60 mg 48.2%

48.8% 40 mg 60 mg [

95% (3.1 28.7) (3.8 29.2)]

2.7.6.1.2-10 (FAS) a)

40 mg 60 mg 40 mg 60 mg

171 85 86 167 30% 98 47 51 59 30% (%) 57.3 55.3 59.3 35.3 <0.0001* (7.1, 32.8) (11.3, 36.6)50% 67 32 35 33 50% (%) 39.2 37.6 40.7 19.8 0.0001* (5.9, 29.8) (8.9, 32.9)75% 21 11 10 16 75% (%) 12.3 12.9 11.6 9.6 0.4876 (-5.1, 11.8) (-6.1, 10.2)100% 5 2 3 0 100% (%) 2.9 2.4 3.5 0.0 0.0607 (-0.9, 5.6) (-0.4, 7.4)* (p<0.05) a) Fisher p 40 mg 60 mg 95%

[ 5.3.5.1-02 11-13 14.2-3 ]

2.7.6.1.2-11 (FAS) a)

40 mg 60 mg 40 mg 60 mg

171 85 86 167 83 41 42 54 (%) 48.5 48.2 48.8 32.3 Pe=0.0028* (3.1, 28.7) (3.8, 29.2)

* (p<0.05) a) Fisher p 40 mg 60 mg 95%

[ 5.3.5.1-02 11-14 14.2-4 ]

30% 2.7.6.1.2-12

2.7.6.1.2-13

30% 30%

- 94 -

40 mg 60 mg

30%

(p<0.0001) 40 mg 60 mg (

p=0.0011 p=0.0003)

(p=0.0006) 40 mg 60 mg

( p=0.0044 p=0.0030)

2.7.6.1.2-12 30% (FAS)

30% ( ) ( ) a)( ) 171 104 67 1 3.0 <0.0001*

40 mg 85 50 35 1 3.0 0.0011* 60 mg 86 54 32 1 4.0 0.0003*

167 67 100 1 4.0 - * (p<0.05) a) p

[ 5.3.5.1-02 11-15 ]

2.7.6.1.2-13 (FAS)

( ) ( ) a)( ) 171 83 88 1 3.0 0.0006*

40 mg 85 41 44 1 3.0 0.0044* 60 mg 86 42 44 1 3.0 0.0030*

167 54 113 1 4.0 - * (p<0.05) a) p

[ 5.3.5.1-02 11-16 ]

2.7.6.1.2-14

( )

( ) 2

1 (LOCF)

BDI-II (LOCF) 2

BDI-II (LOCF)

1 ( p<0.0001 p<0.0001)

(LOCF)

2 (p<0.0001)

99.982% 0.018%

- 95 -

2.7.6.1.2-14 (FAS)

[ ] t a)

1 -1.3396 0.1392 331 -9.63 <0.0001* -0.0157 0.0037 331 -4.23 <0.0001* BDI-II 0.0034 0.0156 331 0.22 0.8294

2 -2.2335 0.4739 332 -4.71 <0.0001* -0.0008 0.0131 332 -0.06 0.9495 * (p<0.05) a) p

[ ]

99.982% 0.018%

[ 5.3.5.1-02 11-17 ]

(B)

12

2.7.6.1.2-15 40 mg 60 mg 2.7.6.1.2-16

12

40 mg 60 mg

24 ( ) 12 (

± ) -2.51±0.19 -1.55±0.19

(p<0.0001)

( ) 12 ( ± )

-2.39±0.19 -1.56±0.19

(p<0.0001) BPI- (

) BPI- (

7 ) PGI- 10

( p<0.0001 p<0.0001 p<0.0001 p<0.0001

p=0.0228 p=0.0076 p=0.0378 p=0.0089 p=0.0095 p<0.0001)

40 mg BPI- (

) BPI- ( )

PGI- 9 [ 95%

(-1.26 -0.49) (-1.17 -0.39) (-1.34 -0.44) (-1.23 -0.33) (-1.39 -0.58)

(-1.35 -0.41) (-1.14 -0.06) (-1.11 -0.03) (-0.90 -0.39)] 60 mg

BPI- ( ) BPI-

( 7 ) PGI- 10

[ 95% (-1.43

- 96 -

-0.66) (-1.28 -0.50) (-1.51 -0.62) (-1.36 -0.46) (-1.41 -0.61) (-1.41 -0.48) (-1.21

-0.22) (-1.27 -0.24) (-0.97 -0.07) (-0.91 -0.40)]

2.7.6.1.2-15 12 (FAS)

95%

a)

()

145 -2.51 0.19 -0.96 -1.27 -0.64 <0.0001* 150 -1.55 0.19 -

145 -2.39 0.19 -0.83 -1.15 -0.51 <0.0001* 150 -1.56 0.19 - BPI- 142 -2.59 0.21 -0.98 -1.34 -0.61 <0.0001*

150 -1.62 0.21 - BPI- 142 -1.98 0.21 -0.85 -1.21 -0.48 <0.0001*

150 -1.13 0.21 - BPI- 142 -2.54 0.20 -1.00 -1.33 -0.67 <0.0001*

150 -1.54 0.20 - BPI- 142 -2.59 0.22 -0.92 -1.29 -0.54 <0.0001*

150 -1.67 0.22 - BPI- 142 -2.29 0.24 -0.41 -0.85 0.03 0.0676

150 -1.88 0.24 - BPI- 142 -2.28 0.24 -0.37 -0.80 0.06 0.0933

150 -1.91 0.24 - BPI- 142 -2.31 0.23 -0.49 -0.91 -0.07 0.0228*

150 -1.82 0.23 - BPI- 142 -1.86 0.23 -0.38 -0.80 0.04 0.0783

150 -1.49 0.23 - BPI- 142 -1.32 0.23 -0.55 -0.96 -0.15 0.0076*

150 -0.77 0.23 - BPI- 142 -2.15 0.24 -0.46 -0.90 -0.03 0.0378*

150 -1.69 0.24 - BPI- 142 -2.15 0.23 -0.56 -0.98 -0.14 0.0089*

150 -1.59 0.23 - BPI- 142 -2.04 0.20 -0.48 -0.85 -0.12 0.0095*7 150 -1.56 0.20 - BDI-II 142 -3.37 0.64 -0.11 -1.22 1.01 0.8517 150 -3.27 0.64 - PGI- 142 2.53 0.12 -0.65 -0.85 -0.44 <0.0001* 150 3.18 0.12 - * (p<0.05) BPI PGI- BDI Beck

- a) p

(PGI- )

× [ 5.3.5.1-02 11-18 ]

- 97 -

2.7.6.1.2-16 12 (FAS)

95%

40 mg 73 -2.42 0.22 -0.87 -1.26 -0.49 60 mg 72 -2.59 0.22 -1.05 -1.43 -0.66 150 -1.55 0.19

40 mg 73 -2.33 0.22 -0.78 -1.17 -0.39 60 mg 72 -2.45 0.23 -0.89 -1.28 -0.50 150 -1.56 0.19 BPI- 40 mg 72 -2.51 0.25 -0.89 -1.34 -0.44

60 mg 70 -2.68 0.25 -1.06 -1.51 -0.62 150 -1.62 0.21 BPI- 40 mg 72 -1.92 0.25 -0.78 -1.23 -0.33

60 mg 70 -2.04 0.25 -0.91 -1.36 -0.46 150 -1.13 0.21 BPI- 40 mg 72 -2.53 0.23 -0.98 -1.39 -0.58

60 mg 70 -2.56 0.23 -1.01 -1.41 -0.61 150 -1.55 0.20 BPI- 40 mg 72 -2.55 0.25 -0.88 -1.35 -0.41

60 mg 70 -2.62 0.26 -0.95 -1.41 -0.48 150 -1.67 0.22 BPI- 40 mg 72 -2.48 0.29 -0.60 -1.14 -0.06

60 mg 70 -2.10 0.29 -0.23 -0.77 0.32 150 -1.88 0.24 BPI- 40 mg 72 -2.18 0.29 -0.27 -0.80 0.27

60 mg 70 -2.39 0.29 -0.48 -1.01 0.05 150 -1.91 0.24 BPI- 40 mg 72 -2.32 0.28 -0.50 -1.02 0.02

60 mg 70 -2.31 0.28 -0.49 -1.01 0.03 150 -1.82 0.23 BPI- 40 mg 72 -1.84 0.28 -0.35 -0.86 0.16

60 mg 70 -1.90 0.28 -0.41 -0.92 0.11 150 -1.49 0.23 BPI- 40 mg 72 -1.16 0.27 -0.39 -0.89 0.11

60 mg 70 -1.49 0.27 -0.71 -1.21 -0.22 150 -0.77 0.23 BPI- 40 mg 72 -2.26 0.29 -0.57 -1.11 -0.03

60 mg 70 -2.05 0.29 -0.36 -0.90 0.18 150 -1.69 0.24 BPI- 40 mg 72 -1.96 0.28 -0.37 -0.88 0.15

60 mg 70 -2.35 0.28 -0.76 -1.27 -0.24 150 -1.59 0.23 BPI- 40 mg 72 -2.00 0.24 -0.45 -0.90 0.00 7 60 mg 70 -2.08 0.24 -0.52 -0.97 -0.07 150 -1.56 0.20

- 98 -

2.7.6.1.2-16 12 (FAS)( )

95%

BDI-II 40 mg 72 -2.94 0.76 0.34 -1.03 1.71 60 mg 70 -3.83 0.77 -0.55 -1.92 0.81 150 -3.28 0.65 PGI- 40 mg 72 2.53 0.14 -0.65 -0.90 -0.39 60 mg 70 2.52 0.14 -0.65 -0.91 -0.40 150 3.18 0.12 BPI PGI- BDI Beck

40 mg ( 60 mg)- (PGI- )

×

[ 5.3.5.1-02 11-19 ]

(LOCF)

2.7.6.1.2-17 40 mg 60 mg

2.7.6.1.2-18

(LOCF)( ± )

-2.39±0.25 -1.46±0.25

(p<0.0001) (LOCF)

-2.31±0.25 -1.52±0.25

(p<0.0001) BPI- (

) BPI- ( )

PGI- 7

( p<0.0001 p<0.0001 p<0.0001 p<0.0001 p=0.0496 p=0.0464 p<0.0001)

40 mg BPI- (

) PGI- 7

[ 95% (-1.32 -0.39) (-1.22 -0.29) (-1.38

-0.36) (-1.25 -0.30) (-1.38 -0.47) (-1.34 -0.33) (-0.90 -0.36)] 60 mg

BPI- (

) BPI- ( ) PGI- 9

[ 95% (-1.47

-0.55) (-1.29 -0.36) (-1.53 -0.51) (-1.41 -0.46) (-1.42 -0.52) (-1.38 -0.38) (-1.05

-0.05) (-1.12 -0.08) (-0.90 -0.37)]

- 99 -

2.7.6.1.2-17 (LOCF)(FAS)

95%

a)

( ) 171 -2.39 0.25 -0.93 -1.31 -0.55 <0.0001*

167 -1.46 0.25 - 171 -2.31 0.25 -0.79 -1.17 -0.41 <0.0001*

167 -1.52 0.25 - BPI- 169 -2.67 0.27 -0.94 -1.36 -0.53 <0.0001*

165 -1.72 0.27 - BPI- 169 -2.02 0.25 -0.85 -1.24 -0.47 <0.0001*

165 -1.17 0.25 - BPI- 169 -2.51 0.24 -0.94 -1.31 -0.57 <0.0001*

165 -1.56 0.25 - BPI- 169 -2.52 0.26 -0.86 -1.27 -0.45 <0.0001*

165 -1.66 0.26 - BPI- 169 -2.18 0.28 -0.33 -0.79 0.12 0.1448

165 -1.84 0.29 - BPI- 169 -2.23 0.28 -0.35 -0.79 0.08 0.1108

165 -1.88 0.28 - BPI- 169 -2.29 0.26 -0.41 -0.83 0.00 0.0496*

165 -1.88 0.26 - BPI- 169 -1.74 0.27 -0.20 -0.62 0.23 0.3600

165 -1.54 0.27 - BPI- 169 -1.30 0.26 -0.38 -0.79 0.03 0.0720

165 -0.92 0.27 - BPI- 169 -2.28 0.28 -0.42 -0.87 0.02 0.0607

165 -1.85 0.28 - BPI- 169 -2.15 0.27 -0.43 -0.86 -0.01 0.0464*

165 -1.72 0.27 - BPI- 169 -2.01 0.24 -0.38 -0.75 0.00 0.0516 7 165 -1.63 0.24 - BDI-II 169 -3.40 0.71 0.39 -0.74 1.52 0.4956 165 -3.79 0.72 - PGI- 169 2.45 0.15 -0.63 -0.85 -0.41 <0.0001* 165 3.08 0.15 - * (p<0.05) BPI PGI- BDI Beck

- a) p

(PGI- )

[ 5.3.5.1-02 11-20 ]

- 100 -

2.7.6.1.2-18 (LOCF)(FAS)

95%

40 mg 85 -2.31 0.28 -0.85 -1.32 -0.39

60 mg 86 -2.47 0.29 -1.01 -1.47 -0.55 167 -1.46 0.25

40 mg 85 -2.28 0.28 -0.75 -1.22 -0.29 60 mg 86 -2.35 0.28 -0.83 -1.29 -0.36 167 -1.52 0.25 BPI- 40 mg 84 -2.59 0.31 -0.87 -1.38 -0.36

60 mg 85 -2.75 0.31 -1.02 -1.53 -0.51 165 -1.73 0.27 BPI- 40 mg 84 -1.94 0.28 -0.77 -1.25 -0.30

60 mg 85 -2.10 0.28 -0.93 -1.41 -0.46 165 -1.17 0.25 BPI- 40 mg 84 -2.48 0.28 -0.92 -1.38 -0.47

60 mg 85 -2.53 0.28 -0.97 -1.42 -0.52 165 -1.56 0.25 BPI- 40 mg 84 -2.49 0.30 -0.83 -1.34 -0.33

60 mg 85 -2.54 0.30 -0.88 -1.38 -0.38 165 -1.66 0.26 BPI- 40 mg 84 -2.37 0.32 -0.53 -1.08 0.02

60 mg 85 -1.98 0.33 -0.14 -0.69 0.41 165 -1.84 0.29 BPI- 40 mg 84 -2.12 0.32 -0.24 -0.77 0.29

60 mg 85 -2.34 0.32 -0.47 -1.00 0.07 165 -1.88 0.28 BPI- 40 mg 84 -2.31 0.30 -0.43 -0.93 0.08

60 mg 85 -2.28 0.30 -0.40 -0.90 0.10 165 -1.88 0.26 BPI- 40 mg 84 -1.75 0.31 -0.21 -0.73 0.31

60 mg 85 -1.73 0.31 -0.19 -0.71 0.33 165 -1.54 0.27 BPI- 40 mg 84 -1.13 0.30 -0.20 -0.71 0.30

60 mg 85 -1.47 0.30 -0.55 -1.05 -0.05 165 -0.93 0.27 BPI- 40 mg 84 -2.39 0.32 -0.54 -1.08 0.01

60 mg 85 -2.16 0.32 -0.31 -0.85 0.23 165 -1.85 0.28 BPI- 40 mg 84 -1.99 0.31 -0.26 -0.78 0.26

60 mg 85 -2.32 0.31 -0.60 -1.12 -0.08 165 -1.73 0.27 BPI- 40 mg 84 -1.99 0.27 -0.35 -0.82 0.11 7 60 mg 85 -2.03 0.28 -0.40 -0.86 0.06 165 -1.63 0.24

- 101 -

2.7.6.1.2-18 (LOCF)(FAS)( )

95%

BDI-II 40 mg 84 -3.01 0.81 0.79 -0.58 2.17 60 mg 85 -3.81 0.82 -0.01 -1.38 1.36 165 -3.80 0.72 PGI- 40 mg 84 2.45 0.16 -0.63 -0.90 -0.36 60 mg 85 2.44 0.17 -0.64 -0.90 -0.37 165 3.08 0.15 BPI PGI- BDI Beck

40 mg ( 60 mg)- (PGI- )

[ 5.3.5.1-02 11-21 ]

(5)

(A)

2.7.6.1.2-19

( ) 145/171 (84.8%) 534 40 mg

72/85 (84.7%) 256 60 mg 73/86 (84.9%) 278 123/167

(73.7%) 373 (

) (p=0.0153) 40 mg 60 mg

( )

( ) (p<0.0001) 40 mg 60 mg

(p=0.0021 p=0.0009)

( ) 138/171 (80.7%) 40 mg 69/85

(81.2%) 60 mg 69/86 (80.2%) 114/167 (68.3%)

( )

(p=0.0090) 40 mg (p=0.0362) 60 mg

( )

( ) (p=0.0005)

40 mg 60 mg (p=0.0047 p=0.0046)

( ) 56/171 (32.7%) 40 mg

29/85 (34.1%) 60 mg 27/86 (31.4%) 39/167 (23.4%)

(

) 40 mg 60 mg

( ) (

)

- 102 -

2.7.6.1.2-19

40 mg 60 mg 40 mg 60 mg 171 85 86 167 171 85 86 167

145 72 73 123 106 52 54 67 534 256 278 373 287 132 155 149 (%) 84.8 84.7 84.9 73.7 62.0 61.2 62.8 40.1 95% 78.5 75.3 75.5 66.3 54.3 50.0 51.7 32.6 95% 89.8 91.6 91.7 80.2 69.3 71.6 73.0 48.0 a) 0.0153* 0.0560 0.0560 <0.0001* 0.0021* 0.0009*

138 69 69 114 93 46 47 59 415 190 225 244 233 105 128 92 (%) 80.7 81.2 80.2 68.3 54.4 54.1 54.7 35.3 95% 74.0 71.2 70.2 60.6 46.6 43.0 43.5 28.1 95% 86.3 88.8 88.0 75.2 62.0 65.0 65.4 43.1 a) 0.0090* 0.0362* 0.0536 0.0005* 0.0047* 0.0046*

56 29 27 39 29 15 14 25 119 66 53 129 54 27 27 57 (%) 32.7 34.1 31.4 23.4 17.0 17.6 16.3 15.0 95% 25.8 24.2 21.8 17.2 11.7 10.2 9.2 9.9 95% 40.3 45.2 42.3 30.5 23.4 27.4 25.8 21.3 a) 0.0692 0.0736 0.1766 0.6578 0.5884 0.8546 * (p<0.05) a) Fisher p

[ 5.3.5.1-02 12-3 12-4 ]

(MedDRA )

2.7.6.1.2-20

5% 37 (21.6%) 39

24 (14.0%) 28 24 (14.0%) 27 AST 13 (7.6%) 13

11 (6.4%) 12 10 (5.8%) 12 ALT 10 (5.8%)

10 9 (5.3%) 12 9 (5.3%) 10 9 (5.3%) 9

40 mg 16 (18.8%) 16 10 (11.8%) 11

6 (7.1%) 8 CK 6 (7.1%) 6 AST ALT

5 (5.9%) 5 60 mg 21 (24.4%) 23 14

(16.3%) 17 14 (16.3%) 16 AST 8 (9.3%) 8 7 (8.1%)

7 6 (7.0%) 7 5 (5.8%) 7 5 (5.8%) 6 ALT

-GTP LDH HbA1c 5 (5.8%) 5

24 (14.4%) 24 14 (8.4%) 14 9 (5.4%) 9

( p<0.0001 p=0.0007 p=0.0354)

127 (74.3%) 362

- 103 -

90 (52.6%) 162 4 (2.3%) 10 40 mg 66 (77.6%)

180 39 (45.9%) 71 3 (3.5%) 5 60 mg

61 (70.9%) 182 51 (59.3%) 91 1 (1.2%) 5

83 (49.7%) 200 81 (48.5%) 164 4 (2.4%)

9

171 118 (69.0%) 356

17 (9.9%) 29 40 mg 85 60 (70.6%) 172 9 (10.6%)

16 60 mg 86 58 (67.4%) 184 8 (9.3%) 13

167 86 (51.5%) 202 8 (4.8%) 17

907 267 640

604

5% 37 (21.6%) 39

24 (14.0%) 27 9 (5.3%) 10 40 mg

16 (18.8%) 16 10 (11.8%) 11 5 (5.9%) 5 60 mg

21 (24.4%) 23 14 (16.3%) 16 6 (7.0%) 7

13 (7.8%) 13

( p<0.0001 p=0.0004)

97 (56.7%) 221 37

(21.6%) 63 2 (1.2%) 3 40 mg 51 (60.0%) 105

16 (18.8%) 26 1 (1.2%) 1 60 mg

46 (53.5%) 116 21 (24.4%) 37 1 (1.2%) 2

51 (30.5%) 100 28 (16.8%) 48 1 (0.6%)

1

171 80 (46.8%) 195

9 (5.3%) 15 40 mg 85 38 (44.7%) 89 5 (5.9%) 6

60 mg 86 42 (48.8%) 106 4 (4.7%) 9 167

36 (21.6%) 61 2 (1.2%) 6 436

145 291 277

- 104 -

2.7

.6.1

.2-2

0

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

127

(362

) 74

.3%

66

(180

) 77

.6%

61

(182

) 70

.9%

83

(200

) 49

.7%

97

(221

) 56

.7%

51

(105

) 60

.0%

46

(116

) 53

.5%

51

(100

) 30

.5%

90

(162

) 52

.6%

39

(71)

45.

9% 5

1 (9

1) 5

9.3%

81

(164

) 48

.5%

37

(63)

21.

6% 1

6 (2

6) 1

8.8%

21

(37)

24.

4% 2

8 (4

8) 1

6.8%

4 (1

0)

2.3%

3

(5)

3.5%

1

(5)

1.2%

4

(9)

2.4%

2

(3)

1.2%

1

(1)

1.2%

1

(2)

1.2%

1

(1)

0.6%

14

5 (5

34)

84.8

% 7

2 (2

56)

84.7

% 7

3 (2

78)

84.9

%12

3 (3

73)

73.7

%10

6 (2

87)

62.0

% 5

2 (1

32)

61.2

% 5

4 (1

55)

62.8

% 6

7 (1

49)

40.1

%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

5

(5)

2.9%

1

(1)

1.2%

4

(4)

4.7%

4

(4)

2.4%

3

(3)

1.8%

0

(0)

0.0%

3

(3)

3.5%

4

(4)

2.4%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6 (6

) 3.

5%

1 (1

) 1.

2%

5 (5

) 5.

8%

4 (4

) 2.

4%

4 (4

) 2.

3%

0 (0

) 0.

0%

4 (4

) 4.

7%

4 (4

) 2.

4%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

2

(2)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

- 105 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

7

(7)

4.1%

4

(4)

4.7%

3

(3)

3.5%

1

(1)

0.6%

3

(3)

1.8%

2

(2)

2.4%

1

(1)

1.2%

1

(1)

0.6%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

9 (9

) 5.

3%

5 (5

) 5.

9%

4 (4

) 4.

7%

1 (1

) 0.

6%

4 (4

) 2.

3%

2 (2

) 2.

4%

2 (2

) 2.

3%

1 (1

) 0.

6%

4

(4)

2.3%

3

(3)

3.5%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

5 (5

) 2.

9%

4 (4

) 4.

7%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

1 (1

) 0.

6%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

3

(3)

1.8%

2

(2)

2.4%

1

(1)

1.2%

1

(1)

0.6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

5 (6

) 2.

9%

2 (2

) 2.

4%

3 (4

) 3.

5%

8 (9

) 4.

8%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

8 (9

) 4.

7%

4 (4

) 4.

7%

4 (5

) 4.

7%

9 (1

0)

5.4%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

- 106 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(2)

0.6%

0

(0)

0.0%

1

(2)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(2)

0.6%

0

(0)

0.0%

1

(2)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

- 107 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

41

(62)

24.

0% 2

3 (2

9) 2

7.1%

18

(33)

20.

9% 1

4 (1

9)

8.4%

32

(48)

18.

7% 1

7 (2

3) 2

0.0%

15

(25)

17.

4%

9 (1

2)

5.4%

2

7 (3

1) 1

5.8%

11

(11)

12.

9% 1

6 (2

0) 1

8.6%

22

(25)

13.

2% 1

9 (2

3) 1

1.1%

8

(8)

9.4%

11

(15)

12.

8% 1

2 (1

2)

7.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

61

(93)

35.

7% 3

0 (4

0) 3

5.3%

31

(53)

36.

0% 3

3 (4

4) 1

9.8%

46

(71)

26.

9% 2

2 (3

1) 2

5.9%

24

(40)

27.

9% 2

0 (2

4) 1

2.0%

1

7 (2

0)

9.9%

7

(7)

8.2%

10

(13)

11.

6%

1 (1

) 0.

6% 1

7 (1

9)

9.9%

7

(7)

8.2%

10

(12)

11.

6%

1 (1

) 0.

6%

8

(8)

4.7%

4

(4)

4.7%

4

(4)

4.7%

2

(2)

1.2%

8

(8)

4.7%

4

(4)

4.7%

4

(4)

4.7%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

24

(28)

14.

0% 1

0 (1

1) 1

1.8%

14

(17)

16.

3%

3 (3

) 1.

8% 2

4 (2

7) 1

4.0%

10

(11)

11.

8% 1

4 (1

6) 1

6.3%

3

(3)

1.8%

4 (5

) 2.

3%

3 (3

) 3.

5%

1 (2

) 1.

2%

1 (1

) 0.

6%

3 (4

) 1.

8%

2 (2

) 2.

4%

1 (2

) 1.

2%

1 (1

) 0.

6%

7

(7)

4.1%

3

(3)

3.5%

4

(4)

4.7%

8

(8)

4.8%

6

(6)

3.5%

3

(3)

3.5%

3

(3)

3.5%

5

(5)

3.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

11

(12)

6.

4%

6 (6

) 7.

1%

5 (6

) 5.

8%

9 (9

) 5.

4%

9 (1

0)

5.3%

5

(5)

5.9%

4

(5)

4.7%

6

(6)

3.6%

- 108 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

10

(11)

5.

8%

4 (5

) 4.

7%

6 (6

) 7.

0%

3 (3

) 1.

8%

7 (8

) 4.

1%

4 (5

) 4.

7%

3 (3

) 3.

5%

2 (2

) 1.

2%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

3

(3)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

11

(12)

6.

4%

4 (5

) 4.

7%

7 (7

) 8.

1%

6 (6

) 3.

6%

7 (8

) 4.

1%

4 (5

) 4.

7%

3 (3

) 3.

5%

3 (3

) 1.

8%

5

(5)

2.9%

3

(3)

3.5%

2

(2)

2.3%

2

(2)

1.2%

4

(4)

2.3%

2

(2)

2.4%

2

(2)

2.3%

1

(1)

0.6%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

2 (2

) 1.

2%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

7 (8

) 4.

1%

3 (4

) 3.

5%

4 (4

) 4.

7%

4 (4

) 2.

4%

6 (7

) 3.

5%

2 (3

) 2.

4%

4 (4

) 4.

7%

1 (1

) 0.

6%

7

(9)

4.1%

4

(5)

4.7%

3

(4)

3.5%

2

(2)

1.2%

6

(7)

3.5%

4

(5)

4.7%

2

(2)

2.3%

1

(1)

0.6%

2 (3

) 1.

2%

0 (0

) 0.

0%

2 (3

) 2.

3%

0 (0

) 0.

0%

2 (3

) 1.

2%

0 (0

) 0.

0%

2 (3

) 2.

3%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

9 (1

2)

5.3%

4

(5)

4.7%

5

(7)

5.8%

2

(2)

1.2%

8

(10)

4.

7%

4 (5

) 4.

7%

4 (5

) 4.

7%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

3 (3

) 1.

8%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

3 (3

) 1.

8%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

4

(4)

2.4%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

3 (3

) 1.

8%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

3 (3

) 1.

8%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

1 (1

) 0.

6%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

- 109 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

- -

- -

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(2)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(2)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (2

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (2

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

- 110 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

- 111 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

22

(26)

12.

9% 1

3 (1

3) 1

5.3%

9

(13)

10.

5%

7 (8

) 4.

2% 2

0 (2

3) 1

1.7%

12

(12)

14.

1%

8 (1

1)

9.3%

5

(5)

3.0%

4 (4

) 2.

3%

3 (3

) 3.

5%

1 (1

) 1.

2%

4 (4

) 2.

4%

3 (3

) 1.

8%

2 (2

) 2.

4%

1 (1

) 1.

2%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

5 (3

0) 1

4.6%

15

(16)

17.

6% 1

0 (1

4) 1

1.6%

11

(12)

6.

6% 2

2 (2

6) 1

2.9%

13

(14)

15.

3%

9 (1

2) 1

0.5%

7

(7)

4.2%

7 (8

) 4.

1%

2 (2

) 2.

4%

5 (6

) 5.

8%

3 (3

) 1.

8%

7 (8

) 4.

1%

2 (2

) 2.

4%

5 (6

) 5.

8%

3 (3

) 1.

8%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

9

(10)

5.

3%

3 (3

) 3.

5%

6 (7

) 7.

0%

3 (3

) 1.

8%

9 (1

0)

5.3%

3

(3)

3.5%

6

(7)

7.0%

3

(3)

1.8%

8 (8

) 4.

7%

4 (4

) 4.

7%

4 (4

) 4.

7%

3 (3

) 1.

8%

7 (7

) 4.

1%

4 (4

) 4.

7%

3 (3

) 3.

5%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

8

(8)

4.7%

4

(4)

4.7%

4

(4)

4.7%

3

(3)

1.8%

7

(7)

4.1%

4

(4)

4.7%

3

(3)

3.5%

2

(2)

1.2%

3 (3

) 1.

8%

3 (3

) 3.

5%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3

(3)

1.8%

3

(3)

3.5%

0

(0)

0.0%

1

(1)

0.6%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

1

(1)

0.6%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

0

(0)

0.0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

- 112 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

- 113 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

8

(9)

4.7%

2

(2)

2.4%

6

(7)

7.0%

10

(10)

6.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

30

(36)

17.

5% 1

2 (1

4) 1

4.1%

18

(22)

20.

9% 3

1 (3

6) 1

8.6%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

3

(3)

1.8%

1 (2

) 0.

6%

1 (2

) 1.

2%

0 (0

) 0.

0%

2 (4

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

38

(47)

22.

2% 1

5 (1

8) 1

7.6%

23

(29)

26.

7% 4

2 (5

0) 2

5.1%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

3

(3)

1.8%

7 (7

) 4.

1%

2 (2

) 2.

4%

5 (5

) 5.

8%

6 (6

) 3.

6%-

- -

-

1

8 (2

0) 1

0.5%

8

(9)

9.4%

10

(11)

11.

6% 1

8 (1

8) 1

0.8%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

24

(27)

14.

0% 1

0 (1

1) 1

1.8%

14

(16)

16.

3% 2

4 (2

4) 1

4.4%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

3

(3)

1.8%

- -

- -

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

3

(3)

1.8%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

4

(4)

2.3%

1

(1)

1.2%

3

(3)

3.5%

6

(6)

3.6%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

1 (1

) 0.

6%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(2)

0.6%

1

(2)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

4 (5

) 2.

3%

2 (3

) 2.

4%

2 (2

) 2.

3%

1 (1

) 0.

6%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

- 114 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

- 115 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

- 116 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

- 117 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

9

(9)

5.3%

5

(5)

5.9%

4

(4)

4.7%

4

(5)

2.4%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

1

2 (1

3)

7.0%

6

(7)

7.1%

6

(6)

7.0%

5

(6)

3.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

3 (4

) 1.

8%

2 (2

) 2.

4%

1 (2

) 1.

2%

1 (1

) 0.

6%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

20

(26)

11.

7% 1

2 (1

4) 1

4.1%

8

(12)

9.

3% 1

0 (1

2)

6.0%

2

(4)

1.2%

1

(1)

1.2%

1

(3)

1.2%

0

(0)

0.0%

3 (3

) 1.

8%

0 (0

) 0.

0%

3 (3

) 3.

5%

3 (3

) 1.

8%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

5

(5)

2.9%

2

(2)

2.4%

3

(3)

3.5%

3

(3)

1.8%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

2 (3

) 1.

2%

2 (3

) 2.

4%

0 (0

) 0.

0%

1 (1

) 0.

6%-

- -

-

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%-

- -

-

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

1 (1

) 0.

6%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%-

- -

-

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- 118 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

- 119 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

55

(114

) 32

.2%

28

(58)

32.

9% 2

7 (5

6) 3

1.4%

39

(97)

23.

4% 2

7 (5

0) 1

5.8%

14

(22)

16.

5% 1

3 (2

8) 1

5.1%

24

(50)

14.

4%

9

(16)

5.

3%

6 (1

2)

7.1%

3

(4)

3.5%

9

(40)

5.

4%

7 (1

0)

4.1%

4

(6)

4.7%

3

(4)

3.5%

5

(12)

3.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6

0 (1

30)

35.1

% 3

1 (7

0) 3

6.5%

29

(60)

33.

7% 4

4 (1

37)

26.3

% 3

1 (6

0) 1

8.1%

16

(28)

18.

8% 1

5 (3

2) 1

7.4%

28

(62)

16.

8%

AST

13

(13)

7.

6%

5 (5

) 5.

9%

8 (8

) 9.

3%

3 (3

) 1.

8%

7 (7

) 4.

1%

3 (3

) 3.

5%

4 (4

) 4.

7%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3

(3)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

13

(13)

7.

6%

5 (5

) 5.

9%

8 (8

) 9.

3%

6 (6

) 3.

6%

7 (7

) 4.

1%

3 (3

) 3.

5%

4 (4

) 4.

7%

4 (4

) 2.

4%

ALT

9

(9)

5.3%

4

(4)

4.7%

5

(5)

5.8%

4

(4)

2.4%

5

(5)

2.9%

2

(2)

2.4%

3

(3)

3.5%

3

(3)

1.8%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

0 (1

0)

5.8%

5

(5)

5.9%

5

(5)

5.8%

6

(6)

3.6%

6

(6)

3.5%

3

(3)

3.5%

3

(3)

3.5%

4

(4)

2.4%

- 120 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

8

(8)

4.7%

3

(3)

3.5%

5

(5)

5.8%

3

(3)

1.8%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

9 (9

) 5.

3%

4 (4

) 4.

7%

5 (5

) 5.

8%

4 (4

) 2.

4%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

CK

6

(6)

3.5%

6

(6)

7.1%

0

(0)

0.0%

5

(5)

3.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6 (6

) 3.

5%

6 (6

) 7.

1%

0 (0

) 0.

0%

6 (6

) 3.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

3 (3

) 1.

8%

-GTP

6

(6)

3.5%

1

(1)

1.2%

5

(5)

5.8%

3

(3)

1.8%

3

(3)

1.8%

0

(0)

0.0%

3

(3)

3.5%

2

(2)

1.2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

7 (7

) 4.

1%

2 (2

) 2.

4%

5 (5

) 5.

8%

5 (5

) 3.

0%

4 (4

) 2.

3%

1 (1

) 1.

2%

3 (3

) 3.

5%

2 (2

) 1.

2%

3

(5)

1.8%

2

(4)

2.4%

1

(1)

1.2%

5

(13)

3.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

2

(2)

1.2%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

4

(6)

2.3%

2

(4)

2.4%

2

(2)

2.3%

7

(15)

4.

2%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%

LDH

7

(7)

4.1%

2

(2)

2.4%

5

(5)

5.8%

2

(2)

1.2%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

7 (7

) 4.

1%

2 (2

) 2.

4%

5 (5

) 5.

8%

4 (4

) 2.

4%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

3 (3

) 1.

8%

/

5 (5

) 2.

9%

2 (2

) 2.

4%

3 (3

) 3.

5%

5 (5

) 3.

0%

4 (4

) 2.

3%

2 (2

) 2.

4%

2 (2

) 2.

3%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

5

(5)

2.9%

2

(2)

2.4%

3

(3)

3.5%

6

(6)

3.6%

4

(4)

2.3%

2

(2)

2.4%

2

(2)

2.3%

2

(2)

1.2%

H

bA1c

5

(5)

2.9%

1

(1)

1.2%

4

(4)

4.7%

2

(2)

1.2%

3

(3)

1.8%

0

(0)

0.0%

3

(3)

3.5%

2

(2)

1.2%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6 (6

) 3.

5%

1 (1

) 1.

2%

5 (5

) 5.

8%

4 (4

) 2.

4%

4 (4

) 2.

3%

0 (0

) 0.

0%

4 (4

) 4.

7%

3 (3

) 1.

8%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

5

(5)

3.0%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

2

(2)

1.2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

4 (4

) 2.

3%

2 (2

) 2.

4%

2 (2

) 2.

3%

5 (5

) 3.

0%

4 (4

) 2.

3%

2 (2

) 2.

4%

2 (2

) 2.

3%

2 (2

) 1.

2%

- 121 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

BU

N

5 (5

) 2.

9%

2 (2

) 2.

4%

3 (3

) 3.

5%

3 (3

) 1.

8%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

5

(5)

2.9%

2

(2)

2.4%

3

(3)

3.5%

4

(4)

2.4%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

A

LP

5 (5

) 2.

9%

3 (3

) 3.

5%

2 (2

) 2.

3%

1 (1

) 0.

6%

4 (4

) 2.

3%

3 (3

) 3.

5%

1 (1

) 1.

2%

1 (1

) 0.

6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

6

(6)

3.5%

4

(4)

4.7%

2

(2)

2.3%

2

(2)

1.2%

5

(5)

2.9%

4

(4)

4.7%

1

(1)

1.2%

1

(1)

0.6%

3 (3

) 1.

8%

2 (2

) 2.

4%

1 (1

) 1.

2%

2 (2

) 1.

2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3

(3)

1.8%

2

(2)

2.4%

1

(1)

1.2%

3

(3)

1.8%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

3 (3

) 1.

8%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

4

(4)

2.4%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

3 (3

) 1.

8%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

4

(4)

2.4%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

3 (3

) 1.

8%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

4

(4)

2.4%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

4 (4

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

4

(4)

2.4%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

4 (4

) 2.

3%

2 (2

) 2.

4%

2 (2

) 2.

3%

1 (1

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

4

(4)

2.3%

2

(2)

2.4%

2

(2)

2.3%

1

(1)

0.6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

- 122 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

4

(4)

2.4%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

5 (5

) 3.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

4

(4)

2.3%

2

(2)

2.4%

2

(2)

2.3%

1

(1)

0.6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

4 (4

) 2.

3%

2 (2

) 2.

4%

2 (2

) 2.

3%

1 (1

) 0.

6%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

2

(2)

1.2%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

3 (3

) 1.

8%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

3 (3

) 1.

8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3

(3)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

4 (4

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3

(3)

1.8%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

4 (4

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 1.

8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3 (3

) 1.

8%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

- 123 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

C-

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(2)

0.6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (3

) 1.

2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

0

(0)

0.0%

2

(2)

2.3%

0

(0)

0.0%

2

(2)

1.2%

0

(0)

0.0%

2

(2)

2.3%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

1 (1

) 0.

6%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

- 124 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

T

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

ST

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

ST

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- 125 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

- 126 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(2)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(2)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

- 127 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

CK

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

11

(13)

6.

4%

4 (6

) 4.

7%

7 (7

) 8.

1%

1 (1

) 0.

6% 1

0 (1

0)

5.8%

3

(3)

3.5%

7

(7)

8.1%

1

(1)

0.6%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

1 (2

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

4 (1

7)

8.2%

6

(8)

7.1%

8

(9)

9.3%

2

(3)

1.2%

12

(12)

7.

0%

5 (5

) 5.

9%

7 (7

) 8.

1%

1 (1

) 0.

6%

4

(4)

2.3%

0

(0)

0.0%

4

(4)

4.7%

0

(0)

0.0%

4

(4)

2.3%

0

(0)

0.0%

4

(4)

4.7%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

5 (5

) 2.

9%

1 (1

) 1.

2%

4 (4

) 4.

7%

0 (0

) 0.

0%

5 (5

) 2.

9%

1 (1

) 1.

2%

4 (4

) 4.

7%

0 (0

) 0.

0%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

1

(1)

0.6%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

1 (1

) 0.

6%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

1 (1

) 0.

6%

1

(3)

0.6%

1

(3)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (2

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

3 (5

) 1.

8%

2 (4

) 2.

4%

1 (1

) 1.

2%

1 (2

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

- 128 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

10

(12)

5.

8%

3 (4

) 3.

5%

7 (8

) 8.

1% 1

0 (1

1)

6.0%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

0

(0)

0.0%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

8 (9

) 4.

8%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

2 (1

6)

7.0%

3

(5)

3.5%

9

(11)

10.

5% 1

8 (2

1) 1

0.8%

4

(4)

2.3%

2

(2)

2.4%

2

(2)

2.3%

1

(1)

0.6%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

2

(2)

1.2%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3

(3)

1.8%

2

(2)

2.4%

1

(1)

1.2%

0

(0)

0.0%

3

(3)

1.8%

2

(2)

2.4%

1

(1)

1.2%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%-

- -

-

- 129 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

(2)

1.2%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

- 130 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

(

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

- )

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%-

- -

-

4

7 (5

9) 2

7.5%

23

(32)

27.

1% 2

4 (2

7) 2

7.9%

22

(23)

13.

2% 4

4 (5

3) 2

5.7%

22

(28)

25.

9% 2

2 (2

5) 2

5.6%

17

(17)

10.

2%

6

(10)

3.

5%

2 (3

) 2.

4%

4 (7

) 4.

7% 1

0 (1

2)

6.0%

5

(9)

2.9%

1

(2)

1.2%

4

(7)

4.7%

5

(7)

3.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (2

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

52

(70)

30.

4% 2

5 (3

5) 2

9.4%

27

(35)

31.

4% 2

9 (3

7) 1

7.4%

48

(62)

28.

1% 2

3 (3

0) 2

7.1%

25

(32)

29.

1% 2

1 (2

5) 1

2.6%

- 131 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

35

(37)

20.

5% 1

5 (1

5) 1

7.6%

20

(22)

23.

3% 1

4 (1

4)

8.4%

35

(37)

20.

5% 1

5 (1

5) 1

7.6%

20

(22)

23.

3% 1

3 (1

3)

7.8%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3

7 (3

9) 2

1.6%

16

(16)

18.

8% 2

1 (2

3) 2

4.4%

14

(14)

8.

4% 3

7 (3

9) 2

1.6%

16

(16)

18.

8% 2

1 (2

3) 2

4.4%

13

(13)

7.

8%

8

(10)

4.

7%

5 (7

) 5.

9%

3 (3

) 3.

5%

1 (1

) 0.

6%

5 (6

) 2.

9%

3 (4

) 3.

5%

2 (2

) 2.

3%

1 (1

) 0.

6%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

2

(2)

1.2%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

10

(12)

5.

8%

6 (8

) 7.

1%

4 (4

) 4.

7%

2 (3

) 1.

2%

7 (8

) 4.

1%

4 (5

) 4.

7%

3 (3

) 3.

5%

2 (2

) 1.

2%

5

(5)

2.9%

4

(4)

4.7%

1

(1)

1.2%

2

(2)

1.2%

3

(3)

1.8%

3

(3)

3.5%

0

(0)

0.0%

1

(1)

0.6%

1 (2

) 0.

6%

0 (0

) 0.

0%

1 (2

) 1.

2%

5 (7

) 3.

0%

1 (2

) 0.

6%

0 (0

) 0.

0%

1 (2

) 1.

2%

1 (3

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

6 (7

) 3.

5%

4 (4

) 4.

7%

2 (3

) 2.

3%

6 (9

) 3.

6%

4 (5

) 2.

3%

3 (3

) 3.

5%

1 (2

) 1.

2%

1 (4

) 0.

6%

2

(3)

1.2%

2

(3)

2.4%

0

(0)

0.0%

0

(0)

0.0%

2

(3)

1.2%

2

(3)

2.4%

0

(0)

0.0%

0

(0)

0.0%

1 (2

) 0.

6%

0 (0

) 0.

0%

1 (2

) 1.

2%

0 (0

) 0.

0%

1 (2

) 0.

6%

0 (0

) 0.

0%

1 (2

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3 (5

) 1.

8%

2 (3

) 2.

4%

1 (2

) 1.

2%

0 (0

) 0.

0%

3 (5

) 1.

8%

2 (3

) 2.

4%

1 (2

) 1.

2%

0 (0

) 0.

0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

- 132 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

3

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%-

- -

-

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%-

- -

-

- 133 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

6

(6)

3.5%

5

(5)

5.9%

1

(1)

1.2%

2

(2)

1.2%

5

(5)

2.9%

5

(5)

5.9%

0

(0)

0.0%

1

(1)

0.6%

4 (4

) 2.

3%

2 (2

) 2.

4%

2 (2

) 2.

3%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

1 (1

1)

6.4%

7

(7)

8.2%

4

(4)

4.7%

2

(2)

1.2%

7

(7)

4.1%

5

(5)

5.9%

2

(2)

2.3%

1

(1)

0.6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

3

(3)

1.8%

2

(2)

2.4%

1

(1)

1.2%

1

(1)

0.6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- 134 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

8

(8)

4.7%

2

(2)

2.4%

6

(6)

7.0%

5

(5)

3.0%

7

(7)

4.1%

2

(2)

2.4%

5

(5)

5.8%

3

(3)

1.8%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

8 (8

) 4.

7%

2 (2

) 2.

4%

6 (6

) 7.

0%

7 (7

) 4.

2%

7 (7

) 4.

1%

2 (2

) 2.

4%

5 (5

) 5.

8%

4 (4

) 2.

4%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

1

(1)

0.6%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

2 (2

) 1.

2%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

2 (2

) 1.

2%

- 135 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

2

(2)

1.2%

0

(0)

0.0%

2

(2)

2.3%

2

(2)

1.2%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

2 (2

) 1.

2%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

1 (1

) 0.

6%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

4

(4)

2.3%

3

(3)

3.5%

1

(1)

1.2%

1

(1)

0.6%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

8 (9

) 4.

7%

4 (4

) 4.

7%

4 (5

) 4.

7%

3 (3

) 1.

8%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

2 (1

3)

7.0%

7

(7)

8.2%

5

(6)

5.8%

4

(4)

2.4%

4

(4)

2.3%

1

(1)

1.2%

3

(3)

3.5%

1

(1)

0.6%

- 136 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

3

(3)

1.8%

2

(2)

2.4%

1

(1)

1.2%

1

(1)

0.6%

- -

- -

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

1 (1

) 0.

6%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

- 137 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

12

(13)

7.

0%

8 (8

) 9.

4%

4 (5

) 4.

7%

6 (6

) 3.

6%

5 (5

) 2.

9%

2 (2

) 2.

4%

3 (3

) 3.

5%

1 (1

) 0.

6%

14

(15)

8.

2%

5 (5

) 5.

9%

9 (1

0) 1

0.5%

11

(11)

6.

6%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

7 (7

) 4.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2

4 (2

8) 1

4.0%

12

(13)

14.

1% 1

2 (1

5) 1

4.0%

16

(17)

9.

6%

8 (8

) 4.

7%

3 (3

) 3.

5%

5 (5

) 5.

8%

7 (8

) 4.

2%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

2

(2)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

3 (3

) 1.

8%

2 (2

) 2.

4%

1 (1

) 1.

2%

3 (3

) 1.

8%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

5 (5

) 2.

9%

4 (4

) 4.

7%

1 (1

) 1.

2%

5 (5

) 3.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

3 (3

) 1.

8%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

0

(0)

0.0%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

4 (4

) 2.

3%

1 (1

) 1.

2%

3 (3

) 3.

5%

1 (1

) 0.

6%

4 (4

) 2.

3%

1 (1

) 1.

2%

3 (3

) 3.

5%

1 (1

) 0.

6%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

2

(2)

1.2%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (2

) 1.

2%

2 (2

) 2.

4%

0 (0

) 0.

0%

2 (2

) 1.

2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

2 (2

) 1.

2%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

1 (1

) 0.

6%

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

2

(2)

1.2%

2

(2)

2.4%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

- 138 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

2 (2

) 1.

2%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

- 139 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(2)

0.6%

0

(0)

0.0%

1

(2)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(2)

0.6%

0

(0)

0.0%

1

(2)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

- 140 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

9

(10)

5.

3%

4 (5

) 4.

7%

5 (5

) 5.

8%

5 (5

) 3.

0%

5 (5

) 2.

9%

2 (2

) 2.

4%

3 (3

) 3.

5%

3 (3

) 1.

8%

7

(7)

4.1%

4

(4)

4.7%

3

(3)

3.5%

2

(3)

1.2%

3

(3)

1.8%

2

(2)

2.4%

1

(1)

1.2%

1

(1)

0.6%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

16

(17)

9.

4%

8 (9

) 9.

4%

8 (8

) 9.

3%

7 (8

) 4.

2%

8 (8

) 4.

7%

4 (4

) 4.

7%

4 (4

) 4.

7%

4 (4

) 2.

4%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

2

(2)

1.2%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

2

(2)

1.2%

4 (4

) 2.

3%

3 (3

) 3.

5%

1 (1

) 1.

2%

2 (3

) 1.

2%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

5 (5

) 2.

9%

3 (3

) 3.

5%

2 (2

) 2.

3%

4 (5

) 2.

4%

2 (2

) 1.

2%

1 (1

) 1.

2%

1 (1

) 1.

2%

3 (3

) 1.

8%

3

(3)

1.8%

1

(1)

1.2%

2

(2)

2.3%

1

(1)

0.6%

2

(2)

1.2%

1

(1)

1.2%

1

(1)

1.2%

1

(1)

0.6%

2 (2

) 1.

2%

0 (0

) 0.

0%

2 (2

) 2.

3%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

5 (5

) 2.

9%

1 (1

) 1.

2%

4 (4

) 4.

7%

1 (1

) 0.

6%

3 (3

) 1.

8%

1 (1

) 1.

2%

2 (2

) 2.

3%

1 (1

) 0.

6%

1

(2)

0.6%

1

(2)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

2 (3

) 1.

2%

2 (3

) 2.

4%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1 (1

) 0.

6%

1 (1

) 1.

2%

0 (0

) 0.

0%

0 (0

) 0.

0%

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

1

(1)

1.2%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

- -

- -

- 141 -

2.7

.6.1

.2-2

0 (

)

(SO

C)

(PT

)

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

N

=171

40

mg

N=8

5 60

mg

N=8

6

N=1

67

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

1

(1)

0.6%

0

(0)

0.0%

1

(1)

1.2%

0

(0)

0.0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

1 (1

) 0.

6%

0 (0

) 0.

0%

1 (1

) 1.

2%

0 (0

) 0.

0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

- -

- -

0

(0)

0.0%

0

(0)

0.0%

0

(0)

0.0%

1

(1)

0.6%

- -

- -

()

(%

) [

5.3.

5.1-

02

14.3

-5

14.3

-14 ]

- 142 -

(B)

2.7.6.1.2-21

1

1

40 mg 60 mg

2.7.6.1.2-21

a)

171 40 mg 85

60 mg 86

167

0 1 171 85 86 167 1 2 167 82 85 166 2 4 165 80 85 162 4 8 161 80 81 161 8 12 153 76 77 155 12 144 73 71 150 171 85 86 167

0 1 64 (121) 37.4% 31 (59) 36.5% 33 (62) 38.4% 27 (33) 16.2%

1 2 31 (41) 18.6% 17 (25) 20.7% 14 (16) 16.5% 24 (34) 14.5% 2 4 55 (99) 33.3% 24 (47) 30.0% 31 (52) 36.5% 46 (71) 28.4% 4 8 57 (117) 35.4% 26 (49) 32.5% 31 (68) 38.3% 47 (83) 29.2% 8 12 49 (85) 32.0% 23 (34) 30.3% 26 (51) 33.8% 45 (88) 29.0% 12 43 (71) 29.9% 23 (42) 31.5% 20 (29) 28.2% 33 (64) 22.0% 145 (534) 84.8% 72 (256) 84.7% 73 (278) 84.9% 123 (373) 73.7%

0 1 53 (103) 31.0% 25 (49) 29.4% 28 (54) 32.6% 17 (22) 10.2%

1 2 19 (26) 11.4% 8 (13) 9.8% 11 (13) 12.9% 10 (16) 6.0% 2 4 34 (48) 20.6% 15 (24) 18.8% 19 (24) 22.4% 21 (26) 13.0% 4 8 27 (50) 16.8% 11 (16) 13.8% 16 (34) 19.8% 25 (42) 15.5% 8 12 19 (32) 12.4% 7 (11) 9.2% 12 (21) 15.6% 12 (18) 7.7% 12 21 (28) 14.6% 14 (19) 19.2% 7 (9) 9.9% 15 (25) 10.0% 106 (287) 62.0% 52 (132) 61.2% 54 (155) 62.8% 67 (149) 40.1%

( ) (%) a) 0 1 7 1 2 8 14 2 4 15 28 4 8 29 56

8 12 57 84 12 85 [ 5.3.5.1-02 12-11 14.3-19 ]

(C)

2.7.6.1.2-22

31/171 (18.1%) 43 40 mg

16/85 (18.8%) 22 60 mg 15/86 (17.4%) 21 23/167

(13.8%) 26 12/171

(7.0%) 14 40 mg 9/85 (10.6%) 11 60 mg 3/86 (3.5%) 3

8/167 (4.8%) 10

- 143 -

40 mg 60 mg

2 4 (2.3%) 4

3 (1.8%) 3 2 (1.2%) 2 40 mg

2 (2.4%) 2 60 mg 3 (3.5%) 3 2 (2.3%) 2

3 (1.8%) 3 2 (1.2%) 2

2.7.6.1.2-22

171 40 mg 85

60 mg 86

167

a) ( ) 31 (43) 18.1% 16 (22) 18.8% 15 (21) 17.4% 23 (26) 13.8% 95% (12.7, 24.7) (11.2, 28.8) (10.1, 27.1) (8.9, 19.9)

b) 0.3009 0.3571 0.4608 a) ( ) 12 (14) 7.0% 9 (11) 10.6% 3 (3) 3.5% 8 (10) 4.8% 95% (3.7, 11.9) (5.0, 19.2) (0.7, 9.9) (2.1, 9.2)

b) 0.4908 0.1098 0.7540 ( ) (%)

a) b) Fisher p

[ 5.3.5.1-02 12-3 12-4 ]

(D)

(E)

2.7.6.1.2-23

5 (2.9%) 7 40 mg 3 (3.5%) 4

60 mg 2 (2.3%) 3 6 (3.6%) 18

40 mg

60 mg

40 mg 60 mg

60 mg 2 1 ( 0824)

- 144 -



Documents

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