Tables 2

14 TABLES, FIGURES AND GRAPHS REFERRED TO BUT NOT INCLUDED IN THE TEXT

14.1 Demographic Data

14.1.1 Summary of Demographic Data

(A05000_dem_Cohort 1)

(A05000_dem_Cohort 2)

14.1.2 Study Conduct Data

14.1.2.1 Earliest and Latest Subject Visit/Contact Date

(A01100_studydates_Cohort 1)

(A01100_studydates_Cohort 2)

14.1.2.2 Subject Disposition - Treatment Phase

(A02200_disptreat_Cohort 1)

(A02200_disptreat_Cohort 2)

14.2 Pharmacokinetic Data: Summary Tables and Figures

14.2.1 Pharmacokinetic Data: Summary Figures

0

2

4

6

8

10

12

14

0 4 8 12 16 20 24Hour (hr)

Day=Day 1

Day=Day 1 Error

Day=Day 14

Day=Day 14 Error

TRT_ARM=1

Figure 1 Mean Plasma CAS Concentration vs Time Plot (CAS Alone)

0

2

4

6

8

10

12

0 4 8 12 16 20 24Hour (hr)

Day=Day 1

Day=Day 1 Error

Day=Day 14

Day=Day 14 Error

TRT_ARM=2

Figure 2 Mean Plasma CAS Concentrations vs. Time Plot (CAS + POS)

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

0 2 4 6 8 10 12Hour (hr)

Day=1

Day=1 Error

Day=14

Day=14 Error

Figure 3 Mean Plasma POS Concentration vs. Time Plot (CAS + POS)

1

2

3

4

5

11 12 13 14 15Day

TRT_ARM=1

Figure 4 Mean (SD) of Trough Plasma CAS Concentrations on Days 12-14 (Cohort 1, Treatment Arm 1)

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

11 12 13 14 15Day

TRT_ARM=2

Figure 5 Mean (SD) of Trough Plasma CAS Concentrations on Days 12-14 (Cohort 1, Treatment Arm 2)

2000

3000

4000

5000

11 12 13 14 15Day

Cohort=1

Figure 6 Mean (SD) of Trough Plasma POS Concentrations on Days 12-14 (Cohort 1, Treatment Arm 2)

Figure 7 Mean Plasma MICA Concentrations vs. Time Plot (MICA Alone)

Figure 8 Mean Plasma MICA Concentration vs. Time plot (MICA + POS)

0

500

1000

1500

2000

2500

3000

3500

4000

4500

0 2 4 6 8 10 12Hour (hr)

Day=1

Day=1 Error

Day=7

Day=7 Error

Figure 9 Mean (SD ) of Plasma POS Concentrations on Day 1 and Day 7 (Cohort 2, Treatment Arm 2)

3

4

5

6

4 5 6 7 8Day

Treatment_Arm=1

Figure 10 Mean (SD) of Trough Plasma MICA Concentrations on Days 5 -7 (Cohort 2, Treatment Arm 1)

Figure 11 Mean (SD) of Trough Plasma MICA Concentrations on Days 5 -7 (Cohort 2, Treatment Arm 2)

Figure 12 Mean (SD) of Trough Plasma POS Concentrations on Days 5 -7 (Cohort 2, Treatment Arm 2)

14.2.2 Pharmacokinetic Data: Summary Tables

Table 1 Mean and Other Descriptive Statistics of Plasma Concentrations of CAS (ug/ml)Protocol No. P04931

Subject #. Hour (hr)

0.00 1.00 1.25 1.50 2.00 3.00 4.00 5.00 6.00 8.00 12.00 16.00 20.00 24.00

N 16 16 16 16 16 16 16 16 16 16 16 15 16 16

Mean 0.0 11.8 10.5 9.1 8.0 6.7 5.9 5.3 5.5 4.8 3.4 2.5 2.1 1.7

SD 0.0 1.5 1.2 1.1 1.5 1.1 1.0 0.8 1.2 0.8 0.8 0.5 0.5 0.3

Min 0.0 10.1 8.3 6.9 5.8 5.1 4.6 3.6 3.3 3.0 1.8 1.6 1.4 1.3

Median 0.0 11.7 10.4 9.0 7.5 6.7 5.8 5.3 6.0 5.0 3.5 2.7 2.1 1.7

Max 0.0 15.0 12.7 11.2 10.9 9.3 7.6 7.2 6.9 5.9 4.6 3.6 3.1 2.4

CV% M 12.5 11.8 12.2 18.5 17.0 17.4 14.3 20.8 16.2 24.2 19.4 23.8 18.7

*M=MissingSource Data: Section 16.1.9.2.1- Table 1

Table 2 Mean and Other Descriptive Statistics of Plasma Concentrations of CAS (g/mL) versus Time (Treatment Arm 1, Day 14)Protocol No. P04931

Hour (hr)

0.00 1.00 1.25 1.50 2.00 3.00 4.00 5.00 6.00 8.00 12.00 16.00 20.00 24.00

N 16 16 16 16 16 16 16 16 16 16 16 16 16 16

Mean 1.6 9.6 9.1 7.9 7.1 6.2 5.5 5.2 5.0 4.2 3.2 2.3 1.9 1.7

SD 0.5 1.3 1.3 1.4 1.2 0.9 0.9 1.2 0.8 0.7 0.6 0.5 0.4 0.4

Min 0.7 7.6 6.8 5.4 5.0 4.7 4.2 3.5 3.9 3.2 2.2 1.5 0.7 1.1

Median 1.6 9.9 9.2 8.1 7.1 6.2 5.7 5.5 5.1 4.0 3.3 2.4 1.9 1.7

Max 2.5 11.4 11.2 9.8 8.9 7.7 6.9 7.4 6.9 5.4 4.1 2.9 2.4 2.3

CV% 27.8 13.2 14.3 17.6 16.4 15.2 15.6 22.5 16.7 16.0 19.0 21.3 22.6 20.4

Source Data: Section 16.1.9.2.1- Table 2

Table 3 Mean and Other Descriptive Statistics of Plasma Concentrations of CAS ( g/mL) versus (Treatment Arm 2, Day 1)

Protocol No. P04931Subject #. Hour (hr)

N 19 19 19 19 19 19 19 19 19 19 19 19 19 19

Mean 0.0 10.8 9.1 8.4 6.8 5.9 5.3 4.8 5.0 4.0 3.2 2.2 2.0 1.6

SD 0.0 1.1 1.4 1.3 1.2 0.8 0.9 0.9 1.1 1.0 0.8 0.4 0.5 0.4

Min 0.0 8.7 6.9 6.2 4.9 4.6 3.4 3.4 3.3 2.3 2.0 1.6 1.2 1.1

Median 0.0 11.2 9.2 8.5 6.9 6.1 5.4 4.5 4.8 4.0 3.0 2.2 2.0 1.5

Max 0.0 13.3 12.3 11.0 9.1 7.1 7.4 6.5 6.7 6.0 4.6 3.1 3.2 2.5

CV% M 10.6 15.2 15.8 18.1 13.4 16.6 18.3 21.6 25.7 24.1 19.3 26.5 26.9

*M=MissingSource Data: Section 16.1.9.2.1- Table 3

Table 4 Mean and Other Descriptive Statistics of Plasma Concentrations of CAS (g/mL) versus Time (Treatment Arm 2, Day 14)Protocol No. P04931

Subject # Hour (hr)

0.00 1.00 1.25 1.50 2.00 3.00 4.00 5.00 6.00 8.00 12.00 16.00 20.00 24.00

N 15 15 15 15 15 15 15 15 15 15 15 15 15 15

Mean 2.2 8.5 8.1 7.5 6.4 5.9 5.4 5.1 4.7 4.0 3.2 2.4 2.0 1.7

SD 2.5 1.4 1.2 1.3 1.2 1.0 1.1 0.7 0.8 0.7 0.6 0.4 0.4 0.3

Min 1.0 6.4 6.5 6.0 4.5 4.1 3.9 3.7 3.6 2.9 2.3 1.7 1.4 1.1

Median 1.6 8.0 7.7 7.0 6.2 5.8 5.5 5.1 4.7 3.9 3.3 2.4 2.1 1.7

Max 11.3 10.7 10.7 9.9 9.0 8.1 7.9 6.0 6.0 5.6 4.7 3.1 2.6 2.1

CV% 113.0 16.6 14.7 16.9 18.1 16.5 19.6 13.3 17.5 18.3 19.9 18.4 19.5 18.2


Table 5 Mean and Other Descriptive Statistics of Plasma PK Parameters of CAS (Treatment Arm 1, Day 1)Protocol No. P04931

Cmax

(g/mL)

Tmax

(hr)

AUC()

(gh/mL)

N 16 16 16

Mean 11.9 1.05 96

SD 1.4 0.10 12

Min 10.1 1.00 73

Median 11.8 1.00 98

Max 15.0 1.25 117

CV% 11.9 9.6 12.7

Geometric Mean 11.8 1.04 95


Table 6 Mean and Other Descriptive Statistics of Plasma PK Parameters of CAS (Treatment Arm 1 , Day 14)Protocol No. P04931

Cmax

(g/mL)

Tmax

(hr)

AUC()

(ghr/mL)

Cmin

(ug/mL)

CLss

(mL/hr)

Vss

(mL)

N 16 16 16 16 16 16

Mean 9.8 1.08 87 1.5 588 9769

SD 1.2 0.12 13 0.4 96 2192

Min 7.6 1.00 64 0.7 472 6237

Median 10.0 1.00 88 1.5 571 9298

Max 11.4 1.25 106 2.3 783 14855

CV% 12.3 11.1 15.1 27.4 16.4 22.4

Geometric Mean 9.7 1.07 86 1.4 581 9547


Table 7 Mean and Other Descriptive Statistics of Plasma PK Parameters of CAS (Treatment Arm 2, Day 1)Protocol No. P04931

Cmax

(g/mL)

Tmax

(hr)AUC()

(gh/mL)

N 19 19 19

Mean 10.9 1.05 86

SD 1.1 0.13 12

Min 8.7 1.00 70

Median 11.2 1.00 83

Max 13.3 1.50 108

CV% 10.5 12.7 13.5

Geometric Mean 10.8 1.05 85


Table 8 Mean and Other Descriptive Statistics of Plasma PK Parameters of CAS (Treatment Arm 2 , Day 14)Protocol No. P04931

Cmax

(g/mL)

Tmax

(hr)

AUC()

(ghr/mL)

Cmin

(ug/mL)

CLss

(mL/hr)

Vss

(mL)

N 15 15 15 15 15 15

Mean 8.8 1.05 85 1.6 603 9915

SD 1.3 0.33 14 0.3 97 1716

Min 7.3 0.00 66 1.0 455 6422

Median 8.1 1.00 87 1.6 575 10444

Max 11.3 1.50 110 2.0 758 11905

CV% 15.2 31.4 15.9 17.7 16.1 17.3

Geometric Mean 8.7 *M 84 1.5 596 9763

*M=Missing


Table 9 Mean and Other Descriptive Statistics of Plasma Concentrations of POS (ng/mL) versus Time (Cohort 1, Arm 2, Day 1)

Protocol No. P04931Hour

0 1 3 4 5 6 8 12

N 19 19 19 19 19 19 19 19

Mean 0.0 26.3 309 470 616 584 554 553

SD 0.0 15.6 148 210 233 209 166 138

Min 0.0 9.9 163 197 293 255 283 260

Median 0.0 21.9 275 476 596 592 530 538

Max 0.0 60.9 707 943 1210 1160 1040 833

CV% *M 59.4 47.9 44.7 37.9 35.8 30.0 24.9

*M=Missing


Table 10 Mean and Other Descriptive Statistics of Plasma Concentrations of POS (ng/mL) versus Time (Cohort 1, Arm 2, Day 14)


0 1 3 4 5 6 8 12

N 15 15 15 15 15 15 15 15

Mean 3039 2745 3039 3196 3536 3179 2978 3088

SD 1189 1178 1007 990 1261 1223 1125 1242

Min 1500 1290 1400 1540 1920 1570 1380 1580

Median 2810 2580 3040 3230 3350 3040 2920 2930

Max 6610 6280 5700 5630 7160 6570 6310 6650

CV% 39.1 42.9 33.1 31.0 35.7 38.5 37.8 40.2


Table 11 Mean and Other Descriptive Statistics of Plasma PK Parameters of POS (Cohort 1, Arm 2, Day 1)Protocol No. P04931

POS PK Parameters Cohort 1, Arm 2, Day 1

Cmax (ng/mL) Tmax (hr) AUC() (ng•hr/mL)

N 19 19 19

Mean 674 7.63 5231

SD 193 3.45 1535

Min 293 4.00 2563

Median 624 5.00 4926

Max 1210 12.0 9630

CV% 28.6 45.2 29.3

Geometric Mean 648 6.96 5031


Table 12 Mean and Other Descriptive Statistics of Plasma PK Param eters of POS (Cohort 1, Arm 2, Day 14)Protocol No. P04931


N 15 15 15

Mean 3588 5.80 36807

SD 1251 2.60 13541

Min 1920 3.00 17900

Median 3430 5.00 36215

Max 7160 12.00 76150

CV% 34.9 44.8 36.8



Table 13 Mean and O ther Descriptive Statistics of CAS ( g/mL) Trough Concentrations (Cohort 1, Treatment Arm 1)

Protocol No. P04931Day 12 Day 13 Day 14

N 16 16 16

Mean 1.9 1.7 1.6

SD 0.5 0.4 0.5

Min 1.1 0.7 0.7

Median 1.8 1.7 1.6

Max 2.6 2.5 2.5

CV% 25.3 26.6 27.8


Table 14 Mean and O ther Descriptive Statistics of CAS ( g/mL) Trough Concentrations (Cohort 1, Treatment Arm 2)

Protocol No. P04931Day 12 Day 13 Day 14

N 15 15 15

Mean 2.0 1.7 2.2

SD 0.6 0.5 2.5

Min 1.3 1.1 1.0

Median 2.0 1.5 1.6

Max 3.1 2.6 11.3

CV% 28.4 31.5 113


Table 15 Mean and O ther Descriptive Statistics of POS (ng/mL) Trough Concentrations (Cohort 1, Treatment Arm 2)

Protocol No. P04931Day

12 13 14

N 15 15 15

Mean 3023 3055 3039

SD 1240 1275 1189

Min 1270 1280 1500

Median 2940 3020 2810

Max 6500 6750 6610

CV% 41.0 41.7 39.1


Table 16 Mean and Other Descriptive Statistics of Plasma MICA (g/mL) Concentrations (Treatment Arm 1, Day 1)Protocol No. P04931

Hour

0.00 1.00 1.25 1.50 2.00 3.00 4.00 5.00 6.00 8.00 12.00 16.00 20.00 24.00

N 16 16 16 16 16 16 16 16 16 16 16 16 16 16

Mean 0.00 11.62 10.41 9.58 8.64 7.80 7.25 6.73 6.29 5.57 4.46 3.51 2.83 2.52

SD 0.00 2.27 2.06 1.71 1.64 1.53 1.26 1.36 1.21 1.22 0.84 0.70 0.58 0.57

Min 0.00 7.01 5.60 5.42 4.74 4.49 4.42 3.72 3.69 2.82 2.60 1.86 1.57 1.43

Median 0.00 12.11 11.21 9.97 9.35 8.30 7.81 7.10 6.62 5.91 4.73 3.65 2.91 2.56

Max 0.00 15.10 13.22 11.60 10.80 9.66 8.60 8.30 7.73 7.03 5.61 4.26 3.64 3.35

CV% M 19.5 19.8 17.9 19.0 19.6 17.4 20.2 19.2 21.8 18.7 20.0 20.5 22.6

*M=Missing



Hour

0.00 1.00 1.25 1.50 2.00 3.00 4.00 5.00 6.00 8.00 12.00 16.00 20.00 24.00

N 15 15 15 15 15 15 15 15 15 15 15 15 15 15

Mean 4.35 15.63 14.34 13.56 12.79 11.48 10.84 9.92 9.57 8.52 7.13 5.81 4.72 4.34

SD 0.97 2.63 2.29 2.13 2.13 2.06 2.05 1.77 1.86 1.44 1.44 1.33 1.00 0.92

Min 3.06 11.52 10.27 10.00 9.42 7.93 7.79 7.26 6.88 6.40 5.49 3.90 3.30 3.29

Median 3.87 16.14 14.68 13.99 12.85 11.43 10.65 9.66 9.31 7.94 6.45 5.51 4.42 3.92

Max 5.91 19.77 17.66 16.68 15.56 14.67 13.70 12.15 12.75 10.76 9.83 8.06 6.23 5.96

CV% 22.3 16.8 16.0 15.7 16.7 17.9 18.9 17.8 19.5 16.9 20.2 22.9 21.2 21.3


Table 18 Mean and other Descriptive Statistics of Plasma MICA (g/mL) Concentrations (Treatment Arm 2, Day 1)Protocol No. P04931

Hour

0 1 1.25 1.5 2 3 4 5 6 8 12 16 20 24

N 16 16 16 16 16 16 16 16 16 16 16 16 16 16

Mean 0.00 12.76 10.95 10.22 9.09 8.34 7.73 7.01 6.65 5.87 5.02 3.66 3.08 2.67

SD 0.00 1.64 1.53 1.35 1.02 1.02 1.05 0.87 0.90 0.58 0.62 0.48 0.33 0.31

Min 0.00 10.17 8.45 7.94 7.37 6.81 5.93 5.85 5.30 5.02 4.24 2.91 2.67 2.09

Median 0.00 13.15 11.01 9.96 9.02 8.31 7.74 6.93 6.52 5.71 4.88 3.58 3.02 2.65

Max 0.00 15.63 13.89 12.30 10.98 10.48 9.75 8.95 8.29 6.79 6.46 4.58 3.75 3.30

CV% M 12.9 14.0 13.2 11.3 12.2 13.6 12.5 13.5 9.8 12.3 13.0 10.7 11.5

*M=Missing



Hour

0.00 1.00 1.25 1.50 2.00 3.00 4.00 5.00 6.00 8.00 12.00 16.00 20.00 24.00

N 16 16 16 16 16 16 16 16 16 16 16 16 16 16

Mean 4.84 16.23 15.28 14.35 13.45 11.88 11.22 10.73 9.91 9.15 8.41 6.39 5.08 4.59

SD 0.61 2.34 2.34 1.76 1.89 1.78 1.67 1.63 1.66 1.30 1.26 1.13 0.66 0.62

Min 3.47 11.99 11.01 11.17 10.22 8.42 8.20 8.39 7.10 6.28 5.83 3.31 3.38 3.01

Median 4.81 16.22 15.10 13.91 13.63 11.78 11.25 10.45 9.52 9.06 8.22 6.58 5.11 4.53

Max 6.09 21.02 19.01 17.10 17.22 14.93 13.97 13.47 12.65 11.34 10.54 8.41 6.19 6.06

CV% 12.6 14.4 15.3 12.3 14.0 15.0 14.9 15.2 16.7 14.2 14.9 17.6 13.0 13.6


Table 20 Mean and Other Descriptive Statistics of Plasma MICA PK Parameters (Treatment Arm 1, Day 1)Protocol No. P04931

Cmax

g/mL

Tmax

hr

AUC()

ghr/mL

N 16 16 16

Mean 11.67 1.02 116.1

SD 2.24 0.06 22.3

Min 7.01 1.00 65.0

Median 12.11 1.00 120.6

Max 15.10 1.25 141.8

CV% 19.2 6.2 19.2

Geometric Mean 11.45 1.01 113.8



Cmax

g/mL

Tmax

hr

AUC()

ghr/mL

Cmin

g/mL

CLss

mL/hr

Vss

mL

N 15 15 15 15.00 15 15

Mean 15.63 1.00 182 4.25 853 18260

SD 2.63 0.00 34 0.92 161 3182

Min 11.52 1.00 137 3.06 664 13915

Median 16.14 1.00 168 3.81 894 17912

Max 19.77 1.00 226 5.63 1095 24512

CV% 16.8 0.0 18.5 21.6 19 17.4

Geometric Mean 15.41 1.00 179 4.16 839.4 18014



Cmax

g/mL

Tmax

hr

AUC()

ghr/mL

N 16 16 16

Mean 12.76 1.00 124.4

SD 1.64 0.00 13.7

Min 10.17 1.00 104.8

Median 13.15 1.00 123.6

Max 15.63 1.00 152.9

CV% 12.9 0.0 11.0

Geometric Mean 12.66 1.00 123.7



Cmax

g/mL

Tmax

hr

AUC()

ghr/mL

Cmin

g/mL

CLss

mL/hr

Vss

mL

N 16 16 16 16.00 16 16

Mean 16.26 1.03 197 4.57 777 16715

SD 2.35 0.09 27 0.63 118 2918

Min 11.99 1.00 135 3.01 627 11622

Median 16.34 1.00 193 4.53 777 17309

Max 21.02 1.25 239 6.06 1111 21610

CV% 14.4 8.3 13.6 13.8 15 17.5

Geometric

Mean

16.10 1.03 195 4.53 769.8 16467


Table 24 Mean and O ther Descriptive Statistics of Plasma Concentrations of POS (ng/mL) versus Time (Cohort 2, Treatment Arm 2, Day 1)


0 1 3 4 5 6 8 12

N 16 16 16 16 16 16 16 16

Mean 0.4 25.9 241.1 392.3 554.7 574.6 555.8 683.2

SD 1.4 17.9 101.7 143.7 194.8 182.0 168.8 208.1

Min 0.0 8.8 125.0 207.0 269.0 284.0 240.0 306.0

Median 0.0 18.5 206.5 369.0 571.0 533.5 559.5 671.5

Max 5.7 75.5 486.0 694.0 912.0 856.0 839.0 1110.0

CV% 400.0 69.1 42.2 36.6 35.1 31.7 30.4 30.5


Table 25 Mean and O ther Des criptive Statistics of Plasma Concentrations of POS (ng/mL) versus Time (Cohort 2, Treatment Arm 2, Day 7)

Protocol No. P04931Hours

0 1 3 4 5 6 8 12

16 16 16 16 16 16 16 16

Mean 2620.6 2344.4 2593.1 2723.8 2888.1 2646.9 2604.4 2886.3

SD 1049.3 791.2 948.8 928.9 1275.7 984.6 887.4 1130.1

Min 1200.0 1040.0 1330.0 1230.0 1340.0 1190.0 1200.0 1110.0

Median 2450.0 2275.0 2300.0 2435.0 2625.0 2455.0 2530.0 2725.0

Max 5630.0 4080.0 4870.0 4460.0 6750.0 5280.0 4500.0 5500.0

CV% 40.0 33.7 36.6 34.1 44.2 37.2 34.1 39.2


Table 26 Mean and Other Descriptive Statistics of POS PK Parameters (Cohort 2, Treatment Arm 2, Day 1)Protocol No. P04931


N 16 16 16

Mean 734 8.75 5243

SD 209 3.44 1416

Min 306 5.00 2453

Median 764.5 10.0 4952

Max 1110 12.0 7379

CV% 28.5 39.3 27.0



Table 27 Mean and Other Descriptive Statistics of POS PK Parameters (Cohort 2, Treatment Arm 2, Day 7)Protocol No. P04931

Cmax Tmax AUC()

(ng/mL) (hr) (ng•hr/mL)

N 16 16 16

Mean 3153 7.6 31884

SD 1320 4.2 11389

Min 1340 0.0 14330

Median 2740 5.0 29808

Max 6750 12.0 59870

CV% 41.9 54.6 35.7

Geometric Mean 2927 M 30050

*M=Missing


Table 28 Mean and O ther Descriptive Stat istics of Trough MICA Plasma Concentrations ( g/mL) ( Cohort 2, Treatment Arm 1)


5 6 7

N 16.00 16.00 16.00

Mean 4.23 4.27 4.82

SD 0.58 0.49 0.68

Min 3.20 3.35 3.74

Median 4.30 4.18 5.01

Max 4.93 5.00 5.91

CV% 13.71 11.47 14.18


Table 29 Mean and O ther Descriptive Statistics of Trough MICA Plasma Concentrations ( g/mL) ( Cohort 2, Treatment Arm 2)


5 6 7

N 15.00 15.00 15.00

Mean 4.19 4.30 4.37

SD 0.99 0.88 0.93

Min 2.79 3.19 3.06

Median 4.30 4.25 4.28

Max 6.43 5.92 6.09

CV% 23.61 20.48 21.17


Table 30 Mean and O ther Descriptive Statistics of Plasma Trough Concentrations (ng/mL) of POS (Cohort 2, Treatment Arm 2)


5 6 7

N 16 16 16

Mean 2374 2427 2621

SD 769 815 1049

Min 1220 1130 1200

Median 2345 2450 2450

Max 4100 4190 5630

CV% 32.4 33.6 40.0


14.3 Safety Data

14.3.1 Displays of Adverse Events

14.3.1.1 Summary of Treatment-Emergent Adverse Events

(B01000_ae_Cohort 1)

(B01000_ae_Cohort 2)

Tables 2

Documents

Transcript of Tables 2