Table 1 Baseline characteristics and demographics
Run-in only | Placebo | 498 2 mg | 498 5 mg | Total | |
|---|---|---|---|---|---|
Number of subjects | |||||
Planned, N | 0 | 20 | 20 | 20 | 60 |
Dosed, N | 4 | 21 | 21 | 21 | 67 |
Completed, n (%) | 0 | 21 (100) | 18 (86) | 21 (100) | 60 (90) |
Total number of subjects withdrawn, n (%) | 4 (100) | 0 | 3 (14) | 0 | 7 (10) |
Withdrawn due to adverse event, n (%) | 1 (25) | 0 | 2 (10)a | 0 | 3 (4)a |
Withdrawn at investigator discretion, n (%) | 2 (50) | 0 | 1 (5) | 0 | 3 (4) |
Subject withdrew consent, n (%) | 1 (25) | 0 | 0 | 0 | 1 (1) |
Demographics | |||||
|---|---|---|---|---|---|
N (all subjects) | 4 | 21 | 21 | 21 | 67 |
Mean age in years (s.d.) | 44.8 (9.50) | 41.3 (9.22) | 44.9 (10.08) | 37.8 (10.06) | 41.5 (10.00) |
Females: males | 2:2 | 11:10 | 12:9 | 12:9 | 37:30 |
Mean Weight in kg (s.d.) | 109.7 (21.68) | 109.2 (18.17) | 110.9 (23.63) | 104.0 (9.82) | 108.1 (18.11) |
Mean body mass index in kg m−2 (s.d.) | 36.2 (4.15) | 37.8 (4.87) | 37.1 (5.37) | 37.1 (4.38) | 37.3 (4.76) |
White/Caucasian/European heritage, n (%) | 4 (100) | 17 (81) | 19 (90) | 17 (81) | 57 (85) |
African American/African heritage, n (%) | 0 | 3 (14) | 2 (10) | 3 (14) | 8 (12) |
White—Arabic/North African heritage, n (%) | 0 | 1 (5) | 0 | 1 (5) | 2 (3) |
