Table 2.
Overall demographic and baseline characteristics
| Study I N = 48 |
Study II N = 44 |
Study III N = 48 |
Study IV N = 48 |
Study V N = 48 |
|
|---|---|---|---|---|---|
| Age, years | 35.0 (9.5) | 35.0 (9.4) | 32.9 (8.5) | 37.9 (9.5) | 35.4 (8.7) |
| Sex, n (%) | |||||
| Female | 22 (46%) | 15 (34%) | 17 (35%) | 12 (25%) | 14 (29%) |
| Male | 26 (54%) | 29 (66%) | 31 (65%) | 36 (75%) | 34 (71%) |
| Race, n (%) | |||||
| White | 28 (58%) | 27 (61%) | 24 (50%) | 32 (67%) | 23 (48%) |
| Other | 20 (42%) | 17 (39%) | 24 (50%) | 16 (33%) | 25 (52%) |
| Ethnicity, n (%) | |||||
| Not Hispanic or Latino | 37 (77%) | 29 (66%) | 39 (81%) | 28 (58%) | 35 (73%) |
| Height, cm | 170.1 (8.4) | 170.6 (8.0) | 170.8 (8.0) | 171.5 (10.8) | 170.7 (8.5) |
| Weight, kg | 75.2 (12.3) | 76.3 (10.6) | 76.2 (11.8) | 78.1 (12.7) | 75.0 (11.8) |
| BMI, kg/m2 | 25.9 (2.9) | 26.1 (2.3) | 26.0 (2.9) | 26.4 (2.4) | 25.7 (2.9) |
| Discontinuationsa | |||||
| Overall, n (%) | 3 (6%) | 1 (2%) | 1 (2%) | 0 (0%) | 0 (0%) |
| 10 mg OCA, n (%) | 0 (0%) | 0 (0%) | 1 (4%) | 0 (0%) | 0 (0%) |
| 25 mg OCA, n (%) | 3 (13%) | 1 (4%) | 0 (0%) | 0 (0%) | 0 (0%) |
Data are presented as n (percentage of subjects) or mean (SD), as appropriate
BMI body mass index
aDiscontinuations are given as n (percentage of subjects) where n represents the number of subjects in each treatment group