Table 1.
Summary of baseline characteristics (safety population)
| Characteristic | Study 1 | Study 2 | Study 3 | |||
|---|---|---|---|---|---|---|
|
Test (n = 115) |
Control (n = 115) |
Test (n = 117) |
Control (n = 116) |
Test (n = 102) |
Control (n = 102) |
|
| Sex, n (%) | ||||||
| Male | 24 (20.9) | 23 (20.0) | 36 (30.8) | 31 (26.7) | 37 (36.3) | 28 (27.5) |
| Female | 91 (79.1) | 92 (80.0) | 81 (69.2) | 85 (73.3) | 65 (63.7) | 74 (72.5) |
| Age, years | ||||||
| Mean (SD) | 40.7 (8.62) | 39.9 (9.18) | 34.3 (12.92) | 32.8 (11.52) | 22.8 (6.61) | 22.2 (5.12) |
| Range | 20–55 | 18–55 | 18–64 | 18–64 | 18–55 | 18–51 |
| Race, n (%) | ||||||
| White | 112 (97.4) | 112 (97.4) | 93 (79.5) | 102 (87.9) | 85 (83.3) | 90 (88.2) |
| Black | 2 (1.7) | 0 | 4 (3.4) | 3 (2.6) | 5 (4.9) | 4 (3.9) |
| Asian | 1 (0.9) | 1 (0.9) | 20 (17.1) | 8 (6.9) | 11 (10.8) | 5 (4.9) |
| Other | 0 | 2 (1.7) | 0 | 3 (2.6) | 1 (1.0) | 3 (2.9) |
| Schiff strata 2, n (%) | 12 (10.4) | 11 (9.6) | 98 (83.8) | 98 (84.5) | 75 (73.5) | 76 (74.5) |
| Schiff strata 3, n (%) | 103 (89.6) | 104 (90.4) | 19 (16.2) | 18 (15.5) | 27 (26.5) | 26 (25.5) |