Table 1.
Baseline characteristics in the OLE (safety population)
| Characteristics | Re-entry (n = 27) | Rollover (n = 47) | Total (N = 74) |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 42.2 (11.79) | 35.0 (12.45) | 37.6 (12.63) |
| Median (range) | 41.0 (23–68) | 33.0 (18–70) | 38.0 (18–70) |
| Sex, n (%) | |||
| Female | 20 (74.1) | 29 (61.7) | 49 (66.2) |
| Male | 7 (25.9) | 18 (38.3) | 25 (33.8) |
| Race, n (%) | |||
| White | 26 (96.3) | 42 (89.4) | 68 (91.9) |
| Black or African American | 0 | 5 (10.6) | 5 (6.8) |
| Missing | 1 (3.7) | 0 | 1 (1.4) |
| Region, n (%) | |||
| Europe | 24 (88.9) | 17 (36.2) | 41 (55.4) |
| North America | 3 (11.1) | 30 (63.8) | 33 (44.6) |
| Days from end of main study to OLE day 1 | |||
| Mean (SD) | 16.6 (7.33) | 1.0 (0) | 6.7 (8.75) |
| Median (range) | 15.0 (4.0–33.0) | 1.0 (1.0–1.0) | 1.0 (1.0–33.0) |
| Division of dosing during SDP, n (%) | |||
| Unequal nighttime dosing | 0 | 2 (4.3) | 2 (2.7) |
| Equal nighttime dosing | 27 (100.0) | 45 (95.7) | 72 (97.3) |
OLE open-label extension, SD standard deviation, SDP stable-dose period