Table 2 Subject disposition by treatment sequence
| Randomization Sequence | ||||
|---|---|---|---|---|
| n (%) |
Discontinued Prior to Randomization
(n = 15) |
LDX/Placebo
(n = 63) |
Placebo/LDX
(n = 64) |
All Subjects
(N = 142) |
| Safety population | 15 (100.0) | 63 (100.0) | 64 (100.0) | 142 (100.0) |
| Randomized safety population | - | 63 (100.0) | 64 (100.0) | 127 (89.4) |
| Intention-to-treat population | - | 53 (84.1) | 52 (81.3) | 105 (73.9) |
| Per protocol population | - | 49 (77.8) | 49 (76.6) | 98 (69.0) |
| Completed study | - | 52 (82.5) | 51 (79.7) | 103 (72.5) |
| Discontinuations | 15 (100.0) | 11 (17.5) | 13 (20.3) | 39 (27.5) |
| Reasons for discontinuations | ||||
| Total | 15 (100.0) | 11 (17.5) | 13 (20.3) | 39 (27.5) |
| AE | 4 (26.7) | 0 | 2 (3.1) | 6 (4.2) |
| Lack of efficacy | 0 | 0 | 0 | 0 |
| Refused further participation | 5 (33.3) | 3 (4.8) | 2 (3.1) | 10 (7.0) |
| Protocol nonadherence/subject noncompliant | 0 | 0 | 0 | 0 |
| Lost to follow-up | 2 (13.3) | 0 | 0 | 2 (1.4) |
| Other | 4 (26.7) | 8 (12.7)a | 9 (14.1)a | 21 (14.8) |
