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Summary of subject disposition
| Total, n (%) | |
|---|---|
| ENROLLED POPULATION, N | 53 |
| AE = adverse event; ITT = intention-to-treat. | |
| Safety population | 53 (100.0) |
| ITT population | 52 (98.1) |
| Completed study | 35 (66.0) |
| Terminated early | 18 (34.0) |
| REASON FOR TERMINATION | |
| Lost to follow-up | 7 (13.2) |
| AEs/serious AEs | 9 (17.0) |
| Subject withdrew consent | 1 (1.9) |
| Lack of efficacy | 1 (1.9) |
| REASON NOT IN ITT POPULATION | |
| No postbaseline assessment | 1 (1.9) |
