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Primary reasons for discontinuation
| Category and reason | Phase I (N = 9) | Phase II (N = 38) |
|---|---|---|
| Discontinuation in multiple-dose period (early termination), n (%) | ||
| Adverse event | 0 | 5 (13.2) |
| Worsening of disease | 1 (11.1) | 5 (13.2) |
| Withdrawal by subject | 0 | 2 (5.3) |
| Discontinuation in overall study, n (%) | ||
| Adverse event | 0 | 8 (21.1) |
| Worsening of disease | 5 (55.6) | 18 (47.4) |
| Withdrawal by subject | 0 | 2 (5.3) |
