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| Category | No. (%) |
|---|---|
| Enrolled subjects | 897 (100) |
| Completed study | 749 (83.5) |
| Early dropouts | 148 (16.5) |
| Reasons for dropouts | |
| Adverse events | 45 (30.4) |
| Abnormal laboratory tests | 19 (12.9) |
| Protocol violation | 7 (4.7) |
| Withdrawal of informed consent | 18 (12.2) |
| Follow-up loss | 52 (35.1) |
| Death | 7 (4.7) |
