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Reasons for randomization failure.
| Reason | n (%) |
|---|---|
| Eligibility failure | 105 (58.2) |
| Loss to follow-up | 4 (2.2) |
| Consent withdrawal | 9 (4.8) |
| Lack of adherence to protocol | 6 (3.3) |
| Use of medications not allowed in the study | 11 (6.1) |
| End of position in one of the strata in the study | 46 (25.4) |
