1. Obtaining informed consent from patients* | |
Yes | 210 (90.9) |
No | 21 (9.1) |
2. Approval by a REC* | |
Yes | 154 (66.7) |
No | 77 (33.3) |
3. Risk–benefit ratio valuation | |
Yes | 5 (2.2) |
No | 226 (97.8) |
4. Respect for the principle of a priori equivalence | |
Yes | 231 (100) |
No | 0 (0) |
5. Refusal of consent | |
Yes | 9 (3.9%) |
No | 222 (96.1) |
6. Placebo ethical justification† | |
Yes | 1 |
No | 23 |
7. Fairness of participant selection (inclusion/exclusion criteria) | |
Yes | 230 (>99) |
No | 1 (<1) |
8. Planned interim analysis | |
Yes | 67 (29.0) |
No | 164 (71.0) |
9. Prospectively defined stopping rules | |
Yes | 37 (16.0) |
No | 194 (84.0) |
10. Independent monitoring committee | |
Yes | 33 (14.3) |
No | 198 (85.7) |