Clinical Study
Treatment of Bacterial Vaginosis: A Multicenter, Double-Blind, Double-Dummy, Randomised Phase III Study Comparing Secnidazole and
Metronidazole
Table 1
Major deviations leading to the exclusion of patients from the per protocol population.
| | Metronidazole | Secnidazole | | | | | % () | % () |
| Nonrespect of scheduled visits | 4.9 (14) | 3.8 (11) | Nonevaluability of primary efficacy endpoint | 4.5 (13) | 1.7 (5) | Concomitant antibiotic treatment | 3.5 (10) | 2.1 (6) | Nonrespect of compliance | 2.4 (7) | 1.4 (4) | of which missing data on compliance | 1.4 (4) | 1.4 (4) | Error in randomisation | 1.4 (4) | 1.4 (4) | Treatment initiated more than 3 days after randomisation | 1.0 (3) | 0 (0) | Nonrespect of inclusion criteria | 0.3 (1) | 0.7 (2) | Vaginal treatment | 0 (0) | 0.7 (2) | Nonrespect of exclusion criteria | 0 (0) | 0.3 (1) |
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