Statistical analyses
ProVate
SECONDARY
Sample size calculations were based on the primary endpoint, and estimations were based on a previous study [The full analysis (FA) set included all eligible participants who used at least one device (even if the insertion process was never completed) and served as the principal analysis set for the safety assessment. The per-protocol (PP) analysis set included all participants from the FA set who had used the study devices for at least 16 days without considerable protocol deviation and served as the principal analysis set for the primary and secondary endpoint analyses. Two-tailed tests were performed for all analyses with a significance level of 0.05. Differences were considered statistically significant at As the primary endpoint, the proportion of participants who met the failure criteria was evaluated for non-inferiority of ProVate vs. the commercially available vaginal ring pessary (control). Non-inferiority of ProVate is present if the upper limit of a one-sided 97.5% confidence interval constructed on the difference in proportions (ProVate—commercial vaginal ring pessary), considering the correlation due to the crossover design, is less than the noninferiority limit of 15%.For the secondary endpoints, the proportion of participants treated with each device meeting each individual failure criterion and the proportion of participants with an increase in microbial count > 1 unit-scale in any study organism are described.