Statistical analysis
Data was analyzed using SPSS version 23, IBM Company, USA. The data were expressed as the number (percentage), mean (standard deviation [SD]) or median (±interquartile range), and 95% confidence interval [95% CI] as appropriate. Categorical variables were compared using the Chi-squared test and Fisher’s exact test, as necessary and relationship expressed using relative risks and 95% confidence intervals. Independent t-test or Mann-Whitney U-test was used to compare mean (±standard deviation) or median (±interquartile range) of continuous variables between treatment groups, depending on their normality of distribution. The intention-to-treat efficacy analysis was based on all the patients who received the study medication and had completed the follow-up visit. Interim analyses were done after 30 participants have been recruited. Participants with no observed outcome were considered as treatment failures. When possible, subgroup analysis were also done, where applicable. A p value of <0.05 was considered to be significant. Interim analyses of principal safety and efficacy outcomes were performed on behalf of the data and safety monitoring committee by the trial statistician (who remained unaware of the treatment assignments). The authors acknowledge the slip in planning the statistical analysis as both the interim analysis and the final analysis were performed (without attempting to make any adjustments, with respect to maintaining Type I error overall or for the final analysis). The result of interim analysis was presented as an abstract/E-poster in the XXIII World Congress of Gynecology and Obstetrics (FIGO) held virtually in Australia in October 2021, and is available at 