2.6. Sample Size and Statistical Analysis
SECONDARY
Baseline characteristics and all outcomes are presented descriptively, using means, medians, standard deviations, and ranges (continuous measures) or proportions (dichotomous or categorical data), as appropriate, along with 95% confidence intervals. Baseline characteristics and secondary outcomes were calculated separately for each treatment arm and calculated for both the ITT and PP populations. Given that the primary aim of this study was to evaluate study feasibility, safety outcomes are secondary aims. Therefore, any reporting of secondary outcomes prioritizes the PP population over the ITT population.Differences in outcomes between treatment arms were estimated using descriptive statistics, along with 95% confidence intervals. The Kaplan–Meier method was used to estimate time-to-event outcomes. Statistical testing was performed using Fisher’s exact tests, Wilcoxon rank sum tests, or log-rank tests as appropriate. No adjustments were made for multiple tests, and exact All the statistical analysis was carried out using SAS version-9 or higher for Windows (Cary, NC, USA) or R version 3.2.2. (