2.5. Sample Size Estimation and Statistical Analysis
EVENT, SECONDARY
Based on a previous study [The intention-to-treat principle was applied to all data analysis. Baseline data are presented as means with 95% confidence intervals (CIs) for continuous variables. The median time to event and associated 95% CIs were calculated after the Kaplan–Meier method was applied to analyze time-to-event data. Hazard ratios (HRs) with 95% CIs were calculated using Cox proportional hazards models after adjusting for age and the BMI. Mean differences between the two treatment groups are presented as least-squares mean changes with 95% CIs. Group differences in the primary and secondary outcomes were evaluated using covariance analysis for continuous variables, with the corresponding baseline assessment as the covariate and randomized treatment as the fixed factor, and the chi-square test or Fisher exact test for categorical variables where appropriate. A two-sided 