Statistical analyses
Shapiro–Wilk test was used to test the normality of the numeric data. Mean ± standard deviation (SD), median (IQR) and frequency (%) were used to report descriptive statistics, as applicable. Between-group comparisons were examined using Mann–Whitney U test and independent samples t-test with mean difference (MD) and 95% confidence interval (95%CI). Within-group comparisons were investigated through Friedman test with a post-hoc analysis using Wilcoxon signed-rank test with Bonferroni correction. The CONSORT flow diagram