Statistical analysis
ADVERSE EVENTS
The sample size was estimated based on data from previous studies in the literature (Flowchart for participant selection.Quantitative data are described as the mean ± standard deviation. For those with a normal distribution, one-way ANOVA was used to analyze the differences in each indicator at the four specified time points. The data of the two groups at the 4 specified time points were compared between the groups. Homogenous and unequal variances were analyzed with t tests. Those nonnormally distributed were tested by the Wilcoxon rank sum test. The chi-square test was used to compare the differences in the incidence of adverse events between the two groups.IBM SPSS 26.0 was used for statistical analysis, and a P value < 0.05 was considered statistically significant.