Statistical analysis
ADVERSE EVENTS, SECONDARY
The baseline characteristics of patients between groups were compared to verify intergroup differences. Medians with interquartile ranges were used for continuous variables, and proportions were used for categorical variables. The t-test or Mann-Whitney U test was used for continuous variables, and the χ2 test or Fisher exact test was used for categorical variables. The primary and secondary outcomes were studied using odds ratios with a 95% confidence interval, and the χ2 test or Fisher exact test was used for comparisons between groups. The number of adverse events was compared by using Fisher exact test. All analyses were performed using SPSS version 23 (IBM, Armonk, New York). All tests were two-sided, and P < 0.05 was considered statistically significant.