Statistical analyses
SECONDARY
Data for all endpoints were evaluated using intention-to-treat analysis. All data are expressed as mean ± standard deviation. The unpaired Student’s t-test and Mann–Whitney rank test were used to compare continuous variables. Categorical variables were compared using the chi-squared and Fisher’s exact tests. The Kaplan-Meier method with a log-rank test was used to compare the cumulative incidence of primary and secondary endpoints. A p value < 0.05 was considered statistically significant. All statistical analyses were performed using the SPSS software (version 20.0, SPSS Inc., Chicago, IL, USA).