Variable and outcome analyses
deaths
REGRESSION, RECURRENCE
The analysis of continuous variables was performed using measures of central tendency (including mean and median) and measures of dispersion. The Kolmogorov–Smirnov and Shapiro–Wilk tests were applied to assess data distribution characteristics. We used the Chi-square test or Fisher's exact test to compare outcomes with categorical variables. If it was non-normally distributed data, we used the nonparametric Mann–Whitney U test. The risk ratio was used to estimate the effect size for dichotomous outcomes effect size for dichotomous outcomes.The time-to-local recurrence and OS were analyzed using the Kaplan-Meyer survival function with a stratified log-rank test and HRs estimated via a stratified Cox regression model to compare treatment groups. The follow-up losses and deaths were censored. The data were analyzed using the SPSS v 20.0 program. For all tests, a significance level of 5% was considered. The analyses were performed in the intention to treat the population, which included all randomized patients.