In addition, a secondary per-protocol analysis will be performed. Chi-square or Fisher's exact test that will be used to analyze all categorical variables. Time to treatment failure will be estimated using Kaplan-Meier product-limit estimates (that will be presented graphically). The log-rank test will be used to assess the difference between the survival curves for each arm, while ANOVA test and Student's t test will be used for continuous variables unless the variables will not be normally distributed, in which case the Kruskal-Wallis and Mann-Whitney U tests will be used. Logistic regression analysis (forward stepwise model) will be used to evaluate the relationship between variables and outcome.