Statistical analysis
SECONDARY
MMR rate at week 96 was calculated based on the intent-to-treat population (all randomized patients). The Cochran-Mantel-Haenszel chi-square test, stratified by MCyR status at baseline, was used to compare MMR rates between the treatment groups. Hypothesis testing for the primary and key secondary endpoints followed a hierarchical testing approach to preserve an overall alpha level of 5%. Because the test of the primary endpoint was significant, the key secondary endpoint was tested at the 5% level of significance (two-sided test). The Mantel-Haenszel estimates of the common risk difference and the corresponding 95% CIs and the MMR rates and 95% CIs based on the Pearson-Clopper method for each treatment arm are presented.