Statistical analysis
ADVERSE EVENT
All Japanese patients who were randomized in the ASCEMBL study were included in the efficacy analysis (full analysis set, FAS). All Japanese patients who received at least one dose of study drug were included in the safety analysis (safety set). For efficacy endpoints, the rate and associated 95% CI (based on the Clopper‐Pearson method) were presented for each treatment group. Owing to the limited number of patients in this subgroup analysis, no statistical testing was performed between treatment arms, and results are presented by descriptive statistics only. AEs were coded using the MedDRA terminology (Version 23.0) and assessed as per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.