Statistical analyses
Efficacy analyses were carried out using data for the full analysis set (FAS), defined as all eligible patients who had received at least one dose of the study drug and for whom baseline data were available. Supplementary analyses for efficacy endpoints were conducted using data for the per protocol set (PPS), defined as all patients in the FAS whose treatment was provided in compliance with the study protocol and the Japanese package insert of mirogabalin [For the primary endpoint, the primary analysis was performed by calculating summary statistics, 95% CIs and Statistical analysis was carried out using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA). The significance level for hypothesis testing was set at 5% (two-sided), and the CI for both sides was 95%. Because the study was exploratory, no adjustments were made for multiple comparisons.