Statistical analysis
SECONDARY
Demographic patient characteristics included age and sex by median, range (minimum to maximum), and frequencies. Clinical characteristics are presented as mean and standard deviation.The primary and secondary endpoints were analyzed in the full analysis set, defined as all patients who underwent at least one TdES session and had at least one efficacy assessment. The results are presented as mean and mean difference from the baseline, 95% confidence intervals (CIs).Mayo Co., Ltd. had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. All authors had full access to all data in this trial, and the corresponding author was responsible for the decision to submit for publication.