Statistical analysis
Data were analyzed with the ITT population. Normality was analyzed by the Shapiro-Wilk test. Data of normal distribution are reported as the mean ± standard deviation (SD) and compared with the Student’s t-test. Non-normally distributed data or ordinal data are presented as the median (interquartile range) and were compared with the Mann–Whitney U test. Categorical data are presented as numbers (percentages) and compared with the χ2 test or Fisher’s exact test. Changes in mYPAS-SF over time were analyzed using a mixed-effect model with repeated measurement (MMRM) analysis using m-YPAS scores at all follow-up time points (T1, T2, and T3) as the dependent variable, treatment as the main factor, m-YPAS scores at T0 as a covariate, and a random intercept to model within-subject correlation. A p value < 0.05 was considered statistically significant. R for Windows version 4.1.2 was used for statistical analysis.