Data Analysis
PBC
R (Version 4.1.3; R Core Team) and R Studio (Version 2021.09.1; Posit PBC) were used for statistical analysis and creation of the graphs. Statistical analysis of all variables was performed with robust linear mixed models using the R packages lme4 [Per-protocol (PP) and intention-to-treat (ITT) analyses were performed. In the PP analysis, only subjects without missing values for the respective variable were included (complete cases). If missing data were available for individual outcomes, fewer study participants were considered accordingly. In the ITT analysis, all randomized cases were included. Missing values were imputed by multiple imputation (n=50) using the R package micemd [