Statistical analysis
The primary outcome was the composite tolerability score based on four (For the microbial analysis, the Kruskal–Wallis and Wilcoxon signed-rank test, implemented among classes set to 0.01, were used to determine alpha-diversity indices. Differences in beta-diversity were determined using permutational multivariate analysis of variance (PERMANOVA), a permutation-based multivariate analysis of variance to a matrix of pairwise distance to partition the inter-group and intra-group distance. An unpaired two-tailed Student’s t-test was used to compare alpha-diversity indices and bacterial abundance between the two groups. The LEfSe (Linear discriminatory analysis [LDA] Effect Size) was used to identify unique bacterial taxa that drive differences between different study groups (