Statistical analysis
Statistical analysis was conducted by an International Statistical Institute Elected Member not involved in the study using IBM SPSS Statistics 25 package. Using a two-way mixed model analysis of variance, checks were made to assess whether there were statistically significant differences between the study periods analyzed in the two groups, as well as whether the groups differed in terms of the variable under analysis in the same study period. Spearman’s rank correlation made it possible to check whether there was a statistically significant relationship between the analyzed variables. The Mann-Whitney U test was used to assess the presence of statistically significant differences between the two independent groups (in terms of age). A two-tailed P value lower than 0.05 was considered as statistically significant. Analyses were based on the intent-to-treat (ITT) population (patients who took ≥ 1 tablet and had ≥ 1 post-randomization assessment).