Statistical Analysis
Pseudo-anonymazed data were collected in an encrypted database; statistical analyses were performed using SPSS statistic (version 27.0 IBM Corp.). Data are described as number (percentage) or median (interquartile range, IQR). Non-parametric tests were used for the analysis according to categorical or continuous nature of the variables (Chi-square test, Fisher’s exact test, Spearman’s rank correlation, and Mann–Whitney test). The intra-subject median change from baseline to W24 was analyzed by paired Wilcoxon test; significance for changes in binary and multinomial variables were analyzed by the symmetry McNemar chi-square test and by the marginal homogeneity test, respectively. The Delta of the variables of interest was calculated as the difference between week 24 and baseline median values. The study was designed as an analysis of a continuous variable between two independent groups of subjects (experimental arm and control arm). The reference study is the one mentioned earlier by Gates and colleagues (Gates et al. 