2.13. Statistical methods
Considering this is a pilot study, analyses will be primarily performed in the per protocol population; however, we will also perform intention-to-treat analyses whenever feasible. We will perform a general descriptive analysis of all study variables. The results will be expressed as means (standard deviation [SD]) or medians (range) for the quantitative variables and as absolute and relative frequencies for the categorical variables.We will use Pearson’s χ