Statistical analysis
This was a pilot study and, in the absence of previous data to build a statistical hypothesis, the sample was not statistically sized. The inclusion of 40 patients, 20 per group, was believed to be a clinically significant sample allowing to calculate the sample size for any future larger studies. Assuming a drop-out rate post-randomization of 20%, a total of 48 patients (24 per group) was randomized.Categorical data were summarized by absolute frequencies and tested by the chi-square tests with Yates’ correction. Continuous data did not show a normal distribution, therefore they were summarized by median and interquartile range (IQR) and tested by Wilcoxon Rank-sum tests. Statistical computations and visualizations were carried out by R-studio (2022.07.2), which is the integrated development environment of R. In all analyses, a 