Statistical analysis
Patients were analyzed according to their ongoing therapy to identify possible differences in any of the demographic or clinical variables collected. Frequency and percentages were the descriptive analyses performed on the categorical variables. Continuous variables were summarized as means ± standard deviation. For categorical variables, differences between groups were evaluated using Chi-square test or Fisher’s exact test (if more than 20% of the cells in a contingency table have expected counts less than 5). For quantitative variables, the Shapiro-Wilk test was performed in order to test the normality of data. If the p-value was less than or equal to 0.05 (non-normality), the comparison between groups was performed by means of the non-parametric Wilcoxon rank sum test. Otherwise, the comparison was performed using the T test. Moreover, comparison between timepoint 1 value and the other timepoints was performed using the paired t-test (or the Wilcoxon signed rank test in the case of non-normal data). Finally, an ANOVA test (or Kruskal–Wallis test in the case of non-normal data) was performed to compare the means in case of more than 2 groups. Differences were considered statistically different if p values resulted <0.05. Analyses were performed using software SAS 9.4 version (SAS, NC, USA).