Statistical analysis
Continuous variables were checked for normality using the Shapiro-Wilk
test, and are reported as mean and standard deviation if normally
distributed, or as median and interquartile range (IQR) if non-normally
distributed. Categorical variables are presented as counts and
percentages, and differences between groups were calculated with the
2-tailed Fisher exact test. The primary outcome was assessed in a
time-to-event analysis, according to the Kaplan-Meier method. The EHRA
scores at baseline and at 9-month follow-up were compared with the
Wilcoxon rank-sum test for repeated measures. A 2-sided
p<0 .05 defined statistical significance. All statistical
analyses were performed with the software RStudio (RStudio Inc., Boston,
MA).