Statistical analyses
Normality of continuous variables was tested with the Skewness and Kurtosis test and examined with visual inspection of a histogram. Continuous variables are reported as medians with interquartile ranges (IQR) or mean ± standard deviation (SD); frequencies and percentages are used to describe categorical data. Continuous variables were assessed with the Mann-Whitney U-test. Categorical variables were evaluated with the Pearson’s chi-square test (or Fisher’s exact test if appropriate). To assess the treatment effect on 6-month change in LVMi in each of the LVMi stratified sub-groups we used a linear model adjusting for baseline differences in LVMi (ANCOVA), that included an interaction term between the baseline LVMi subgroup and treatment. We also estimated treatment effect over baseline LVMi values from 40 to 90 g/m