Statistical analysis
Data are expressed as mean and standard deviation (SD). The statistical analysis was performed using JMP® Version Pro 17 software for Windows (SAS Institute Inc, Cary, NC, USA). Rough data were analyzed for the presence of outliers by using Tietjen-Moore test and by robust PCA outliers’ method, which identifies outliers in the residuals of a robust decomposition of the data into a low-rank matrix and a sparse matrix of residuals. The comparison of variables at time 0 (basal) and after 5 years of treatment was obtained as after treatment minus before treatment mathematical difference (delta, Δ); it follows that a negative delta value indicates a reduction in the value of the variable under examination after treatment, while a positive delta indicates an increase.The statistical significance of the difference of each continuous variable in each arm of the study was evaluated using the Student’s 