Intention-to-treat analysis will be applied in the analysis of both primary and secondary end-points. Statistical analyses will be performed using "Statistical" software (StatSoft v.8, OK, USA). Quantitative variables will be summarized as mean and standard deviation for normally distributed data and median and interquartile range for abnormally distributed data. Groups will be compared with the Student-t test for independent samples in case of normally distributed quantitative variables. Otherwise, the comparison will be performed with the Mann-Whitney test. Categorical variables will be summarized as frequencies and percentage with 95% associated confidence intervals. Groups will be compared with the Chi-square or Fischer exact test, as appropriate. Statistical analysis will be conducted at a significance level of 5%.