 Statistical analysis The analysis of continuous variables will be performed via Students t-test, one or two way analysis of variance depending on the characteristics of the analysis. The study of association between continuous variables will be performed through linear regression methods keeping in consideration possible non-linear effects. The analysis of non-categorical variables will be performed with contingency tables through the use of Fishers exact test and Chi-square test, together with appropriate indicators of association. P0.05 will be considered as significant. A detailed statistical analysis plan will specify the phases of the analysis in relation to the objectives of the research protocol. Publications deriving from this research protocol will present data according to the current recommendations on parallel-group randomized controlled trials involving non-pharmacological treatments. 