Statistical analysis: single analysis in intention to treat (arms assigned by the randomization). Overall first species risk = 5%. Bilateral formulation of statistical tests. Statistical methods used: bivariate analysis (one factor ANOVA, Pearson Chi2 test or Fisher test), multivariate analysis (ANCOVA, logistic regression). Taking into account the longitudinal data (M0-M3-M5) with generalized estimating equations (GEE). Graphic representation of the evolutions over the study.