Main efficacy analysis The main variable of efficacy will be evaluated by comparing the difference between baseline and end values of the different treatments using ANCOVA model with the baseline value of the test as covariate. Adjusted means were calculated and confidence intervals at 95% (95%) by the ANCOVA model. As the main decision criterion of efficacy the contrast between the adjusted means at the endpoint of the study between the two treatment groups will be performed. Additionally and as an exploratory intent, shall be evaluated the compared effect at the different times of observation. No multiplicity adjustments will be made due to the exploratory nature of this second analysis.