Demographic and baseline characteristics will be represented by distributions of frequency and summarized statistics based on the dataset, both for each treatment group and all clinical trial subjects combined. The main baseline characteristics will be presented. ANCOVA will be used with adjustment for baseline values. For primary and secondary variables, all quantitative, it will be used Student's t-test or Mann-Whitney test for the statistical evaluation and comparison between groups. In all tests, it will be used the significance level of 5% or p<0.05.