The primary outcome will be analyzed based on the ITT population. A supportive analysis based on the PP population will be performed. For the primary outcome, the change in weight will be calculated from baseline to week 52. The null hypothesis will be tested using a two-sided Wilcoxon signed-rank test with significance level 0.05. All outcomes will be analyzed based on the ITT population. Supportive analyses based on the PP population will be performed. For all secondary outcomes the changes will be calculated from baseline to the specified time points. The changes over the whole observation period will be investigated using non-parametric ANOVA methods for longitudinal data. Post-hoc tests for changes at all measured time points may be performed using Wilcoxon signed-rank tests. Correlations between outcome variables will be investigated using Spearman's rank correlation coefficient. Two-tailed tests with significance level 0.05 will be used for all analyses. No adjustment for multiple testing will be performed. All outcome variables will be summarized using descriptive statistics. All analyses will be performed using the latest version of R (http://www.r-project.org).