2.4. Statistical Analysis
No formal sample size calculations or between-group comparisons were performed for these explorative Phase 2 studies that were designed to obtain additional knowledge to elucidate further Phase 2/3 studies. The primary analysis was performed for the intent-to-treat (ITT) dataset, which included all patients who received at least one dose of study drug and at least one testosterone measurement after first administration of the study drug. The safety evaluation was based on all patients who received at least one dose of study medication. Descriptive statistics were conducted for all study variables. Categorical data were presented using counts and percentages, whilst continuous variables were presented using the mean, standard deviation (SD), standard error of the mean (SEM), median and range.