Analysis of baseline parameters and concomitant medications
Baseline parameters, medical history and concomitant medication will be documented during screening and throughout the trial until the last follow-up visit. Enrolment, protocol deviations and discontinuations from the study drug and the study will be summarised. Demographics (e.g. age, race, ethnicity and sex) and medical history and concomitant medication will also be summarised by treatment group. For qualitative variables (e.g. sex), absolute (