Treatment allocation and randomization
All patients were informed about the study design and study interventions to support them in their decision to be allocated to one of the intervention groups, based on balanced randomization with a group proportion of 1:1:1 with varying permutation block sizes, or, if they did not wish to be randomized, to choose by their own preference. The randomized allocation was conducted via central randomization at the Institute for Clinical Research (IKF), Berlin.