Randomization
The randomization procedure will consist of a computer-generated sequence of random numbers using SPSS (SPSS Statistics, version 28), which will then be used to allocate patients to either of the 2 treatment arms. The randomization sequence will be generated and maintained by an independent study administrator in Frankfurt. Once the patient is included the ID number is communicated to the study administration in Frankfurt. On the same day, the randomization arm will be communicated to the local team and applied to the participant included.