|1. Enrolled||All participants who sign the ICF|
|2. Randomly assigned to trial intervention (RAI)||Randomized to either intervention or control arm|
|3. Modified intent to treat (mITT)||Participants in RAI with partial data (but not fully compliant with the protocol)|
|4. Evaluable per protocol population (PP)||All participants who fully complied with the protocol|
|5. Safety population for analysis||
All participants randomly assigned to trial intervention.|
Participants will be analysed according to the intervention they actually received.