Table 5.

Populations for statistical analyses

Population	Description
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.