Table 3.

Populations for analysis.

Population	Description
All screened	All participants who sign the informed consent form.
Intent-to-treat (ITT)	All randomized participants whether or not the randomized intervention was administered. This population will be based on the study intervention to which the participant was randomized and will be the primary population for the analysis of efficacy data.
Per-protocol	All randomized participants completing at least two QoL questionnaires 6 months apart, as long as the study participant is disease-free. Participants will be analyzed according to the intervention they actually received.