Criteria for discontinuing or modifying allocated interventions {11b}
PEx
SECONDARY
Participants in the PEx cohort may discontinue or modify one or more PERIT intervention(s) at any time in consultation with their treating clinician, except as required by participation in a nested sub-study. They may also discontinue from the PEx cohort entirely if (i) they and/or their legal guardian requests withdrawal or (ii) their treating medical team decides continued participation is not in their best interests. Consent to the use of study data, including data collected until the time of discontinuation and data to inform primary and secondary outcomes, will be requested specifically from participants or their legal representative. Following discontinuation, participants will receive all care as directed by their treating medical team. Any procedures for withdrawal from or modification of any assigned interventions will be specified in their relevant subprotocols.