Adverse events/reactions (AE/AR)
infection, CRF
INFECTION, EVENTS, CRF, COMPLICATIONS
AE/ARs that will be recorded daily for the first 7 days after inclusion in the trial. The AE/ARs that will be recorded are infection and any skin complications. All events will be evaluated as “related to the trial medicine/unrelated to the trial medicine” and entered in a pre-specified form in the electronic CRF in REDCap.