Withdrawal and loss to follow-up
A participant may be withdrawn for the following reasons:Withdrawal of parental consent for the intervention, follow-up, data collection, and/or the entire trialAny alteration in the participant’s condition, which, in the opinion of the treating clinician, justifies the discontinuation of the interventionReasons for withdrawal will be reported in the CONSORT diagram. Withdrawals will be presented as frequencies and percentages, overall, and by trial arm. Participants will be identified as lost to follow-up if it is not possible to contact them for 6 weeks after randomisation. Loss to follow-up will also be reported in the CONSORT diagram.