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In case of modifications in the study protocol that are not merely of a formal nature but contain changes pertinent to the study participants, a renewed vote of the relevant ethics committees will be obtained. If applicable, the patients (parents) will be informed in the patient information and consent form about changes in the terms and conditions of the trial. The SURV1VE trial will only start the randomization of participants after approvals from the relevant ethics committees have been obtained. The SURV1VE trial has been approved by the Human Research Ethics Board, University of Alberta, Edmonton, Canada (Pro00066739). In case of a necessary protocol amendment, the amendment will be submitted to the ethics committee.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable. 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