Schmölzer, Georg M.
,
Pichler, Gerhard
Solevåg, Anne Lee
Fray, Caroline
van Os, Sylvia
Cheung, Po-Yin
Funding for this research was provided by:
Thrasher Research Fund (no award number)
Institute of Circulatory and Respiratory Health (AR1 155222)
Article History
Received: 30 August 2018
Accepted: 1 February 2019
First Online: 19 February 2019
Ethics approval and consent to participate
: The SURV1VE trial will be conducted in compliance with the guidelines of the Declaration of Helsinki in its latest form, the International Conference on Harmonization of Good Clinical Practice Guidelines [CitationRef removed]. 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.
: Not applicable. Results will be presented at relevant national and international conferences as well as being published in peer-reviewed journals.
: The authors declare that they have no competing interests.
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