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[DOI] [PubMed] [Google Scholar] 78.Engebretsen K.V., Blom-Hgestl I.K., Hewitt S., Risstad H., Moum B., Kristinsson J.A., Mala T

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Any important protocol modification such as changes to eligibility criteria, outcome analyses will be thoroughly communicated with DSMB members and will obtain amendment clearance from the institutional review board (IRB)