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They deserve an award. ❶Reasons for protocol deviations, should they arise, will be recorded. Alternatively, the patient will be randomized and consent will be obtained subsequently under a deferred consent model, where permitted by the site Research Ethics Board REB and as per individual country requirements concerning informed consent in medical research. Due to blinding of all relevant parties, decisions to discontinue life-sustaining therapies and other outcomes that require subjective assessments e.

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