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Conflict of interest: EV was a consultant for Amphora Medical Inc. LMT was a consultant for Amphora Medical Inc. All other coauthors have no conflict of interest to disclose.
Clinical Trial Registration Number: NCT02480829.
Author Contributions: R Brière: Data acquisition and analysis, data interpretation, drafting of manuscript, critical revision of manuscript, final approval of manuscript; E Versi: Protocol design, data interpretation, critical revision of manuscript, final approval of manuscript; PO Richard: Conception and design, data interpretation, critical revision of manuscript, final approval of manuscript; M Gratton: Conception and design, data acquisition and interpretation, critical revision of manuscript, final approval of manuscript; LM Tu: Conception and design, data acquisition and interpretation, critical revision of manuscript, final approval of manuscript.