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Article History

Received: 24 August 2020

Accepted: 15 November 2020

First Online: 26 November 2020

Ethics approval and consent to participate

: The trial was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines and was approved by local authorities. An independent ethics committee or institutional review board approved the clinical protocol at every participating center.

: All patients provided written informed consent before study entry.

: J.P.F. has received travelling fees from Behringer Ingelheim. S.V. is President of the Canadian Medical and Surgical Knowledge Translation Research Group, a federally incorporated not-for-profit physician organization; holds a Tier 1 Canada Research Chair in Cardiovascular Surgery; S.V. has also received grants and personal fees for speaker honoraria and advisory board participation from AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, and Merck. He has received grants and personal fees for advisory board participation from Amgen, grants from Bristol-Myers Squibb, personal fees for speaker honoraria and advisory board participation from Eli Lilly, Novo Nordisk and Sanofi, and personal fees for speaker honoraria from EOCI Pharmacomm Ltd, Novartis, Sun Pharmaceuticals and Toronto Knowledge Translation Working Group. D.H.F. has received honoraria from Amgen, AstraZeneca, BI, Eli Lilly and Company, Merck & Co., and Sanofi. C.W. has received honoraria for consultancy and lecturing from AstraZeneca, Bayer, BI, GlaxoSmithKline, Eli Lilly and Company, Merck Sharp & Dome, Mundipharma, Sanofi Genzyme, and Takeda. B.Z. has received research grants awarded to his institution from BI, AstraZeneca and Novo Nordisk, and honoraria from Janssen, Sanofi, Eli Lilly and Company, BI, Novo Nordisk and Merck Sharp & Dome. S.E.I. has consulted and/or served on Clinical Trial Steering/Executive/Publications Committees for Boehringer Ingelheim (BI), AstraZeneca, Novo Nordisk, Sanofi/Lexicon Pharmaceuticals, Merck and Abbott. A.P.O, I.Z. and J.T.G. are employees of Boehringer Ingelheim. S.L. has received honoraria for consultancy from BI and F. Hoffmann La Roche.