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Article History

Received: 25 July 2019

Accepted: 24 October 2019

First Online: 9 November 2019

Availability of data and materials

: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: ExternalRef removed.

: The study protocol was approved by local institutional review boards and/or ethics committees. This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki, consistent with Good Clinical Practices, and applicable regulatory requirements.

: Informed consent was obtained from each patient prior to performing any study procedures and following adequate explanation of the aims, methods, objectives, and potential hazards of the study.

: Kausik K. Ray has received significant research grants from Pfizer Inc., Amgen, Sanofi, Regeneron Pharmaceuticals, Inc., and MSD Pharma outside of the submitted work; modest honoraria from Dr. Reddys, Zuellig Pharma, Sanofi, Amgen, Boehringer Ingelheim, Novo Nordisk, and Pfizer Inc.; and modest consultant/advisory board fees from Medco, AstraZeneca, Resverlogix, Kowa, Abbvie, Sanofi, Amgen, Boehringer Ingelheim, Esperion, Akcea, and Regeneron Pharmaceuticals, Inc. Stefano Del Prato has received research funding from AstraZeneca, Boehringer Ingelheim, Novartis Pharmaceuticals Co., and Merck Sharpe & Dohme; and is a consultant for or has received honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceuticals, Laboratoires Servier, Merck Sharpe & Dohme, Novartis Pharmaceuticals Co., Novo Nordisk, Sanofi, Servier, and Takeda Pharmaceuticals. Dirk Müller-Wieland has received speaker’s bureau and consultant/advisory board fees from Amgen, AstraZeneca, Boehringer Ingelheim, MSD (Merck), Novartis, Novo Nordisk, and Sanofi. Bertrand Cariou has received research funding and honoraria from Amgen, Sanofi and Regeneron Pharmaceuticals, Inc.; research funding from Pfizer; and honoraria from Abbott, Amgen, Akcea, AstraZeneca, Pierre Fabre, Genfit, Eli Lilly and Company, MSD Merck & Co., Novo Nordisk, and Servier. Helen M. Colhoun has received grants, personal fees, and non-financial support from Sanofi and Regeneron Pharmaceuticals, Inc.; grants, institutional fees, and non-financial support from Eli Lilly and Company; grants from AstraZeneca and Pfizer Inc.; and grants and fees from Novo Nordisk; and owns stock in Roche Pharmaceuticals and Bayer. Francisco J. Tinahones has received speaker’s bureau and consultant/advisory board fees from AstraZeneca, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceuticals, Merck Sharpe & Dohme, Novartis Pharmaceuticals Co., Novo Nordisk, Sanofi, and Regeneron Pharmaceuticals, Inc. Catherine Domenger is an employee and shareholder in Sanofi. Alexia Letierce is an employee of and shareholder in Sanofi. Jonas Mandel is an employee of IviData Stats, contracted to Sanofi. Rita Samuel is an employee of and shareholder in Regeneron Pharmaceuticals, Inc. Maja Bujas-Bobanovic is an employee and shareholder in Sanofi. Lawrence A. Leiter has received personal fees from Esperion and HLS; grants and personal fees from Amgen, AstraZeneca, Eli Lilly and Company, Merck, Regeneron Pharmaceuticals, Inc., and Sanofi; and grants from Kowa and The Medicines Company.