Ethics approval and consent to participate
The EXSCEL study protocol was approved by the ethics committee at each participating site, and the statistical analyses were performed by the Duke Clinical Research Institute, independent of the sponsor, Amylin Pharmaceuticals (a wholly owned subsidiary of AstraZeneca). All patients provided written informed consent.
Consent for publication
Not applicable.
Competing interests
R.J.M. reports research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. M.F. reports support by the NIH, Alleviant, Gradient, Novo Nordisk, Reprieve, Sardocor, Tenax, and Doris Duke. M.F. is a consultant and/or has ownership interest in Abbott, Acorai, Ajax, Alio Health, Alleviant, Artha, Astellas, Audicor, AxonTherapies, Berlin Heals, Bioventrix, BMS, Bodyguide, Bodyport, Boston Scientific, Broadview, Cadence, Cardiosense, Cardioflow, Corstasis, Clinical Accelerator, CVRx, Daxor, Edwards LifeSciences, Echosens, Feldschuh Foundation, Fire1, FlowMod, FutureCardia, Gradient, Hatteras, HemodynamiQ, Impulse Dynamics, ISHI, Lumia Health, Medtronic, Novo Nordisk, NucleusRx, Omega, Orchestra, Paragate, Parasym, Pharmacosmos, Procyreon, Proton Intelligence, Puzzle, ReCor, Scirent, SCPharma, Shifamed, Splendo, Summacor, SutroSam, SyMap, Terumo, Tricav, Vifor Pharma, Vironix, Viscardia, VizAI, and Zoll. N.S. has received personal fees from Amgen, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Sanofi, and Novo Nordisk. R.R.H. reports personal fees from AstraZeneca, Lilly, Merck KGaA and Novartis. R.L.C and A.I.A have no disclosures.