Inagaki, Nobuya
Yang, Wenying
Watada, Hirotaka
Ji, Linong
Schnaidt, Sven
Pfarr, Egon
Okamura, Tomoo
Johansen, Odd Erik
George, Jyothis T.
von Eynatten, Maximilian
Rosenstock, Julio
Perkovic, Vlado
Wanner, Christoph
Cooper, Mark E.
Alexander, John H.
Komuro, Issei
Nangaku, Masaomi
Funding for this research was provided by:
Boehringer Ingelheim
Article History
Received: 9 August 2019
Accepted: 1 October 2019
First Online: 22 October 2019
Compliance with ethical standards
:
: N.I. has received honoraria from Kowa company; research funding from Mitsubishi Tanabe, Daiichi Sankyo and AstraZeneca; and subsidies/donations from Takeda, MSD, Ono, Sanofi, Japan Tobacco Inc., Mitsubishi Tanabe, Novartis, Boehringer Ingelheim, Kyowa Kirin, Astellas, Daiichi Sankyo, Kissei Pharmaceutical, Dainippon Pharma, Sanwa kagaku, Eli Lilly, Novo Nordisk, Teijin Pharma, and Taisho-Toyama Pharma. W.Y. has attended advisory boards for Novo Nordisk; received investigator-initiated trial research funds from AstraZeneca; been a speaker for Novo Nordisk, Bayer, Sanofi Aventis, Merck Sharp & Dohme China, AstraZeneca, Eli Lilly, Boehringer Ingelheim, and Servier; and received honorarium and travel support as an advisory board member from Merck & Co., Inc. H.W. has received honoraria from Eli Lilly, Mitsubishi Tanabe Pharma, Sanofi, Takeda Pharmaceutical Company, Novartis Pharma, Nippon Boehringer Ingelheim, Daiichi Sankyo, Ono Pharmaceutical, Astellas Pharma, FUJIFILM Pharma, Terumo Corporation, MSD; research funding from Eli Lilly, Novartis Pharma, Sanwa kagaku; subsidies/donations from Mitsubishi Tanabe Pharma, Kissei Pharmaceutical, Nippon Boehringer Ingelheim, Novartis Pharma, Sumitomo Dainippon Pharma, Sanofi, MSD, Pfizer Japan, Astellas Pharma, Takeda Pharmaceutical Company, Novo Nordisk, Teijin Pharma; and departmental endowments from Takeda Pharmaceutical Company, MSD, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Ono Pharmaceutical, Kowa company, and Sanwa kagaku. L.J. has received consulting and lecture fees from Eli Lilly and Company, Bristol-Myers Squibb, Novartis, Novo Nordisk, Merck, Bayer, MSD, Takeda, Sanofi, Roche, Boehringer Ingelheim, and AstraZeneca; and research support from Roche, Sanofi, MSD, AstraZeneca, Novartis, and Bristol-Myers Squibb. S.S., E.P., T.O., O.E.J., J.T.G., and M.v.E are employees of Boehringer Ingelheim. J.R. has served on scientific advisory boards and received honoraria or consulting fees from Eli Lilly, Sanofi, Novo Nordisk, Janssen, AstraZeneca, Boehringer Ingelheim, and Intarcia; he has also received grants/research support from Merck, Pfizer, Sanofi, Novo Nordisk, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Genentech, Janssen, Lexicon, Boehringer Ingelheim, and Intarcia. V.P. has received research support from the Australian National Health and Medical Research Council (Project and Program Grant); served on steering committees for trials supported by AbbVie, Boehringer Ingelheim, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Novo Nordisk, Pfizer, Retrophin, and Tricida; and served on advisory boards, spoken at scientific meetings, or both for AbbVie, Astellas Pharma, AstraZeneca, Bayer, Baxter, Bristol-Myers Squibb, Boehringer Ingelheim, Durect Corporation, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Novartis, Novo Nordisk, Pfizer, Pharmalink, Relypsa, Roche, Sanofi, Servier, and Vitae. He has a policy of having honoraria paid to his employer. C.W. has received fees for advisory services to Boehringer Ingelheim and MSD as well as honoraria for lecturing from AstraZeneca, Eli Lilly and Sanofi. M.E.C. has received fees for advisory services and honoraria from Boehringer Ingelheim, Sanofi, Servier, Bayer, Astra Zeneca, Reata, MundiPharma and MSD and a grant from NovoNordisk. J.H.A. has received personal fees from Abbvie, Bristol-Myers Squibb, CSL Behring, Janssen Pharmaceutics, Novo Nordisk, Pfizer, Portola, and Teikoku; and institutional research support from Boehringer Ingelheim, Bristol-Myers Squibb, Cryolife, CSL Behring, Tenax Therapeutics, and VoluMetrix. I.K. has received honororia from Astellas Pharma Inc., MSD K.K., Edwards Laboratories Corporation, Otsuka Pharmaceutical Co. Ltd, Kowa Company, Ltd., Daiichi Sankyo Company, Limited, Taisho Pharma Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd, Takeda Pharmaceutical Company Limited, Mitsubishi Tanabe Pharma Corporation, Teijin Pharma Limited, Toa Eiyo Ltd, Bayer Yakuhin, Ltd, Terumo Corporation, Nipro Corporation; research funding from Ono Pharmaceutical Co., Ltd; and subsidies/donations from Actelion Pharmaceuticals Japan Ltd. Astellas Pharma Inc., Amgen Astellas BioPharma K.K., AstraZeneca K.K., MSD K.K., Shionogi & Co., Ltd, Daiichi Sankyo Company, Limited, Takeda Pharmacentical Company Limited, Toa Eiyo Ltd, Nippon Boehringer Ingelheim Co., Ltd, Bayer Yakuhin, Ltd, and Pfizer Japan Inc. M.N. is an advisor for KHK, Astellas, GSK, Daiichi-Sankyo, Mitsubishi-Tanabe, JT, Boehringer-Ingelheim; has received honoraria from KHK, Astellas, AstraZeneca, GSK, Daiichi-Sankyo, Mitubishi-Tanabe, Chugai, Torii, JT; manuscript fees from KHK; research funding from JT, KHK; and subsidies/donations from KHK, Astellas, Ono, Daiichi-Sankyo, Takeda, Mitsubishi-Tanabe, Chugai, Torii, MSD, Otsuka, Dainippon-Sumitomo, JT, and Boehringer Ingelheim.
: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and/or with the Helsinki Declaration of 1964 and later versions.
: This research involves human participants. This report was limited to the Asian population from the CARMELINA<sup>®</sup> trial (ClinicalTrials.gov Identifier, NCT01897532). The study protocol was approved by the institutional review board or independent ethics committee from each site (approval numbers: not applicable) and all patients provided written informed consent before entering the trial. Full details of the approval process are provided in previous publications [CitationRef removed, CitationRef removed].
: Informed consent or substitute for it was obtained from all patients for being included in the study.