Kadowaki, Takashi
Wang, Guang
Rosenstock, Julio
Yabe, Daisuke
Peng, Yongde
Kanasaki, Keizo
Mu, Yiming
Mattheus, Michaela
Keller, Annett
Okamura, Tomoo
Johansen, Odd Erik
Marx, Nikolaus
Funding for this research was provided by:
Boehringer Ingelheim
Article History
Received: 12 February 2020
Accepted: 5 June 2020
First Online: 27 June 2020
Compliance with ethical standards
:
: TK reports consulting/lecture fees from Abbott, Asahi Mutual Life Insurance, Astellas Pharma Inc., AstraZeneca KK, Bayer, Boehringer Ingelheim, Cosmic, Daiichi Sankyo Company, Limited, Eli Lilly and Company, Fujifilm, FUJIREBIO, Johnson & Johnson Co., Ltd., Kissei Pharmaceutical Co., Ltd., Kowa Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Medical Review, Medscape Education, Medtronic Sofamor Danek, Mitsubishi Tanabe Pharma Corporation, MSD, Musashino Foods, Nipro, Novartis International AG, Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi S.A., SANWA KAGAKU KENKYUSHO CO., LTD., Sumitomo Dainippon, Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited., and Terumo; grants from Astellas Pharma Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kissei Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD, Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi S.A., Sumitomo Dainippon, Taisho Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Company Limited.; contracted research from AstraZeneca KK and Takeda Pharmaceutical Company Limited.; joint research from Daiichi Sankyo Company, Limited.; endowed chair from Asahi Mutual Life Insurance, Boehringer Ingelheim, Kowa Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD, Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd, and Takeda Pharmaceutical Company Limited. JR 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. DY has received consulting or speaker fees from MSD KK, Novo Nordisk Pharma Ltd. and Taisho Toyama Pharmaceutical Co. Ltd., and clinically commissioned/joint research grants from Taisho Toyama Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Novo Nordisk Pharma Ltd., Arklay Co. Ltd. and Terumo Co. Ltd. KK has received lecture fees from Boehringer Ingelheim, Eli Lilly and Sanofi. Boehringer Ingelheim, Mitsubishi Tanabe Pharma and Ono Pharmaceutical contributed to establishing the Division of Anticipatory Molecular Food Science and Technology, Medical Research Institute, Kanazawa Medical University, and is under contract for consultancy with Boehringer Ingelheim. GW, YP, YM have no conflicts to disclose. MM, AK, TO, and OEJ are employees of Boehringer Ingelheim. NM is funded by the German Research Foundation SFB TRR 219 (projects M-03 and M-05); reports giving lectures for and receiving honoraria from Amgen, Boehringer Ingelheim, Sanofi-Aventis, Merck Sharp & Dohme, Bristol-Myers Squibb, AstraZeneca, Lilly, Novo Nordisk; receiving unrestricted research grants from Boehringer Ingelheim; serving as an advisor for Amgen, Bayer, Boehringer Ingelheim, Sanofi-Aventis, Merck Sharp & Dohme, Bristol-Myers Squibb, AstraZeneca, Novo Nordisk; serving in trial leadership for Boehringer Ingelheim and Novo Nordisk; and declining all personal compensation from pharmaceutical and device companies.
: 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 CAROLINA<sup>®</sup> trial (ClinicalTrials.gov Identifier, NCT01243424). 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.