Minegishi, Yuji http://orcid.org/0000-0001-5023-8058
Yamaguchi, Ou
Sugawara, Shunichi
Kuyama, Shoichi
Watanabe, Satoshi
Usui, Kazuhiro
Mori, Masahide
Hataji, Osamu
Nukiwa, Toshihiro
Morita, Satoshi
Kobayashi, Kunihiko
Gemma, Akihiko
Funding for this research was provided by:
Nippon Boehringer Ingelheim Co. Ltd.
Article History
Received: 24 June 2020
Accepted: 31 January 2021
First Online: 1 March 2021
Ethics approval and consent to participate
: The study was approved by the Institutional Review Boards of all participating institutions and by the Institutional Review Board of Nippon Medical School Foundation (approval number: nnms2018–1002-01). The study was performed in accordance with the Declaration of Helsinki, the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practice, and local laws. All patients provided written informed consent. The trial is registered with the Japan Registry of Clinical Trials (JRCT) as trial number 031180136, and the University Hospital Network (UMIN) as trial number 000017877.
: Not applicable.
: O.Y. reports honoraria from Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, Taiho Pharmaceutical Co., Ltd., MSD, Chugai Pharmaceutical Co., Ltd., and AstraZeneca. S.S. reports honoraria from Nippon Boehringer Ingelheim Co., Ltd., AstraZeneca, Chugai Pharmaceutical Co., Ltd., MSD, Bristol-Myers Squibb, Ono Pharmaceutical Co., Ltd., Eli Lilly and Company, Pfizer, Novartis, Taiho Pharmaceutical Co., Ltd., and Kyowa Hakko Kirin Co., Ltd. S.W. reports honoraria from Eli Lilly and Company, Pfizer, Novartis, AstraZeneca, Chugai Pharmaceutical Co., Ltd., Bristol-Myers Squibb, Boehringer Ingelheim, MSD, Ono Pharmaceutical Co., Ltd., Daiichi Sankyo and Taiho Pharmaceutical Co., Ltd. M.M. reports honoraria from AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical Co., Ltd., Eli Lilly and Company, MSD, Novartis Pharma, Ono Pharmaceutical Co., Ltd. and Taiho Pharmaceutical Co., Ltd. O.H. reports honoraria from AstraZeneca, Boehringer Ingelheim and Novartis, and grants or funds from GlaxoSmithKline, AstraZeneca, Novartis, Bayer Health Care, Boehringer Ingelheim and Daiichi Sankyo. S.M. reports honoraria from AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan, MSD, Nippon Boehringer Ingelheim Co., Ltd., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., and Taiho Pharmaceutical Co., Ltd., and research funding to their institution from Nippon Boehringer Ingelheim Co., Ltd. K.K. reports honoraria (speech fees) from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Eli Lilly and Company, Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co. and Ono Pharmaceutical Co., Ltd. A.G. reports honoraria from Boehringer Ingelheim. Y.M., S.K., K.U., and T.N. declare no conflict of interest.