Funding for this research was provided by:
Astellas Pharma US
Received: 21 April 2020
Accepted: 8 June 2020
First Online: 13 June 2020
Ethics approval and consent to participate
: Local certified review boards approved the trial protocol. The trial will be conducted in full compliance with the articles of the Declaration of Helsinki and in accordance with the Clinical Trial Act in Japan. After the patients are initially screened for eligibility on the basis of their prior medical records, they will receive adequate explanations of the trial plan before they provide written informed consent.
: Not applicable.
: AT received modest honoraria from Ono, Kowa, Daiichi Sankyo, Taisho Toyama, Takeda, Mitsubishi Tanabe, Teijin, Novo Nordisk, Bayer, Fukuda Denshi, and Boehringer Ingelheim, and a research grant from GlaxoSmithKline. MS received grants non-purpose research grants from Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Chugai, Eli Lilly, Kowa, Mitsubishi Tanabe, MSD, Novo Nordisk, Ono, Taisho Toyama, and Takeda; lecturer fees from Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Chugai, Eli Lilly, Kowa, Mitsubishi Tanabe, Mochida, MSD, Novo Nordisk, Ono, Taisho Toyama, and Takeda; and advisory board for Novo Nordisk. YO received lecture fees from Astellas, AstraZeneca, Ono, Mitsubishi Tanabe, Bayer, Novo Nordisk, Kowa, and Sanofi. KN received honoraria from Astellas, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, Mitsubishi Tanabe, MSD, Ono, Otsuka, and Takeda, research grants from Asahi Kasei, Astellas, Bayer, Boehringer Ingelheim, Mitsubishi Tanabe, Teijin, and Terumo, and scholarships from Astellas, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Takeda, and Teijin. Other authors declare no potential competing interests.