Abe, Ichitaro
Takahashi, Naohiko
Mukai, Yasushi
Kimura, Tetsuya
Yamaguchi, Keita
Takita, Atsushi
Origasa, Hideki
Okumura, Ken
,
Funding for this research was provided by:
Daiichi Sankyo Company (Not applicable)
Article History
Received: 10 May 2021
Accepted: 14 July 2021
First Online: 3 August 2021
Declarations
:
: The study was approved by the ethics committee of Oita University Faculty of Medicine (approval number B17–021, dated 12 December 2017), and by the appropriate review board at each participating center. All study procedures were conducted in accordance with the principles of the Declaration of Helsinki (as revised in Fortaleza, Brazil, October 2013) and the International Council for Harmonisation Good Clinical Practice Guidelines. All patients provided written informed consent. The study was registered in the University hospital Medical Information Network Clinical Trials Registry under the identifier UMIN000029693.
: Not applicable.
: IT has nothing to disclose. NT received remuneration from Daiichi Sankyo, Bristol-Myers Squibb, and Pfizer Japan, and received research funding from Ono Pharmaceutical. YM received remuneration from Daiichi Sankyo, Bristol-Myers Squibb, and Pfizer Japan, and received research funding from Bristol-Myers Squibb. TK, KY, and AT are employees of Daiichi Sankyo. HO has nothing to disclose. KO received remuneration from Nippon Boehringer Ingelheim, Daiichi Sankyo, Johnson & Johnson, and Medtronic.