Yamashita, Takeshi
Hagii, Joji
Morishima, Yoshiyuki
Akasaka, Takaaki
Matsumoto, Takuyuki
Kimura, Tetsuya
Funding for this research was provided by:
Daiichi-Sankyo
Article History
Received: 26 September 2018
Accepted: 18 January 2019
First Online: 15 February 2019
Ethics approval and consent to participate
: The study was conducted in compliance with the ethical principles stated in the Declaration of Helsinki (revised in 2013), the International Conference on Harmonisation Good Clinical Practice Guidelines, the Ethical Guidelines for Medical and Health Research Involving Human Subjects (Partially Amended on February 28, 2017), and the protocol for this study. The appropriateness of this study was reviewed and approved by the ethics committee of each participating facility. Written informed consent was obtained from all participants in this study.
: Not applicable.
: This study was planned and funded by Daiichi Sankyo Co., Ltd. It was implemented as a company-initiated clinical study. EP-CRSU Co., Ltd. oversaw the monitoring, data management, statistical analysis, and other duties. Audit was conducted by Linical Co., Ltd. TY has received research funds from Bristol-Myers Squibb Company, Bayer HealthCare, Daiichi Sankyo Co., Ltd., and Mitsubishi-Tanabe Pharma Corporation; and remuneration from Daiichi Sankyo Co., Ltd., Bayer HealthCare, Pfizer Japan Inc., Bristol-Myers Squibb Company, Boehringer Ingelheim Co., Ltd., Eisai Co., Ltd., TOA EIYO LTD., Takeda Pharmaceutical Company Limited, and ONO PHARMACEUTICAL CO., LTD. JH has received speakers’ bureau honoraria from Daiichi Sankyo Co., Ltd., Boehringer Ingelheim Co., Ltd., Bayer Healthcare, Bristol-Myers Squibb Company, and Pfizer Japan Inc. YM, TA, TM, and TK are employees of Daiichi Sankyo Co., Ltd.
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