Funding for this research was provided by:
Received: 26 November 2019
Accepted: 19 May 2020
First Online: 12 June 2020
Ethics approval and consent to participate
: The study was conducted in compliance with the ethical principles of the Declaration of Helsinki and International Conference on Harmonization Guidelines for Good Clinical Practice. The Kyushu University Certified Institutional Review Board for Clinical Trials reviewed the study protocol and informed consent documents following the 2018 Clinical Research Act of Japan. The Certified Institutional Review Board for Clinical Trials found the study in compliance with clinical research methods and protocols described therein and approved the study. The study was registered in the Japan Registry of Clinical Trials No. jRCTs071190006 on April 26, 2019.All participants were required to provide direct, written consent for participation in the study.
: Not applicable.
: This study was supported by Daiichi Sankyo Co., Ltd. Daiichi Sankyo was involved in the design of the study and drafting of the manuscript. IDD Inc. (Tokyo, Japan) oversaw the monitoring, data management, statistical analysis, and other duties. The audit was conducted by CMIC HOLDINGS Co., Ltd. (Tokyo, Japan).II declares that he has no other competing interests. TA, YM, AT, TM, and TK are employees of Daiichi Sankyo Co., Ltd.