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Article History

Accepted: 28 November 2021

First Online: 21 January 2022

Declarations

:

: The study was funded by Daiichi Sankyo Co., Ltd.

: Nobuyuki Sakai received honoraria from Daiichi Sankyo in relation to the organization of this study and for non-related work, and non-related honoraria from Asahi-Intec, Biomedical Solutions, Medtronic, Stryker, and Terumo. Masataka Takeuchi reports the receipt of lecture fees from Stryker. Hirotoshi Imamura has received non-related honoraria from Medtronic and Stryker. Shinichi Yoshimura has received speakers’ bureau fees or honoraria from Boehringer Ingelheim, Daiichi Sankyo, Bayer, Bristol-Myers Squibb, Otsuka Pharmaceutical, Stryker, Kaneka Medics and Medtronic. Kazunori Toyoda reports personal fees from Daiichi Sankyo, Bayer Yakuhin, Bristol-Myers Squibb, Takeda and Nippon Boehringer-Ingelheim, unrelated to the submitted work. Hiroshi Yamagami reports receipt of research grants from Bristol-Myers Squibb; lecture fees from Stryker, Terumo, Medtronic, Johnson and Johnson, Bayer, Daiichi Sankyo, Bristol-Myers Squibb, Boehringer Ingelheim and Otsuka Pharmaceutical; and membership of advisory boards for Daiichi Sankyo in a non-related trial. Shigeru Fujimoto has received lecture fees from Takeda, Nippon Boehringer Ingelheim, Dai-Nippon Sumitomo Pharma, Bayer Yakuhin, Otsuka Pharmaceutical, Pfizer Japan, Daiichi Sankyo, Eisai, Bristol-Myers Squibb, Sanofi K.K. and MSD K. K., and received an honorarium from Daiichi Sankyo in relation to the organization of this study. Norihito Shimamura, Hiromichi Naito, Naoto Kimura, Osamu Masuo, Nobuyuki Hirotsune, Kenichi Morita, and Hideyuki Ishihara have no conflicts of interest to declare. Takafumi Nakatsu, Naoki Miyoshi and Miharu Suda are employees of Daiichi Sankyo.

: The trial was performed in compliance with the Declaration of Helsinki, the International Conference on Harmonization Integrated Guideline for Good Clinical Practice, and additional regulatory codes applicable in Japan. The trial protocol was approved by the Institutional Review Board at each participating center before any patients were enrolled at that center.

: All patients, or a legally competent representative, gave written informed consent to participate.

: Not applicable.

: De-identified individual participant data (IPD) and applicable supporting clinical trial documents (study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code) may be available upon request at . In cases where clinical trial data and supporting documents are provided pursuant to company policies and procedures, Daiichi Sankyo will continue to protect the privacy of clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address:

: Not applicable.

: Nobuyuki Sakai contributed to study design and preparation of manuscript. Masataka Takeuchi, Hirotoshi Imamura, Norihito Shimamura, Shinichi Yoshimura, Hiromichi Naito, Naoto Kimura, Osamu Masuo, Nobuyuki Hirotsune, Kenichi Morita, Kazunori Toyoda, Hiroshi Yamagami and Hideyuki Ishihara contributed to patient enrollment. Shigeru Fujimoto contributed to data analysis and determining outcomes. Takafumi Nakatsu, Naoki Miyoshi and Miharu Suda contributed to study design, statistical analysis and preparation of the manuscript. All authors read and approved the drafts, including the final version for submission, and agree to be accountable for all aspects of the work.