The authors wish to thank the participants of the study. The authors also wish to thank Tsunenori Nakazawa for providing support with the bioanalysis of this study; and Yoshitake Furuta, Yoko Urasaki, and Nobuaki Watanabe, PhD, for assisting with the plasma protein binding ratio analysis of DS-8500a.
Sponsorship for this study and article processing charges were funded by Daiichi Sankyo Co. Ltd., Tokyo, Japan. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
Medical Writing and Editorial Assistance
The authors wish to thank Michelle Belanger, MD, of Edanz Medical Writing for providing medical writing assistance, which was funded by Daiichi Sankyo Co., Ltd.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Manabu Kato was responsible for conception and design of the work and acquisition and interpretation of data. Hitoshi Ishizuka was responsible for conception and design of the work and interpretation of data. Takashi Taguchi was responsible for conception of the work and interpretation of data. Kazuhito Shiosakai and Emi Kamiyama were responsible for design of the work and analysis and interpretation of data. Michio Sata and Takafumi Yoshida were responsible for acquisition of data.
Manabu Kato is an employee of Daiichi Sankyo Co., Ltd. Hitoshi Ishizuka is an employee of Daiichi Sankyo Co., Ltd. Takashi Taguchi is an employee of Daiichi Sankyo Co., Ltd. Kazuhito Shiosakai is an employee of Daiichi Sankyo Co., Ltd. Emi Kamiyama is an employee of Daiichi Sankyo Co., Ltd. Michio Sata and Takafumi Yoshida have nothing to disclose.
Compliance with Ethics Guidelines
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. The study received institutional review board approval and all participants provided written informed consent.
The datasets generated during and/or analyzed during the current study are not publicly available, because the sponsor has the rights to the data generated in this study. However, datasets are available from the corresponding author on reasonable request.