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Authors
Takeuchi, Tsutomu http://orcid.org/0000-0003-1111-8218
Tanaka, Yoshiya
Erdman, Jay
Kaneko, Yuichiro
Saito, Masako
Higashitani, Chieri
Smulders, Ronald
Lademacher, Christopher
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Funding
Funding for this research was provided by:
Astellas Pharma, Inc.
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Article History
Received: 28 March 2020
Accepted: 2 October 2020
First Online: 21 October 2020
Ethics approval and consent to participate
: The study was conducted in accordance with the protocol, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, applicable regulations and guidelines governing clinical study conduct, and the ethical principles that have their origin in the Declaration of Helsinki. Written informed consent was obtained from each study patient prior to any study-related procedures. The study protocol and all materials used to obtain informed consent were reviewed and approved by an Institutional Review Board at each study site to ensure that patients’ human rights, safety, and well-being were protected.
: Not applicable.
: T. Takeuchi reports grants from Astellas Pharma, Inc.; Chugai Pharmaceutical Co, Ltd.; Daiichi-Sankyo Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; AbbVie GK; Asahikasei Pharma Corp.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Eisai Co., Ltd.; AYUMI Pharmaceutical Corporation; Nipponkayaku Co. Ltd.; Novartis Pharma K.K.; and Shionogi & Co., LTD and personal fees from Astellas Pharma, Inc.; AbbVie GK; AYUMI Pharmaceutical Corporation; Eisai Co., Ltd.; Gilead Sciences, Inc.; GlaxoSmithKline K.K.; Sanofi K.K.; Taiho Pharmaceutical Co., Ltd.; Mitsubishi Tanabe Pharma Co.; Daichi Sankyo Co. Ltd.; Chugai Pharmaceutical Co., Ltd.; Taisho Pharmaceutical Co., Ltd.; Eli Lilly Japan K.K.; Novartis Pharma K.K.; Boehringer-Ingelheim Co., Ltd.; Nipponkayaku Co. Ltd.; Pfizer Japan Inc.; Bristol-Myers K.K.; Janssen Pharmaceutical K.K.; and UCB Japan Co. Ltd.Y. Tanaka reports personal fees from Daiichi-Sankyo; Astellas Pharma, Inc.; Chugai; Eli Lilly; Pfizer; AbbVie; YL Biologics; Bristol-Myers; Takeda; Mitsubishi-Tanabe; Novartis; Eisai; Janssen; and Teijin and grants from Asahi-kasei, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Ono.C. Lademacher, J. Erdman, Y. Kaneko, M. Saito, C. Higashitani, and R. Smulders are employees of Astellas Pharma, Inc.
