Kitano, Shigehisa http://orcid.org/0000-0002-4041-8298
Shimizu, Toshio
Koyama, Takafumi
Ebata, Takahiro
Iwasa, Satoru
Kondo, Shunsuke
Shimomura, Akihiko
Fujiwara, Yutaka
Yamamoto, Noboru
Paccaly, Anne
Li, Siyu
Rietschel, Petra
Sims, Tasha
Funding for this research was provided by:
The study was funded by Regeneron Pharmaceuticals, Inc. and Sanofi.
Article History
Received: 29 May 2020
Accepted: 30 September 2020
First Online: 4 November 2020
Compliance with ethical standards
:
: SK: Research grants from Regeneron Pharmaceutical, Inc. during the conduct of the study; personal lecture fees from Sanofi, Nippon Kayaku, Meiji Seika Pharma, Taiho, Celgene, and Sumitomo Dainippon Pharma; personal lecture and advisory board fees from AstraZeneca, Chugai, Pfizer, Boehringer Ingelheim, Novartis, Daiichi-Sankyo, MSD, Kyowa Hakko Kirin, Ono Pharmaceutical Co., Ltd., and Bristol-Myers Squibb; research grants and personal lecture and advisory board fees from Eisai; research grants from Astellas, Gilead Sciences, AMED (Japan Agency for Medical Research and Development), and JSPS (Japan Society for the Promotion of Science). TS: Institutional research expenses from Regeneron Pharmaceuticals, Inc. during the conduct of the study; institutional research expenses from Novartis, Eli Lilly, AbbVie, AstraZeneca, Eisai, Astellas, Chordia Therapeutics, Bristol-Myers Squibb, Daiichi-Sankyo, Milleniam-Takeda, PharmaMar, FivePrime, 3D-Medicine and Symbio-Pharma, advisory role personal fees from Milleniam-Takeda, personal lecture fees from Boehringer Ingelheim, Taiho Pharma, Chugai Pharmaceutical, Co., Ltd., Ono Pharmaceutical Co., Ltd., Ono Pharma Taiwan Co., Ltd., outside the submitted work. TK, TE, SI, SK, AS: No conflict of interest declared. YF: Research funding grants from Abbie, AstraZeneca, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Incyte, Merck Serono, MSD, and Novartis; advisory role personal fees from AstraZeneca, Bristol-Myers Squibb, Novartis, and Ono Pharmaceutical Co., Ltd., speaker’s bureau personal fees from Bristol-Myers Squibb, Ono Pharmaceutical Co., Ltd., and Taiho, all outside of the submitted work. NY: Research grants from Chugai, Taiho, Eisai, Lilly, Quintiles, Astellas, Bristol-Myers Squibb, Novartis, Daiichi-Sankyo, Pfizer, Boehringer Ingelheim, Kyowa-Hakko Kirin, Bayer, Ono Pharmaceutical Co., Ltd. and Takeda; honoraria from Ono Pharmaceutical Co., Ltd., Chugai, AstraZeneca, Pfizer, Lilly, Bristol-Myers Squibb; and consulting fees from Eisai, Otsuka, Takeda, and Boehringer Ingelheim, outside the submitted work. AP, SL, PR, TS: Employee and shareholder of Regeneron Pharmaceuticals, Inc.
: This study was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. The study protocol was approved by ethics committees.
: Informed consent was obtained from all individual participants included in the study. This article does not report data from animals performed by any of the authors.
: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication has been approved by major health authorities (e.g., FDA, EMA, PMDA, etc.), if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to ExternalRef removed.