Yamaoka, Kunihiro http://orcid.org/0000-0001-8858-9435
Tanaka, Yoshiya http://orcid.org/0000-0002-0807-7139
Kameda, Hideto http://orcid.org/0000-0002-4330-5782
Khan, Nasser
Sasaki, Nobuhito
Harigai, Masayoshi http://orcid.org/0000-0002-6418-2603
Song, Yanna
Zhang, Ying
Takeuchi, Tsutomu http://orcid.org/0000-0003-1111-8218
Funding for this research was provided by:
AbbVie
Article History
Accepted: 30 March 2021
First Online: 27 May 2021
Declarations
:
: This work was supported by AbbVie, who contributed to the study design; data collection, analysis and interpretation; and writing, reviewing, and approval of the final version.
: Kunihiro Yamaoka has received speakers bureau fees from AbbVie GK, Astellas Pharma Inc., Bristol-Myers Squibb, Chugai Pharmaceutical Co. Ltd, Mitsubishi Tanabe Pharma Corporation, Pfizer Japan Inc., and Takeda Pharmaceutical Co. Ltd. Yoshiya Tanaka has received speaking fees and/or honoraria from AbbVie, Asahi-Kasei Pharma Corporation, Astellas Pharma Inc., Bristol-Myers Squibb, Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Eisai Co. Ltd, Eli Lilly Japan KK, Gilead, GlaxoSmithKline KK, Janssen Pharmaceutical KK, Mitsubishi Tanabe Pharma Corporation, Novartis, Pfizer Japan Inc., Sanofi KK, and YL Biologics; and research grants from AbbVie, Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Eisai Co. Ltd, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co. Ltd, and UCB. Hideto Kameda has received consulting fees, speaking fees, and/or honoraria from AbbVie GK, Asahi-Kasei Pharma Corporation, Bristol-Myers Squibb, Chugai Pharmaceutical Co. Ltd, Eli Lilly Japan KK, Gilead, Janssen Pharmaceutical KK, Mitsubishi Tanabe Pharma Corporation, Novartis, Pfizer Japan Inc., Sanofi KK, and UCB Japan; and research grants from AbbVie GK, Asahi-Kasei Pharma Corporation, Astellas Pharma Inc., Chugai Pharmaceutical Co. Ltd, Eisai Co. Ltd, Mitsubishi Tanabe Pharma Corporation, and Novartis. Nasser Khan, Nobuhito Sasaki, Yanna Song, and Ying Zhang are employees of AbbVie and may own stocks or stock options. Masayoshi Harigai has received grants from AbbVie Japan Co. Ltd, Bristol-Myers Squibb KK, Chugai Pharmaceutical Co. Ltd, Eisai Co. Ltd, Mitsubishi Tanabe Pharma Co., Santen Pharmaceutical Co. Ltd, Takeda Pharmaceutical Co. Ltd, and Teijin Pharma, Ltd; and personal fees from AbbVie Japan Co. Ltd, Astellas Pharma Inc., Bristol-Myers Squibb KK, Chugai Pharmaceutical Co. Ltd, Eisai Co. Ltd, Janssen Pharmaceutical KK, Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co. Ltd, Takeda Pharmaceutical Co. Ltd, and Teijin Pharma, Ltd. Tsutomu Takeuchi has received grants from AbbVie GK, Asahi-Kasei Pharma Corporation, Astellas Pharma Inc., AYUMI Pharmaceutical Corporation, Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Eisai Co. Ltd, Mitsubishi Tanabe Pharma Corporation, Nippon Kayaku Co. Ltd, Novartis Pharma KK, Pfizer Japan Inc., and Takeda Pharmaceutical Co. Ltd; and personal fees from AbbVie GK, Astellas Pharma Inc., AstraZeneca KK, Bristol-Myers Squibb KK, Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Eisai Co. Ltd, Eli Lilly Japan KK, GlaxoSmithKline KK, Janssen Pharmaceutical KK, Mitsubishi Tanabe Pharma Corporation, Nippon Kayaku Co. Ltd, Novartis Pharma KK, Pfizer Japan Inc., Sanofi KK, Teijin Pharma Ltd, Taiho Pharmaceutical Co. Ltd, Taisho Pharmaceutical Co. Ltd, Takeda Pharmaceutical Co. Ltd, and UCB.
: All studies were conducted according to the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, applicable regulations and guidelines governing clinical study conduct, and the Declaration of Helsinki. Study-related documents were reviewed and approved by independent Ethics Committees and Institutional Review Boards.
: All patients provided written informed consent.
: Not applicable.
: These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: ExternalRef removed.
: Not applicable.
: All authors contributed to the study concept/design, data acquisition, analysis, and interpretation, as well as writing and critical review of the manuscript. All authors provided final approval of the submitted version.