Kinoshita, Taku
Shinoda, Masahiro
Nishizaki, Yasuhiro
Shiraki, Katsuya
Hirai, Yuji
Kichikawa, Yoshiko
Tsushima, Kenji
Shinkai, Masaharu
Komura, Naoyuki
Yoshida, Kazuo
Kido, Yasutoshi
Kakeya, Hiroshi
Uemura, Naoto
Kadota, Junichi
Funding for this research was provided by:
Ono Pharmaceutical
Article History
Received: 28 April 2022
Accepted: 5 August 2022
First Online: 27 September 2022
Change Date: 8 December 2022
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s12916-022-02695-5
Declarations
:
: This study adhered to the Declaration of Helsinki, Good Clinical Practice, and relevant local/international guidelines. The protocol and patient consent forms were first reviewed and approved by the institutional review board at the leading study site (International University of Health and Welfare Narita Hospital, approval number FN-1-2005-075) and subsequently by the institutional review boards/ethics committees at all participating sites, which are listed in Additional file : IRB information. All patients provided written informed consent to participate in this study.
: Not applicable.
: The sponsor provided funding for the study and publication of the manuscript. Employees of the sponsor were involved in the study design and collection, analysis, and interpretation of the data and reviewed the manuscript. The corresponding author had full access to all the data and had final responsibility for the decision to submit the manuscript for publication.TK, MS1, KS, YH, and KT report institution research funding from Ono Pharmaceutical Co. Ltd. in relation to this work.YN reports institution research funding from Ono Pharmaceutical Co. Ltd. in relation to this work and institution research funding from ITO EN Co. Ltd., AstaReal Co. Ltd., Mizkan Holdings Co. Ltd., and Kanagawa Institute of Industrial Science and Technology unrelated to this work.YK1 reports institution research funding from Ono Pharmaceutical Co. Ltd. in relation to this work and institution research funding from Nobelpharma Co. Ltd., Chugai Pharmaceutical Co. Ltd., Japan Tobacco Inc., and Pfizer Japan Inc. unrelated to this work.MS2 reports institution research funding from Ono Pharmaceutical Co. Ltd. in relation to this work and institutional research funding from FUJIFILM Toyama Chemical Co. Ltd., AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., Pfizer Japan Inc., and Genova Inc. unrelated to this work.NK and KY are employees of Ono Pharmaceutical Co. Ltd.YK2 reports consultancy fees from Ono Pharmaceutical Co. Ltd. in relation to this work; research funding from Abbott Medical Japan, LLC, and ROHTO Pharmaceutical Co. Ltd. unrelated to this work; lecture fees from Abbott Medical Japan, LLC, unrelated to this work; equity in Quantum Molecular Diagnostics Japan, LLC, unrelated to this work; and reagents for serological testing from Abbott Medical Japan, LLC, unrelated to this work.HK reports consultancy fees from Ono Pharmaceutical Co., Ltd. in relation to this work and lecture fees from MSD K.K., Pfizer Japan Inc., and Shionogi & Co. Ltd. unrelated to this work.NU reports consultancy fees from Ono Pharmaceutical Co. Ltd. in relation to this work and the following activities unrelated to this work: institution research grants from Regeneron Pharma Inc., Eli Lilly Japan K.K., Japan Agency for Medical Research and Development, ARTham Therapeutics Inc., EA Pharma Co. Ltd., and VLP Therapeutics, LLC; consultancy fees from Ono Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corp., Sato Pharmaceutical, Co. Ltd., ARTham Therapeutics Inc., Otsuka Pharmaceutical Co. Ltd., EA Pharma Co. Ltd., and Maruho Co. Ltd., honoraria from Mochida Pharmaceutical Co. Ltd., fees for participating on advisory boards from Japan Research Foundation Clinical Pharmacology, the Ministry of Education, Culture, Sports, Science and Technology, and the Ministry of Health, Labour and Welfare; fees for leadership or fiduciary roles for American Society for Clinical Pharmacology and Therapeutics and GHIT Fund; unpaid board member for Japanese Society for Clinical Pharmacology and Therapeutics, Clinical Research Support Center Kyushu and Oita IAM; stock or stock options in ARTham Therapeutics Inc. and Oita IAM; and monetary gifts to the institution from Oita IAM.JK reports consultancy fees from Ono Pharmaceutical Co. Ltd. in relation to this work and consultancy fees from FUJIFILM Toyama Chemical Co. Ltd., KOBAYASHI Pharma Co. Ltd., and Kyorin Pharma Co. Ltd. unrelated to this work; institutional research funding from MSD Co. Ltd., Taisho Pharma Co. Ltd., Nippon Boehringer Ingelheim Co. Ltd., Daiichi Sankyo Co. Ltd., Pfizer Japan Inc., Kyorin Pharma Co. Ltd., Astellas Pharma Inc., Chugai Pharmaceutical Co. Ltd., Shionogi & Co. Ltd., and Teijin Pharma Ltd. unrelated to this work; and lecture fees from Ono Pharmaceutical Co. Ltd., MSD Co. Ltd., AstraZeneca K.K., Nippon Boehringer Ingelheim Co. Ltd., Pfizer Japan Inc., Shionogi & Co. Ltd., Taisho Toyama Pharma Co. Ltd., Meiji Seika Pharma Co. Ltd., Sanofi K.K., Kyorin Pharma Co. Ltd., Astellas Pharma Inc., Sumitomo Dainippon Pharma Co. Ltd., Bristol-Myers Squibb Company, Daiichi Sankyo Co. Ltd., Chugai Pharmaceutical Co. Ltd., Novartis Pharma K.K., Taisho Pharma Co. Ltd., FUJIFILM Medical Co. Ltd., GlaxoSmithKline K.K., and DENKA SEIKEN Co. Ltd. unrelated to this work.