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Article History

Accepted: 10 June 2024

First Online: 2 July 2024

Declarations

:

: This study was sponsored by Kyowa Kirin Co., Ltd.

: Y Okubo reports grants from Kyowa Kirin during the conduct of the study and grants and/or personal fees from AbbVie, Amgen Inc., Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, Janssen Pharma, Jimro, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sanofi, Shiseido, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB Pharma outside the submitted work. SK reports grants from Kyowa Kirin during the conduct of the study and personal fees from AbbVie, Janssen Pharma, and Taiho Pharmaceutical outside the submitted work. MM reports grants from Kyowa Kirin during the conduct of the study and grants and/or personal fees from AbbVie, Amgen Inc., Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, Janssen Pharma, Kyowa Kirin, Maruho, Novartis Pharma, Taiho Pharmaceutical, and Torii Pharmaceutical outside the submitted work. SS reports grants from Kyowa Kirin during the conduct of the study and grants and/or personal fees from AbbVie, Amgen Inc., Eisai, Eli Lilly, Janssen Pharma, Kaken Pharmaceutical, Kyowa Kirin, Maruho, Mitsubishi Tanabe Pharma, Nippon Kayaku, Nippon Zoki Pharmaceutical, Sanofi, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB Pharma outside the submitted work. NK is an employee of Kyowa Kirin. Y Ouchi is an employee of Kyowa Kirin. TT reports personal fees from Kyowa Kirin during the conduct of the study and grants and/or personal fees from AbbVie, Amgen Inc., Boehringer Ingelheim, Maruho, and Taiho Pharmaceutical outside the submitted work.

: The study (NCT04061252) was conducted in compliance with the protocol, the Declaration of Helsinki (World Medical Association [WMA]), the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice Guidelines, and other applicable laws and regulations. It was approved by the concerned institutional review board.

: All participants gave written informed consent to participate in the research and publish the results.

: The data that support the findings of this study will be available in the Vivli repository () as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied. Individual participant data (text, tables, figures, and appendices) that provide the basis for the results reported in this paper will be deidentified and shared.

: All authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article. Conceptualization: All authors contributed equally. Investigation: All authors contributed equally. Data curation: NK and Y Ouchi. Formal analysis: Y Ouchi. Methodology: NK and Y Ouchi. Writing: All authors contributed equally. Review/editing: All authors contributed equally. All authors have given their approval for this version to be published and are in agreement to be accountable for all aspects of the work as a whole.