Nishiyama, Hiroyuki http://orcid.org/0000-0001-7423-596X
Tsuzuki, Toyonori http://orcid.org/0000-0002-4855-4366
Ohyama, Chikara http://orcid.org/0000-0003-1550-8379
Matsuyama, Hideyasu http://orcid.org/0000-0001-5607-7769
Shinozaki, Kenta
Hayashi, Yuko
Hayashi, Nobuya
Koto, Ryo
Shin, Eisei
Ogawa, Osamu http://orcid.org/0000-0001-5491-8878
Funding for this research was provided by:
AstraZeneca
Article History
Received: 20 January 2023
Accepted: 2 July 2023
First Online: 27 July 2023
Declarations
:
: Dr. Nishiyama has received research funding support from Ono, Chugai, Bayer, Takeda Pharmaceutical and Astellas Pharma, and received advisory or consulting fees from Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb (BMS), Chugai, Janssen, and Merck Sharp & Dohme (MSD), and participated in speakers' bureaus for Astellas Pharma, AstraZeneca, Chugai, and MSD. Dr. Tsuzuki has received honoraria for lectures from AstraZeneca and Chugai. Dr. Ohyama has received honoraria for lectures from Janssen, Astellas Pharma, Nippon Shinyaku, AstraZeneca, Bayer, BMS, and Chugai, received research funding support from AstraZeneca, Parexel International, Ono, and MSD, and received grants from Sanofi, Nippon Shinyaku, Astellas, Ono, and Bayer. Dr. Matsuyama has received honoraria from Janssen Pharma, Chugai, Bayer, AstraZeneca, and MSD, and research funding support from Janssen Pharma, Chugai, Bayer, AstraZeneca, and MSD. Drs. Shinozaki, N Hayashi, Shin, Y Hayashi and Koto are employees of AstraZeneca K.K. and hold stocks of AstraZeneca PLC. Dr. Ogawa has received research funding support from Takeda, Nippon Shinyaku, AstraZeneca, and Bayer. All authors confirm that they have full control of all primary data and agree to allow the journal to review this data if requested.
: The study protocol was approved by an independent ethical committee (Non-Profit Organization MINS Institutional Review Board, Approval ID: 190235). The study was reviewed and approved by the ethics committee in each site under the guidelines of the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects (promulgated on December 22, 2014 and partially revised on February 28, 2017). All patients included in the study provided written informed consent prior to study participation. In patients who had died or were lost to follow-up prior to registration, opt-out was applicable according to the ethical committee/institutional review board’s approval.