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Article History

Received: 12 July 2023

Accepted: 2 October 2023

First Online: 14 October 2023

Declarations

:

: The study protocol was approved by the Ethics Committee of the National Center for Global Health and Medicine (NCGM-S-004537-00) (Tokyo, Japan) and conducted in accordance with the tenets of the Declaration of Helsinki. There was no written or verbal informed consent because informed consent was obtained from all participants as per Ethical Guidelines for Medical and Health Research Involving Human Subjects of Japan. The guidelines state that, “it is not always necessary to obtain informed consent from study participants. However, researchers must publish information on the implementation of the study, including the purpose of the study for observational studies only using past clinical records and not human tissue samples.” The purpose, methods, and analyses of the study and the details on how to refuse participation were posted in the hospital outpatient clinic.

: Not applicable.

: Katsunaka Mikami received financial support from Otsuka Pharmaceutical Co., Ltd. and Shionogi & Co., Ltd.; honoraria from Otsuka Pharmaceutical Co., Ltd., Shionogi & Co., Ltd., Sumitomo Pharma Co., Ltd., and Takeda Pharmaceutical Co., Ltd.; travel expenses for the spouse from Pfizer; and consulting fees from Otsuka Pharmaceutical Co., Ltd., Shionogi & Co., Ltd., and Viatris. The other authors declare that they have no competing interests that could affect this study.