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Article History

Accepted: 27 February 2023

First Online: 28 March 2023

Declarations

:

: Kazutaka Nozawa was an employee of Pfizer Japan, Inc. during the conduct of the study and manuscript development, and is an employee of Viatris Pharmaceuticals Japan, Inc. at the time of submission. Nozomi Ebata is an employee of Pfizer Japan, Inc. Ryozo Wakabayashi is an employee of Clinical Study Support, Inc. Yingsong Lin, Takahiro Ushida, Masataka Deie, and Shogo Kikuchi were not financially compensated for their collaboration in this project or for the development of this manuscript; however, Takahiro Ushida has received an honorarium from Pfizer Japan Inc. outside of this work. The authors have no other conflicts of interest that are directly relevant to the content of this article.

: This study did not require patient consent or approval from an institutional review board and independent ethics committee because the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects do not apply to studies that exclusively use de-identified data. Nonetheless, the ethics committee at Aichi Medical University was consulted, and the committee decided evaluation by the committee was unnecessary. This study was conducted in accordance with guidelines including the Good Pharmacoepidemiology Practices (Revision 3) issued by the International Society for Pharmacoepidemiology.

: Not applicable.

: Not applicable.

: The dataset that supports the findings of this study are available from Medical Data Vision Co., Ltd. (Tokyo, Japan), a commercial database provider. The dataset analyzed for this study cannot be shared publicly because of contractual agreements between Medical Data Vision Co., Ltd. and medical facilities. For inquiries regarding access to the dataset used in this study, please contact Medical Data Vision Co., Ltd. ().

: Not applicable.