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Article History

Received: 21 December 2022

Accepted: 16 July 2023

First Online: 3 October 2023

Declarations

:

: The Independent Ethics Committee and the Institutional Review Boards at Japanese Red Cross Narita Hospital and Kameda Medical Center approved the study protocol. The study was conducted in accordance with accepted practices for pharmacoepidemiology studies issued by the International Society for Pharmacoepidemiology [CitationRef removed] and the Council for International Organizations of Medical Sciences [CitationRef removed]. Patients identified in the claims databases were not required to provide consent and could opt-out from participating in the study. As this study was a cross-sectional review using de-identified claims data and medical records without invasive procedures and interventions that did not use samples from human participants, written or oral informed consent was waived by the Institutional Review Boards of Japanese Red Cross Narita Hospital and Kameda Medical Center. This study used an opt-out approach to guarantee opportunities for study participants to obtain disclosed information and to refuse to participate in this study.

: Not applicable.

: R.H., E. N., T.H., M.K., S.J., and T.M. have received consultancy fees from Pfizer Inc in connection with this study. D.S. has received consultancy fees from Pfizer Inc in connection with this study and is currently affiliated with the Department of Infectious Diseases, Anjo Kosei Hospital, Anjo, Aichi, Japan. K.K. has received consultancy fees from Pfizer Inc in connection with this study and is currently affiliated with the Faculty of Informatics, Gunma University, Maebashi, Gunma, Japan. H.C. has received funding from Pfizer Inc in connection with this study through her university and has received funding from the Cystic Fibrosis Foundation, National Institute of Health, and Pfizer Inc. C.D. and N.S. are employees of Pfizer Inc. Y.T. has received speaker fees and/or honoraria from AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, GlaxoSmithKline, Mitsubishi Tanabe Pharma, and Pfizer Inc; and research grants from AbbVie, Asahi Kasei, Boehringer Ingelheim, Chugai Pharmaceutical Co., Ltd, Daiichi Sankyo, Eisai, and Takeda. S.S. has received consultancy fees from Pfizer Inc in connection with this study and has received funding from Bristol Myers Squibb, the Cystic Fibrosis Foundation, Janssen, National Institute of Health, PCORI, Pfizer Inc, and Pfizer Japan Inc, and personal consulting fees from Daiichi Sankyo, Janssen, Medtronic, Merck, and Pfizer Inc.