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Article History

Accepted: 10 December 2020

First Online: 15 January 2021

Declarations

:

: This research was sponsored and funded by Pfizer.

: SH, KN, and YA are full-time employees of Pfizer Japan, Inc. and hold Pfizer stock. YI is a full-time employee of Pfizer R&D Japan and holds Pfizer stock. YY and KO have no conflicts of interest to declare.

: This study involved data that exist in an anonymized structured format and contained no personal information. Studies exclusively using unlinkable anonymized data are outside the scope of the “Ethical Guidelines for Medical and Health Research Involving Human Subjects” by the Japanese government. Therefore, obtaining informed consent and approval from the ethical review committee were not required for this study.

: Not applicable.

: The data that support the findings of this study are available from the database maintained by MinaCare Co. Ltd. (Tokyo, Japan), independent of Pfizer. Pfizer is not involved in validating or storing the data included in the database. Restrictions apply to the availability of these data, which were used under license for the current study, and are not publicly available. However, data are available from the authors upon reasonable request and with permission from MinaCare Co. Ltd.

: Not applicable.

: SH, YI, and KN were involved in the development of the protocol. YY developed the database, and YI analyzed the data. All authors, including KO and YA, contributed to conceptualizing and designing the study, interpreting the results, and drafting and revising the manuscript. All authors approved the final manuscript and agreed to be accountable for all aspects of the work.