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Article History

Accepted: 6 November 2022

First Online: 28 November 2022

Declarations

:

: This study was conducted as part of a joint research course (Real-World Evidence and Data Assessment) between Juntendo University and Shin Nippon Biomedical Laboratories Ltd.

: RW, TH, and TL are employees of Clinical Study Support, Inc.

: The datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request.

: The ethics committee of Juntendo University, Tokyo, Japan, approved this study (approval number: E21-0041). This study was conducted in accordance with the provisions of the Declaration of Helsinki.

: This observational study used only secondary, fully anonymized data. An observational study that exclusively uses anonymized data is outside the scope of the Ethical Guidelines for Medical and Health Research Involving Human Subjects in Japan. Therefore, informed consent was not required for this study.

: RW and TH contributed to the study conception and design. TH and TL conducted the statistical analyses. RW contributed to the manuscript drafting. All authors contributed to data interpretation, revised the manuscript critically for important intellectual content, and approved the final manuscript for submission. All authors read and approved the final manuscript.