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Article History

Received: 26 June 2023

Accepted: 28 September 2023

First Online: 19 October 2023

Declarations

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: All authors declare funding support for this study and manuscript from Eli Lilly Japan K.K. and Mitsubishi Tanabe Pharma Corporation. Yasushi Ishigaki declares speaker honoraria from Bayer Yakuhin, Novo Nordisk, Sanofi K.K, Eli Lilly Japan K.K., Kowa Pharmaceutical Company, Ono Pharmaceutical, and Sumitomo Pharma. Tetsuaki Hirase is an employee of Eli Lilly Japan K.K. and a minor shareholder in Eli Lilly and Company. Swathi Pathadka is an employee of Eli Lilly Services Private Ltd, India and a minor shareholder in Eli Lilly and Company. Zhihong Cai is an employee of Eli Lilly Japan K.K. and a minor shareholder in Eli Lilly and Company. Manaka Sato is an employee of Eli Lilly Japan K.K. and a minor shareholder in Eli Lilly and Company. Ryo Takemura and Noriyuki Ishida declare no further competing interests.

: This study was conducted in accordance with the Declaration of Helsinki of 1964 and its later amendments and all applicable laws and regulations in Japan. As this was a retrospective observational study based on secondary use of previously collected, anonymized patient data, informed consent from patients and independent ethical review board approval of the protocol were not required according to the Ethical Guidelines for Medical and Health Research Involving Human Subjects by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare, Japan. The JMDC database is a commercial database, and the datasets were used through a license with JMDC Inc. (Tokyo, Japan) in accordance with the JMDC Privacy Policy (ExternalRef removed).