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The sponsor was involved in the development of the study design, data analysis, data interpretation, writing of the manuscript, and the decision to submit the manuscript for publication. All authors had full access to the study results.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Shoki Okuda, Yukiko Yanagida, and Shigeru Tokita are employees of MSD K.K., Tokyo, Japan, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and may own stock and\/or stock options in Merck & Co., Inc., Rahway, NJ, USA. Zaina P. Qureshi was an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may have owned stock and\/or stock options in Merck & Co., Inc., Rahway, NJ, USA at the time of the study. Yuji Homma is an employee of JMDC Inc. and Chie Ito was an employee of JMDC Inc. at the time of the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study utilized commercially available de-identified secondary data from the JMDC Claims Database, which contains a significant level of protection against the release of personal information to outside entities. Furthermore, all analyses were conducted by JMDC Inc., and the project deliverables comprised aggregated data, as descriptive statistics in the form of tables and figures. Patient counts below five were reported as \u2018<\u20095\u2019 to protect privacy. No reporting of individual cases to regulatory agencies was planned as part of this retrospective observational database analysis. The Japanese ethical guidelines for medical research do not require ethics review of studies using a de-identified database comprising previously collected secondary data (Notified 23 March 2021, amended 10 March 2022: Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare; and Ministry of Economy, Trade and Industry). Therefore, no ethics review or Institutional Review Board review was required for this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"In accordance with Japanese guidelines, informed consent was not required for this study using a de-identified database comprising previously collected secondary data.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The JMDC Claims Database analyzed in this study (analysis dataset) is not publicly accessible, and the data cannot be shared with external researchers according to the contract with JMDC Inc. Please contact JMDC Inc. () for inquiries about access to the dataset used in this study.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Shoki Okuda, Yukiko Yanagida, Zaina P. Qureshi, and Shigeru Tokita conceived the study. Shoki Okuda, Chie Ito, and Yuji Homma designed the study and data analysis plan. Chie Ito and Yuji Homma analyzed the data. Zaina P. Qureshi and Shigeru Tokita contributed to study design. All authors contributed to interpretation of data, reviewed the manuscript, and approved the final version of the manuscript. Shoki Okuda is the guarantor and accepts full responsibility for the work.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}