Okuda, Shoki
Qureshi, Zaina P.
Yanagida, Yukiko
Ito, Chie
Homma, Yuji
Tokita, Shigeru
Article History
Received: 30 May 2022
Accepted: 14 March 2023
First Online: 20 April 2023
Declarations
:
: This study is not considered human subject research because it does not involve any interactions or interventions with human subjects. This is because this study utilized commercially available de-identified secondary data provided from JMDC Inc. JMDC Inc. is responsible for collecting claims data and for managing the database. All analyses were conducted by JMDC Inc. using the fixed, de-identified database, which is only accessible to the data analysts and system administrators as employees of JMDC Inc. The project deliverables comprised aggregated data, which were prepared by JMDC Inc., under a research contract with the authors. To protect privacy, patient counts below five were reported as “ < 5”. No reporting of individual cases to regulatory agencies was planned as part of this retrospective observational database summarization. This study was performed in compliance with the principles enshrined in the Declaration of Helsinki as well as the Japanese Ethical Guidelines for Medical and Biological Research Involving Human Subjects (Notified 23<sup>rd</sup> March 2021, amended 10<sup>th</sup> March 2022: Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare; and Ministry of Economy, Trade and Industry). Because these Japanese guidelines do not require ethics review of studies using a de-identified database comprising previously obtained secondary data, review by an Ethics Committee/Institutional Review Board and informed consent were not required for this study or obtained for the use of these data in this study.
: Not applicable.
: SO, YY, and ST are employees of MSD K.K., Tokyo, Japan, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. ZPQ 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. YH is an employee of JMDC Inc. and CI was an employee of JMDC Inc. at the time of the study.