Khandker, Rezaul Karim
Chekani, Farid
Mirchandani, Kirti
Kathe, Niranjan
Article History
Received: 1 March 2023
Accepted: 22 November 2023
First Online: 5 December 2023
Declarations
:
: All the methods in this research study were carried out in accordance with the Declaration of Helsinki. This study used a secondary de-identified database which contained anonymized patient-level data, in compliance with the U.S privacy laws and regulations i.e., the Health Insurance Portability and Accountability Act (HIPAA) of 1996. This study did not involve any interaction with human subjects, collection, use, or transmittal of individually identifiable data, and thus does not fall under the regulatory definitions of human subjects’ research. Thus, this study is exempt from institutional review board (IRB) review and the requirement of obtaining written informed consent from participants, as defined by the US Department of Health and Human Services regulations – 45 CFR 46.102(f)(2)).
: Not applicable.
: FC and RKK employees of Merck Sharp & Dohme Corp., a Merck & Co., Inc. subsidiary, Rahway, NJ, USA, who may own and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. KM is an employee of Complete HEOR Solutions, Chalfont, PA, USA, which received financial compensation to conduct the study analysis. NK was an employee of Complete HEOR Solutions when the study was conducted. The authors report no other relevant conflicts of interest to report.