Puzniak, Laura A.
Bauer, Karri A.
Yu, Kalvin C.
Watts, Janet A.
Ai, ChinEn
Gupta, Vikas
Article History
Received: 21 June 2022
Accepted: 30 January 2023
First Online: 24 February 2023
Declarations
:
: This electronic surveillance system and clinical research database, which has been previously described, is exempted from patient consent requirements because it uses deidentified data. This retrospective, deidentified data set was approved, and informed consent requirements were waived by the New England Institutional Review Board (Wellesley, MA, USA; IRB No. 120180023). This report follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for cohort studies [CitationRef removed]. The study was performed in accordance with all relevant guidelines and regulations, including the Declaration of Helsinki.
: Not applicable.
: LAP was an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and a shareholder in Merck & Co., Inc., Kenilworth, NJ, USA, at the time of the study. KAB is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and a shareholder in Merck & Co., Inc., Kenilworth, NJ, USA. KCY, JAW, CA, and VG are employees of Becton, Dickinson and Company, which was contracted by Merck to conduct the study. KCY and VG also own stock in Becton, Dickinson and Company.