Document is current

Article History

Received: 25 April 2022

Accepted: 14 October 2022

First Online: 11 November 2022

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.

: LP was an employee of Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., Kenilworth, NJ, USA (MSD), at the time the study was conducted and may own stock and/or hold stock options in Merck and Co., Inc., Kenilworth, NJ, USA. LF, PM, and KAB are current employees of MSD, who may own stock and/or hold stock options in Merck and Co., Inc., Kenilworth, NJ, USA. VG, KCY, and CA are employees of Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA; KCY and VG may own stock and/or hold stock options in BD. BD was paid to perform the analyses presented. Drs Bauer, Finelli, and Moise reported being employees of Merck Sharpe and Dohme, a subsidiary of Merck and Co, Inc, and they may own stock and/or hold stock options in Merck and Co, Inc. Dr. Puzniak was an employee of Merck and Co, Inc, at the time of the analysis and may own stock and/or hold stock options in in Merck and Co, Inc. Drs Gupta, Ai, Watts, and Yu reported being employees of Becton, Dickinson and Company (BD), and Drs. Gupta and Yu may own stock and/or hold stock options in Becton, Dickson and Company.