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Authors
Singer, David https://orcid.org/0000-0001-8008-8003
Thompson-Leduc, Philippe https://orcid.org/0000-0001-9047-3941
Ma, Siyu https://orcid.org/0000-0001-7269-2884
Gupta, Deepshekhar https://orcid.org/0000-0002-3695-3546
Cheng, Wendy Y. https://orcid.org/0000-0002-8281-2496
Sendhil, Selvam R. https://orcid.org/0000-0001-8010-4296
Sundar, Manasvi https://orcid.org/0000-0001-5858-8685
Hagopian, Ella https://orcid.org/0000-0003-0506-7004
Stempniewicz, Nikita https://orcid.org/0000-0002-0877-4460
Duh, Mei Sheng https://orcid.org/0000-0001-5035-6687
Poston, Sara https://orcid.org/0000-0003-4735-057X
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Funding
Funding for this research was provided by:
GlaxoSmithKline Biologicals SA
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Article History
Received: 5 June 2023
Accepted: 18 July 2023
First Online: 22 September 2023
Declarations
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: David Singer, Nikita Stempniewicz, and Sara Poston are employees of, and hold shares in, GSK. Philippe Thompson-Leduc, Deepshekhar Gupta, Wendy Y. Cheng, Selvam R. Sendhil, Manasvi Sundar, Ella Hagopian, and Mei Sheng Duh are employees of Analysis Group, Inc., a consulting firm that has received funding from GSK for the conduct of this study. Siyu Ma declares to have received postdoctoral fellowship grant from GSK during the conduct of the study. The authors declare no other financial and non-financial relationships and activities.
: The study employed a retrospective cohort study design using a large administrative claims database. Data were de-identified and comply with the requirements of the Health Insurance Portability and Accountability Act. Institutional Review Board review and approval was therefore not required, as per United States Department of Health and Human Services regulation for the protection of human subjects in research (45 CFR 46, ). The study has been conducted in accordance with the guiding principles of the Declaration of Helsinki. As only existing de-identified data has been analyzed and as patients have not been contacted during the course of this study, informed consent process is not applicable.
