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Authors
Schimmel, Jonathan https://orcid.org/0000-0002-6383-8308
Epperson, Lindsey Claire https://orcid.org/0000-0001-7141-2019
Aldy, Kim https://orcid.org/0000-0002-3198-2321
Wax, Paul
Brent, Jeffrey https://orcid.org/0000-0003-3763-4755
Buchanan, Jennie https://orcid.org/0000-0001-9855-8915
Levine, Michael https://orcid.org/0000-0003-3866-0509
Burkhart, Keith https://orcid.org/0000-0001-8107-4818
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Funding
Funding for this research was provided by:
U.S. Food and Drug Administration (75F40119D10031)
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Article History
Accepted: 22 November 2023
First Online: 10 January 2024
Declarations
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: This study was supported by the US Food and Drug Administration (FDA), contract 75F40119D10031. This publication reflects the views of the authors and should not be construed to represent FDA’s views or policies.
: The authors have no competing interests to declare that are relevant to the content of this article.
: The datasets analyzed during the current study are available from the corresponding author on reasonable request.Institutional Review BoardThis project was deemed non-human subjects research by the Western Institutional Review Board (WIRB)-Copernicus Group Institutional Review Board (IRB) and exempted or approved by institutional IRBs at participating sites.
: JS conceptualized the study, cleaned and analyzed the data, and drafted and revised the paper. LCE drafted and revised the paper. KA, PW, KB, and J Brent designed and implemented the registry database, and revised the paper. J Buchanan contributed to the registry and revised the paper. ML contributed to the registry and revised the paper.
