Nduaguba, Sabina O. http://orcid.org/0000-0001-6383-2603
Smolinski, Nicole E.
Thai, Thuy N.
Bird, Steven T.
Rasmussen, Sonja A.
Winterstein, Almut G. http://orcid.org/0000-0002-6518-5961
Funding for this research was provided by:
U.S. Food and Drug Administration (HHSF223201810083C)
Article History
Accepted: 1 March 2023
First Online: 12 April 2023
Declarations
:
: This work was supported by the Food and Drug Administration (contract HHSF223201810083C).
: SON, NES, and TNT have no conflict of interest to declare. STB works for the US Food and Drug Administration and have no conflicts of interest to disclose. SAR has served on an advisory committee for the Teva Pregnancy Registry; has consulted for F. Hoffmann-La Roche AG as a litigation consultant; and receives grant support from the National Institutes of Health, and the Centers for Disease Control and Prevention, and Health Services Research Administration. AGW has received funding for research studies unrelated to this work from NIH, AHRQ, PCORI, FDA, the Bill and Melinda Gates Foundation, CDC, Merck Sharpe and Dohme, and the state of Florida. She has received consulting fees from Arbor Pharmaceuticals, Bayer, Ipsen, and Genentech Inc., likewise unrelated to this work.
: Not applicable.
: Not applicable.
: Not applicable.
: The data that support the findings of this study are available from the Centers for Medicaid and Medicare Services but restrictions apply to the availability of these data, which were used under a data user agreement for the current study and are not publicly available.
: Codes will be made available upon request.
: SON made substantial contribution to the design, analysis, and interpretation of data; as well as drafting the manuscript. NES made substantial contribution to the design, analysis, and interpretation of data and also contributed to the critical revision of the manuscript. TNT made substantial contribution to the design and interpretation of data and also contributed to the critical revision of the manuscript. STB made substantial contribution to the interpretation of data and also contributed to the critical revision of the manuscript. SAR made substantial contribution to the design and interpretation of data and also contributed to the critical revision of the manuscript. AGW made substantial contribution to the conception and design, data acquisition, analysis, and interpretation of data; as well as the critical revision of the manuscript. All authors read and approved the final version.
: This work represents the opinions of the authors and not necessarily those of the Food and Drug Administration.