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Authors
Winterstein, Almut G. https://orcid.org/0000-0002-6518-5961
Ewig, Celeste L. Y.
Wang, Yanning
Smolinski, Nicole E.
Toyserkani, Gita A.
LaCivita, Cynthia
Lackey, Leila
Eggers, Sara
Zhou, Esther H.
Diaby, Vakaramoko
Sarayani, Amir
Thai, Thuy
Maro, Judith C.
Rasmussen, Sonja A.
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Funding
Funding for this research was provided by:
U.S. Food and Drug Administration (HHS75F40121C00188)
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Article History
Accepted: 8 October 2024
First Online: 5 November 2024
Declarations
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: This study was funded by contract HHS75F40121C00188 with the US Food and Drug Administration.
: The views in this manuscript are those of the authors and not necessarily those of the US Food and Drug Administration.
: AGW has received research funding from Merck, Sharp and Dohme and has served as consultant for Merck, Bayer KG, Genentech Inc., Ipsen, Novo Nordisk, and Arbor Pharmaceuticals. AGW is an editorial board member of Drug Safety. AGW was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. NES owns stock through inheritance in Baxter, CVS Health, Edwards LifeSciences, and Takeda unrelated to this work. SAR serves on scientific advisory committees for several pregnancy registries, including registries for Wakix (Harmony), Sunosi (Axsome), Nurtec (Biohaven, recently acquired by Pfizer), and the Myfembree (Myovant Sciences). VD is presently an employee at Otsuka Pharmaceutical Development Corporation Inc. He declares that there are no conflicts of interest that could be perceived as influencing the content of this manuscript. At the time of study protocol development, VD’s professional affiliation was with the University of Florida. AS contributed to this study protocol during his previous tenure at the University of Florida, and his current employer, Janssen Research and Development, did not provide funding nor had any role in the conception, design, or decision to publish this manuscript. The remaining authors have no conflict of interest relevant to the content of this study.
: Not applicable.
: Not applicable at the design stage.
: Not applicable.
: Not applicable.
: Not applicable.
: All authors made substantial contributions to conception or design of the work; AGW, CE, NES, AS, TT and SAR acquired funding; AGW drafted the manuscript, and all other authors reviewed it critically for important intellectual content and gave final approval of the version to be published.
