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Authors
Mease, Catherine https://orcid.org/0009-0005-0156-198X
Fermaglich, Lewis J. https://orcid.org/0000-0001-7151-1615
Jackler, Karen
Shermer, Shawn
Miller, Kathleen L. https://orcid.org/0000-0002-3939-3660
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Funding
Funding for this research was provided by:
Oak Ridge Institute for Science and Education (FDA Rare Disease, Orphan Product Fellowship)
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Article History
Accepted: 26 September 2023
First Online: 13 October 2023
Declarations
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: This project was supported in part by an appointment to the Research Participation Program at the US Food and Drug Administration administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the US Department of Energy and the US Food and Drug Administration.
: The authors declare that they have no conflicts of interest.
: This manuscript reflects the views of the authors and should not be construed to represent FDA’s or the Department of Health and Human Services (HHS)’s views or policies.
: Session summaries analyzed in the manuscript can be found on the FDA’s website for condition-specific meeting reports and other information related to patients’ experience ().
: The FDA institutional research board (IRB) found this study exempt from IRB review.
: Not applicable.
: Not applicable.
: The codes generated and analyzed for this study are available from the corresponding author.
: K.L.M. conceived the study. C.M., L.J.F., K.J., S.S., and K.L.M. designed the study. C.M. and K.L.M. collected, analyzed, and interpreted the data. C.M. and K.L.M. drafted the manuscript. L.J.F., K.J., and S.S. provided substantive edits to the manuscript. All authors read and approved the final version of the manuscript.
