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Article History

Accepted: 8 June 2025

First Online: 8 July 2025

Declarations

:

: This work was supported by Kenvue LLC. The funder contributed to the development of the research question, study design, conduct and interpretation, manuscript development and decision to submit the manuscript for publication.

: Dr. Alexander is a past Chair of FDA’s Peripheral and Central Nervous System Advisory Committee and co-founding Principal and equity holder in Stage Analytics. Dr. Alexander is an Editorial Board member of Drug Safety. Dr. Alexander was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Ms. Chingcuanco is an employee of Stage Analytics. These arrangements have been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. Dr. Budnitz and Dr. Garg are employees of Kenvue, LLC.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by GA, FC, and DB. The first draft of the manuscript was written by FC and GA, DB, and AG contributed to revision of the manuscript for important intellectual content. All authors read and approved the final manuscript.