Schaaf, Katie
Mullin, Christopher M.
Cunningham, Kyle W. http://orcid.org/0000-0002-6526-183X
Eaton, Jonathan
Conrad, Steven A. http://orcid.org/0000-0002-4014-969X
Article History
Received: 3 February 2024
Accepted: 24 July 2024
First Online: 2 August 2024
Declarations
:
: This trial protocol was reviewed and approved by a central institutional review board (WIRB-Copernicus Group, Princeton, NJ, ), Work Order Number 1601635. The study complies with the Declaration of Helsinki and will be conducted with Good Clinical Practice. Written informed consent will be obtained from all participants.
: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information and informed consent forms are available from the corresponding author upon request.
: KS is an employee of Stimdia Medical, Inc., the sponsor of the trial. CMM is an employee of the trial management firm contracted by Stimdia Medical, Inc. SAC receives compensation from Stimdia Medical, Inc., for consulting services related to the clinical trial. KWC and JE have no competing interests.