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Authors
O’Gara, Brian
Serra, Alexis L. https://orcid.org/0000-0001-7366-1350
Englert, Joshua A. https://orcid.org/0000-0002-1257-2239
Sachdev, Alisha https://orcid.org/0000-0001-6501-1390
Owens, Robert L.
Chang, Steven Y. https://orcid.org/0000-0002-7365-5265
Park, Pauline K. https://orcid.org/0000-0002-5972-4340
Talmor, Daniel
Sverud, Ida
Sackey, Peter
Beitler, Jeremy R. https://orcid.org/0000-0003-0797-2374
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Article History
Received: 26 June 2024
Accepted: 4 March 2025
First Online: 31 March 2025
Declarations
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: This study was approved by the institutional review board of each participating site. Written informed consent will be obtained prior to enrollment from each participant or their legally authorized representative. A representative example of a consent form is included as Additional File 2. Consent forms include language that is specific to each site in accordance with local law and institutional policies.
: Not applicable.
: BO and DT receive consulting fees from Sedana Medical for participation on the scientific advisory board. ALS and JRB have received compensation from Columbia University for their work on the trial. JRB previously received consulting fees from Sedana Medical for support with trial design but ended any direct financial relationship prior to initiating the trial. IS and PS are employed by Sedana Medical. All other authors declare that they have no competing interests.
