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Authors
Malay, Donald Scot https://orcid.org/0000-0002-2400-5629
Kim, Hye Rin
Perfetti, Nicholas John
Marshall, Yolanda R.
Bregman, Peter J.
Vavra, Allysa M.
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Funding
Funding for this research was provided by:
Marlinz Pharma (Marlinz Pharma #1)
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Article History
Received: 4 March 2025
Accepted: 30 April 2025
First Online: 25 May 2025
Declarations
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: Donald Scot Malay and Peter J. Bregman received research funding from Marlinz Pharma to conduct this investigation. Donald Scot Malay, Hye Rin Kim, and Yolanda R. Marshall receive research funding from The American College of Foot and Ankle Surgeons. Nicholas John Perfetti and Allysa M. Vavra have nothing to disclose.
: The protocol for this randomized controlled trial was approved by WCG IRB Connexus (Tracking no. 20211891, WCG North America; ), an institutional review board (IRB) accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP, 5335 Wisconsin Avenue, NW, Suite 510, Washington, DC 20015, telephone 202–783-1112; accredit@aahrpp.org). The IRB approved each clinical research site, as well as the consent to participate in clinical research form used by each study site. The trial was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments. Informed consent to voluntarily participate in the investigation was obtained from all participants.
