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Authors
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Sprague, Sheila
Bzovsky, Sofia
Connelly, Daniel
Thabane, Lehana
Adachi, Jonathan D.
Slobogean, Gerard P.
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Funding
Funding for this research was provided by:
Orthopaedic Trauma Association (1701455)
McMaster Surgical Associates
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Article History
Received: 18 June 2018
Accepted: 23 October 2019
First Online: 22 November 2019
Ethics approval and consent to participate
: This protocol, the consent form template, and the CRFs have been reviewed and approved by the University of Maryland IRB and the McMaster University REB prior to commencement of the study. In addition, an Investigation New Drug Application was approved by the Food and Drug Administration.Any amendments to the study protocol which may affect the conduct of the study, or the potential safety of or benefits to participants (e.g., changes to the study objectives, study design, sample size, or study procedures) will require a formal amendment to the protocol. Any protocol amendments will be approved by the principal investigators and will require approval by the University of Maryland IRB and the McMaster University REB. Administrative changes (e.g., minor corrections or clarifications that have no effect on the way the study is conducted) will not need to undergo a formal amendment process.
: Not applicable
: The authors declare that they have no competing interests.
