,
Slobogean, Gerard P.
Sprague, Sheila
Bzovsky, Sofia
Heels-Ansdell, Diane
Thabane, Lehana
Scott, Taryn
Bhandari, Mohit
Funding for this research was provided by:
Canadian Institutes of Health Research (MOP-130271, MTO-130912)
McMaster Surgical Associates (N/A)
Hamilton Health Sciences (NIF 13329)
Article History
Received: 17 May 2018
Accepted: 13 May 2019
First Online: 28 May 2019
Ethics approval and consent to participate
: This protocol, the consent form template, and the case report forms have been reviewed and approved by the Hamilton Integrated Research Ethics Board. The protocol, clinical site-specific informed consent forms, and any participant recruitment material will be reviewed and approved by each clinical site’s local ethics board. Prior to commencement of the study, the clinical site must provide the Methods Centre with a copy of the ethics board approval. In addition, a No Objection letter was obtained from Health Canada and an Investigation New Drug Application as approved by the Food and Drug Administration.
: Not applicable.
: The authors declare that they have no competing interests.
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