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Authors
Nguyen, Julie K.
Weedon, Jeremy
Jakus, Jeannette
Heilman, Edward
Isseroff, R. Rivkah
Siegel, Daniel M.
Jagdeo, Jared R.
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Funding
Funding for this research was provided by:
National Institute of General Medical Sciences (K23GM117309)
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Article History
Received: 19 February 2019
Accepted: 29 June 2019
First Online: 15 July 2019
Ethics approval and consent to participate
: The clinical trial protocol (version 4.0), informed consent forms, and all other study documents were approved by the SUNY Downstate IRB on 21 November 2018 (reference # 1304108). The protocol was written in accordance with SPIRIT guidelines (Additional file InternalRef removed). Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. Written informed consent will be obtained from all subjects by the clinical research team prior to enrollment and any study-related procedures. Additional consent will be obtained for the collection and use of optional skin biopsies. Subjects will be given sufficient opportunity to consider participation in this study before signing the consent form. Study participation is voluntary and can be withdrawn at any time. This study will be conducted in accordance with the Declaration of Helsinki, ICH GCP, and applicable regulatory requirements.
: Not applicable.
: The authors declare that they have no competing interests.
