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Authors
Kuhns, Lisa M. https://orcid.org/0000-0001-8294-7801
Garofalo, Robert
Hidalgo, Marco
Hirshfield, Sabina
Pearson, Cynthia
Bruce, Josh
Batey, D. Scott
Radix, Asa
Belkind, Uri
Jia, Haomiao
Schnall, Rebecca
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Funding
Funding for this research was provided by:
National Center on Minority Health and Health Disparities (U01MD011279)
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Article History
Received: 3 January 2020
Accepted: 8 January 2020
First Online: 15 January 2020
Ethics approval and consent to participate
: This protocol has been approved by the Institutional Review Board of Columbia University as the single IRB (IRB-AAAQ6500) with a waiver of parental permission for participation of minors (aged 13–17). Study participants complete a written informed e-assent or e-consent process through a web portal prior to participation in research activities. Current protocol version: September 4, 2019. Any modifications to the protocol are submitted to and approved by the IRB of Record prior to implementation. Spontaneously reported adverse events and unintended effects of the trial are tracked by the study Principal Investigators and reported to the IRB of Record. This study is monitored by a Data Safety and Monitoring Board (DSMB), the composition of which may be obtained from the study principal investigator at the lead institution. No criteria for discontinuing or modifying the intervention or trial stopping rules were defined for this study.
: Not applicable.
: The authors declare that they have no competing interests.
