Funding for this research was provided by:
National Institutes of Health (R01 HD091935)
Received: 16 October 2019
Accepted: 11 December 2019
First Online: 30 December 2019
Ethics approval and consent to participate
: This study has been registered under ExternalRef removed (identifier: NCT03286504). This study was approved by the institutional review boards at GHESKIO Centers and Weill Cornell Medicine. Written informed consent is obtained from all study participants 18 years and older. Adolescents 16–17 years old provide written assent with written parental or guardian consent. The trial is overseen by a data and safety monitoring board independent of the funding body with no competing interests to declare.
: Not applicable.
: The authors declare that they have no competing interests.