Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (1R01HD099344-01)
Received: 19 June 2020
Accepted: 29 October 2020
First Online: 16 November 2020
Ethics approval and consent to participate
: Written, informed consent to participate will be obtained from all subjects. The sponsor and investigator will ensure that this research is carried out in accordance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual. The trial protocol was approved by Advarra, Inc. (IRB), which, as a central IRB, all sites involved in this study had access to and utilized Protocol #00039201.
: Not applicable.
: The authors declare that they have no financial and other competing interests.