Institutional Review Board Statement
The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Boards of Rhode Island Hospital (RIH; initial approval by the Memorial Hospital IRB, date: 27 January 2017, IRB protocol code: 993434-2, IRB reference number: 16-18; further approval by Lifespan IRB, date: 19 November 2019, IRB protocol code: 1517444-1,2,3, IRB reference number: 416419), the Pennington Biomedical Research Center (PBRC; date: 19 June 2019, IRB code: 2019-023-PBRC Connect), and Boston Children’s Hospital (BCH; date: 11 September 2017, IRB protocol code: IRB-P00026076).