Ethics approval and consent to participate
The study is approved by the Institutional Review Board (IRB) of Weill Cornell Medicine (IRB #: 21–02023315). The IRB-approved protocol and study data are reviewed by the Weill Cornell Medicine Data and Safety Monitoring Board (DSMB). The methods in this study were carried out in accordance with all guidelines and regulations, including the Declaration of Helsinki and the Weill Cornell Medicine Data and Safety Monitoring Plan (DSMP). Informed consent will be obtained from all participants and/or their legal guardians. Patients’ eligibility on the trial are reviewed and signed off by the treating physicians. Consented and eligibility verified patients are enrolled on the Weill Cornell Medicine Clinical Trial Management System (CTMS).