Title {1}	Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Trial registration {2a and 2b}.	Trials Registration: NCT04214834; Registered January 2, 2020
Protocol version {3}	Protocol Version 08, July 28,2021
Funding {4}	This research was supported by the National Institutes for Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative® through administrative supplements to NIH grants U24HD095254 and U2COD023375, and NIH grant U24OD024957. Project Officers: Drew Bremer Andrew.Bremer@nih.gov and Carol Blaisdell Carol.Blaisdell@nih.gov , Rockville, MD.
Author details {5a}	Adam Czynski, DO, Connecticut Children’s Medical Center Abbot Laptook, MD, Brown University/Women & Infants Hospital of Rhode Island Abhik Das, PhD, NICHD NRN Brian Smith, MD, Duke Clinical Research Institute Alan Simon, MD, National Institutes of Health Rachel Greenberg, MD, Duke Clinical Research Institute Robert Annett, PhD, University of Mississippi Jeannette Lee, PhD, UAMS Jessica Snowden, MD, UAMS Claudia Pedroza, PhD, University of Texas, Houston Barry Lester PhD, Brown University/Women & Infants Hospital of Rhode Island Barry Eggleston, PhD, RTI International Drew Bremer, MD, NICHD NRN Elisabeth McGowan, MD, Brown University/Women & Infants Hospital of Rhode Island
Name and contact information for the trial sponsor {5b}	National Institutes of Health - Drew Bremer Andrew.Bremer@nih.gov and Carol Blaisdell Carol.Blaisdell@nih.gov
Role of sponsor {5c}	The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and NIH Environmental influences on Child Health Outcomes (ECHO) staff are part of the study team and had/will have input into the study design, conduct, analysis, and manuscript drafting. The comments and views of the authors do not necessarily represent the views of the NICHD or the ECHO Program, the National Institutes of Health, the Department of Health and Human Services, or the United States (U.S) government. The NICHD and NIH ECHO staff provided oversight of the project through a cooperative agreement—a grant wherein the funding federal agency is substantially involved in carrying out the research program and federal scientists collaborate with researchers on a joint research project. Only National Institutes of Health staff listed as authors have contributed to this protocol.