Author Contributions: Drs Bagiella and Friedewald had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Zafonte, Bagiella, Ansel, Novack, Friedewald, Hesdorffer, Timmons, Eisenberg, Hart, Ricker, Diaz-Arrastia, Merchant, Temkin, Melton, Dikmen.
Acquisition of data: Zafonte, Bagiella, Novack, Hesdorffer, Timmons, Eisenberg, Hart, Ricker, Diaz-Arrastia, Merchant, Temkin, Melton, Dikmen.
Analysis and interpretation of data: Zafonte, Bagiella, Novack, Friedewald, Hesdorffer, Timmons, Jallo, Eisenberg, Hart, Ricker, Diaz-Arrastia, Merchant, Temkin.
Drafting of the manuscript: Zafonte, Bagiella, Ansel, Novack, Friedewald, Jallo, Hart, Diaz-Arrastia, Merchant, Temkin.
Critical revision of the manuscript for important intellectual content: Zafonte, Bagiella, Ansel, Novack, Friedewald, Hesdorffer, Timmons, Eisenberg, Hart, Ricker, Temkin, Melton, Dikmen.
Statistical analysis: Zafonte, Bagiella, Friedewald, Hesdorffer, Jallo.
Obtained funding: Zafonte, Bagiella, Ansel, Novack, Friedewald, Timmons, Eisenberg, Hart, Diaz-Arrastia, Merchant, Temkin, Dikmen.
Administrative, technical, or material support: Zafonte, Ansel, Novack, Friedewald, Timmons, Hart, Ricker, Diaz-Arrastia, Merchant, Melton, Dikmen.
Study supervision: Zafonte, Ansel, Novack, Friedewald, Timmons, Eisenberg, Hart, Ricker, Diaz-Arrastia.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: This study was supported by National Institute of Child Health and Human Development grants at the following institutions: Temple University (U01HD042738); University of Alabama at Birmingham (U01HD042687); University of Maryland (U01HD042736); University of Pittsburgh (U01HD042678); University of Tennessee Health Sciences Center (U01HD042686); University of Texas Southwestern (U01HD042652); University of Washington (U01HD042653); Virginia Commonwealth University (U01HD042689); and Columbia University (U01HD042823). Ferrer Grupo provided the citicoline and identical placebo used in the study.
Role of the Sponsors: The National Institute of Child Health and Human Development and Ferrer Grupo had no role in the design and conduct of the study; the collection, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript.
COBRIT Data and Safety Monitoring Committee: M. D. Walker (chair), S. C. Kunitz, H. S. Levin, C. Robertson. COBRIT Study Group: Steering Committee: R. Zafonte (study principal investigator), J. Jallo (chair), *D. Good (ex-chair), B. Ansel, R. Diaz-Arrastia, H. Eisenberg, W. Friedewald, R. Merchant, S. Melton, J. Ricker, N. Temkin, S. Timmons. Clinical Sites: Alabama: University of Alabama at Birmingham (S. Melton, T. Novack, O. Hogue, R. McPhearson, W. Garrett, B. McDowell, M. Doss, T. Woods-Bell, S. Caldwell). Maryland: University of Maryland School of Medicine, Baltimore (H. Eisenberg, B. Aarabi, E.F. Aldrich, C. Aldrich, H. Thomas, D. Beam, K. Booker, M. Rosado, S. Roberts, L. Grattan, J. Rowe, J. Kostelec, M. Lee). Pennsylvania: University of Pittsburgh School of Medicine, Pittsburgh (J.H. Ricker, J. DeFeo, A. Fetzick, C. Harrison, L.J. Kessler, D.O. Okonkwo, A. Puccio); Temple University Hospital & Moss Rehabilitation Research Institute, Philadelphia (C. Loftus, *J. Jallo, E. Clement, T. Hart, C. Morita). Tennessee: University of Tennessee Health Science Center, Memphis (*S.D. Timmons, T. Bee, I. Fine, D. Blackford); Texas: University of Texas Southwestern Medical Center, Dallas (R. Diaz-Arrastia, C. Madden, C. Moore, N. Sayed, C. Paliotta, L. Peng, C. Harper). Virginia: Virginia Commonwealth University, Richmond (Randall Merchant, J. Ward, T. Graf, S. Desai, K. Mathern, C. Gilman, M. Merchant, J. Coulter, M. Moorman, Ryan Merchant, N. Hsu, J. Marwitz, M. Wetsel, L. Farrish). Washington: University of Washington, Seattle (N. Temkin, S. Dikmen, S. Whitkanack, G. Otto, J. Machamer, R. Fontanilla, S. Wellnitz, K. Boase, S. Pereira, R. Chesnut, J. Chang, J. Celix). Data Coordinating Center: Columbia University, New York, New York: W. Friedewald, E. Bagiella, H. Andrews, E. Benn, M. Feng, D. C. Hesdorffer, S. Lee, B. Levin, S. Lyn, D. Merle, F. Sanders. NICHD Project Scientist: The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland: B. Ansel. Asterisks denote persons no longer affiliated with the study unit.