Study concept and design: Litonjua, Carey, O’Connor, Strunk, Macones, Zeiger, Schatz, Hollis, Hawrylowicz, Weiss.
Acquisition, analysis, or interpretation of data: Litonjua, Carey, Laranjo, Harshfield, McElrath, O’Connor, Sandel, Iverson, Lee-Paritz, Strunk, Bacharier, Macones, Zeiger, Hollis, Hornsby, Wu, Weiss.
Drafting of the manuscript: Litonjua, Carey, O’Connor, Macones, Zeiger, Hollis, Wu, Weiss.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Carey, Laranjo, Harshfield, Wu.
Obtained funding: Litonjua, Carey, O’Connor, Strunk, Hollis, Weiss.
Administrative, technical, or material support: Litonjua, Laranjo, McElrath, O’Connor, Sandel, Iverson, Strunk, Macones, Zeiger, Hollis, Hornsby, Hawrylowicz.
Study supervision: Litonjua, Carey, O’Connor, Sandel, Strunk, Macones, Weiss.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Litonjua reported receiving personal fees from UpToDate Inc and Springer Humana Press. Dr McElrath reported receiving grants from the National Institutes of Health (NIH). Dr O’Connor reported receiving grants from the NIH. Dr Bacharier reported receiving grants from the NIH and National Heart, Lung, and Blood Institute (NHBLI), and personal fees from Aerocrine, GlaxoSmithKline, Genentech/Novartis, Merck, Schering, Cephalon, DBV Technologies, Teva, Boehringer Ingelheim, AstraZeneca, WebMD/Medscape, Sanofi, and Vectura. Dr Zeiger reported receiving grants from the NHBLI, AstraZeneca, Aerocrine, MedImmune, Genentech, Merck, and GlaxoSmithKline and personal fees from Genentech, Novartis, GlaxoSmithKline, and TEVA. Dr Hornsby reported receiving an NIH ancillary grant. Dr Hawrylowicz reported receiving an NIH ancillary grant, a fellowhip grant from Wellcome Trust Clinical Training Research Fellowship, grant G100758 from the Medical Research Council Centre, and grants from Asthma UK, the Lord Leonard and Lady Estelle Wolfson Foundation, and the Alpha 1 Foundation. No other disclosures were reported.
Funding/Support: VDAART was supported by grant U01HL091528 from the NHLBI. Additional support was provided by grant U54TR001012 from the National Centers for Advancing Translational Sciences (NCATS) for participant visits at the Boston Medical Center.
Role of the Funder/Sponsor: The NHLBI monitored the conduct of the trial and selected the membership of the data and safety monitoring board (DSMB). All communication between the investigators and the DSMB coursed through the staff of the NHLBI. The manuscript was presented to the DSMB for approval prior to submission for peer review. The NHLBI had no role in the design and the conduct of the study, in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript, other than what pertained to the DSMB.
Disclaimer: Dr O’Connor, JAMA associate editor, was not involved in the editorial evaluation or decision to publish the article.
Data Coordinating Center: Augusto A. Litonjua, Scott T. Weiss, Vincent J. Carey, Nancy Laranjo, Benjamin J. Harshfield, Sharon O’Toole, Stacey Brown, Amali Chung, Sujata Datta, Caroline Holcomb, Sarah Kraft, and Bruce Hollis.
Clinical Centers:Washington University at St Louis: Robert C. Strunk (lead clinical center principal investigator [PI]), Leonard B. Bacharier (coinvestigator), Michael Nelson, Monica Anderson, Danae Larson, Yvonne Burrage, Jennifer Byers, Megan Isaac-Schmid; Boston University Medical Center: George T. O’Connor (clinical center PI), Megan Sandel (coinvestigator), Katherine Muse, Jessica Long, Erin Collins, Amanda Barbeau, Benvy Caldwell, Tawil Contreras, Corey Costanzo, Ingrid Gonzalez, Mahsan Mohammadi, Ashley Oliver, Penny Price, Chloe Sakow, Danuzia Silva, AneesaThannicka, Lena Wang; Kaiser Permanente Southern California: Robert S. Zeiger (clinical center PI), Michael X. Schatz (coinvestigator), Shawn Menafee, Diana Donofero, Kathleen Harden, Terrie Long, Travis Macaraeg, Maria Marcial, Elsa Rodriguez, Elizabeth Sanchez.
Data and Safety Monitoring Board: Lynn M. Taussig, MD (chair), Mitchell P. Dombrowski, MD, Carol L. Freund, PhD, Frank R. Greer, MD, Martin Hewison, PhD, Dennis R. Ownby, MD, Anthony Scialli, MD, Gerald Teague, MD, John N. Van Den Anker, MD, PhD, O. Dale Williams, PhD, Susan R. Hintz, MD, MS, and Jean Lowe, PhD.
Additional Contribution: We thank the participants of VDAART for their participation and contribution to the trial.