Author Contributions: Dr Lamas had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Lamas, Goertz, Boineau, Mark, Rozema, Nahin, Drisko, Lee.
Acquisition of data: Lamas, Rozema, Lewis, Drisko, Lee.
Analysis and interpretation of data: Lamas, Goertz, Boineau, Mark, Nahin, Lindblad, Lewis, Drisko, Lee.
Drafting of the manuscript: Lamas, Goertz, Boineau, Mark, Lindblad, Drisko, Lee.
Critical revision of the manuscript for important intellectual content: Lamas, Boineau, Mark, Rozema, Nahin, Lewis, Drisko, Lee.
Statistical analysis: Lamas, Lindblad, Lee.
Obtained funding: Lamas, Boineau, Mark, Lee.
Administrative, technical, or material support: Lamas, Boineau, Mark, Rozema, Nahin, Lewis, Drisko, Lee.
Study supervision: Lamas, Boineau, Mark, Nahin, Lewis, Lee.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Lamas reports that from 2000 to 2003 he served as a consultant to OmniComm, the electronic data capture company used in the trial. No funds were received and all relationships were severed as of September 10, 2003. No other disclosures were reported.
Funding/Support: The NCCAM (grant U01AT001156) and the NHLBI (grant U01HL092607) provided sole support for this study.
Role of the Sponsor: Robin Boineau, MD, NHLBI, Richard Nahin, PhD, NCCAM, Mario Stylianou, PhD, NHLBI, and Yves Rosenberg, MD, NHLBI, respectively, were involved as part of the NIH Cooperative Agreement process, in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Disclaimer: The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NHLBI, the NCCAM, or the National Institutes of Health.
Online-Only Material: The Author Video Interviewis available here.
Additional Contributions: We gratefully acknowledge the scientific contributions and support of Yves Rosenberg, MD, and Mario Stylianou, PhD, NHLBI; the organizational skills of Ana Mon, MPH, clinical coordinating center at Mt Sinai Medical Center; Alyssa Cotler, NCCAM, Susan Dambrauskas (formerly NHLBI), and Vivian Thompson, DCRI, for their competent professional assistance; and the Florida Heart Research Institute for supporting the pilot study. The above mentioned contributors received no compensation for their work other than their usual salary.
A complete list of the TACT Investigators appears in the eAppendix.