Author Contributions: Dr Watkins 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: Watkins, Kaplowitz, Slattery, Harris, Colonnese.
Acquisition of data: Harris, Colonnese.
Analysis and interpretation of data: Watkins, Kaplowitz, Slattery, Colucci, Stewart, Harris, Colonnese.
Drafting of the manuscript: Watkins, Colucci, Harris, Colonnese.
Critical revision of the manuscript for important intellectual content: Watkins, Kaplowitz, Slattery, Colucci, Stewart, Harris, Colonnese.
Statistical analysis: Watkins, Colucci, Stewart, Harris, Colonnese.
Obtained funding: Slattery, Harris.
Administrative, technical, or material support: Colonnese.
Study supervision: Harris.
Financial Disclosures: Drs Watkins, Kaplowitz, and Slattery report having served as paid consultants to Purdue Pharma L.P. during the planning and execution of the study but were not paid for the preparation of this article. The manufacturers of Tylenol, Dilaudid, and Percocet are McNeil, Knoll, and Endo Labs, respectively. Drs Watkins, Kaplowitz, and Stewart report that they have never had financial relationships with these companies. Dr Slattery reports having served as a consultant for McNeil. Morphine is a generic drug with several manufacturers with information that we have not included in this article. This information can be provided on request.
Independent Statistical Analysis: Paul Stewart, PhD, professor of biostatistics at the University of North Carolina School of Public Health, had access to all of the data used for the primary analyses reported. He performed an independent verification of the calculations and interpretations presented in those primary analyses (ie, the primary test of the null hypothesis of no differences among the active treatment regimens along with all of the computations in all 3 tables in the article, which comprise all of the main results discussed in the abstract, results section, and comment section of the paper). As a result of this check, there were some minor corrections made to the findings reported in the article. In addition, based on review of the study protocol documents, and the inventory of all data collected in the study, Dr Stewart confirmed that the set of analyses presented in the paper are appropriate and sufficient. Dr Stewart was not compensated directly for this analysis; however, with ongoing studies in the UNC GCRC in this area, the GCRC's Scientific Advisory Committee agreed that this work by Dr Stewart should be considered an appropriate part of his efforts that are funded by the GCRC's grant (RR000046).
Funding/Support: The study was entirely funded by Purdue Pharma L.P. and was conducted at 2 contract research organizations. The handling and interpretation of the data was shared among all authors. Dr Stewart's efforts were supported by National Institutes of Health grant RR-000046.
Role of the Sponsor: The originally submitted manuscript went through the standard publication review process at Purdue Pharma, but no changes were suggested.