Study concept and design: Fakhry, D’Souza.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Fakhry, D’Souza.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Fakhry, D’Souza.
Obtained funding: All authors.
Administrative, technical, or material support: Fakhry, D’Souza.
Study supervision: Fakhry, D’Souza.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Gillison and D’Souza reported receiving previous research support from Merck Inc. Dr Gillison also reported serving as an unpaid consultant to GlaxoSmithKline. No other disclosures were reported.
Funding/Support: This study was supported by grants P50DE019032, R01DE021395, R01DE023175 from the National Institute of Dental and Craniofacial Research and funding from the Milton J. Dance Head and Neck Center and Merck.
Role of the Funder/Sponsor: The National Institute of Dental and Craniofacial Research, the Milton J. Dance Head and Neck Center, and Merck had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: Timothy S. McNeel, BA (Information Management Services Inc), assisted with statistical analyses and received compensation.