Study concept and design: Hughes, West, Rennard, Russ, Treadow, Yu, Park.
Acquisition, analysis, or interpretation of data: Ebbert, Hughes, West, Rennard, Russ, McRae, Treadow, Yu, Dutro.
Drafting of the manuscript: Ebbert, Hughes, West, Rennard, Russ, McRae, Treadow, Yu, Park.
Critical revision of the manuscript for important intellectual content: Ebbert, Hughes, Rennard, Russ, Yu, Dutro, Park.
Statistical analysis: Yu.
Obtained funding: Park.
Administrative, technical, or material support: Treadow, Dutro, Park.
Study supervision: Ebbert, Russ, McRae, Treadow, Park.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ebbert reports receiving grants from JHP Pharmaceuticals, Orexigen, Pfizer, and the National Institutes of Health; and receiving personal fees from GlaxoSmithKline during the conduct of the study. Dr Hughes reports receiving personal fees from Alere/Free and Clear, Cicatelli, DLA Piper, Dorrffermeyer, Embera, Equinox, GlaxoSmithKline, Healthwise, Nicoventures, Pfizer, Pro Ed, Publicis, Selecta, and nonfinancial support from Swedish Match. Dr West reports receiving grants, personal fees, and nonfinancial support from Pfizer, GlaxoSmithKline, and Johnson & Johnson. His salary is funded by a Centre grant from Cancer Research UK. Dr Rennard reports being an advisory board member for A2B Bio, Almirall, Dalichi Sankyo, Novartis, Nycomed, and Pfizer; consulting for Almirall, APT Pharma/Britnall, AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, Decision Resource, Dunn Group, Easton Associates, Gerson, GlaxoSmithKline, MedImmune, Novartis, Pearl, Roche, Takeda, and Theravance; receiving lecture fees from CME Incite, Forest, Novis, PriMed, and Takeda; receiving grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Johnson & Johnson, Novartis, and Otsuka. Drs Russ, McRae, Yu, Dutro, Park, and Ms Treadow are employees and stockholders of Pfizer.
Funding/Support: This study was funded by Pfizer.
Role of the Funders/Sponsors: Pfizer was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank the investigators and study site personnel involved in the study. They were compensated for their contributions by Pfizer. Editorial support in the form of developing tables and figures; editing, proofing, and formatting the text; collating review comments; and preparing the manuscript for submission was provided by Abegale Templar, PhD (Engage Scientific, Horsham, United Kingdom), and funded by Pfizer.