Examining the Relationships Among Treatment, Pain, and Physical Function in Patients With Osteoarthritis: A Mediation-Modeling Approach.

"Pfizer (New York, NY) and Eli Lilly and Company (Indianapolis, IN) contributed to the study design; Pfizer contributed to the management and collection of data. In their role as authors, employees of Pfizer and Eli Lilly were involved in the interpretation of data, preparation, review, and approval of the manuscript and the decision to submit it for publication, along with their co-authors. The study sponsors approved the manuscript from an intellectual property perspective but had no right to veto the publication. This study was sponsored by Pfizer (New York, NY) and Eli Lilly and Company (Indianapolis, IN) R.H.D. has received in the past 5 years research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health, and compensation for serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, Biogen, Biohaven, Boston Scientific, Braeburn, Cardialen, Celgene, Centrexion, Chiesi, Chromocell, Clexio, Collegium, Concert, Confo, Decibel, Editas, Eli Lilly, Endo, Ethismos (equity), Eupraxia, Exicure, Glenmark, Gloriana, Grace, Hope, Lotus, Mainstay, Merck, Mind Medicine (also equity), Neumentum, Neurana, NeuroBo, Novaremed, Novartis, OliPass, Pfizer, Q-State, Reckitt Benckiser, Regenacy (also equity), Sangamo, Sanifit, Scilex, Semnur, SIMR Biotech, Sinfonia, SK Biopharmaceuticals, Sollis, SPRIM, Teva, Theranexus, Toray, Vertex, Vizuri, and WCG. D.C.T. has received research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health and has received compensation for consulting on clinical trials and patient preferences from AccelRx, Eli Lilly and Company, Flexion, GlaxoSmithKline, and Pfizer. D.A.W. has received research grants from the National Institutes of Health and has received compensation for consulting on clinical trials and behaviorally based interventions with Swing Therapeutics, Inc. and Community Health Focus Inc. J.D.M. has the following to disclose: Ad board: Clexio Biosciences, Flexion Therapeutics, Quark Pharmaceuticals, Quartet Medicine, Collegium Pharmaceutical, Purdue Pharma, Biogen, Novartis, Aptinyx, Nektar, Allergan, Grünenthal, Eli Lilly and Company, Depomed, Janssen, Teva Pharmaceutical Industries, KemPharm, Abbott Laboratories, Plasma Surgical, Chromocell, Convergence Pharmaceuticals, Inspirion, Pfizer, Sanofi, Daiichi Sankyo, and Trevena. Consultant: Trigemina, Editas Medicine, and Plasma Surgical. Data safety monitoring board: Novartis and Allergan. J.A.H. is an employee of Eli Lilly and Company with stock and/or stock options. A.G.B., L.A., D.C.S., J.C.C., and R.Y. are employees of Pfizer with stock and/or stock options."

"The clinical studies were conducted in compliance with the ethical principles originating in, or derived from, the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines, and were reviewed and approved by institutional review boards and/or independent ethics committees. All local regulatory requirements were followed, particularly those affording greater protection to the safety of trial participants. The studies were sponsored by Pfizer and Eli Lily and Company; both studies were registered on ClinicalTrials.gov, and the Identifiers are NCT02697773 and NCT02709486. This study was sponsored by Pfizer (New York, NY) and Eli Lilly and Company (Indianapolis, IN) R.H.D. has received in the past 5 years research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health, and compensation for serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, Biogen, Biohaven, Boston Scientific, Braeburn, Cardialen, Celgene, Centrexion, Chiesi, Chromocell, Clexio, Collegium, Concert, Confo, Decibel, Editas, Eli Lilly, Endo, Ethismos (equity), Eupraxia, Exicure, Glenmark, Gloriana, Grace, Hope, Lotus, Mainstay, Merck, Mind Medicine (also equity), Neumentum, Neurana, NeuroBo, Novaremed, Novartis, OliPass, Pfizer, Q-State, Reckitt Benckiser, Regenacy (also equity), Sangamo, Sanifit, Scilex, Semnur, SIMR Biotech, Sinfonia, SK Biopharmaceuticals, Sollis, SPRIM, Teva, Theranexus, Toray, Vertex, Vizuri, and WCG. D.C.T. has received research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health and has received compensation for consulting on clinical trials and patient preferences from AccelRx, Eli Lilly and Company, Flexion, GlaxoSmithKline, and Pfizer. D.A.W. has received research grants from the National Institutes of Health and has received compensation for consulting on clinical trials and behaviorally based interventions with Swing Therapeutics, Inc. and Community Health Focus Inc. J.D.M. has the following to disclose: Ad board: Clexio Biosciences, Flexion Therapeutics, Quark Pharmaceuticals, Quartet Medicine, Collegium Pharmaceutical, Purdue Pharma, Biogen, Novartis, Aptinyx, Nektar, Allergan, Grünenthal, Eli Lilly and Company, Depomed, Janssen, Teva Pharmaceutical Industries, KemPharm, Abbott Laboratories, Plasma Surgical, Chromocell, Convergence Pharmaceuticals, Inspirion, Pfizer, Sanofi, Daiichi Sankyo, and Trevena. Consultant: Trigemina, Editas Medicine, and Plasma Surgical. Data safety monitoring board: Novartis and Allergan. J.A.H. is an employee of Eli Lilly and Company with stock and/or stock options. A.G.B., L.A., D.C.S., J.C.C., and R.Y. are employees of Pfizer with stock and/or stock options."

"Clinical trial registration: NCT02697773 and NCT02709486."