Supplementary Appendix

This appendix has been provided by the authors to give readers additional information about their work.

Supplement to: Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or
ibuprofen for arthritis. N Engl J Med 2016;375:2519-29. DOI: 10.1056/NEJMoa1611593
 Supplementary Appendix
This appendix has been provided by the authors to give readers additional information about
their work.

Supplement to: manuscript citation
Table of Contents
Author affiliations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 1
Committees for the PRECISION Trial. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 1
PRECISION Study Team Acknowledgements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3
List of Investigators and Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 4
Approach to Inferential Analyses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 19
Cardiovascular Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 20
Endpoint Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 22
Figure S1. Patient Disposition in the PRECISION Trial . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 29
Figure S2. Time to Study Drug Discontinuation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 30
Figure S3. Time to Non-retention. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 31
Figure S4. Adjudicated Outcomes for the On-Treatment Population. . . . . . . . . . . . . Page 32
Figure S5. Subgroup Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 36
Table S1. Adjudicated Outcomes: Intention-to-Treat Population. . . . . . . . . .. . . . . . .Page 38
Table S2. Adjudicated Outcomes: On-Treatment Population. . . . . . . . . . . . . . . . . . . . . Page 39
Table S3. Measures of Anti-Arthritic Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 40
Table S4. Investigator Reported Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 41

Author Affiliations: From Steven E. Nissen M.D., Cleveland Clinic, Cleveland, OH, USA; Jeffrey S.
Borer M.D., State University of New York, Downstate Health Sciences Center, New York, NY, USA;
M. Elaine Husni M.D. M.P.H., Cleveland Clinic, Cleveland, OH, USA; David Y. Graham M.D., Baylor
College of Medicine, Veterans Affairs Medical Center, Houston, TX, USA; Peter Libby M.D., Brigham
and Women’s Hospital, Harvard Medical School, Boston, MA, USA; A. Michael Lincoff M.D.,
Cleveland Clinic, Cleveland, OH, USA; Thomas F. Lüscher M.D., University Hospital Zurich, Zurich,
Switzerland; Venu Menon M.D., Cleveland Clinic, Cleveland, OH, USA; Frank Ruschitzka, University
Hospital Zurich, Zurich, Switzerland; Daniel H. Solomon M.D. M.P.H., Harvard Medical School,
Brigham and Women’s Hospital, Boston, MA, USA; Qiuqing Wang M.S., Cleveland Clinic, Cleveland,
OH, USA; Lisa M. Wisniewski RN, Cleveland Clinic, Cleveland, OH, USA; Katherine E. Wolski M.P.H.,
Cleveland Clinic, Cleveland, OH, USA; Neville D. Yeomans M.D., Western Sydney University,
Campbelltown, NSW, Australia; Michael Gaffney Ph.D., Pfizer, New York, NY, USA; Bruce
Beckerman M.D., Pfizer, New York, NY, USA; Manuela Berger, M.D., Pfizer, New York, NY, USA;
Weihang Bao Ph.D, Pfizer, New York, NY, USA

PRECISION Committee Members
Executive Committee: Steven E. Nissen, Cleveland Clinic, Cleveland, OH, USA; Jeffrey S Borer, State
University of New York, Downstate Health Sciences Center, New York, NY, USA; M Elaine Husni,
Cleveland Clinic, Cleveland, OH, USA; David Y Graham, Baylor College of Medicine, Veterans Affairs
Medical Center, Houston, TX, USA; Peter Libby, Brigham and Women’s Hospital, Harvard Medical
School, Boston, MA, USA; A Michael Lincoff, Cleveland Clinic, Cleveland, OH, USA; Thomas F
Lüscher, University Hospital Zurich, Zurich, Switzerland; Daniel H Solomon, Harvard Medical School,
Brigham and Women’s Hospital, Boston, MA, USA; Neville D Yeomans, Western Sydney University,
Campbelltown, NSW, Australia; Michael Gaffney, Pfizer, New York, NY, USA

Data Monitoring Committee: Thomas R Fleming, University of Washington, Seattle, WA, USA;
James Brophy, McGill University Health Center, Montreal, Quebec, Canada; Leslie J Crofford,
Vanderbilt University Medical Center, Nashville, TN, USA; David A Peura, University of Virginia,
Charlottesville, VA, USA; David R Kerr, (External Independent Statistician), Axio Research LLC,
Seattle, WA, USA

Substudy Committee: Frank Ruschitzka, University Hospital Zurich, Zurich, Switzerland; Jeffrey S
Borer, State University of New York, Downstate Health Sciences Center, New York, NY, USA; M.
Elaine Husni, Cleveland Clinic, Cleveland, OH, USA; David Y Graham, Baylor College of Medicine,
Veterans Affairs Medical Center, Houston, TX, USA; Henry Krum, Centre of Cardiovascular
Research and Education in Therapeutics, Monash University, Melbourne, Victoria, Australia; Peter
Libby, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; A. Michael
Lincoff, Cleveland Clinic, Cleveland, OH, USA; Thomas F Lüscher, University Hospital Zurich, Zurich,
Switzerland; Steven Nissen, Cleveland Clinic, Cleveland, OH, USA; Daniel H Solomon, Harvard
Medical School, Brigham and Women’s Hospital, Boston, MA, USA; Neville D Yeomans, Western
Sydney University, Campbelltown, NSW, Australia

Event Adjudication Committees
Chair: Venu Menon, Cleveland Clinic, Cleveland, OH, USA

Cardiovascular: Saif Anwaruddin, Cleveland Clinic, Cleveland, OH, USA; Arman Askari, Cleveland
Clinic, Cleveland, OH, USA; Bryan Baranowski, Cleveland Clinic, Cleveland, OH, USA; Gregory
Bashian, Cleveland Clinic, Cleveland, OH, USA; Terri-Ann Benjamin, Cleveland Clinic, Cleveland, OH,
USA; Sorin Brener, Cleveland Clinic, Cleveland, OH, USA; Matthew Cavender, Cleveland Clinic,
Cleveland, OH, USA; Michael Chenier, Cleveland Clinic, Cleveland, OH, USA; Adnan Chhatriwalla,
Cleveland Clinic, Cleveland, OH, USA; Corey Coleman, Cleveland Clinic, Cleveland, OH, USA; Paul
Cremer, Cleveland Clinic, Cleveland, OH, USA; Ross Downey, Cleveland Clinic, Cleveland, OH, USA;
John Galla, Cleveland Clinic, Cleveland, OH, USA; Brandon Jones, Cleveland Clinic, Cleveland, OH,
USA; Anne Kanderian, Cleveland Clinic, Cleveland, OH, USA; Deborah Kwon, Cleveland Clinic,
Cleveland, OH, USA; Rony Lahoud, Cleveland Clinic, Cleveland, OH, USA; Jason Lappe, Cleveland
Clinic, Cleveland, OH, USA; Evan Lau, Cleveland Clinic, Cleveland, OH, USA; Lawrence Lazar,
Cleveland Clinic, Cleveland, OH, USA; Telly Meadows, Cleveland Clinic, Cleveland, OH, USA; Venu
Menon, Cleveland Clinic, Cleveland, OH, USA; Mehdi Shishehbor, Cleveland Clinic, Cleveland, OH,
USA; Amila (Dilusha) William, Cleveland Clinic, Cleveland, OH, USA; Willis Wu, Cleveland Clinic,
Cleveland, OH, USA; Omeed Zardkoohi, Cleveland Clinic, Cleveland, OH, USA

Neurology: Rishi Gupta, Cleveland Clinic, Cleveland, OH, USA; Jitendra Sharma, University of
Alabama at Birmingham, Birmingham, AL, USA; Robert Shields, Cleveland Clinic, Cleveland, OH,
USA; Cathy Sila, University Hospital Case Medical Center, Cleveland, OH, USA; Patrick Sweeney,
Cleveland Clinic, Cleveland, OH, USA; Vincent V Truong, Cleveland Clinic, Cleveland, OH, USA; Ken
Uchino, Cleveland Clinic, Cleveland, OH, USA

Gastroenterology: Gary Falk, Cleveland Clinic, Cleveland, OH, USA; Ahmed Kandiel, Cleveland
Clinic, Cleveland, OH, USA; Jessica Philpott, Cleveland Clinic, Cleveland, OH, USA; Mohammed A
Qadeer, Cleveland Clinic, Cleveland, OH, USA; Tyler Stevens, Cleveland Clinic, Cleveland, OH, USA;
Prashanthi Thota, Cleveland Clinic, Cleveland, OH, USA; John Vargo, Cleveland Clinic, Cleveland, OH,
USA; Yinghong Mimi Wang, Cleveland Clinic, Cleveland, OH, USA

ECG reviewers: Mateen Akhtar, Cleveland Clinic, Cleveland, OH, USA; Bethany Austin, Cleveland
Clinic, Cleveland, OH, USA; Daniel Cantillon, Cleveland Clinic, Cleveland, OH, USA; Clay Cauthen,
Cleveland Clinic, Cleveland, OH, USA; Joao L Cavalcante, Cleveland Clinic, Cleveland, OH, USA; Arun
Dahiya, Cleveland Clinic, Cleveland, OH, USA; Adam Goldberg, Cardiovascular Associates of
Charlottesville, Charlottesville, VA, USA; Eiran Gorodeski, Cleveland Clinic, Cleveland, OH, USA;
Matthew Kaminski, Cleveland Clinic, Cleveland, OH, USA; James E Lai, Cardiovascular Consultants
Medical Group, Stanford Healthcare, Oakland, CA, USA; Khaldoun Tarakji, Cleveland Clinic,
Cleveland, OH, USA; Donald Underwood, Cleveland Clinic, Cleveland, OH, USA

PRECISION Study Team Acknowledgements

Cleveland Clinic, C5Research: Ilijia Atanasovski, Cleveland, OH, USA; Craig Balog, Cleveland, OH,
USA; Dianna Bash, Cleveland, OH, USA; Matthew Becker, Cleveland, OH, USA; Kimberly Brown,
Cleveland, OH, USA; Antoinette Bruce, Cleveland, OH, USA; Deborah Davey, Cleveland, OH, USA;
Patricia D’Angelo, Cleveland, OH, USA; Liz Fabry, Cleveland, OH, USA; Debbie Gladish, Cleveland,
OH, USA; Patricia Hodge, Cleveland, OH, USA; Rosemary Klancar, Cleveland, OH, USA; Lisa
Lamovsky, Cleveland, OH, USA; Betty Moore, Cleveland, OH, USA; Karen Myers, Cleveland, OH,
USA; Narcis Pasca, Cleveland, OH, USA; Claire Pothier, Cleveland, OH, USA; Lisa Prcela, Cleveland,
OH, USA; Robin Rodriguez, Cleveland, OH, USA; Tambria Scebbi, Cleveland, OH, USA; Maura
Schnauffer, Cleveland, OH, USA; Linda Suchar, Cleveland, OH, USA; Gus Theodos, Cleveland, OH,
USA; Thomas Wang, Cleveland, OH, USA

Sponsor Study Team: Samia Ali-Akhtar, New York, NY, USA; Tricia Anderson, New York, NY, USA;
Karen C Baker, New York, NY, USA; Suzanne Collins, New York, NY, USA; Rosetta DeShields, New
York, NY, USA; Christine Fasano, New York, NY, USA; Rana Fayyad, New York, NY, USA; Heidi
Goldfarb, New York, NY, USA; Myrna Gomez, New York, NY, USA; Tameika Graham, New York, NY,
USA; Linda Guilds-Zamarka, New York, NY, USA; Vivian Herman, New York, NY, USA; Debra
Holmes, New York, NY, USA; Yue Lisa Hua, Collegeville, PA, USA; Dinu Iorga, New York, NY, USA;
Karen Ivanac, New York, NY, USA; Sinde Krapf, Groton, CT, USA; Adrian Liepins, Sandwich, Kent,
UK; Valerie Marquino, New York, NY, USA; Tom McDonagh, New York, NY, USA; Carol Mihalik,
New York, NY, USA; Cesar Miranda, Lima, Peru; Mary Anne Nemeth, New York, NY, USA; Ha
Nguyen, New York, NY, USA; Maria Pagano, New York, NY, USA; Milton L Pressler, New York, NY,
USA; Mary Kay Ratigan, Groton, CT, USA; Erlande Shine, New York, NY, USA; Tamara Simpson,
New York, NY, USA; Anna Spolnik, New York, NY, USA; Beth Sullivan, New York, NY, USA; Elsa S
Tantiongco, Makati City, Philippines; Oleksandr I. Tarakhonych, Kyiv, Ukraine; Xu Wang, New York,
NY, USA; Daniel Wilson, New York, NY, USA; Wayne Wisemandle, New York, NY, USA; Richard Feng
Xia, New York, NY, USA; Richard Zhang, New York, NY, USA

Quintiles: Christina Berger, Durham, NC, USA; Aksana Brock, Durham, NC, USA; Karin Brink,
Durham, NC, USA; Priscilla Byrd, Durham, NC, USA; Desmond Cabrera, Morrisville, NC, USA; Regan
Caleen, Durham, NC, USA; Serena Cavin, Durham, NC, USA; Jeannetta Crutchfield, Morrisville, NC,
USA; Brian Dallas, Durham, NC, USA; Shabnam Dawood, Bangalore, India; Matthew Dey,
Morrisville, NC, USA; John DiLiberti, Morrisville, NC, USA; Sharyn D’Souza, Durham, NC, USA;
Catherine Edwards, Durham, NC, USA; Amy Finn, Durham, NC, USA; Sarah Gardiner, Melbourne,
Australia; Angela Garrett, Durham, NC, USA; Julie Gauley, Durham, NC, USA; Betsy Goldman,
Cambridge, MA, USA; Jamie Gross, Durham, NC, USA; Kevin Hinnant, Durham, NC, USA; Amy
Horwhat, Durham, NC, USA; Philippe Houle, Durham, NC, USA; Kristina Humphreys, Durham, NC,
USA; Janet Iles, Morrisville, NC, USA; Matthew Kimball, Durham, NC, USA; Marek Kisly, Warsaw,
Poland; Stacy Kopcha, Durham, NC, USA; Subha Krishnan, Durham, NC, USA; Wendy Lloyd, Durham,
NC, USA; Gaston Lopez, Durham, NC, USA; Kaye Lowe, Melbourne, Australia; Adriane Machado,
Sao Paulo, Brazil; Erin Martin, Durham, NC, USA; Joy Martin, Morrisville, NC, USA; Madhura Nene,
Bangalore, India; Miriam Oren, Durham, NC, USA; Renata Pompilio, Sao Paulo, Brazil; Jamie
Schimmel, Durham, NC, USA; Shivani Shah, Durham, NC, USA; Leticia Simari, Buenos Aires,
Argentina; Angad Singh, Durham, NC, USA; Christie Steflik, Durham, NC, USA; Karyn Thompson,
Durham, NC, USA; Renata Toledo, Sao Paulo, Brazil; Caren Welborne, Durham, NC, USA; John
Whitt, Durham, NC, USA; Mark Williamson, Morrisville, NC, USA; Ella-Mai Wright, Overland Park,
MO, USA; Julia Zarate, Bogota, Colombia; Janet Zucker, Morrisville, NC, USA

PAREXEL: April Bradick, Billerica, MA, USA; Linda Taylor Bustamente, Billerica, MA, USA; Kasu
Harris, Billerica, MA, USA; Tam Smith, Billerica, MA, USA

PRECISION Study Investigators

Australia: David Bossingham, Cairns Base Hospital, Cairns, QLD; Russell Buchanan, Repatriation
Hospital, Heidelberg West, VIC; David Colquhoun, Core Research Group, Milton, OLD; Ferdinandus
De Looze, Jeff Karrasch, AusTrials Pty Ltd, Kippa Ring, QLD; Ferdinandus De Looze, Robyn
Huttenmeister, AusTrials Pty Ltd, Sherwood, QLD; Ferdinandus De Looze, Deborah Day, Bridget
Healy, Jeff Karrasch, Pauline Pryor, Australian Clinical Research Organisation, Caboolture, QLD;
Stephen Hall, Emeritus Research, Malvern East, VIC; Geoffrey Littlejohn, Monash Medical Center,
Dept of Rheumatology, Clayton, VIC; Marc Russo, Hunter Clinical Research, Broadmeadow, NSW;
Andrew Taylor, The Goatcher Clinical Research Unit, Shenton Park, WA; Robert Will, The Colin
Bayliss Research and Teaching Unit, Victoria Park, WA

Brazil: Mário Azevedo, Hospital Universitário Clementino Fraga Filho - UFRJ, Rio de Janeiro, RJ;
Cesar Baaklini, Ambulatorio de Especialidades Mario Covas, Marilia/SP; Victoria Borba, Hospital e
Maternidade Angelina Caron, Sala Pesquisa Clinica, Campina Grande do Sul, PR; Joao Carlos Brenol,
Hospital de Clinicas de Porto Alegre, Porto Alegre, RS; Marise Castro, Fabio Castro, IMA Brasil -
Instituto de Medicina Avancada, São Paulo, SP; Fernando Cavalcanti, Hospital das Clinicas da UFPE,
Recife - Pernambuco; Francisco Antonio Helfenstein Fonseca, Setor de Lip., Arterosc. e BioVasc. -
Disc. de Cardiologia, Sao Paulo, SP; Marco Gomes, CLINCOR - Clinica de Exames Cardiologicos e
Ecografia S/C Ltda, Maceio, AL; Swami Guimaraes, Hospital Dos Servidores Do Estado do Rio de
Janeiro, Rio de Janeiro, RJ; Mauro Keiserman, Hospital São Lucas - Pontificia, Porto Alegre, RS;
Jussara Kochen, Hospital Alemao Oswaldo Cruz, São Paulo, SP; Cristina Lanna, Hopsital das Clinicas
da Universidade Federal de Minas Gerais, Belo Horizonte, MG; Roger Levy, Hospital Ipanema Plus,
Rio de Janeiro, RJ; Andrea Lomonte, CEPIC - Centro Paulista de Investigacao Clínica, Sao Paulo, SP;
Flora Marcolino, Freddy Eliaschewitz, CPCLIN - Centro de Pesquisas Clínicas, São Paulo, SP; Ana
Claudia Melazzi, CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda, Rio de Janeiro, RJ; Emilio
Moriguchi, Associação Hospitalar Moinhos de Vento (AHMV) / CMIC, Porto Alegre, RS; Joao
Francisco Marques Neto, Hospital das Clinicas da UNICAMP, Campinas, SP; Ernesto Neto,
Faculdade de Medicina DO ABC, Santo Andre; Maurilio Pinto, CEPEME-CERHFAC Centro de Estudos
e Pesquisas Medicas, Curitiba, PR; Jose Provenza, PUC Campinas, Campinas, SP; Sebastiao
Radominski, Centro de Estudos do Hospital de Clínicas da UFPR, Curitiba, PR; Luis Roimicher,
Clinica de Reumatologia do Centro Médico BarraShopping, Rio de Janeiro, RJ; Jose Francisco
Saraiva, Hospital e Maternidade Celso Pierro - Puc Campinas, Campinas, SAO PAULO; Antonio
Scotton, CMIP - Centro Mineiro de Pesquisa, Juiz de Fora, MG; Julio Simon, Hospital Nossa Senhora
da Conceicao, Porto Alegre, RS; Antonio Sousa, Centro de Ensino e Pesquisa Hospital Sao Lucas,
Aracaju, SE; Weimar Kunz Sebba Barroso de Souza Souza, Via Medica - Centro Clinico, Goiania, GO;
Antonio Ximenes, CIP - Centro Internacional de Pesquisas, Goiania, GO

Canada: Jonathan Adachi, Office of Dr. Jonathan D. Adachi, Hamilton, ON; Naresh Aggarwal,
Aggarwal and Associates Ltd., Brampton, ON; Nabil Attie, Centre de Recherche Hochelaga/
Clinique Medicale Hochelaga, Montreal, QC; Milton Baker, Office of Dr. Milton F. Baker, Victoria,
BC; Frederick Barkhuizen, Jacobus Kooy, The Medical Arts Health Research Group, Penticton, BC;
John Bartlett, London Road Diagnostic Clinic & Medical Center, Sarnia, ON; Andre Beauchesne,
Centre de recherche clinique Adapra Inc., Quebec City, QC; Ira Bernstein, Office of Dr. Ira Bernstein,
Toronto, ON; Hassen Bhamjee, East London Medical Centre, London, ON; Sabyasachi Bose,
Downtown Medical Specialists, Saskatoon, SK; William Bowler, Office of Dr. William Blake Bowler,
London, ON; Ian Campbell, Kells Medical Research Group, Inc., Pointe-Claire, QC; Domino Roy
Chaulk, Paradise Medical Clinic, Paradise, NL; Guy Chouinard, Recherche Clinique Sigma, Inc.,
Quebec City, QC; John Collingwood, The Clinical Trials Centre, St. John's, NL; Howard Conter, MSHJ
Research Associates, Inc., Halifax, NS; John Corey, The Medical Arts Health Research Group, West
Vancouver, BC; Brian Craig, Office of Dr. Brian N. Craig, Saint John, NB; Pierre Dauth, Clinique de
Medicine Familiale de Cowansville, Cowansville, QC; Maurice Dufresne, AIM Health Group
Trainyards Health and Wellness Centre, Ottawa, ON; Peter Dzongowski, London East Medical
Centre, London, ON; Rafat Faraawi, KW Musculoskeletal Research Inc., Kitchener, ON; Pierre
Filteau, Centre Medical des Carrieres, Saint-Marc-des-Carrieres, QC; Claude Garceau, Institut
universitaire de cardiologie et de pneumologie de Québec, Quebec City, QC; Iris Gorfinkel, Prime
Health Clinical Research, Toronto, ON; Eric Grant, Eric N. Grant Professional Corporation,
Quispamis, NB; Randy Hart, White Hills Medical Clinic, St. John's, NL;Sam Henein, SKDS Research
Inc., Newmarket, ON; Catherine Hudon, Martin Fortin, ECOGENE-21 / Centre de sante et de
services sociaux de Chicoutimi, Chicoutimi, QC; Gregory Jasey, Research Office, Windsor, ON;
Subodh Kanani, Office of Dr. Subodh Kanani, Toronto, ON; Philippa Keegan, South Calgary Medical
Clinic, Calgary, AB; David Kendler, Prohealth Clinical Research Inc., Vancouver, BC; Majed Khraishi,
Dennis O'Keefe, Nexus Clinic Research, St. John's, NL; Benjamin Lasko, Manna Research, Toronto, ON;
Normand Lavoie, Jacob Karsh, Clinique Services Sante Rosemere, Rosemere, QC; John Li, G.A.
Research Associates Ltd/Ltee, Moncton, NB; Tersia Lichtenstein, Neil Hudson, Medical Arts Health
Research Group, Kelowna, BC; Derek Lowe, Ocean West Research Clinic Inc., Surrey, BC; Maynard
Luterman, C & L Research, Fort Erie, ON; Robert Luton, Office of Dr. Robert G. Luton, London, ON;
Claude Maranda, Cardiology and Research, Westmount, QC; Timothy McCarthy, Manitoba Clinic,
Winnepeg, MB; Karl Misik, Topsail Road Medical Clinic, St. John's, NL; Frederic Morin, Centre de
Recherche Musculo-Squelettique, Trois-Rivieres, QC; John Mutrie, Steven Taylor, Office of Dr. John
Mutrie, Kitchener, ON; Rohit Nagpal, Office of Dr. Rohit Nagpal, Brampton, ON; Dennis O'Keefe,
Commonwealth Medical Clinic, Mount Pearl, NL; William O'Mahony, Corunna Medical Research
Center, Corunna, ON; Michael O'Mahony, London Road Diagnostic Clinic & Medical Centre, Sarnia,
ON; Yves Pesant, St-Jerome Medical Research Inc., St-Jerome, QC; Jude Rodrigues, Clinical
Research and Arthritis Centre, Windsor, ON; Timothy Salter, Aviva Clinical Trial Group Inc.,
Burlington, ON; Kevin Saunders, Rivergrove Medical Clinic, Winnepeg, MB;Gordon Schacter, Office
of Dr. Gordon Schacter, London, ON; Manohara Senaratne, Dr. MPJ Senaratne Professional
Corporation, Edmonton, AB; Kenneth Skeith, Allin Clinic, Edmonton, AB;Jack Sussman, Keele
Medical Place, Toronto, ON; Swaran Syan, Gurcharan Syan, Office of Dr. Swaran K. Syan, Sudbury,
ON; J. Thorne, The Arthritis Program Research Group Inc., Newmarket, ON; George Tsoukas,
Recherche Medicale Appliquee Informatics (AMIR) Inc., Montreal, QC; Azim Velji, Office of Dr.
Azim M. Velji, Niagara Falls, ON; Brian Zidel, Malton Medical Center, Mississauga, ON

Colombia: Carmen Arango, Fundacion Cardioinfantil, Bogota, CUNDINAMARCA; Juan Gomez,

Fundacion Valle del Lili, Cali; Maria Jannaut, CLINICA COLSANITAS SA, Bogota, CUNDINAMARCA;
Rodrigo Botero Lopez, IPS Rodrigo Botero S.A.S., Medellin, ANTIOQUIA; Luis Pinto Penaranda,
Hospital Pablo Tobon Uribe, Medellin, ANTIOQUIA; Gerardo Ramirez, Fundacion Cardiovascular de
Colombia, Floridablanca, SANTANDER; Jose Molina Restrepo, Reumalab S.A.S., Medellin,
ANTIOQUIA

Costa Rica: Alvaro Badilla-Gomez, Centro Medico San Rafael, Alajuela; Javier Cespedes-Vargas,
Clinica San Agustin, San Jose; Fernando Garzona-Meseguer, Centro Medico San jose, San Jose;
Mortjay Gutreiman-Goldberg, Clínica Monte Sión, Heredia; Alberto Lainez-Ventosilla, Consultorio
Medico Alberto Lainez Ventosilla, San Jose; Pablo Monge-Zeledon, Oficina Privada, San Jose; Javier
Moya-Rodriguez, Clinica Catolica, San Jose; Oscar Oeding-Bermudez, Clinica Biblica, San Jose;
Jonathan Poveda-Fernandez, Edificio Panda, San Jose; Ricardo Saenz-Castro, Clinica de
Especialidades Medicas Drs. Saenz Castro, Heredia; Mary Vinocour-Fornieri, Clínica Vía San Juan,
Cartago

Hong Kong: Yat Yin Lam, Gabriel Wai-Kwok, Prince of Wales Hospital, Shatin, NT; StephenLee,
Department of Medicine, Queen Mary Hospital, Pokfulam; Chi-ChiuMok, Centre for Assessment
and Treatment of Rheumatic Diseases, New Territories, NT
Mexico: Carlos Abud-Mendoza, Hospital Central "Dr. Ignacio Morones Prieto" Unidad Regional de
Reumatologia y Osteoporosis, San Luis Potosi, SLP; Hilario Avila Armengol, Instituto Jalisciense de
Investigación Clínica SA de CV, Guadalajara, Jalisco; Luis Carmona-Furusho, Investigadores Clinicos
Asociados, Mexico, DF; Hermann Enkerlin-Pauwells, Instituto Mexicano de Investigación Clínica,
S.A. de C.V, Mexico, DF; Ignacio Garcia-De La Torre, Centro de Estudios de Investigacion Basica y
Clinica SC., Guadalajara, JALISCO; Rafael Garcia-Lopez, Mario Cardiel Rios, Unidad De Investigacion
Dr. Mario Alvizouri Munoz AC del Hospital General Dr. Miguel Silva, Morella, Michoacan; Roberto
Hernandez-Paz, Hospital Regional ISSSTE, Leon, Guanajuato; Pindaro Martinez-Osuna, CIF-BIOTEC,
Medica Sur, Mexico, DF; Luis Ochoa-Ortega, Comite Mexicano para la Prevencion de la
Osteoporosis, A.C., Mexico, DF; Manuel Robles-San Roman, Centro Medico Toluca, Metepec,
Estado de Mexico; Maria Saldate-Alonso, Centro de Investigacion del Noroeste S.C., Tijuana, Baja
California

Panama: Generoso Guerra Bautista, Centro de Investigación Marbella, Panama City; Rita Trujillo,
Dr. Rita Trujillo, Panama City

Peru: Luis Vega Espinoza, Alfredo Enrique Berrocal Kasay, Clinica San Felipe, Lima; Jorge Ravelo
Hernandez, Clinica Nuevo San Juan S.A.C., Lima; Rita Kuroiwa, IPC - Centro de Salud Integral S.A.,
San Isidro; Manuel Leon-Portocarrero, Centro Empresarial - Altavista Polo 4, Santiago de Surco;
Luis Morales Olazabal, Hospital Nacional Maria Auxiliadora/Consultorio de Reumatologia, Lima

Philippines: Ronald Eullaran, Chong Hua Hospital, Cebu City; Allan Lanzon, Mary Mediatrix Medical
Center, Lipa City; Juan Javier Lichauco, St. Lukes Medical Center, Quezon City; Julie Li-Yu, Chinese
General Hospital and Medical Center, Manila; Sandra Navarra, University of Santo Tomas Hospital,
Manila; Edgar Ramiterre, Southern Philippines Medical Center, Davao City; Evelyn Salido, De La
Salle Health Sciences Institute, Cavite; Perry Tan, Jose R. Reyes Memorial Medical Center, Manila

Taiwan: Der-Yuan Chen, Taichung Veterans General Hospital, Taichung; Hsiang-Cheng Chen, Jenn-
Haung Lai, Tri-Service General Hospital, Taipei; Hung-An Chen, Pei-Chih Chen, He-Hsiung Cheng,
Chi-Mei Medical Center, Tainan; Ping-Ning Hsu, National Taiwan University Hospital, Taipei; Ning-
Sheng Lai, Buddhist Tzu Chi Dailin General Hospital, Dailin Town; Hsiao-yi Lin, Taipei Veterans
General Hospital, Taipei; Shue-Fen Luo, Chang Gung Medical Foundation-Linkou Branch, Gueishan
Township; Wen-Chan Tsai, Chung-Ho Memorial Hospital, Kaoshiung Medical University Hospital,
Kaohsiung; Gregory Tsay, Chung Shan Medical University Hospital, Taichung

Ukraine: Larysa Bula, Treatment-and-Diagnostic Center LLC "Desna" Ltd, Temopil; Svitlana Danyliuk,
Grygorii Lysenko, Family Medicine Department of NMAPE, Kyiv; Grygoriy Ignatenko, Donetsk
National Med University, Donetsk; Oleksandr Karpenko, City Clinical Hospital #1, Kyiv; Lyudmyla
Kononenko, Municipal Establishment of Health Care, Kharkiv; Volodymyr Koshlia, Zaporizhzhya
Multiple Discipline Clinical Hospital # 9, Zaporizhzhya; Volodymyr Kovalenko, National Scientific
Center “The Strazhesko Institute of Cardiology”, Kyiv; Olexandr Kuryata, MI Dnipropetrovsk
Regional Clinical Hospital, Dnipropetrovsk; Yuriy Nikirenkov, Zhytomyr Regional Clinical Hospital
n.a. O.F. Gerbachevs’kyy/ Rheumatology Center, Zhytomyr; Oleksandr Parkhomenko, National
Scientific Center “The Strazhesko Institute of Cardiology”, Kyiv; Andriy Petrov, CRI "Clinical
Territorial Medical Association "University Clinic", Simferopol; Nataliya Shpyleva, MMI "City
Clinical Hospital #5", Donetsk; Anatoliy Svintsitskyy, State Institution "Republican clinical hospital
of MOH of Ukraine", Kyiv; Vira Tseluyko, City Clinical Hospital # 8, Dept of Cardiology and
Functional Diagnostics, Kharkiv; Susanna Tykhonova, Odesa National Medical University, Odesa;
Vadym Vizir, Municipal enterprise " City Hospital # 7", Zaporizhzhia; Oleksandr Voloshyn,
Bukovinian State Medical University, Chernivtsi; Andriy Yagensky, Lutsk City Clinical Hospital, Lutsk

United States: Marietta Abalos-Galito, San Jose Valley Research, Inc., San Jose, CA; John Adams,
Pacific Internal Medicine Group, Inc, Long Beach, CA; Angela Adelizzi, Shore Health Group, Toms
River, NJ; Adegbenga Adetola, Adegbenga A. Adetola, M.D., Lynwood, CA; Patrick Adler, Jeffry A.
Lindenbaum DO, PC, Yardley, PA; Jacob Aelion, Arthritis Clinic, Jackson, TN; Shilpi Ahmed,
Chesapeake CardioVascular Associates, Baltimore, MD; Mark Akerson, Panhandle Family Care
Associates & Emerald Coast Research Group, Marianna, FL; Basil Akpunonu, South Toledo
Internists, Toledo, OH; Jose Aldrich, Pedro Hernandez, DC Health Clinical Trials, Miami, FL;
Mohammed Allaw, Clinical Research Advantage, Inc., Evansville, IN; Jeffrey Alloway, Physicians
East P. A., Greenville, NC; Jeffrey Alper, Jeffrey Alper M.D. Research, Naples, FL; Odilon Alvarado,
The Medical Group of Texas, Fort Worth, TX; German Alvarez, Clinical Research of Brandon, LLC,
Brandon, FL; Lawrence Alwine, Brandywine Clinical Research, Dowington, PA; Pamela Amador,
Genetic Medical Research Corporation, Hialeah, FL; George Anagnostis, Family Health Care
Association, Arlington, TX; Jerome Anderson, Integris Cardiovascular Physicians LLC, Oklaholma
City, OK; Marshall Anderson, Kernodle Clinic Inc., Burlington, NC; Nabil Andrawis, Manassas Clinical
Research Center, Manassas, VA; Richard Andron, Andron Medical Associates, Englewood, NJ;
Stephen Apaliski, DCT - Anchor, LLC dba Discovery Clinical Trials, Arlington, TX; Ramesh Arora,
Medvin Clinical Research, Van Nuys, CA; Ronald Asher, Mark Nielsen, Internal Medicine Associates,
North Platter, NE; Robert Ashley, Florida Research Network, Gainesville, FL; George Atiee, GSA
Research, San Antonio, TX; Vivek Awasty, R&R Research-Smith Clinic, Marion, OH; Kwabena Ayesu,
Omega Research Consultants, LLC, Debary, FL; James Bacon, Gregory Eaton, OhioHealth Research
Institute, Mansfield, OH; William Baer, Grand Valley Medical Specialist, PLC, Grand Rapids, MI;
Wa'el Bakdash, Community Clinical Research Center, Anderson, IN; Jeffrey Baker, Women's
Healthcare Associates dba Rosemark WomenCare Specialists, Idaho Falls, ID; Thomas Ballard,
Mountain View Clinical Research, Inc., Greer, SC; Herbert Baraf, The Center for Rheumatology and
Bone Research, Wheaton, MD; Mark Barber, Professional Clinical Research, Interlochen, MI; Abdul
Bari, Abdul Bari MD Inc, Cairo, GA; Andre Barkhuizen, Portland Rheumatology Clinic, LLC, Portland,
OR; Robert Barnes, Robert D. Barnes, MD, LLC, Evansville, IN; Scott Baron, Capitol Interventional
Cardiology, Carmichael, CA; Thomas Barringer, William Cromwell, Daniel Wise, Mid Carolina
Cardiology Research, Charlotte, NC; Harold Bays, Louisville Metabolic and Atherosclerosis
Research Center, Louisville, KY; James Beach, 43rd Medical Associates, P.C., Pheonix, AZ; Richard
Beasley, Health Concepts, Rapid City, SD; Matthew Becker, Mark Izzo, Saint Vincent Consultant in
Cardiovascular Diseases, LLC, Erie, PA; Gary Bedel, TriPhase Research, Ltd., Franklin, OH; Gary
Bedel, Prestige Clinical Research, Franklin, OH; Ricardo Bedoya, Dr. Ricardo A. Bedoya, M.D.,
Jupiter, FL; Michael Bennett, Medical Associates Research Group, San Diego, CA; Ramon Berenguer,
Florida Medical Center & Research, Inc., Miami, FL; James Beretta, James P. Beretta, PC, Pleham,
AL; Richard Berkowitz, Phoenix Clinical Research, LLC., Tamarac, FL; Anupama Bhat, Sierra
Rheumatology, Roseville, CA; Subodh Bhuchar, Pioneer Research Solutions, Houston, TX; Veita
Bland, Bland Clinic, PA, Greensboro, NC; Kenneth Blaze, South Broward Research LLC, Pembroke
Pines, FL; Edgar Blecker, Ralph Geiger, North County Medical, Sebastian, FL; Bradley Block, Block
and Nation, PA, Oviedo, FL; Allan Bloom, Holy Cross Medical Group Northridge Internal Medicine,
Fort Lauderdale, FL; Fernando Boccalandro, Odessa Heart Institute, Odessa, TX; Barry Bockow,
Arthritis Northwest, Seattle, WA; Stephen Bookbinder, Ocala Rheumatology Research Center,
Ocala, FL; David Borenstein, The Center For Rheumatology and Bone Research, Washington, DC;
Brian Bowers, James Englebrecht, Regional Medical Clinic-Rheumatology, Rapid City, SD; Bruce
Bowling, Regional Clinical Research, Inc., Endwell, NY; David Brabham, Sheryl Williams, Pharma Tex
Research, LLC, Amarillo, TX; Donald Brandon, California Research Foundation, San Diego, CA;
Donald Brautigam, Great Lakes Medical Research, Westfield, NY; Clayton Bredlau, Randy Hartman,
Heart & Vascular Center Research, Sarasota, FL; Ognjenka Brkic-Vukotic, Atlanta Center for Clinical
Research, Roswell, GA; Andrew Brockmyre, Holston Medical Group, Bristol, TN; Alan Brodsky,
Arthritis Care and Diagnostic Center, P.A., Dallas, TX; Terri-Ann Brogan, Pharmaceutical Research
Associates, Merritt Island, FL; Robert Broker, Hillcrest Clinical Research, LLC, Simpsonville, SC;
Michael Brooks, Physicians Clinic of Iowa, Cedar Rapids, IA; Tami Bruce, Central Arizona Medical
Associates, PC, Mesa, AZ; Richard Brunner, Family Healthcare of Chipley, Chipley, FL; William Brus,
Eagle's View Family Medicine, Boise, ID; John Brusky, St. Lukes Pain Management Center,
Milwaukee, WI; Timothy Bruya, Pulmonary and Research Associates, Spokane, WA; David Burack,
The Carolina Center for Rheumatology & Arthritis Care, PA, Rock Hill, SC; Joseph Burchenal, South
Denver Cardiology Associates, PC, Littleton, CO; Robert Buynak, Buynak Clinical Research,
Valparasio, IN; Barbara Caciolo, Barbara A. Caciolo, MD, St. Louis, MO; Cas Cader, Crystal Coast
Family Practice, Morehead City, NC; Joe Campbell, Patrick Rask, Daniel Urbach, Affinity Research,
Portland, OR; Michael Campolo, Newark Physician Associates, Newark, OJ; James Capo, Executive
Health and Research Associates, Atlanta, GA; John Cappleman, CEC Research, INC., Ocoee, FL; John
Card, Clinical Trials of America, Inc., Winston-Salem, NC; Jose Cardona, Farid Marquez, Indago
Research & Health Center, Inc., Hialeah, FL; George Carr, Jefferson City Medical Group, Jefferson
City, MO; Albert Carr, Southern Clinical Research and Management, Inc., Augusta, GA; Jenecsis
Castro-Skoglund, Redhead Research Inc., DBA Research Associates of Central Illinois, Peoria, IL;
Mushtaque Chachar, Novex Clinical Research, LLC, New Bedford, MA; Maia Chakerian, Samaritan
Center for Medical Research Medical Group, Los Gatos, CA; John Chandler, Chandler Family
Practice, Bossier City, LA; Christopher Chappel, Office of Christopher Chappel, Kissimmee, Fl;
Michael Chen, Cardiac Associates, Shady Grove Adventist Hospital, Rockville, MD; Deanna Cheung,
Long Beach Center for Clinical Research, Long Beach, CA; Sapna Chilka, Midland Clinical Research
Center, Midland, TX; Jirayos Chintanadilok, Everest Medical Care & Emerald Coast Reserach Group
Inc., Marianna, FL; Allen Chodock, Office of Dr. Allen Chodock, Mamaroneck, NY; Tom Christensen,
Calabash Medical Center, Calabash, NC; Melanie Christina, Clinical Investigations of Texas, LLC,
Plano, TX; Rita Chuang, Clinical Research Advantage, Inc., Henderson, NV; Lisa Clark, Clark Family
Medicine & Emerald Coast Research Group, Destin, FL; James Clower, Westside Center for Clinical
Research, Jacksonville, FL; Amy Clunn, Southeastern Rehabilitation Medicine, Ocala, FL; Stanley
Cohen, Metroplex Clinical Research Center, Dallas, TX; Kenneth Cohen, New West Physicians,
Golden, CO; Robert Cohen, Cohen Medical Associates, PA, Delray Beach, FL; Paul Collins,
Orthopedic Health Care Clinic, Boise, ID; Harry Collins, Anderson and Collins, Clinical Research Inc.,
Edison, NJ; Lisa Connery, Robert McArthur, LION Research, Norman, OK; John Conte,
Rheumatology Associates, Pawtucket, RI; Abner Cordero, James Lassiter, JL Clinical Research, Tiffin,
OH; George Cornett, Jill Beavins, Fleming Island Center for Clinical Research, Franklin, IN; Franklin
Coulter, Coulter Clinic, Orangeburg, SC; Susan Courtnage, Office of Dr. Susan Courtnage, Eaton
Rapids, MI; Peter Cowen, Medical Specialist of the Palm Beaches, Atlantis, FL; William Cox, CFP
Research, Inc., Cincinnati, OH; Kevin Coy, James Margolis, Miami International Cardiology
Consultants, Miami, FL; Michael Creamer, Compass Research, LLC, Orlando, FL; Jairo Cruz,
WellGroup Healthpartners, Olympia Fields, IL; Kathleen Cullen, Dalton Benson, DMI Research, Inc.,
Pinellas Park, FL; John Curtis, Orthopaedics West, Bessemer, AL; Tillmann Cyrus, Joseph Chinn,
Samer Nakhle, VA Southern Nevada Healthcare System, North Las Vegas, NV; Adnan Dahdul,
FutureCare Studies, Springfield, MA; Erik Daly, Ami Milton, Crouse Medical Practice, PLLC d/b/a
Internist Associates of Central New York, Syracuse, NY; Ramprasad Dandillaya, Ram Dandillaya, MD,
Inc., Torrance, CA; Arthur Davida, Arthur I Davida, MD PC, Bloomingdale, IL; Cedrice Davis, Urban
Family Practice Associates, PC, Marietta, GA; Kenneth Dawes, George Rubeiz, Dawes Fretzin
Clinical Research Group, LLC, Indianapolis, IN; Jose Burbano De Lara, Leading Edge Research, PA,
Carrolton, TX; Julius Dean, William Short, St. Vincent's Cardiology, Jacksonville, FL; Peter Deane,
AAIR Research Center, Rochester, NY; Ronald DeGarmo, DeGarmo Institute of Medical Research,
Greer, SC; Drake DeHart, Dairyland Medical Center, Red Lion, PA; Ruth DeHaven, St. Andrews
Medical, Charleston, SC; John Delgado, Integrated Medical Research, PC, Ashland, OR; William
Deluccia, AMS Research, Elmira, NY; David Dennis, Carolyn Maldonado-Garcia, Sigrid Sanchez,
Michael Szczesny, Gina Vendetti, Boca Raton Clinical Research Associates, Boca Raton, FL; Dolph
Denny, Research Institute of Middle America/River Cities Cardiology, Jeffersonville, IN; Vikas Desai,
Charles River Medical Associates, Pchi, Natick, MA; Michael DeSantis, Clinical Trials of America, Inc.,
Hickory, NC; Deborah Desir, Arthritis and Osteoporosis Center, PC, Hamden, CT; Robert Detweiler,
Detweiler Family Medicine and Associates, PC, Lansdale, PA; Isam Diab, Southwest Rheumatology
and Research Group, LLC, Middleburgh Heights, OH; Joseph Diaz, DCT - Barlite, LLC dba Discovery
Clinical Trials, San Antonio, TX; John Dice, Araceli Elizalde, Mirie Hosler, Discovery Clinical Trials,
San Antonio, TX; Frederick Dietz, Rockford Health Physicians, Rockford, IL; Michael DiGiovanna,
DiGiovanna Family Care Center, North Massapequa, NY; Ara Dikranian, San Diego Arthritis Medical
Clinic, San Diego, CA; James Doris, Lovelace Scientific Resources, Inc., Pheonix, AZ; Brandon Downs,
Marcia Montgomery, Access Clinical Trials, Inc., Nashville, TN; Natalie Doyle, Natalie A. Doyle, MD
PA, Wilson, NC; James Dreyfus, Medical Specialists, Munster, IN; Veemal D'Souza, David Kaner,
Kaner Medical Group PA, Bedford, TX; Veemal D'Souza, David Kaner, David Livingston, Kaner
Medical Group, Euless, TX; Anit Dua, Rancho Internal Medicine, Las Vegas, NV; Pamela Dugano-
Daphnis, Office of Pamela Dugano-Daphnis, Webster, TX; Gary DuMontier, Patients First Health
Care, LLC, Washington, MO; Shelly Dunmyer, Pharmacotherapy Research Associates Incorporated,
Zanesville, OH; Michael Dunn, Quality Clinical Research LLC, Omaha, NE; Leonard Dunn, Clinical
Research of West Florida, Clearwater, FL; Edwin Dunteman, A & A Pain Institute, Saint Louis, MO;
Holly Dushkin, Mira Baron, Alan Kravitz, Nancy Tresser, Alan Wine, Rapid Medical Research, Inc.,
Cleveland, OH; Joel Eade, Internal Medicine Research Association, Campbellsville, KY; Cara East,
Soltero Cardiovascular Research Center/Baylor University Medical Center, Dallas, TX; John Eberly,
Bernard Corbett, Southeastern Research Associates, Inc., Taylors, SC; Richard Eddy, Institute of
Diabetes and Endocrinology, Medford, OR; Marwan Edris, Prime-Care Clinical Research, Mission
Viejo, CA; James Edwards, Bruton Avenue Family Practice, Newport News, VA; William Edwards,
Low Country Rheumatology, PA/Low Country Research Center, Charleston, SC; Wendy Eider,
Clinical Trials Northwest, Yakima, WA; Nabil El Sayad, Avalon Family Medical Group, Wilmington,
CA; Imad Elasmar, IMD Medical Group, Los Angeles, CA; Rochelle Elijah, Lynn Institute of Pueblo,
Pueblo, CO; William Ellison, Radiant Research, Inc, Greer, SC; Edward Engel, Arthritis Associates,
Erie, PA; Eli Engel, Chwi-Young Yang, Bayview Research Group, Valley Village, CA; Bernard Erickson,
Central Minnesota Heart Center at St. Cloud Hospital, St. Cloud, MN; Robert Ettlinger, Tacoma
Center for Arthritis Research, PS, Tacoma, WA; David Evanko, Butler Medical Associates, Chicora,
PA; Paul Evans, Dennis O’Neill, The Center for Excellence in Aging and Geriatric Health,
Williamsburg, VA; Carlos Everett, Victor Guerrero, Discovery Clinical Research, Corpus Christi, TX;
Robert Eyzaguirre, OWENS Pharma Research Center, Long Beach, CA; Michael Fairfax, ArthroCare,
Arthritis Care & Research P.C., Gilbert, AZ; Christopher Fallows, Nature Coast Clinical Research, LLC,
Crystal River, FL; Azmi Farag, Office of Azmi Farag, MD, Colorado Springs, CO; Cecil Farrington,
PMG Research of Salisbury, Salisbury, NC; Robert Fedor, Doctors Inn, Madeira Beach, FL; Howard
Feinberg, Howard L. Feinberg, D.O., Ashland, KY; Gary Feldman, Pacific Arthritis Care Center, Los
Angeles, CA; Bryan Feldman, Ali Ashrafzadeh, Feldman Family Practice, Columbus, OH; Elpidio
Feliciano, MIcheal DeWitt, Community Clinical Research Center, Muncie, IN; Ira Fenton, Deerbrook
Medical Associates, Vernon Hills, IL; Ronald Fernando, Anthony Firek, VA Loma Linda Healthcare
System, Loma Linda, CA; Justus Fiechtner, Justus J Fiechtner, MD, Lansing, MI; Thomas Fiel, Clinical
Research Advantage, Inc., Tempe, AZ; Harold Fields, Village Family Practice, Houston, TX; Carolyn
Fields, Paris View Family Practice, Greenville, SC; Romel Figueredo, Reliable Clinical Research, LLC,
Hialeah, FL; Timothy Fiorillo, Perkiomen Valley Family Practice, PC, Collegeville, PA; George Fisher,
Lehigh Wellness Center Outpatient Services, Philadelphia, PA; David Fitz-Patrick, East-West
Medical Research Institute, Honolulu, HI; Jerrold Flatt, Office of Jerrold V Flatt, Des Moines, IA;
Leslie Fleischer, White-Wilson Medical Center, PA, Fort Walton Beach, FL; Kathleen Flint, Ronald
Collins, Columbia Arthritis Center Pa, Columbia, SC; Gregory Flippo, Perry Savage, Alabama Clinical
Therapeutics, LLC, Birmingham, AL; Steven Folkerth, Clinical Research Center of Nevada, Las Vegas,
NV; Theresa Lawrence Ford, North Georgia Rheumatology Group, PC, Lawrenceville, GA; Bruce
Forney, Alliance Medical Center, Alliance, NE; Joseph Forstot, RASF - Clinical Research Center, Boca
Raton, FL; Miguel Franco, MCA Research, Houston, TX; David Francyk, Family Practice Specialists,
LTD, Pheonix, AZ; Neil Fraser, Troy Internal Medicine Research, Troy, MI; Asad Fraser, Graves
Gilbert Clinic, Bowling Green, KY; Robert Freed, Office of Dr. Robert L. Freed, MD, Irvine, CA; Jared
Freiburger, Medical Associates Clinic, PC, Dubuque, IA; Gerald Fruchter, IMA Medical Research PC,
Kew Gardens, NY; Nashwa Gabra, Burke Internal Medicine, Inc., Burke, VA; Lewis Gamarra, Coastal
Medical Research Group, Inc., San Louis Obispo, CA; Raul Gaona, Abbot Clinical Research Group,
San Antonio, TX; Raul Gaona, Quality Assurance Research Center, San Antonio, TX; Bernard Garcia,
Rene Casanova, Dr. Bernard Garcia, Fort Lauderdale, FL; Hiram Garcia, Centex Studies, Inc., Pharr,
TX; Scott Gebhardt, David Heiman, Alan Iezzi, Roland Shepard, West Wind'r Research, Tampa, FL;
William George, Cadillac Clinical Research, Cadillac, MI; Anu George, Seven Corners Medical
Research Center, Falls Church, VA; Catherine Gerrish, Brown Clinic PLLP, Watertown, SC; Rose
Gibbs, Berkeley Medical Center, Moncks Corner, SC; Eve Gillespie, Glacier View Cardiology,
Kalispell, MT; Joseph Gimbel, Arizona Research Center, Inc., Pheonix, AZ; Geoffrey Gladstein, New
England Research Associates, LLC, Trumbull, CT; William Glickfield, The Office of William Scott
Glickfield, MD, Trenton, OH; Narendra Godbole, Thunderbird Internal Medicine, Glendale, AZ;
Marc Goldberg, New Jersey Physicians, LLC, Clifton, NJ; Edward Goldberger, Arthritis Associates of
Northwest Ohio, Inc., Toledo, OH; Emilio Gonzalez, Rheumatology-UTMB, Galveston, TX; Manuel
Gonzalez, Sunbelt Research, LLC, Plantantion, FL; Salim Gopalani, Salim Gopalani, MD, PA, Houston,
TX; Darrell Gorman, Darrell E. Gorman, MD, Arvada, CO; David Grant, Sun Research Institute, San
Antonio, TX; William Gray, The Office of William Gray, Md, Family Practice, Spokane, WA; Gina
Greco, Stephen Sissleman, East Meadow Family Practice Associates, PC, Wantagh, NY; Jerry
Greenberg, Aurora Denver Cardiology Associates, Aurora, CO; Paul Grena, Cardiology Consultants
of Philadelphia, Yardley, PA; John Gresh, Paddock Park Clinical Research, Ocala, FL; Robert Griffin,
William Schnitz, Larry Willis, Clinical Research Center of Reading, LLC, Wyomissing, PA; Carl Griffin,
Lynn Health Science Institute, Oklaholma City, OK; Jason Griffin, Archibold Primary Care,
Thomasville, GA; Colby Grossman, Palmetto Clinical Research, Summerville, SC; Stephen Grubb,
Tabor City Family Medicine, Tabor City, NC; Rao Gudipati, Michigan Cardiovascular Institute,
Saginaw, MI; Rajendra Gupta, Hopewell Valley Medical Group, P.A., Trenton, NJ; Ramesh Gupta,
Gupta, Ramesh C MD, Memphis, TN; Robert Guskiewicz, Southeastern Integrated Medical, PL,
Gainesville, FL; Terrence Hack, Primary Care Cardiology Research, Ayer, MA; Kevin Hackshaw, The
Ohio State University, Columbus, OH; Arthur Hall, Arthur L. Hall MD PA, Orlando, FL; Maxine
Hamilton, Maxine Hamilton, MD PA, Fort Lauderdale, FL; David Hamm, Spectrum Health Medical
Group-Rheumatology, Grand Rapids, MI; Ester Hare, Orangeburg Medical Associates, PA,
Orangeburg, SC; Wayne Harper, Wake Research Associates, LLC, Raleigh, NC; Lisa Harris, Chase
Research Group, LLC, Virginia Beach, VA; Boyde Harrison, Winston Technology Inc., Haleyville, AL;
Terence Hart, Office of Terence T. Hart, MD, Muscle Shoals, AL; Ethan Haskel, MidAtlantic
Cardiovascular Associates, PA, Baltimore, MD; David Headley, Planters Clinic, Port Gibson, MS;
Archie Hearne, Hearne Family Practice Clinic, Little Rock, AR; G. Heigerick, GCH Research, Lilbum,
GA; Bruce Henry, South Arlington Primary Care Associates PA, Arlington, Tx; Lee Herman, Herman
Clinical Research, LLC, Suwanee, GA; Mark Hermann, Danville Orthopedic Clinic, Danville, VA;
Robert Herring, Quality Medical Research, Nashville, TN; John Herrod, Cochise Clinical Research,
Sierra Vista, AZ; Vernon Hershberger, Daystar Clinical Research, Akron, OH; William Herzog,
Cardiovascular Specialists, LLC, Columbia, MD; John Hill, Avail Clinical Research, LLC, DeLand, FL;
General Hilliard, Comprehensive Adult Risk Evaluation, San Leandro, CA; Eric Hochman, Anchor
Health Centers, Naples, FL; Susan Hole, Riverside Clinical Research, Edgewater, FL; Maynard
Holgado, Robert Aiken, Sicklerville Internal Medicine Associates, Sicklerville, NJ; Reid Holkesvik,
Odyssey Research/Sanford Clinic - Aberdeen, Aberdeen, SD; Peter Holt, Peter A. Holt, Baltimore,
MD; Curtis Horn, Quality Research Inc., San Antonio, TX; Stanley Horner, Allergy Athsma
Immunology Services, LLC, Jefferson City, MO; Angela House, CTL Research, Eagle, ID; Timothy
Howard, Medical Affiliated Research Center, Incorporated, Huntsville, AL; Mary Howell, Klein &
Associates, MD, PA, Hagerstown, MD; James Howell, SJS Clinical Research, Inc, Destin, FL; Stephen
Hufman, Wenatchee Valley Medical Center, Research Department, Wenatachee, WA; William
Hughes, Parkway Medical Group, Fayetteville, TN; Robert Hunter, Carl Diener, Andrew Slaski, ARA-
Arizona Research Associates, Tucson, AZ; M. Husni, Cleveland Clinic, Cleveland, OH; Murtaza
Hussain, Livernois Family Medical Services, Detroit, MI; Richard Hymowitz, Rheumatology and
Arthritis Associates PC, Medford, NJ; James Igleburger, Emerald Coast Mood & Memory, Fort
Walton Beach, FL; Carlos Ince, Midatlantic Cardiovascular Associates, Pa, Baltimore, MD; Younus
Ismail, Scottsboro Quick Care Clinic, Scottsboro, AL; Timothy Jackson, Tri-State Medical Group,
Beaver, PA; William Jacobs, Brian Goldman, PMG Research of Raleigh, LLC, Raleigh, NC; Kenneth
Jaffe, Achieve Clinical Research, LLC, Birmingham, AL; James Jakes, Montgomery Rheumatology
Associates, Montgomery, AL; Richard Janovitz, DCT FMC, LLC dba Discovery Clinical Trials, Orlando,
FL; Werner Jauch, Clinyx/Pasco Cardiology, Hudson, FL; John Jenkins, The Jackson Clinic, PA,
Jackson, TN; Carol Johnson, Carol M. Johnson MD, LLC, Alabaster, AL; Claudia Johnson, Claude
Mandel Medical Center, Chicago, IL; Beth Jonas, Thurston Arthritis Reaserch Ctr, Chapel Hill, NC;
Richard Jones, Clinic for Rheumatic Diseases, Tuscaloosa, AL; Rebecca Jordan, Center for Clinical
Trials of Sacramento, Inc., Sacramento, CA; Ameer Kabour, Toledo Cardiology Consultants, Toledo,
OH; Wagdy Kades, Office of Wagdy W. Kades, MD, Inc., Los Angeles, CA; Alan Kaell, Rheumatology
Associates of Long Island, Smithtown, NY; Shelly Kafka, Mountain State Clinical Research,
Clarksburg, WV; Vicki Kalen, Eclipse Clinical Research, Green Valley, AZ; Bina Kamdar, Center for
Clinical Trials of San Gabriel, West Covina, CA; Louis Kantaros, Mumtazuddin Jafar, Hudson Valley
Heart Center, Poughkeepsie, NY; Sanjiv Kapil, Florida Arthritis Center, LLC, Lake Mary, FL; Dean
Karras, Robert Hutchins, PMG Research Wilmington Research Associates, Wilmington, NC; Ahmad
Kashif, Arthritis and Osteoporosis Consultants of the Carolinas, Charlotte, NC; Hisham Kashou,
United Health Service Hospitals, Office of Clinical Trials, Johnson City, NY; Arnold Katz, Arthritis
Specialists of Greater KC, Overland Park, KS; Robert Kaufmann, Michael Conlin, The Kaufmann
Clinic, Atlanta, GA; Robert Kaufmann, Kaufmann Clinic, INC, Woodstock, GA; Jennifer Kay, Ridge
Family Practice, PC, Council Bluffs, IA; William Kaye, Robert Levin, Edna Scheindling-Tokayer,
Metabolic Research Institute, Incorporated, West Palm Beach, FL; Richard Kelly, Precision Trials,
Pheonix, AZ; Kevin Kempf, Francis Burch, Radiant Research San Antonio Northeast, San Antonio,
TX; Alastair Kennedy, Office of Alastair C. Kennedy, MD, Vero Beach, FL; Howard Kenney, Arthritis
Northwest Rheumatology, Spokane, WA; David Kenton, Deerfield Beach Cardiology Associates,
Deerfield Beach, FL; Boris Kerzner, Health Trends Research, LLC, Baltimore, MD; Michael
Kesselbrenner, The Valley Hospital, Ridgewood, NJ; Ammar Khalifa, Muna Abuerreish, Radiant
Research, Inc., Overland Park, KS; Saleem Khan, Office of Dr. Saleem Khan, MD, Inc., London, OH;
Jalil Khan, Pri-Med Care, Lewisville, TX; Bobby Khan, Atlanta Vascular Research Foundation, Atlanta,
GA; Shishir Khetan, Rockville Internal Medicine Group, Rockville, MD; Frank Kilpatrick, Douglad
Kutz, UW Health Physicians, Madison, WI; Andrew Kim, Allegiance Research Specialists, LLC,
Wauwatosa, WI; Robert Kimelheim, Elite Medical Research, Inc., Sellersville, PA; Charles King,
North Mississippi Medical Clinics, Inc., Tupelo, MS; Stephanie Kinnaman, American Health Network
of IN, LLC, Greenfield, IN; William Kirby, Simon Williamson Clinic/Clinical Research Advantage, Inc.,
Birmingham, AL; Judith Kirstein, Advanced Clinical Research, West Jordan, UT; Charles Kistler,
Midtowne Family Practice Centre, Columbus, OH; Alan Kivitz, Altoona Center for Clinical Research,
Duncansville, PA; Steven Klein, The Osteoporosis & Clinical Trials Center, Cumberland, MD; Morris
Kliger, Lansdale Medical Group Family Practice, Lansdale, PA; Ronica Kluge, Clinical Physiology
Associates, Fort Myers, FL; William Knapp, Mel Lucas, Patterson Medical Clinic / d.b.a. Prime Care
Research Associates, Florissant, MO; C. Knee, Adult & Pediatric Rheumatology, Midland Park, NJ;
George Kneller, Memorial Health System, Inc. dba LaPorte Medical Group, LaPorte, IN; Sabina
Kobylinski, Joseph Risser, Lindora Research Center, Irvine, CA; Karen Kolba, Pacific Arthritis Center
Medical Group, Santa Maria, CA; Gary Korff, Cassidy Medical Group-Vista, Carlsbad, CA; Edward
Kosinski, Connecticut Clinical Research, LLC, Bridgeport, CT; Perry Krichmar, Research Physician
Network Alliance, Pembroke Pines, FL; Razmig Krumian, Edward Portnoy, Westlake Medical
Research, Thousand Oaks, CA; Mariananda Kumar, Chistopher Fellows, Comprehensive Pain
Management, Inverness, FL; Ullattil Kumar, Nandini Kohli, Discovery Clinical Trials, Austin, TX; Elise
Kwon, Facey Medical Foundation, Mission Hills, CA; Timothy Ladner, Office of Dr. Timothy J.
Ladner, MD, Las Vegas, NV; Jarvis Lambert, Internal Medicine and Cardiology Associates of SENE,
PC, Fall River, MA; Mario Lamothe, Kelsey Seybold Clinic, Houston, TX; Robert Lang, Robert Lang,
MD, P.C., Hamden, CT; Christine Laramee, Alba Clinical research, Clearwater, FL; German Larrain,
Aspirus Cardiovascular Associates, Wausau, WI; Jeffrey Lawson, Palmetto Clinical Trial Services,
LLC, Greenville, SC; Charles Leach, The Medical Group of Texas, Fort Worth, TX; Tat Lee, Lee
Medical Associates, Dunkirk, NY; Richard Leggett, Crossroads Clinical Research, LLC, Victoria, TX;
Thomas Lenzmeier, Lenzmeier Family Medicine, Glendale, AZ; Lester Leung, Midatlantic
Cardiovascular Associates PA, Bel Air, MD; Robert Levin, Robert W. Levin MD, Dunedin, FL; Dale
Levinsky, Genova Clinical Research, Tuscon, AZ; Lawrence Levinson, Tipton Medical and Diagnostic
Center, Tipton, PA; David Lewis, Meriter Medical Group, Madison, WI; Roger Lidman, Center for
Arthritis and Rheumatic Diseases, Chesapeake, VA; Donald Lieberman, Tucson Clinical Researh,
Tuscon, AZ; Esther Lim, Naresh Parikh, David Wyatt, In-Quest Medical Research, LLC, Norcross, GA;
Dennis Linden, Rogue Valley Physicians-Clinical Research Group, Medford, OR; Ronald Littlefield,
Palmetto Research, Spartanburg, SC; John Long, John F. Long, D.O., Spokane, WA; William Long,
Barat Research Group, Inc., Charlotte, NC; Kevin Longshaw, Texas Health Physicians Group, Dallas,
TX; Richard Lorraine, Harleysville Medical Assoc, Harleysville, PA; Gerardo Losoya, Towngate Plaza
Medical Center, Garland, TX; John Lowe, Advanced Research Institute, Ogden, UT; Philip Lozman,
Orthopaedic Specialist of Miami Beach, Aventura, FL; Barry Lubin, National Clinical Research -
Norfolk Inc., Norfolk, VA; Charles Ludivico, East Penn Rheumatology Associates, PC, Bethlehem,
PA; Paul Lunseth, Nektaria Paraskevopoulos, Lori Ann Rusterholtz, Clinical Research of West
Florida, Tampa, FL; Kevin Lutz, Mountain View Clinical Research, Inc., Denver, CO; Michael Lynch,
Saint Luke's Medical Clinic, Fort Collins, CO; Daryl MacCarter, Idaho Arthritis and Osteoporosis
Center, Meridian, ID; Brian MacGillivray, Discovery Clinical Trials, San Antonio, TX; Lisa Madsen,
Associates Reseach Inc., Lansing, KS; Chinedu Maduakolam, Investigators research Group,
Indianapolis, IN; Rodney Magargle, Camp Hill Clinical Research Center, Camp Hill, PA; Frank
Maggiacomo, New England Center for Clinical Research, Cranston, RI; William Makarowski, Center
for Assessment and Research of Erie, Erie, PA; David Mandel, David R. Mandel, MD, Inc, Mayfield
Village, OH; Kris Manlove-Simmons, Rasean Hodge, Clinical Trial Providers, Inc., Tucker, GA;
Deborah Manning, Manning Family Care, LLC, Tempe, AZ; Abe Marcadis, Palm Beach Research
Center, West Palm Beach, FL; Louis Marino, Buckingham Family Medicine, Buckingham, PA; Steven
Marks, Terry O’Reilly, Novara Clinical Research, Mesa, AZ; Kenneth Martin, Rx Medical Research of
AR, Little Rock, AR; Juvenal Martinez, Office of Dr. Juvenal E. Martinez, MD, PA, Miami, FL;
Rajendra Marwah, Rajendra K. Marwah, MD, El Paso, TX; Fadi Matar, Clinyx/Floria Cardiovascular,
Tampa, FL; Steven Mathews, Jacksonville Center for Clincal Research, Jacksonville, FL; Rameshwar
Mathur, Rameshwar N. Mathur, MD, PA, Cocoa, FL; Frank Mazzone, Central Coast Pathology
Consultants, San Louis Obispo, CA; Brian McCormick, Hampton Family Practice, Hampton, VA;
LeeRoy McCurley, ProCare Clinical Trials, Grand Prairie, TX; Edward McDermott, Coastal
Connecticut Research, LLC, New London, CT; David McDonald, Office of David K. McDonald, M.D..
P.A., Pasadena, TX; Martin McElya, Discovery Clinical Trials, Dallas, TX; Mairus McFarland,
McFarland Family Clinic, Shreveport, LA; Frank McGrew, Stern Cardiovascular Foundation, inc.,
Germantown, TN; Marvin McIntosh, Community House of Wellness, Kansas City, KS; Wilfred
McKenzie, M&O Clinical Research, LLC, Fort Lauderdale, FL; Brent McLaurin, AnMed Health,
Anderson, SC; Barry McLean, Central Alabama Research, Birmingham, AL; Jon McRae, Darrekk
Surratt, Bainbridge Medical Associates, Bainbridge, GA; Ivan Mefford, Ivan N. Mefford, MD, PhD,
PA, Richmond, TX; Daksha Mehta, Center for Arthritis and Osteoporosis, Elizabethtown, KY; Praful
Mehta, Heartland Research Associates, LLC, Wichita, KS; Chandrakant Mehta, C. V. Mehta, MD
Medical Corporation, Hemet, CA; Ajay Meka, Office of Ajay G. Meka, MD, Santa Ana, CA; James
Meli, Clinical Research Advantage, Inc., Henderson, NV; Brock Merritt, Phoenix Clinical, Pheonix,
AZ; Bernard Michlin, Wetlin Research Associates, Inc, San Diego, CA; Cody Mihills, Southlake
Clinical Trials, Southlake, TX; Magdy Mikhail, The Center for Clinical Trials, Biloxi, MS; John Milas,
John Milas, Greer, SC; James Miller, Richmond Regional Research, Richmond, KY; Sam Miller, S.A.M.
Clinical Research Center, San Antonio, TX; Jeffrey Miller, Soutwest Florida Clinical Research Center,
Tampa, Fl; Gary Miller, Cardiac Wellness Consultants, Chicago, IL; David Miller, Bucks County
Clinical Research, Morrisville, PA; Paul Miller, Colorado Center for Bone Research PC, Lakewood,
CO; Richard Mills, East Cooper Internal Medicine, Mt. Pleasant, SC; Harold Minkowitz, Office of
Cyril Wolf, MD, Houston, TX; Francisco Miranda, Francisco Miranda, Miami, FL; Wesley Mizutani,
Talbert Medical Group, Huntington Beach, CA; Manuel Modiano, ACRC/Arizona Clinical Research
Center, Incorporated, Tucson, AZ; Sathish Modugu, Drug Trials America, Inc., Hartsdale, NY; Robert
Moidel, Rheumatology Associates, Ltd, Colmar, PA; Arthur Mollen, Southwest Health Ltd.,
Scottsdale, AZ; Darron Molter, North Myrtle Beach Family Practice, North Myrtle Beach, SC; Chadia
Morcos, Office of Dr. Chadia Morcos, Syosset, NY; Joseph Morelli, The Office of Dr. Joseph T.
Morelli, DO, Stoneboro, PA; James Moretti, PEAK Research, LLC, Upper St. Clair, PA; Athol Morgan,
One Heart, LLC, Baltimore, MD; Cynthia Morgan, Office of Cynthia Morgan, MD, Washington, DC;
David Morin, Jerry Miller, Holston Medical Group, Kingsport, TN; David Morris, William Surbeck,
Healthcare Research Consultants, Tulsa, OK; Walter Morris, Keith Davis, Pinehurst Medical Clinic,
Inc., Pinehurst, NC; Bruce Morrison, Office of Dr. Bruce Morrison, Huntingdon Valley, PA; Steen
Mortensen, Richard Lies, Via Christi Clinic, Witchita, KS; Jane Mossberg, Lane Medical Research
Group, Eugene, OR; Jaynier Moya-Hechevarria, Direct Helpers Medical Center, Inc., Hialeah, FL;
Marc Mugmon, Henry Meilman, Chesapeake CardioVascular Associates, Baltimore, MD; Abel
Murillo, AMPM Research Clinic, Miami, FL; Gary Myerson, Arthritis and Rheumatology of Georgia,
Atlanta, GA; Gnanasumathi Naini, Discovery Clinical Trials, Plano, TX; Srinivas Nalamachu,
International Clinical Research Insititute, Inc., Overland Park, KS; Jeffrey Neal, Arthritis Center of
Lexington, Lexington, KY; Nathaniel Neal, Valerius Medical Group and Research Center for Greater
Long Beach, Los Alamitos, CA; David Neidorf, Family Medicine of Lindenwold, Lindenwold, NJ; Joel
Neutel, Orange County Research Center, Tustin, CA; Clark Neuwelt, C Michael Neuwelt, San
Leandro, CA; Thach Nguyen, Cardiovascular Clinics, PC, Merrillville, IN; Richard Nielsen,
Professional Clinical Research-Benzonia, Benzonia, MI; Paul Norwood, Valley Research, Fresno, CA;
Holly Novak, Prairie Cardiovascular Consultants, Springfield, IL; Maria Nualart, Patricia Ares-
Romero, Arsenio Columbie, School of Clinical Research USA, LLC, Miami, FL; Okechi Nwabara,
Internal Medicine Center of Northwest Indiana, P.C., Gary, IN; Uchenna Nwaneri, The Spine & Joint
Center, Greenbelt, MD; Thomas O'Barr, Drug Studies America, Marietta, GA; Mandeep Oberoi,
Central Jersey Health Care, Elizabeth, NJ; Alvaro Ocampo, Future Care Solution, LLC, Miami, FL;
Lydia Oftadeh, Eleanor Azurin, Rx for Life, Inc, Bell, CA; Paul Ogden, Creekside Clinical Research,
Greenbrae, CA; Wayne Old, Cardiovascular Associates, Ltd, Chesapeake, VA; Shelby Olds, Frederick
Martin, PMG Research of Bristol, Bristol, TN; Stephen Ong, MD Medical Research, Oxon Hill, MD; J.
Oppy, Office of J. Miller Oppy, MD, Youghiogheny Primary Care Practice, Connellsville, PA; Kenneth
Otah, Enyibuaku Uzoaga, Oxford Clinical Research, LLC, Houston, TX; Michael Pace, East Lincoln
Internal Medicine, Lincoln, NE; Henry Paez, Roger Rousseau, Pharmax Research Clinic, Miami, FL;
William Palmer, Westroads Medical Group, Omaha, NE; Stanley Pamfilis, Parkersburg Cardiology
Associates, Parkersburg, WV; Jose Pando, John Gomez, Rheumatology Consultants of Delaware,
Lewes, DE; Charles Paraboschi, Penn Cardiac Care at Mercer Bucks, Lawrenceville, NJ; Suresh
Kumar Pasya, Talha Shamim, Heartland Clinical Research, Inc., Omaha, NE; Andres Patron, Andres
Patron, DO, PA, Pembroke Pines, FL; Charles Patton, David Colvin, TFD Research, LLC, Shreveport,
LA; Humberto Pavon, Internal Medicine Kidney and Hypertension Center, Norfolk, VA; Dayton
Payne, PMG Research Of Hickory, LLC, Hickory, NC; Philip Pearlstein, Pearl Clinical Research, Inc.,
Norristown, PA; Brian Peck, Arthritis Center of Connecticut, Waterbury, CT; Jeffrey Peller, Harbin
Clinic, Rome, GA; John Peniston, AMH Feasterville Family HealthCare Center, Featerville, PA; Carl
Pepine, Cardiology West, Gainesville, FL; Jorge Perez, Advanced Research Institute of Miami,
Homestead, FL; Robert Perry, Pembroke Clinical Trials, Pembroke Pines, FL; Lenin Peters, Peters
Medical Research, High Point, NC; Daniel Peterson, Sierra Internal Medicine Associates, Incline
Village, NV; Walter Pharr, Anthony Anderson, Medication Management, LLC, Greensboro, NC;
Peter Philander, Clinical Research Advantage, Las Vegas, NV; Richard Pish, Pish Medical Associates,
Uniontown, PA; Kevin Plancher, Orthopaedics Foundation for Active Lifestyles, Cos Cob, CT;
Samantha Plasner, Minati Pattanayak, Lourdes Medical Associates, Willingboro, NJ; Julie Poludniak,
Community Health Research, North East, MD; Daniel Pomposini, Danville Internal Medicine, Inc.,
Danville, VA; Larry Popeil, Magnolia Research Group, Inc., Ocala, FL; Andrew Porges, NYU Langone
Rheumatology Associates Long Island, Lake Success, NY; Clarence Porter, WellMed Clinical
Research, San Antonio, TX; Annette Porter, Southern Family Healthcare and Health First Research
Group Inc., Chipley, FL; James Porterfield, Midatlantic Cardiovascular Associates, Baltimore, MD;
Geri Poss, Paragon Research Center, LLC, San Antonio, TX; Gary Post, Ranch View Family Medicine,
Highlands Ranch, CO; Jeffrey Potts, Great Lakes Research Group, Incorporated, Bay City, MI; Kevin
Pounds, Orange Grove Family Practice, Tucson, AZ; David Prelutsky, Southampton Healthcare, Inc.,
Saint Louis, MO; Adrienne Prentiss, Prentiss Family Medicine, Colleyville, TX; Blas Prieto, Advance
Medical Research Service, Corp, Miami, FL; Kevin Pritchett, Southern Illiniois Clinical Research
Centre, O'Fallon, IL; Richard Promin, Tequesta Research Group, Ocala, FL; Ronald Pruitt, Nashville
Medical Research Institute, Nashville, TN; Henry Prupas, Arthritis Center of Reno, Reno, NV; Jeffrey
Quartner, Midatlantic Cardiovascular Associates, PA, Baltimore, MD; George Raad, PMG Research
of Charlotte, Charlotte, NC; David Radin, Stamford Therapeutics Consortium, Stamford, CT; Naveen
Raja, Agilence Arthritis and Osteoporosis Medical Center, Inc., Whittier, CA; David Ramstad, David
Ramstad, MD, MPH and Associates, Chesapeake, VA; Elizabeth Ranasinghe, Family Medicine and
Occupational Health Center, Inc., Shaker Heights, OH; William Randall, PriMed Clinical Research,
Kettering, OH; Seppo Rapo, Clinical Research Center of Cape Cod, Inc., Hyannis, MA; Ronald
Rapoport, Truesdale Clinic, Fall River, MA; Mark Raupp, Chapel Hill Family Medicine, Chapel Hill,
NC; Christopher Recknor, United Osteoporosis Centers, Gainesville, GA; Rajneesh Reddy, John
McNeff, T & R Clinic, P. A., Fort Worth, TX; Michael Renzi, Advocare Heights Primary Care, Haddon
Heights, NJ; Albert Reynolds, South Suburban Health Professional Group, Hazel Crest, IL; Robert
Rhodes, Physician, Research Collaboration, Southwest Family Health, Lincoln, NE; Mohammad Riaz,
Bayview Research Group, LLC, Paramount, CA; Anthony Ricca, Hazlet Health Care, Hazlet, NJ;
Patrick Riccardi, Arthritis Health Associates, Syracuse, NY; Donato Ricci, Accord Clinical Research,
LLC, Port Orange, FL; Doris Rice, Arthritis and Rheumatic Research, Portsmouth, VA; Randall
Richwine, MedicalEdge Healthcare Group, PA dba Leading Edge Research, PA, Fort Worth, TX;
Angel Rico, Crystal Biomedical Research, LLC, Miami Lakes, FL; Kenneth Rictor, Sfm Clinical Trials,
PC, Scotland, PA; Brian Riegel, John Corbelli, Buffalo Cardiology and Pulmonary Associates, PC,
Williamsville, NY; Steven Riley, William Reilly, Basin Orthopedics Surgical Specialists, Odessa, TX;
Dency Rivas, Causeway Medical Clinic, Tampa, Fl; Warren Rizzo, Advanced Arthritis Care and
Research, Scottsdale, AZ; Douglas Roberts, Sacramento Heart and Vascular Research Center,
Sacramento, CA; Guy Robins, Richard McDavid, State of Franklin Healthcare Associates Clinical
Research, Johnson City, TN; Jerry Robinson, Conigliaro Jones, Neem Research Group Inc., Columbia,
SC; Hector Rodriguez, Medical Health Center & Research, Miami, FL; Ignacio Rodriguez, M & M
Medical Center, Miami, FL; Brenda Rogers, University of Missouri Kansas City School of Medicine,
Kansas City, MO; Edwin Rogusky, Keystone Clinical Solutions, Inc., Altoona, PA; Christine Rohr,
Rebecca Baumbach, Synergy Medical Education Alliance, Saginaw, MI; Robert Rosen, Ardmore
Family Practice, Winston-Salem, NC; Gary Rosenblum, Winthrop University Hospital, Mineola, NY;
Jack Rosenfeld, Michael Seidner, Green and Seidner Family Practice Associates, Lansdale, PA; Ann
Rosenthal, Gholam Almassi, Zablocki VA Medical Center, Milwaukee, WI; Steven Ross, Clinical
Research Associates, LLC, Florence, SC; William Ryan, Internal Medicine Research, Portland, OR; Ali
Saifi, Florida Research & Testing, LLC, Clearwater, FL; Wassim Saikali, Rheumatology and
Pulmonary Clinic, Beckley, WV; Andrew Sakiewicz, Cleveland Clinic Fairview Cardiovascular
Medicine, Fairview Park, OH; Ellen Sakornbut, Family Health Center of Waterloo, PC, Waterloo, IA;
Jorge Salazar, Health First Medical Group, Melbourne, FL; James Salmon, Fayetteville Diagnostic
Clinic Limited, Fayetteville, AR; Jay Sandberg, Oakland Medical Research Center, Troy, MI; Robert
Saniuk, Bellevue Family Practice, Bellevue, NE; Shankar Santhanam, Romulo Tengco, Family Care
Physicians, Lawrenceville, NJ; Raul Santoscoy, Aris Nikas, Physician PrimeCare Research Institute,
PLLC dba Health Texas Research Institute, San Antonio, TX; Joseph Saponaro, Drug Study Institute,
Jupiter, FL; Michael Sauter, Malcolm Berger, Westmoreland Neurology Associates, Incorporated,
Greensburg, PA; Sifatur Sayeed, AMR Sakeena Research, Aurora, IL; Joy Schechtman, Sun Valley
Arthritis Center, Limited, Peoria, AZ; Alan Schenk, Office of Dr. Alan Schenk, Laguna Hills, CA;
Kenneth Scherbarth, Northwest Family and Spinal Clinic, Tacoma, WA; Lawrence Schiffman,
Northampton Internal Medicine Associates, PC, Northampton, MA; John Schmedtje, Roanoke
Heart Institute, Roanoke, VA; Robert Schneider, Physician Groups, LC, DBA Rheumatology and
Internal Medicine Associates, St. Louis, MO; Joel Schock, Plains Medical Clinic, LLC, Fargo, ND; Erich
Schramm, St. Johns Center for Clinical Research, Ponte Vedra, FL; Kerry Schwartz, Florida Heart
Group, PA, Orlando, FL; Stuart Schwartz, Medical Office Center, Providence, RI; Janet
Schwartzenberg, Amarillo Medical Specialists, LLP, Amarillo, TX; Edward Schwarz, Oregon Medical
Group Adult Medicine Clinic, Eugene, OR; David Scott, Clinical Research Development Associates
LLC, Springfield Gardens, NY; Albert Seals, Rebecca Meiners, East Coast Institute for Research, LLC,
Jacksonville, FL; Bruce Seaton, Research Institute of the Carolinas, PLLC, Mooresville, NC;
Mohamed Sebai, Eugene Boling, Inland Rheumatology Clinical Trials, Inc., Upland, CA; Anthony
Sebba, Arthritis Research of Florida, Inc., Palm Harbor, FL; Gilberto Seco, Homestead Associates in
Research, Inc, Miami, FL; Stewart Segal, Lake Zurich Family Treatment Center, Lake Zurich, IL; Vicki
Seidmeyer, Discovery Clinical Trials, McKinney, TX; Evan Selsky, Scott Jerome, Midatlantic
Cardiovascular Associates, P.A., Westminster, MD; John Sensenbrenner, Sensenbrenner Primary
Care, Charlotte, NC; Shaukat Shah, St. Joseph Medical Associates, Stockton, CA; Ahmed Shah,
Erskine James, Mercer University Mercer Medicine, Macon, GA; Dhiren Shah, Shah Associates,
Prince Frederick, MD; Mahesh Shah, Shah Associates MD, LLC, Charlotte Hall, MD; Gaurang Shah,
Office of Gaurang B. Shah,MD, PSC, Richmond, KY; Nicolas Shammas, Shawna Duke, Midwest
Cardiovascular Research Foundation, Davenport, IA; Fariborz Shams, Anaheim Family Medical
Center, Anaheim, CA; Loknath Shandilya, Ettrick Health Center, Petersburg, VA; Natalie Shemonsky,
Desert Medical Group, Palm Spring, CA; William Shergy, Rheumatology Associates of North
Alabama, PC, Hunstville, AL; Howard Sherman, Richard Khan, Southern Maine Health Care,
Biddeford, ME; Gerald Shockey, Clinical Research Advantage, Inc., Mesa, AZ; Robert Shusman,
Prime Health Network, Springfield, PA; Evan Siegel, The Center for Rheumatology and Bone
Research, Rockville, MD; David Sikes, Florida Medical Clinic, PA, Zephyrhills, FL; Joel Silverfield,
Health Point Medical Group, Inc, Tampa, FL; Robert Simon, Robert Simon, MD, Sherman Oaks, CA;
Atul Singhal, One World Medical Associates, P.A., Lewisville, TX; Neal Sklaver, Medical Specialists
Associated, Dallas, TX; Michael Skyhar, CORE Orthopaedic Medical Center, Encinitas, CA; Stan
Slabic, Stan F. Slabic, M.D., Erie, PA; Teresa Sligh, Providence Clinical Research, North Hollywood,
CA; Lynn Smith, WVVA Healthcare Alliance, Lewisburg, WV; Stephen Smith, Stephen R Smith, MD
FACP, Baltimore, MD; Stephen Smith, Burke Primary Care, Morgantown, NC; Brian Snyder,
Southgate Medical Group, West Seneca, NY; Royce Solano, Colorado Springs Health Partners- East,
Colorado Springs, CO; Kenneth Solinsky, Kenneth F. Solinsky, MD, Babylon, NY; Sheldon Solomon,
Arthritis, Rheumatic and Back Disease Associates, PA, Voorhees, NJ; Deborah Som, Saint Agnes
HealthCare Incorporated, Baltimore, MD; Elif Sonel, Ali Sonel, VA Pittsburgh Healthcare System,
Pittsburgh, PA; Maria Sosenko, Prairie Rheumatology Associates, SC, Joliet, IL; Rodolfo Sotolongo,
Southeast Texas Cardiology Associates, Beaumont, TX; Daniel Sousa, Moustafa Ali, Genesis Clinical
Research & Consulting, Fall River, MA; Eric Spivack, South Florida Medical Research, Aventura, FL;
Amy Sprague, Masters of Clinical Research, Inc., Augusta, GA; Sunny Srivastava, Seth Bilazarian,
Anna Livson, Gary Portnay, Pentucket Medical Associates, Incorporated, Havervill, MA; Michael
Stack, Diagnostic Rheumatology And Research, PC, Indianapolis, IN; Jonathan Staub, Wilmington
Medical Reserach, Wilmington, NC; Pamela Stearns, South Florida Research Solutions, LLC,
Pembroke Pines, FL; Mary Stedman, Stedman Clinical Trials, LLC, Tampa, FL; Rebecca Steffens, Blue
Ridge Family Physicians, PPLC, Raleigh, NC; Ronald Stegemoller, American Health Network of
Indiana, LLC, Avon, IN; Paul Steinberg, Paul L. Steinberg, MD, Cairo, GA; Michael Stephens, Fleming
Island Center for Clinical Research, Fleming Island, FL; Louis Stephens, The Family Healthcare
Center, Clinton, SC; Richard Stern, Office of Dr. Richard Stern, New York, NY; Johnnie Stevens,
Barry Collins, Alabama Clinical Research Associates, Pell City, AL; Steven Stoltz, John Trevino, South
Texas Institute of Health, McAllen, TX; William Stone, Kurt Lesh, Lynn Institute of the Rockies,
Colorado Springs, CO; Rodney Stout, Mehmoodur Rasheed, Holzer Clinic, Inc, Gallipolis, OH;
Richard Strain, Orthopaedic Associates of South Broward, P.A., Hollywood, FL; Nicholas Straniero,
Memorial Medical Group Rheumatology Center, Granger, IN; Mark Studeny, University
Cardiovascular Services. Robert C. Byrd Clinical Center, Huntington, WV; Angela Stupi, Betsy Shook,
Thomas Tyma, Allegheny Rheumatology - WPAHS - ASRI, Wexford, PA; David Subich, North Central
Research, Mansfield, OH; Daniel Suiter, Health Science Research Center, Pratt, KS; Elhan Suley,
Irine Corst, LifeLine Research Institute, Brooklyn, NY; Andrew Sulich, Shores Rheumatology, St.
Clair Shores, MI; Neil Sullivan, Sentara Medical Group, Norfolk, VA; John Sutherland, Matthew
Ulven, Northeast IA Medical Education Foundation, Waterloo, IA; David Swift, Internal Medicine
Associates, PC, Grand Island, NE; Suzann Szewczak, Brain Bock, Lederach Family Medicine,
Harleysville, PA; Raul Tamayo, Adult Medicine Specialists, Longwood, FL; Edison Tan, Florida Med
Center of Countryside, Palm Harbor, FL; Oscar Taunton, Texas Orthopedic Specialists, Bedford, TX;
Edward Tavel, ACCR Pain Research of Charleston, Charleston, SC; Kathryn Tawney, James
Silverblatt, Lake Medical Research, LLC, Willoughby Hills, OH; Philip Taylor, Cape Girardeau
Physicians Associates, Cape Girardeau, MO; William Tidmore, VSC, Valdosta, GA; John Titus, Mark
Woodruff, Southwest Family Physicians, PC, Omaha, NE; Robert Trapp, The Arthritis Center,
Springfield, IL; Miguel Trevino, Innovative Research of West Florida, Inc., Clearwater, FL; Ketan
Trivedi, Arnold Alexander, Physicians Regional Medical Center, Naples, FL; Orrin Troum, Orrin M.
Troum & Medical Associates, Santa Monica, CA; Yong Tsai, International Medical Research,
Daytona, FL; Mark Turner, Advanced Clinical Research, Meridian, ID; Merle Turner, Warner Family
Practice, PC, Chandler, AZ; William Tyndall, University Orthopedics Center, Altoona, PA; Paul
Underwood, NPHC Research, Pheonix, AZ; Donald Valerio, Fanno Creek Clinic, Portland, OR; Martin
van Cleeff, PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary, NC; Ronald
Vanderlaan, Michigan Medical Cardiovascular PC, Grand Rapids, MI; Jill Vargo, Asheville Arthritis &
Osteoporosis, PA, Asheville, NC; Shalendra Varma, Boice-Willis Clinic, Rocky Mount, NC; Michael
Vaughn, Cahaba Research Inc., Birmingham, AL; Rafaelito Victoria, Advanced Research Center,
Anaheim, CA; Larkin Wadsworth, Sundance Clinical Research, LLC, Saint Louis, MO; Stephen
Wagner, University Medical Associates, Louisville, KY; Harry Wallner, Trinity Medical Center, Rock
Island, IL; Norman Walter, McLaren Regional Medical Center-Research Dept., Flint, MI; Samuel
Ward, Emerald Coast Reserach Group, Inc., Chipley, FL; David Warfield, Arizona Center for Clinical
Research, Glendale, AZ; Jack Waxman, Northern California Medical Associates, Santa Rosa, CA;
Jeffrey Wayne, Clinical Trials Research, Lincoln, CA; Cynthia Weaver, Charles Moore, St. Luke's
Hospital Association of Duluth, Inc., Duluth, MN; Nathan Wei, Arthritis & Osteoporosis Center of
Maryland, Frederick, MD; Debra Weinstein, Orthopedic Research Institute, Boynton Beach, FL;
Robert Weiss, Maine Research Associates, Auburn, ME; Michael Weitz, The Center for Arthritis and
Rheumatic Diseases, Miami, FL; Howard Wenocur, Founders Research Corporation, Philadelphia,
PA; Rance Wentworth, Graves Gilbert Clinic, Bowling Green, KY; Stuart Weprin, HWC Women's
Research Center, Englewood, OH; Craig Wiesenhutter, Coeur D'Alene Arthritis Clinic, Couer
D'Alene, ID; Bram Wieskopf, North Georgia Clinical Research, Woodstock, GA; James Wild, Upstate
Clinical Research Associates, Williamsville, NY; David Williams, Atlantic Institute of Clinical
Research, Daytona Beach, FL; Tearani Williams, Scott Conard, Leading Edge Research, PA, Irving,
TX; Charles Wilmer, Piedmont Heart Institute, Atlanta, GA; Jonathan Wilson, Kevin Lutz, Piedmont
Medical Research, Winston-Salem, NC; Scott Wilson, Partners in Clinical Research, Cumberland, RI;
Anne Winkler, St. John's Medical Research, Springfield, MO; John Wood, MedicalEdge Healthcare
Group, PA, Richardson, TX; Bronwyn Woods, Integris Family Care Central, Oklaholma City, OK;
Steven Yakubov, MidWest Cardiology Research Foundation, Columbus, OH; Hugo Yamada, Hugo M.
Yamada, MD, Lincoln, RI; Marcos Yang, The Office of Dr. Marcos Yang, Palos Verdes Estates, CA;
Alberto Yataco, International Research Center, Towson, MD; Scott Yates, North Texas Medical
Research, Plano, TX; Shahbaz Yazdani, The Office of Shahbaz Yazdani, MD, PA, San Antonio, TX;
Pedro Ylisastigui, Pedro Ylisastigui, MD, Lehigh Acres, FL; Robert Yoachim, Dirk Smith, Heartland
Research Associates LLC, Arkansas City, KS; Robert Yood, Reliant Medical Group, Inc., Worcester,
MA; Carol Young, Arthritis Medical Clinic of North County, Inc., Escondido, CA; Douglas Young,
Northern California Research, Carmichael, CA; John Yuen, Puget Sound Osteoporosis Center,
Seattle, WA; Amer Zaheer, The Office of Amer Zaheer MD, PA, Houston, TX; Farrukh Zaidi,
Suncoast Clinical Research, Inc., New Port Richey, FL; Salam Zakko, Connecticut Gastroenterology
Institute, Bristol, CT
Approach to Inferential Analyses

Non-inferiority inference for the primary endpoint APTC was evaluated using the 4 criteria for each
of the planned non-inferiority comparisons. A non-inferiority p-value was calculated for the 1-
sided 97.5% confidence interval non-inferiority criteria (i.e., upper limit of the 1-sided 97.5% CI for
the HR was less than 1.33 for ITT population and 1.40 for on-treatment population), P≤0.025 was
considered statistically significant. Additionally, for all primary and secondary endpoints, as well
as the components of the composite endpoints, pairwise superiority between treatments was
evaluated with two-sided P≤0.05 considered statistically significant.

Cardiovascular Inclusion Criteria

Subject with established or at high risk for CVD defined as one of the following (a – d):

a. Coronary disease
• History of stable angina; or

• History of MI, unstable angina, percutaneous coronary intervention (PCI) or coronary

artery bypass graft (CABG) surgery at least 3 months prior to randomization; or

• An angiographic stenosis greater than 50% by visual estimation at catheterization.

b. Occlusive disease of non-coronary arteries

• History of TIA or ischemic stroke at least 3 months prior to randomization, or

• Angiographic or ultrasound diagnosis of carotid artery stenosis ≥50%, or

• History of carotid endarterectomy at least 3 months prior to randomization, or

• Symptomatic peripheral arterial disease (e.g., intermittent claudication), or

• Other arterial surgery or angioplasty for atherosclerotic vascular disease at least 3

months prior to randomization

c. Diabetes mellitus: clinical diagnosis of Type I or Type II diabetes. Protocol amendment 1

(07July2006) until protocol amendment 6 (07July2011).
The following distinction for females vs. males was implemented with protocol amendment
6 (07July2011; approved by FDA & distributed to sites Oct 2011):
• Females must require current insulin treatment.
• Males can have Type I or Type II with or without insulin therapy.

d. High risk of atherosclerotic vascular disease, which requires at least 3 of the following
• Age > 55 years
• History of hypertension
• History of dyslipidemia (defined as LDL > 150 mg/dL [3.885 mmol/L] or high-density
lipoprotein (HDL) < 40 mg/dL [1.036 mmol/L] in females and < 35 mg/dL [0.906
mmol/L] in males). Subjects currently undergoing lipid lowering therapy with a statin
drug will automatically meet this criterion.
Protocol Amendment 2, 30July2007: LDL changed to > 160mg/dL per current
guidelines; added Omacor® (prescription omega-3-acid ethyl esters) or prescription
niacin (≥1000mg/day).
Protocol Amendment 3, 06May2008 added Lovaza™ and fibrate to lipid lowering
therapy
• Family history of CVD or stroke
Protocol Amendment 2, 30July2007 added: (defined as history of myocardial
infarction, angina pectoris, heart failure, cardiac death or coronary revascularization
[including PCI and CABG]; does NOT include history of hypertension), stroke, carotid
endarterectomy, or other arterial surgery or angioplasty for atherosclerotic vascular
disease in a parent, grandparent or sibling with first symptom onset or diagnosis before
age 55 years for males and 65 years for females;
• Current smoking > 15 cigarettes per day
Protocol Amendment 2, 30July2007 changed to: Current smoking (defined as any
cigarette smoking within the past 30 days). Change made based on Framingham Risk
Score & CDC definitions; > 15 cigarettes/day was based on the definition used in the
CHARISMA study and an arbitrary set point.
• History of microalbuminuria, urine protein / creatinine ratio > 2
• Left ventricular hypertrophy (LVH) as evidenced by electrocardiogram (ECG) or
echocardiography
• Documented Ankle Brachial Index (ABI) < 0.9
• Waist Hip Ratio (WHR) ≥0.90 – added with Protocol Amendment 4, 06May2010 due to
strong association with CVD, MI and mortality and remains independently predictive of
aforementioned after adjusting for confounding variables.

Protocol Amendment 6, 07July2011, d. High risk of atherosclerotic vascular disease criteria
revised for females vs males as follows:

• Females require at least 2 of the following 3:

o Age ≥65 years

o History of hypertension

o Current smoking (defined as any cigarette smoking within the past 30 days)
 • Males require at least 3 of the following:
o Age >55 years

o History of hypertension

o History of dyslipidemia (defined as LDL >160 mg/dL [4.144 mmol/L] or high-density

lipoprotein (HDL) <35 mg/dL [0.906 mmol/L]). Subjects currently undergoing lipid
lowering therapy with a statin drug, fibrate, prescription omega-3-acid ethyl esters
(e.g., Omacor®, Lovaza™) or prescription niacin (≥1000mg/day) will automatically
meet this criterion.

o Family history of premature CVD (defined as history of myocardial infarction, angina

pectoris, heart failure, cardiac death or coronary revascularization [including PCI
and CABG]; does NOT include history of hypertension), stroke, carotid
endarterectomy, or other arterial surgery or angioplasty for atherosclerotic vascular
disease in a parent, grandparent or sibling with first symptom onset or diagnosis
before age 55 years for males and 65 years for females.

o Current smoking (defined as any cigarette smoking within the past 30 days)

o History of microalbuminuria, urine protein / creatinine ratio >2

o Left ventricular hypertrophy (LVH) as evidenced by electrocardiogram (ECG) or

echocardiography

o Documented Ankle Brachial Index (ABI) <0.9

o Waist Hip Ratio (WHR) ≥0.90

Endpoint Definitions

DEATH
Cardiovascular Death
Defined as any death with a clear cardiac or vascular cause or unknown cause (including sudden
death, unobserved and unanticipated death and other death not definitely attributed to a non-
vascular cause).

Non-cardiovascular Death
Death occurs and is due primarily to an identifiable non-cardiovascular cause or etiology. Specific
diagnoses may include respiratory failure, pneumonia, trauma, suicide, or any other non-
cardiovascular defined causes (e.g., liver disease, etc.) not included in the previous categories.

MYOCARDIAL INFARCTION
To confirm the endpoint of myocardial infarction at least one of the following must be present:

a. Elevated CKMB: (preferred)
• Maximal value of CK-MB >2 x the upper limit of normal on one occasion during the first 24
hours after the index clinical event. OR
• Maximal value of CK-MB, preferable CK-MB mass, >upper limit of normal on two successive
samples.

b. Elevated Troponin T or I:
• Maximal concentration of Troponin T or I > the MI decision limit (Upper Limit of Normal) on
at least one occasion during the first 24 hours after the index clinical event.

c. Elevated total CK:
• In the absence of availability of a Troponin or CK-MB assay, total CK >2 x the upper limit of
normal, or the B fraction of CK may be employed, but these last two biomarkers are
considerably less satisfactory than CKMB.

AND at least one of the following:

a. Ischemic symptoms which may include but are not limited to:
• Chest pain, chest pressure or chest discomfort
• Unexplained nausea and vomiting or diaphoresis
• Persistent shortness of breath secondary to left ventricular failure
• Unexplained weakness, dizziness, lightheadedness, or syncope; or
b. ST segment depression of at least 0.1 mV or T wave inversion, or labile ST segment and T wave
change; or
c. LBBB (new or old) or paced rhythm that obscures the assessment of ST elevation.
d. ST-segment elevation: New or presumed new ST segment elevation at the J point in two or
more contiguous leads with the cut-off points >0.2 mV in leads V1, V2, or V3, or >0.1 mV in
other leads, or
e. New, or presumably new, tall R wave with R/S of 1 in V1 and R/S 1.5 in V2(true Posterior MI),
or
f. The development of new Q-waves >40 ms (0.04s). Q wave changes must be present in at least
two contiguous leads.

Special Circumstances:
• For subjects with recent MI, the CK-MB value associated with the recurrent MI must be
increased by at least 50% of the previous value (i.e., a re-elevation of cardiac markers)
• For subjects within 24 hours post PCI, the CK-MB (or CK if MB not available) must be > 3x
 upper limit of normal. No ECG changes or symptoms are required.
• For subjects within 24 hours post CABG, the CK-MB ( or CK if MB not available) must be > 5x
upper limit of normal, and new Q waves must be present as defined above, or the CKMB value
must be greater than or equal to 10 times the upper limit of normal (with or without Q waves).
No symptoms are required.
• An asymptomatic or non-recognized myocardial infarction discovered by the development of
new pathological Q waves (as defined above) in two or more contiguous leads.

STROKE
Acute neurological cerebral vascular event with focal neurologic signs lasting more than 24 hours,
with or without evidence of intracranial hemorrhage. (Note: This does NOT include infarction
involving the retina or optic nerve). If the acute focal signs represent a worsening of a previous
deficit, it must have either:
1. persisted for more than one week, or
2. more than 24 hours and accompanied by an appropriate new CT or MRI finding.

Ischemic Stroke (or non-hemorrhagic stroke)
Acute neurological vascular event with focal neurologic signs lasting more than 24 hours, without
evidence of primary intracranial hemorrhage.

Hemorrhagic Stroke
Acute neurological vascular event with focal neurologic signs lasting more than 24 hours, with
evidence of intracranial hemorrhage supported by neuroimaging (CT or MRI of brain) or by lumbar
puncture, neurosurgery, or autopsy.

Stroke, Uncertain Type
Acute neurological vascular event with focal neurologic signs lasting more than 24 hours, in the
absence of neuroimaging or autopsy data to classify as either an ischemic or hemorrhagic stroke.
If the acute focal signs represent a worsening of a previous deficit, it must have persisted for more
than one week in the absence of neuroimaging or autopsy data to classify as either an ischemic or
hemorrhagic stroke. (Note: This category should NOT be used for a nonspecific event of uncertain
cause, such as a confusional state or dizziness but rather to describe a definite stroke where the
data available is insufficient to classify as ischemic or hemorrhagic.)

HOSPITALIZATION FOR TIA
Hospitalization, defined as any admission to a hospital ward, observation unit, or clinical decision
unit, even if the duration of stay is less than 24 hours (does not include doctor office visits) for TIA
defined as a focal ischemic neurological deficit (cerebral or retinal), considered to be of
atherothrombotic origin, with a neurological deficit persisting less than 24 hours. CT scan or MRI
should be performed to exclude hemorrhage or a mass lesion. Events clearing within 24 hours, but
with neuroimaging evidence of a new ischemic stroke, will be considered TIAs.

REVASCULARIZATION
Coronary Revascularization
Any percutaneous coronary intervention (PCI), (includes PTCA, coronary stenting, and others such
as brachytherapy, atherectomy, laser, and rotational ablation) or surgical coronary
revascularization (CABG, coronary artery endarterectomy). This category does not include TMR
and PTMR.

Cerebrovascular revascularization
Includes carotid endarterectomy, carotid percutaneous transluminal angioplasty (PTA with or
without stent).

Peripheral revascularization
Peripheral arterial bypass surgery, PTA, or any therapeutic intervention for critical leg ischemia
(including thrombolysis), or aortic aneurysm repair.

HOSPITALIZATION FOR UNSTABLE ANGINA
Hospitalization, defined as any admission to a hospital ward, observation unit, or clinical decision
unit, even if the duration of stay is less than 24 hours (does not include doctor office visits) for
unstable angina defined as:

a. New angina (angina pectoris or equivalent type of ischemic discomfort typically described
as a pressing type of pain in the region of the precordium, upper abdomen, neck, or chin,
usually radiating to the left arm, induced or increased by effort, cold environment, or
excitement, and relieved by sublingual nitroglycerin) requiring hospitalization; or
b. Angina occurring at rest and prolonged, usually >20 minutes, requiring hospitalization; or
c. Recent acceleration of angina reflected by a change in Canadian Cardiovascular Society to
at least class III and requiring hospitalization documented by ECG changes compatible with
ischemia (e.g., ST depression [at least 1 mm in two contiguous leads], T-wave inversion [at
least 2 mm in two contiguous leads], or hyperacute peaked T waves, or new normalization
of T waves), or other diagnostic tests confirming cardiac origin, such as echocardiogram,
cardiac catheterization, PET scan, etc. The subject should NOT have cardiac marker
evidence of myocardial necrosis at levels that would satisfy criteria for myocardial
infarction.

HOSPITALIZATION FOR HEART FAILURE
Hospitalization, defined as any admission to a hospital ward, observation unit, or clinical decision
unit, even if the duration of stay is less than 24 hours (does not include doctor office visits) for
heart failure defined as the development of signs and symptoms of Congestive Heart Failure (CHF)
not present at randomization and requiring hospital management.

CHF is clinically manifested by one or more of the following features:

a. Dyspnea on exertion in the absence of new pulmonary disease;

b. Paroxysmal nocturnal dyspnea (shortness of breath that awakens the subject from sleep);
c. Orthopnea (sleeping on two or more pillows to facilitate breathing);
AND one or more of the following criteria:
a. Pulmonary rales >1/3 of the way up the lung fields present after coughing in the absence of
chronic lung disease or respiratory infection;
b. Pulmonary edema on chest x-ray in absence of high suspicion for non-cardiac origin;
c. New use of oral / intravenous diuretics, intravenous inotropes, intravenous vasodilators, or
adjustment of previous diuretic dose;
d. Oxygen desaturation (<90%) with no evidence of acute or chronic lung disease;
e. Jugular venous distention (JVD);
f. Bilateral pedal edema.

HOSPITALIZATION FOR HYPERTENSION
1. Hospitalization, defined as any admission to a hospital ward, observation unit, clinical decision
unit, even if the duration of stay is less than 24 hours (does not include doctor office visits) for
hypertension defined as either:
2. Hypertensive urgency: SBP >180 mmHg or DBP >110 mmHg with minimal or no end organ
damage, or
3. Hypertensive Emergency: elevated BP (>180/110) with acute end organ damage
a. Acute end organ damage to be defined as:
• Neurologic symptoms as defined by encephalopathy, hemorrhagic or ischemic stroke,
papilledema;
• Cardiac damage: unstable angina or acute MI, heart failure with pulmonary edema;
• Renal damage as exhibited by proteinuria, hematuria, or acute renal failure;
• Aortic dissection.

RENAL EVENTS
Development of any of the following during study participation:
1. Verified serum creatinine level of ≥2.0 mg/dL (177μmol/L) (i.e., the persistence of serum
 creatinine elevation ≥24 hours following the initial acute serum creatinine elevation), and an
increase of verified serum creatinine level of ≥0.7 mg/dL (62μmol/L) from Baseline.
2. Hospitalization for acute renal failure defined as:
a. Doubling of the baseline serum creatinine, or
b. Hyperkalemia (defined as >6 mmol/dL) with ≥50% elevation in serum creatinine
(hyperkalemia needs to be confirmed to rule out false elevation related to hemolysis).
3. Initiation of hemodialysis or peritoneal dialysis.

Clinically Significant Gastrointestinal Events (CSGIEs) Definitions

GASTRODUODENAL (GD) HEMORRHAGE
Endoscopic evidence of GD ulceration (mucosal break with definite depth) or erosion (mucosal
break without depth) or other likely causative lesion and clinical evidence of hemorrhage (defined
by frank clinical hematemesis or melena or evidence of recent hemorrhage on
esophagogastroduodenoscopy (EGD) – e.g., clot, blood in stomach or visible vessel)

GASTRIC OUTLET OBSTRUCTION
Clinical, surgical, endoscopic or radiographic evidence with symptoms consistent with obstruction
e.g.: a dilated stomach; a slowly emptying stomach in a patient with clinical evidence of outlet
obstruction and in some instances with an ulcer in the channel or duodenal bulb; or severe
narrowing and edema obstructing the outlet of the stomach (not due to cancer).

GASTRODUODENAL, SMALL BOWEL OR LARGE BOWEL PERFORATION
Clinical, surgical or radiographic confirmation associated with symptoms consistent with
perforation e.g., an opening in the wall of the stomach or duodenum requiring surgery, or
laparoscopic repair but only if the evidence is unequivocal (free air, peritoneal irritation signs, etc.)
in the:
• Stomach or duodenum;
• Jejunum or ileum;
• Caecum, colon or rectum.

LARGE BOWEL HEMORRHAGE
Frank melena or per rectum (PR) blood loss, altered or otherwise with no evidence of source on
EGD and likely causative lesion on colonoscopy. Hemorrhoidal hemorrhage will be included only if
associated with a clinically significant fall in Hct ≥10% points and / or Hb of ≥2gm/dL from Baseline.

SMALL BOWEL HEMORRHAGE
Frank melena or PR blood loss, altered or otherwise with likely causative lesion on small bowel
investigation.b

ACUTE GI HEMORRHAGE OF UNKNOWN ORIGIN, INCLUDING PRESUMED SMALL BOWEL
HEMORRHAGE
Frank hematemesis, melena or PR blood loss, altered or otherwise with no evidence of likely
causative lesion on EGD or colonoscopy (or small bowel investigationb)

SYMPTOMATIC GASTRIC OR DUODENAL ULCER
Abdominal pain or dyspepsia followed by finding of a gastric or duodenal ulcer (break in mucosa
>5mm) on endoscopy or contrast-enhanced radiography of the upper gastrointestinal tract.

CLINICALLY SIGNIFICANT IRON DEFICIENCY ANEMIA OF GI ORIGIN
1. Clinically significant iron-deficiency anemia of defined GI origin (excluding esophageal causes
other than erosive esophagitis)
a. No clinical evidence of acute GI hemorrhage but with fall in Hct ≥10% points and or Hgb ≥2
gm/dL from baseline with likely causative lesion on colonoscopy or EGD (or small bowel
investigationb) with
• Iron deficiency anemia. The diagnosis of iron deficiency is indicated by Hgb <12 gm/dL
for women or <13 gm/dL for men and the presence of any or all of the following
parameters: low serum ferritin (<15 μg/dL), low mean corpuscular volume (MCV, <83 fl),
low serum iron, or high total iron binding capacity (TIBC);
• No non-GI source of anemia identified.
2. Clinically significant iron deficiency anemia of presumed occult GI origin including possible
small bowel blood loss
a. No overt clinical evidence of acute GI hemorrhage but with fall in Hct ≥10% points and/or
Hgb≥2 gm/dl from baseline and with no evidence of likely causative lesion on EGD or
colonoscopy (or small bowel investigationb) with:
• Iron deficiency anemia. The diagnosis of iron deficiency is indicated by Hgb <12 gm/dl
for women or <13 gm/dl for men and the presence of any or all of the following
parameters: low serum ferritin (<15 μg/dl), low mean corpuscular volume (MCV, <83 fl),
low serum iron, or high total iron binding capacity (TIBC)
• With or without heme-occult positive stools.
Investigators are encouraged to ensure that in subjects with anemia non-GI sources are excluded
by evaluation of hematologic parameters (e.g., serum iron, iron binding, ferritin, vitamin B12,
serum or red cell folate, MCV, MCH, reticulocyte count, blood film and manual review, FOBs, CRP
and ESR, deterioration of disease activity and relationship to DMARD therapy in RA subjects).
b
Small bowel imaging (including video capsule endoscopy, small bowel follow through etc.) is not
mandated by the protocol but can be performed at the investigator’s discretion.
Figure S1. Patient Disposition in the PRECISION Trial

 Figure S2. Time to Study Drug Discontinuation

P value is the log-rank statistic which tests the equality between treatment groups. A significant
P-value indicates that treatment discontinuation rates were not the same over the randomized
groups.

 Figure S3. Time to Non-retention

P value is the log-rank statistic which tests the equality between treatment groups. A significant
P-value indicates that treatment discontinuation rates were not the same over the randomized
groups.

Figure S4. Time to Event for Secondary Outcomes (On-Treatment Population)

Figure S5. Subgroup Analyses for Primary Composite Endpoint
A. Celecoxib vs. Naproxen (Intention to Treat Population)

B. Celecoxib vs. Ibuprofen (Intention to Treat Population)

 C. Ibuprofen vs. Naproxen (Intention to Treat Population)

Table S1. Adjudicated Outcomes: Intention-to-Treat Population (Ibuprofen vs.
Naproxen)

Primary Outcome§
Ibuprofen vs Naproxen
Ibuprofen Naproxen
Adjusted HR* P
N=8040 N=7969
(95% CI) value*
n (%) n (%)
APTC Endpoint 218 (2.71) 201 (2.52) 1.08 (0.90, 1.31) 0.41
Ibuprofen vs. naproxen non-inferiority P value 0.02
Other Adjudicated Outcomes

MACE Endpoint‡ 384 (4.78) 346 (4.34) 1.11 (0.96, 1.29) 0.15
Composite of Serious GI Events 130 (1.62) 119 (1.49) 1.08 (0.85, 1.39) 0.53
Clinically Significant GI Events† 72 (0.90) 56 (0.70) 1.28 (0.90, 1.81) 0.17
Iron deficiency Anemia of GI Origin† 64 (0.80) 69 (0.87) 0.92 (0.65,1.29) 0.62
Renal Events 92 (1.14) 71 (0.89) 1.29 (0.95, 1.76) 0.10
Hospitalization for CHF 46 (0.57) 48 (0.60) 0.95 (0.63, 1.42) 0.79
Hospitalization for hypertension 40 (0.50) 34 (0.43) 1.17 (0.74, 1.84) 0.51
All cause mortality 142 (1.77) 163 (2.05) 0.87 (0.70, 1.09) 0.22
Components of Composite Endpoints

Death from Cardiovascular Causes 80 (1.00) 86(1.08) 0.93 (0.69, 1.26) 0.64
Nonfatal Myocardial Infarction 92 (1.14) 66 (0.83) 1.39 (1.01, 1.91) 0.04
Nonfatal Stroke 53 (0.66) 57 (0.72) 0.92 (0.64, 1.34) 0.68
Hospitalization for Unstable Angina 65 (0.81) 64 (0.80) 1.02 (0.72, 1.44) 0.92
Revascularization 198 (2.46) 161 (2.02) 1.24 (1.00, 1.52) 0.05
Hospitalization for TIA 27 (0.34) 18 (0.23) 1.50 (0.83, 2.73) 0.18
*Hazard ratios and P values were estimated with the use of a Cox proportional hazards model with
adjustment for stratification factors. †Definitions are available in the Supplemental Appendix. §The primary
composite outcome in the time-to-event analysis was the first occurrence of the Antiplatelet Trialists
Collaboration (APTC) endpoint (death from cardiovascular causes including hemorrhagic death, nonfatal
myocardial infarction, or nonfatal stroke). ‡ MACE=Major Adverse Cardiovascular Event defined as the
APTC endpoint plus coronary revascularization, hospitalization for unstable angina or Transient Ischemic
Attack (TIA). HR=Hazard ratio. CI=Confidence Interval. APTC=Antiplatelet Trialists Collaboration.
GI=Gastrointestinal. CHF=Congestive Heart Failure.
Table S2. Adjudicated Outcomes: On-Treatment Population (Ibuprofen vs. Naproxen)

Primary Outcome§

Ibuprofen Naproxen
Adjusted HR*
N=7990 N=7933 (95% CI)
n (%) n (%)
APTC Endpoint, 155 (1.94) 144 (1.82) 1.12 (0.89, 1.40)
Ibuprofen vs. naproxen non-inferiority P value 0.025
Other Adjudicated Outcomes
MACE Endpoint‡ 284 (3.55) 253 (3.19) 1.17 (0.99, 1.38)
Composite of Serious GI Events 115 (1.4) 115 (1.4) 1.03 (0.80, 1.34)
Clinically Significant GI Events† 59 (0.74) 52 (0.66) 1.16 (0.80,1.69)
Iron deficiency Anemia of GI Origin† 58 (0.73) 66 (0.83) 0.91 (0.64, 1.29)
Renal Events 73 (0.91) 62 (0.78) 1.21 (0.86, 1.70)
Hospitalization for CHF 38 (0.48) 35 (0.44) 1.12 (0.71, 1.77)
Hospitalization for hypertension 37 (0.46) 32 (0.40) 1.19 (0.74, 1.90)
All cause mortality 73 (0.91) 79 (1.00) 0.96 (0.70, 1.31)
Components of Composite Endpoints
Death from Cardiovascular Causes 51 (0.64) 49 (0.62) 1.08 (0.73, 1.60)
Nonfatal Myocardial Infarction 76 (0.95) 53 (0.67) 1.48 (1.05, 2.11)
Nonfatal Stroke 32 (0.40) 45 (0.59) 0.74 (0.47, 1.16)
Hospitalization for Unstable Angina 49 (0.61) 44 (0.55) 1.16 (0.77, 1.74)
Revascularization 158 (1.98) 122 (1.54) 1.35 (1.07, 1.72)
Hospitalization for TIA 21 (0.26) 16 (0.20) 1.38 (0.72, 2.64)

*Hazard ratios and P values were estimated with the use of a Cox proportional hazards model with adjustment
for stratification factors. †Definitions are available in the Supplemental Appendix. §The primary composite
outcome in the time-to-event analysis was the first occurrence of the Antiplatelet Trialists Collaboration (APTC)
endpoint (death from cardiovascular causes including hemorrhagic death, nonfatal myocardial infarction, or
nonfatal stroke). ‡ MACE=Major Adverse Cardiovascular Event defined as the APTC endpoint plus coronary
revascularization, hospitalization for unstable angina or Transient Ischemic Attack (TIA). HR=Hazard ratio.
CI=Confidence Interval. APTC=Antiplatelet Trialists Collaboration. GI=Gastrointestinal. CHF=Congestive Heart
Failure.

Table S3. Measures of Anti-Arthritic Efficacy

Celecoxib Ibuprofen Naproxen Celecoxib vs. Ibuprofen Celecoxib vs. Naproxen Ibuprofen vs. Naproxen
LS Mean LS Mean LS Mean Difference Difference Difference
P Value P Value P Value
±SE ±SE ±SE in LS Mean in LS Mean in LS Mean
Change in Global
Assessment of -0.25±0.01 -0.25±0.01 -0.26±0.01 0.00 0.72 0.01 0.08 0.01 0.16
Arthritis#
Change in Visual
Analog Scale -9.32±0.26 -9.54±0.26 -10.20±0.26 0.23 0.38 0.89 <0.001 0.66 0.01
(mm)†

Change in HAQ*
-0.13±0.01 -0.14±0.01 -0.14±0.01 0.00 0.39 0.01 0.18 0.00 0.61
disability index

# Scale for Assessment. 1 = Very Good ‑ Asymptomatic and no limitation of normal activities. 2 - Good ‑ Mild symptoms and no limitation of normal activities.
3 = Fair ‑ Moderate symptoms and limitation of some normal activities 4= Poor ‑ Severe symptoms and inability to carry out most normal activities 5 = Very
Poor ‑ Very severe symptoms which are intolerable and inability to carry out all normal activities
† Range of values 0 to 100 mm. Differences of 13.7 mm or greater are considered clinically significant
*Health Assessment Questionnaire Disability Index – A 20-question questionnaire (8 categories) of daily functioning. Overall score ranges from 0 to 3, with zero
indicating ‘no disability’ and 3 indicating ‘complete disability’.

Table S4. Investigator Reported Adverse Effects

Celecoxib Ibuprofen Naproxen Celecoxib vs. Celecoxib vs. Ibuprofen vs.

Adverse Effect N=8030 N=7992 N=7933 ibuprofen Naproxen Naproxen
n (%) n (%) n (%) P value P value P value
Anemia 221 (2.8) 437 (5.5) 331 (4.2) <0.001 <0.001 <0.001
Gastrointestinal disorders
Abdominal pain 243 (3.0) 230 (2.9) 248 (3.1) 0.57 0.71 0.36
Abdominal pain upper 334 (4.2) 342 (4.3) 349 (4.4) 0.71 0.45 0.70
Constipation 275 (3.4) 347 (4.3) 409 (5.2) 0.003 <0.001 0.02
Diarrhea 642 (8.0) 545 (6.8) 569 (7.2) 0.004 0.05 0.38
Dyspepsia 393 (4.9) 424 (5.3) 436 (5.5) 0.24 0.09 0.59
Gastro-esophageal reflux disease 402 (5.0) 407 (5.1) 389 (4.9) 0.80 0.77 0.58
Nausea 430 (5.4) 484 (6.1) 508 (6.4) 0.06 0.005 0.36
General disorders
Chest pain 246 (3.1) 282 (3.5) 259 (3.3) 0.10 0.47 0.36
Edema peripheral 379 (4.7) 389 (4.9) 382 (4.8) 0.66 0.78 0.88
Infections and infestations
Bronchitis 471 (5.9) 483 (6.0) 441 (5.6) 0.63 0.40 0.19
Nasopharyngitis 329 (4.1) 258 (3.2) 322 (4.1) 0.003 0.90 0.005
Sinusitis 373 (4.6) 426 (5.3) 375 (4.7) 0.05 0.81 0.08
Upper respiratory tract infection 586 (7.3) 596 (7.5) 561 (7.1) 0.70 0.58 0.35
Urinary tract infection 427 (5.3) 467 (5.8) 430 (5.4) 0.15 0.77 0.25
Blood creatinine increased 148 (1.8) 270 (3.4) 154 (1.9) <0.001 0.65 <0.001
Blood pressure increased 182 (2.3) 246 (3.1) 200 (2.5) 0.001 0.29 0.03
Musculoskeletal and connective tissue
disorders
Arthralgia 793 (9.9) 679 (8.5) 788 (9.9) 0.003 0.90 0.002
 Arthritis 381 (4.7) 362 (4.5) 354 (4.4) 0.52 0.40 0.84
Back pain 553 (6.9) 526 (6.6) 558 (7.0) 0.44 0.71 0.26
Muscle spasms 240 (3.0) 254 (3.2) 273 (3.4) 0.49 0.10 0.35
Musculoskeletal pain 322 (4.0) 275 (3.4) 324 (4.1) 0.06 0.81 0.03
Osteoarthritis 1102 (13.7) 1011 (12.7) 1007 (12.7) 0.04 0.06 0.93
Pain in extremity 456 (5.7) 426 (5.3) 423 (5.3) 0.33 0.34 0.99
Nervous system disorders
Dizziness 293 (3.6) 282 (3.5) 314 (4.0) 0.68 0.31 0.15
Headache 364 (4.5) 415 (5.2) 365 (4.6) 0.05 0.84 0.08
Psychiatric disorders 291 (3.6) 272 (3.4) 226 (2.8) 0.45 0.006 0.04
Depression 291 (3.6) 272 (3.4) 226 (2.8) 0.45 0.006 0.04
Respiratory, thoracic and mediastinal
disorders
Cough 293 (3.6) 328 (4.1) 275 (3.5) 0.14 0.53 0.04
Dyspnea 192 (2.4) 252 (3.2) 240 (3.0) 0.003 0.01 0.64
Hypertension 776 (9.7) 1039 (13.0) 871 (11.0) <0.001 0.006 <0.001