PRECISION: Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00346216

Collaborator

The Cleveland Clinic (Other)

24,081

Enrollment

1066

Locations

Arms

114.3

Actual Duration (Months)

22.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: celecoxib Drug: Ibuprofen Drug: Naproxen	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

24081 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen

Actual Study Start Date :

Oct 4, 2006

Actual Primary Completion Date :

Apr 12, 2016

Actual Study Completion Date :

Apr 12, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: celecoxib subject receives celecoxib and dummy (placebo) ibuprofen and naproxen	Drug: celecoxib 100 to 200 mg twice daily, taken by mouth
Active Comparator: ibuprofen subject receives ibuprofen and dummy (placebo) celecoxib and naproxen	Drug: Ibuprofen ibuprofen 600 mg to 800 mg three times daily, taken by mouth
Active Comparator: naproxen subject receives naproxen and dummy (placebo) celecoxib and ibuprofen	Drug: Naproxen naproxen 375mg to 500 mg twice daily, taken by mouth

Arm

Intervention/Treatment

Experimental: celecoxib

subject receives celecoxib and dummy (placebo) ibuprofen and naproxen

Drug: celecoxib

100 to 200 mg twice daily, taken by mouth

Active Comparator: ibuprofen

subject receives ibuprofen and dummy (placebo) celecoxib and naproxen

Drug: Ibuprofen

ibuprofen 600 mg to 800 mg three times daily, taken by mouth

Active Comparator: naproxen

subject receives naproxen and dummy (placebo) celecoxib and ibuprofen

Drug: Naproxen

naproxen 375mg to 500 mg twice daily, taken by mouth

Outcome Measures

Primary Outcome Measures

The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). [Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months]
APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).

Secondary Outcome Measures

The First Occurrence of a Major Adverse Cardiovascular Events (MACE) [ITT Population - 30 months; MITT Population - 42 months]
MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA
The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE) [ITT Population - 30 months; MITT Population - 42 months]
CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer
Change From Baseline in Patient's Assessment of Arthritis Pain (VAS) [ITT and MITT Population - Baseline to 42 months]
VAS question "How much pain do you have" was graded on a scale from 0 to 100 with 0 indicating "No pain" and 100 indicating "Worst possible pain".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion Criteria:

Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
Subjects require treatment with aspirin > 325 mg /day
Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carol M. Johnson MD, LLC	Alabaster	Alabama	United States	35007
2	Orthopaedics West	Bessemer	Alabama	United States	35022
3	Central Alabama Research	Birmingham	Alabama	United States	35209
4	Simon Williamson Clinic/Clinical Research Advantage, Inc.	Birmingham	Alabama	United States	35211
5	Achieve Clinical Research, LLC	Birmingham	Alabama	United States	35216
6	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama	United States	35235
7	Cahaba Research Inc.	Birmingham	Alabama	United States	35242
8	Winston Technology Inc.	Haleyville	Alabama	United States	35565
9	Clinical Research Consultants, Inc	Hoover	Alabama	United States	35216
10	Medical Affiliated Research Center, Incorporated	Huntsville	Alabama	United States	35801
11	Rheumatology Associates of North Alabama, PC	Huntsville	Alabama	United States	35801
12	Montgomery Rheumatology Associates	Montgomery	Alabama	United States	36111
13	James P. Beretta, PC	Pelham	Alabama	United States	35124
14	Alabama Clinical Research Associates	Pell City	Alabama	United States	35128
15	Pell City Internal and Family Medicine	Pell City	Alabama	United States	35215
16	Scottsboro Quick Care Clinic	Scottsboro	Alabama	United States	35768
17	Clinic for Rheumatic Diseases	Tuscaloosa	Alabama	United States	35406
18	Terence T. Hart , MD	Tuscumbia	Alabama	United States	35674
19	Clinical Research Advantage Inc./ Warner Family Practice, PC	Chandler	Arizona	United States	85224
20	ArthroCare, Arthritis Care & Research P.C.	Gilbert	Arizona	United States	85234
21	Clinical Research Advantage Inc., /Thunderbird Internal Medicine	Glendale	Arizona	United States	85306-4652
22	Arizona Center for Clinical Research	Glendale	Arizona	United States	85306
23	Clinical Research Advantage, Inc./ Lenzmeier Family Medicine	Glendale	Arizona	United States	85308
24	Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC	Mesa	Arizona	United States	85206
25	Novara Clinical Research	Mesa	Arizona	United States	85206
26	Clinical Research Advantage, Inc.	Mesa	Arizona	United States	85213
27	Sun Valley Arthritis Center, Limited	Peoria	Arizona	United States	85381
28	Lovelace Scientific Resources, Inc.	Phoenix	Arizona	United States	85016
29	Clinical Research Advantage, Inc./ Family Practice Specialists, LTD	Phoenix	Arizona	United States	85018
30	NPHC Research	Phoenix	Arizona	United States	85020
31	Phoenix Clinical	Phoenix	Arizona	United States	85021
32	Arizona Research Center, Inc.	Phoenix	Arizona	United States	85023
33	Precision Trials AZ. LLC; AZ	Phoenix	Arizona	United States	85032
34	43rd Medical Associates, P.C.	Phoenix	Arizona	United States	85051
35	Southwest Health Ltd.	Scottsdale	Arizona	United States	85254
36	Advanced Arthritis Care and Research	Scottsdale	Arizona	United States	85258
37	Arizona Pain Specialist, PLLC	Scottsdale	Arizona	United States	85258
38	Sonora Quest Laboratories	Scottsdale	Arizona	United States	85258
39	Cochise Clinical Research	Sierra Vista	Arizona	United States	85635
40	Clinical Research Advantage, Inc./Skyline Medical Center PC	Tempe	Arizona	United States	85282
41	Clinical Research Advantage, Inc./Urban Family Practice Associates, PC	Tempe	Arizona	United States	85282
42	Clinical Research Advantage, Inc./Warner Family Practice, PC	Tempe	Arizona	United States	85282
43	Clinical Research Advantage, Inc/Manning Family Care	Tempe	Arizona	United States	85282
44	Clinical Research Advantage, Incl Colorado Springs Health Partners, East	Tempe	Arizona	United States	85282
45	Family Medicine Associates/Clinical Research Advantage	Tempe	Arizona	United States	85282
46	Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC	Tempe	Arizona	United States	85283
47	ARA-Arizona Research Associates	Tucson	Arizona	United States	85712
48	Canyon Clinical Research LLC	Tucson	Arizona	United States	85712
49	Tucson Clinical Researh	Tucson	Arizona	United States	85712
50	ACRC/Arizona Clinical Research Center, Incorporated	Tucson	Arizona	United States	85715
51	Clinical Research Advantage, Inc./ Orange Grove Family Practice	Tucson	Arizona	United States	85741
52	Genova Clinical Research	Tucson	Arizona	United States	85741
53	Eclipse Clinical Research	Tucson	Arizona	United States	85745
54	Fayetteville Diagnostic Clinic Limited	Fayetteville	Arkansas	United States	72703
55	Hearne Family Practice Clinic	Little Rock	Arkansas	United States	72205
56	Larry S. Watkins, M.D.	Little Rock	Arkansas	United States	72205
57	Lynn Institute of the Ozarks	Little Rock	Arkansas	United States	72205
58	Rx Medical Research of AR	Little Rock	Arkansas	United States	72205
59	Anaheim Family Medical Center	Anaheim	California	United States	92804
60	Advanced Research Center	Anaheim	California	United States	92805
61	Advanced Arthritis & Rheumatology Center	Artesia	California	United States	90701
62	Bina Akamdar MD	Azusa	California	United States	91702
63	Rx for Life, Inc	Bell	California	United States	90201
64	Clinical Research Advantage Inc., /Cassidy Medical Group-Carlsbad	Carlsbad	California	United States	92008
65	Capitol Interventional Cardiology	Carmichael	California	United States	95608
66	Northern California Research	Carmichael	California	United States	95608
67	CORE Orthopaedic Medical Center	Encinitas	California	United States	92024
68	Arthritis Medical Clinic of North County, Inc.	Escondido	California	United States	92025
69	Med Investigations, Inc.	Fair Oaks	California	United States	95628
70	Valley Research	Fresno	California	United States	93720
71	Creekside Clinical Research	Greenbrae	California	United States	94904
72	C. V. Mehta, MD Medical Corporation	Hemet	California	United States	92543
73	Talbert Medical Group	Huntington Beach	California	United States	92646
74	Alia Clinical Research, Inc	Huntington Park	California	United States	90255
75	Time Clinical Research Inc.	Huntington Park	California	United States	90255
76	Lindora Research Center	Irvine	California	United States	92604
77	Office of Dr. Robert L. Freed, MD	Irvine	California	United States	92618
78	Office of Dr. Alan Schenk	Laguna Hills	California	United States	92653
79	Prime Care Clinical Research	Laguna Hills	California	United States	92653
80	Jeremy Anuntiyo	Lakewood	California	United States	90712
81	Premiere Clinical Research, LLC	Lakewood	California	United States	90712
82	Stuart J. Finkelstein	Lakewood	California	United States	90712
83	Clinical Trials Research	Lincoln	California	United States	95648
84	VA Loma Linda Healthcare System	Loma Linda	California	United States	92357
85	Narbonne Multi-Specialty Medical Group Inc.	Lomita	California	United States	90717
86	Office of Dr. Arvind J. Mehta	Long Beach	California	United States	90806
87	Pacific Internal Medicine Group, Inc	Long Beach	California	United States	90806
88	Long Beach Center for Clinical Research	Long Beach	California	United States	90807-0000
89	National Institute of Clinical Research	Long Beach	California	United States	90807
90	Alliance Research, LLC	Long Beach	California	United States	90813
91	Valerius Medical Group and Research Center	Los Alamitos	California	United States	90720
92	IMD Medical Group	Los Angeles	California	United States	90029
93	Pacific Arthritis Care Center	Los Angeles	California	United States	90045
94	Wagdy W. Kades, MD, Inc.	Los Angeles	California	United States	90057
95	Samaritan Center for Medical Research Medical Group	Los Gatos	California	United States	95032
96	Office of Lewis Gamarra, MD M.P.H.	Los Osos	California	United States	93402
97	Adegbenga A. Adetola, M.D.	Lynwood	California	United States	90262
98	Facey Medical Group	Mission Hills	California	United States	91345
99	Providence Clinical Research	North Hollywood	California	United States	91606
100	Desert Medical Group	Palm Springs	California	United States	92262
101	The Office of Dr. Marcos Yang	Palos Verdes Estates	California	United States	90274
102	Bayview Research Group, LLC	Paramount	California	United States	90723
103	Sierra Rheumatology	Roseville	California	United States	95661
104	Center for Clinical Trials of Sacramento, Inc.	Sacramento	California	United States	95823
105	Sacramento Heart and Vascular Research Center	Sacramento	California	United States	95825
106	California Research Foundation	San Diego	California	United States	92103-6204
107	San Diego Arthritis Medical Clinic	San Diego	California	United States	92108
108	Wetlin Research Associates, Inc	San Diego	California	United States	92120
109	Medical Associates Research Group	San Diego	California	United States	92123
110	San Jose Valley Research, Inc.	San Jose	California	United States	95116
111	Comprehensive Adult Risk Evaluation	San Leandro	California	United States	94578
112	East Bay Rheumatology Medical Group Inc	San Leandro	California	United States	94578
113	Central Coast Pathology Consultants	San Luis Obispo	California	United States	93401
114	Coastal Medical Research Group, Inc.	San Luis Obispo	California	United States	93405
115	Family Medical Center	San Luis Obispo	California	United States	93405
116	Office of Ajay G. Meka, MD	Santa Ana	California	United States	92704
117	Pacific Arthritis Center Medical Group	Santa Maria	California	United States	93454
118	Orrin M. Troum & Medical Associates	Santa Monica	California	United States	90404
119	Northern California Medical Associates	Santa Rosa	California	United States	95403
120	Robert Simon, MD	Sherman Oaks	California	United States	91423
121	St. Joseph Medical Associates	Stockton	California	United States	95204
122	Westlake Medical Research	Thousand Oaks	California	United States	91360
123	Paradigm Clinical Research Institute, Inc.	Torrance	California	United States	90503
124	Orange County Research Center	Tustin	California	United States	92780
125	Inland Rheumatology and Osteoporosis Medical Group	Upland	California	United States	91786
126	Inland Rheumatology Clinical Trials, Inc.	Upland	California	United States	91786
127	Bayview Research Group	Valley Village	California	United States	91607
128	Medvin Clinical Research	Van Nuys	California	United States	91405
129	Center for Clinical Trials of San Gabriel	West Covina	California	United States	91790
130	Agilence Arthritis and Osteoporosis Medical Center, Inc.	Whittier	California	United States	90606
131	Avalon Family Medical Group	Wilmington	California	United States	90744
132	Darrell E. Gorman, MD	Arvada	Colorado	United States	80005
133	Aurora Denver Cardiology Associates	Aurora	Colorado	United States	80012
134	Azmi Emil Farag, MD	Colorado Springs	Colorado	United States	80918
135	Lynn Institute of the Rockies	Colorado Springs	Colorado	United States	80920
136	Colorado Springs Health Partners- East/Clinical Research Advantage	Colorado Springs	Colorado	United States	80922
137	Mountain View Clinical Research, Inc.	Denver	Colorado	United States	80209
138	Saint Luke's Medical Clinic	Fort Collins	Colorado	United States	80525
139	New West Physicians	Golden	Colorado	United States	80401
140	Ranch View Family Medicine	Highlands Ranch	Colorado	United States	80130
141	Colorado Center for Bone Research PC	Lakewood	Colorado	United States	80227
142	South Denver Cardiology Associates, PC	Littleton	Colorado	United States	80120
143	Lynn Institute of Pueblo	Pueblo	Colorado	United States	81008
144	Connecticut Clinical Research, LLC	Bridgeport	Connecticut	United States	06606
145	Connecticut Gastroenterology Institute	Bristol	Connecticut	United States	06010
146	Arthritis and Osteoporosis Center, PC	Hamden	Connecticut	United States	06518
147	Robert Lang, MD, P.C.	Hamden	Connecticut	United States	06518
148	Coastal Connecticut Research, LLC	New London	Connecticut	United States	06320
149	Office of Edward J. McDermott, Jr., MD	New London	Connecticut	United States	06320
150	Orthopaedics Foundation for Active Lifestyles	Stamford	Connecticut	United States	06905
151	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
152	New England Research Associates, LLC	Trumbull	Connecticut	United States	06611
153	Arthritis Center of Connecticut	Waterbury	Connecticut	United States	06708
154	Rheumatology Consultants of Delaware	Lewes	Delaware	United States	19958
155	Office of Cynthia Morgan, MD	Washington	District of Columbia	United States	20003
156	The Center for Rheumatology and Bone Research	Washington	District of Columbia	United States	20006
157	Medical Specialist of the Palm Beaches	Atlantis	Florida	United States	33462
158	South Florida Medical Research	Aventura	Florida	United States	33180
159	RASF - Clinical Research Center	Boca Raton	Florida	United States	33486
160	Orthopedic Research Institute	Boynton Beach	Florida	United States	33472
161	Clinical Research of Brandon, LLC	Brandon	Florida	United States	33511
162	Family Healthcare of Chipley	Chipley	Florida	United States	32428
163	Health First Clinical Research Group, Inc.	Chipley	Florida	United States	32428
164	Southern Family Healthcare and Health First Research Group Inc.	Chipley	Florida	United States	32428
165	Florida Research & Testing, LLC	Clearwater	Florida	United States	33755
166	Alba Clinical Research	Clearwater	Florida	United States	33756
167	Appletree Medical	Clearwater	Florida	United States	33756
168	Innovative Research of West Florida, Inc.	Clearwater	Florida	United States	33756
169	Clinical Research of West Florida	Clearwater	Florida	United States	33765
170	Rameshwar N. Mathur, MD, PA	Cocoa	Florida	United States	32927
171	Nature Coast Clinical Research, LLC	Crystal River	Florida	United States	34429
172	Atlantic Institute of Clinical Research	Daytona Beach	Florida	United States	32114
173	International Medical Research	Daytona Beach	Florida	United States	32117
174	Omega Research Consultants, LLC	DeBary	Florida	United States	32713
175	Physicians Research Alliance, LLC	DeBary	Florida	United States	32713
176	Deerfield Beach Cardiology Associates	Deerfield Beach	Florida	United States	33442
177	Doctors Medical Center of Walton County	DeFuniak Springs	Florida	United States	32435
178	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
179	Florida Research Associates, LLC/Florida Orthopaedic Associates, P.A.	DeLand	Florida	United States	32720
180	Cohen Medical Associates, PA	Delray Beach	Florida	United States	33446
181	Clark Family Medicine & Emerald Coast Research Group	Destin	Florida	United States	32540
182	SJS Clinical Research, Inc	Destin	Florida	United States	32541
183	Robert W. Levin MD	Dunedin	Florida	United States	34698
184	Riverside Clinical Research	Edgewater	Florida	United States	32132
185	Fleming Island Center for Clinical Research	Fleming Island	Florida	United States	32003
186	Invesclinic	Fort Lauderdale	Florida	United States	33308
187	M&O Clinical Research, LLC	Fort Lauderdale	Florida	United States	33316
188	Maxine Hamilton, MD PA	Fort Lauderdale	Florida	United States	33316
189	Holy Cross Medical Group Northridge Internal Medicine	Fort Lauderdale	Florida	United States	33334
190	Clinical Physiology Associates	Fort Myers	Florida	United States	33912
191	Emerald Coast Mood & Memory	Fort Walton Beach	Florida	United States	32547
192	White-Wilson Medical Center, PA	Fort Walton Beach	Florida	United States	32547
193	Cardiology West	Gainesville	Florida	United States	32605
194	Florida Research Network, LLC	Gainesville	Florida	United States	32605
195	Southeastern Integrated Medical, PL	Gainesville	Florida	United States	32607
196	Shands at the University of Florida	Gainesville	Florida	United States	32610
197	University of Florida	Gainesville	Florida	United States	32610
198	Genetic Medical Research Corporation	Hialeah	Florida	United States	33010
199	Direct Helpers Medical Center, Inc.	Hialeah	Florida	United States	33012
200	Indago Research & Health Center, Inc.	Hialeah	Florida	United States	33012
201	Reliable Clinical Research, LLC	Hialeah	Florida	United States	33012
202	Orthopaedic Associates of South Broward, P.A.	Hollywood	Florida	United States	33021
203	Advanced Research Institute of Miami	Homestead	Florida	United States	33030
204	Pasco Cardiology Center	Hudson	Florida	United States	34667
205	Nature Coast Clinical Research	Inverness	Florida	United States	34452
206	Westside Center for Clinical Research	Jacksonville	Florida	United States	32205
207	East Coast Institute for Research, LLC	Jacksonville	Florida	United States	32216
208	Jacksonville Center for Clincal Research	Jacksonville	Florida	United States	32216
209	St. Vincent's Cardiology	Jacksonville	Florida	United States	32216
210	Dr. Ricardo A. Bedoya, M.D.	Jupiter	Florida	United States	33458
211	Drug Study Institute	Jupiter	Florida	United States	33458
212	Christopher Chappel	Kissimmee	Florida	United States	34744
213	Florida Arthritis Center, LLC	Lake Mary	Florida	United States	32746
214	Pedro Ylisastigui, MD	Lehigh Acres	Florida	United States	33936
215	Adult Medicine Specialists	Longwood	Florida	United States	32779
216	Genesis Research International	Longwood	Florida	United States	32779
217	Doctors Inn	Madeira Beach	Florida	United States	33708
218	Everest Medical Care and Palm Court Research Group	Marianna	Florida	United States	32446
219	Panhandle Family Care Associates & Emerald Coast Research Group	Marianna	Florida	United States	32446
220	The Doctor's Office	Marianna	Florida	United States	32446
221	Health First Medical Group	Melbourne	Florida	United States	32901
222	Holmes Regional Medical Center	Melbourne	Florida	United States	32901
223	Pharmaceutical Research Associates	Merritt Island	Florida	United States	32953
224	Orthopaedic Specialist of Miami Beach	Miami Beach	Florida	United States	33181
225	AMPM Research Clinic	Miami Gardens	Florida	United States	33169
226	Crystal Biomedical Research, LLC	Miami Lakes	Florida	United States	33014
227	Pembroke Clinical Trials	Miami Lakes	Florida	United States	33014
228	Homestead Associates in Research, Inc	Miami	Florida	United States	33032
229	Pharmax Research Clinic	Miami	Florida	United States	33126
230	Life Spring Research Foundation	Miami	Florida	United States	33134
231	Miami International Cardiology Consultants	Miami	Florida	United States	33137
232	Florida Medical Center & Research, Inc.	Miami	Florida	United States	33142
233	The Center for Arthritis and Rheumatic Diseases	Miami	Florida	United States	33143
234	Well Pharma Medical Research Corporation	Miami	Florida	United States	33143
235	DC Health Clinical Trials	Miami	Florida	United States	33144
236	School of Clinical Research USA, LLC	Miami	Florida	United States	33144
237	Advance Medical Research Services, Corp	Miami	Florida	United States	33165
238	Future Care Solution, LLC	Miami	Florida	United States	33165
239	New Horizon Research Center	Miami	Florida	United States	33175
240	Miami Cardiology Group	Miami	Florida	United States	33176
241	M & M Medical Center	Miami	Florida	United States	33185
242	Office of Dr. Juvenal E. Martinez, MD, PA	Miami	Florida	United States	33186
243	Anchor Research Center	Naples	Florida	United States	34102
244	Jeffrey Alper M.D. Research	Naples	Florida	United States	34102
245	Anchor Health Centers	Naples	Florida	United States	34108
246	Medical Surgical Specialists, Physicians Regional Medical Center	Naples	Florida	United States	34119
247	Suncoast Clinical Research, Inc.	New Port Richey	Florida	United States	34652
248	Magnolia Research Group, Inc.	Ocala	Florida	United States	34471-5117
249	Ocala Rheumatology Research Center	Ocala	Florida	United States	34474
250	Paddock Park Clinical Research	Ocala	Florida	United States	34474
251	Southeastern Rehabilitation Medicine	Ocala	Florida	United States	34474
252	Tequesta Research Group	Ocala	Florida	United States	34474
253	CEC Research, INC.	Ocoee	Florida	United States	34761
254	Florida Heart Group, PA	Orlando	Florida	United States	32803-1849
255	Florida Hospital	Orlando	Florida	United States	32803
256	Compass Research, LLC	Orlando	Florida	United States	32806
257	DCT FMC, LLC dba Discovery Clinical Trials	Orlando	Florida	United States	32806
258	DCT-FMC, LLC dba Discovery Clinical Trials	Orlando	Florida	United States	32806
259	Arthur L. Hall MD PA	Orlando	Florida	United States	32814
260	Block and Nation, PA	Oviedo	Florida	United States	32765
261	Arthritis Research of Florida, Inc.	Palm Harbor	Florida	United States	34684
262	Florida Med Center of Countryside	Palm Harbor	Florida	United States	34684
263	Rene CaSanova Medical Office Inc	Pembroke Pines	Florida	United States	33024
264	Boulevard Professional Centre	Pembroke Pines	Florida	United States	33026
265	Research Physician Network Alliance	Pembroke Pines	Florida	United States	33026
266	South Broward Research LLC	Pembroke Pines	Florida	United States	33027
267	South Florida Research Solutions, LLC	Pembroke Pines	Florida	United States	33029
268	DMI Research, Inc.	Pinellas Park	Florida	United States	33782
269	Sunbelt Research, LLC	Plantation	Florida	United States	33322
270	Boca Raton Clinical Research	Plantation	Florida	United States	33323
271	St. Johns Center for Clinical Research	Ponte Vedra	Florida	United States	32081
272	Accord Clinical Research, LLC	Port Orange	Florida	United States	32129
273	Administrative Address: Florida Arthritis & Osteoporosis Center	Port Richey	Florida	United States	34668
274	Heart & Vascular Center Research	Sarasota	Florida	United States	34239
275	Edgar R. Blecker, MD	Sebastian	Florida	United States	32958
276	Phoenix Clinical Research, LLC.	Tamarac	Florida	United States	33321
277	Clinical Research of West Florida	Tampa	Florida	United States	33603
278	Soutwest Florida Clinical Research Center	Tampa	Florida	United States	33609-3018
279	Clinyx/Floria Cardiovascular	Tampa	Florida	United States	33609
280	Stedman Clinical Trials, LLC	Tampa	Florida	United States	33613
281	West Wind'r Research	Tampa	Florida	United States	33613
282	Health Point Medical Group, Inc	Tampa	Florida	United States	33614
283	Causeway Medical Clinic	Tampa	Florida	United States	33619-6364
284	Office of Alastair C. Kennedy, MD	Vero Beach	Florida	United States	32960
285	Metabolic Research Institute, Incorporated	West Palm Beach	Florida	United States	33401
286	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
287	Central Florida Primary Care	Winter Park	Florida	United States	32792
288	Florida Medical Clinic, PA	Zephyrhills	Florida	United States	33542
289	The Kaufmann Clinic	Atlanta	Georgia	United States	30308
290	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
291	Arthritis and Rheumatology of Georgia	Atlanta	Georgia	United States	30342
292	Atlanta Center for Clinical Research, Corp.	Atlanta	Georgia	United States	30342
293	Atlanta Vascular Research Foundation	Atlanta	Georgia	United States	30342
294	Executive Health and Research Associates	Atlanta	Georgia	United States	30342
295	Southern Clinical Research and Management, Inc. (SCRAM)	Augusta	Georgia	United States	30904
296	Masters of Clinical Research, Inc.	Augusta	Georgia	United States	30909
297	Amelia Medical Plaza	Bainbridge	Georgia	United States	39819
298	Bainbridge Medical Associates	Bainbridge	Georgia	United States	39819
299	Abdul Bari MD Inc	Cairo	Georgia	United States	39828
300	Southern Clinical Research Management and Consulting	Cairo	Georgia	United States	39828
301	North Georgia Rheumatology Group, PC	Duluth	Georgia	United States	30096
302	United Osteoporosis Centers	Gainesville	Georgia	United States	30501
303	North Georgia Rheumatology Group, PC	Lawrenceville	Georgia	United States	30046
304	GCH Research Dr. G Craig Heigerick DO	Lilburn	Georgia	United States	30047
305	Mercer University Mercer Medicine	Macon	Georgia	United States	31201
306	Drug Studies America	Marietta	Georgia	United States	30060
307	Drug Studies America	Marietta	Georgia	United States	30066
308	Clinical Research Advantage, Inc./Urban Family Practice Associates, PC	Marietta	Georgia	United States	30067
309	In-Quest Medical Research, LLC	Norcross	Georgia	United States	30071
310	Harbin Clinic	Rome	Georgia	United States	30165-1698
311	Atlanta Center for Clinical Research	Roswell	Georgia	United States	30075
312	Herman Clinical Research, LLC	Suwanee	Georgia	United States	30024
313	Archibold Primary Care	Thomasville	Georgia	United States	31792
314	Clinical Trial Providers, Inc.	Tucker	Georgia	United States	30084
315	VSC	Valdosta	Georgia	United States	31602
316	Kaufmann Clinic, INC	Woodstock	Georgia	United States	30188
317	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
318	North Georgia Internal Medicine	Woodstock	Georgia	United States	30189
319	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
320	Orthopedic Health Care Clinic	Boise	Idaho	United States	83702
321	Sonora Clinical Research, LLC	Boise	Idaho	United States	83702
322	Eagle's View Family Medicine	Boise	Idaho	United States	83713-0997
323	Coeur D'Alene Arthritis Clinic	Coeur d'Alene	Idaho	United States	83814
324	CTL Research	Eagle	Idaho	United States	83616
325	Women's Healthcare Associates P.A. dba Rosemark WomenCare Specialists	Idaho Falls	Idaho	United States	83404
326	Idaho Arthritis and Osteoporosis Center	Meridian	Idaho	United States	83642-6356
327	Advanced Clinical Research	Meridian	Idaho	United States	83642
328	AMR Sakeena Research	Aurora	Illinois	United States	60506
329	Arthur I Davida, MD PC	Bloomingdale	Illinois	United States	60108
330	Cardiac Wellness Consultants	Chicago	Illinois	United States	60611
331	Chicago Peripheral Nerve Center	Chicago	Illinois	United States	60611
332	ICCT Research International Incorporated	Chicago	Illinois	United States	60611
333	Claude Mandel Medical Center	Chicago	Illinois	United States	60617
334	Windy City Orthopedics and Sports Medicine	Evanston	Illinois	United States	60202
335	South Suburban Health Professional Group	Hazel Crest	Illinois	United States	60429
336	Prairie Rheumatology Associates, SC	Joliet	Illinois	United States	60435
337	Lake Zurich Family Treatment Center	Lake Zurich	Illinois	United States	60047
338	Southern Illiniois Clinical Research Centre	O'Fallon	Illinois	United States	62269
339	Speciality phhysicians of Illinois, LLC	Olympia Fields	Illinois	United States	60461
340	Redhead Research Inc., DBA Research Associates of Central Illinois	Peoria	Illinois	United States	61614
341	Trinity Medical Center	Rock Island	Illinois	United States	61201
342	Rockford Health Physicians	Rockford	Illinois	United States	61103
343	Prairie Cardiovascular Consultants	Springfield	Illinois	United States	62701
344	Prairie Education & Research	Springfield	Illinois	United States	62701
345	Springfield Clinic	Springfield	Illinois	United States	62702
346	Springfield Clinic	Springfield	Illinois	United States	62703
347	Deerbrook Medical Associates	Vernon Hills	Illinois	United States	60061
348	Community Clinical Research Center	Anderson	Indiana	United States	46011
349	American Health Network of Indiana, LLC	Avon	Indiana	United States	46123
350	Robert D. Barnes, MD, LLC	Evansville	Indiana	United States	47710
351	Clinical Research Advantage, Inc.	Evansville	Indiana	United States	47714
352	Destiny Clinical Research, LLC	Evansville	Indiana	United States	47714
353	Clinical Research Advantage/Family Medicine Associates	Evansville	Indiana	United States	47725
354	American Health Network of Indiana, LLC	Franklin	Indiana	United States	46131
355	Internal Medicine Center of Northwest Indiana, P.C.	Gary	Indiana	United States	46409
356	Beacon Medical Group Rheumatology	Granger	Indiana	United States	46530
357	American Health Network of IN, LLC	Greenfield	Indiana	United States	46140-2834
358	Diagnostic Rheumatology And Research, PC	Indianapolis	Indiana	United States	46227
359	Investigators research Group	Indianapolis	Indiana	United States	46234
360	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46256
361	Dawes Fretzin Dermatology Group, LLC	Indianapolis	Indiana	United States	46256
362	Arthritis Associates of Southern Indiana	Jeffersonville	Indiana	United States	47130
363	Research Institute of Middle America/River Cities Cardiology	Jeffersonville	Indiana	United States	47130
364	Beacon Medical Group LaPorte	LaPorte	Indiana	United States	46350
365	Cardiovascular Clinics, PC	Merrillville	Indiana	United States	46410
366	Community Clinical Research Center	Muncie	Indiana	United States	47304
367	Medical Specialists Clinical Research Center	Munster	Indiana	United States	46321
368	Medical Specialists	Munster	Indiana	United States	46321
369	Arthritis Associates of Southern Indiana	New Albany	Indiana	United States	47150
370	Buynak Clinical Research	Valparaiso	Indiana	United States	46383
371	Physician's Clinic of Iowa, PC	Cedar Rapids	Iowa	United States	52403
372	Ridge Family Practice, PC/Clinical Research Advantage, Inc.	Council Bluffs	Iowa	United States	51503
373	Midwest Cardiovascular Research Foundation	Davenport	Iowa	United States	52803
374	Office of Jerrold V Flatt	Des Moines	Iowa	United States	50316
375	Medical Associates Clinic, PC	Dubuque	Iowa	United States	52002
376	Family Health Center of Waterloo, PC	Waterloo	Iowa	United States	50701
377	Northeast IA Medical Education Foundation/Family Practice Center	Waterloo	Iowa	United States	50702
378	Heartland Research Associates LLC	Arkansas City	Kansas	United States	67005
379	Community House of Wellness	Kansas City	Kansas	United States	66104
380	Associates Reseach Inc.	Lansing	Kansas	United States	66043
381	Radiant Research, Inc.	Overland Park	Kansas	United States	66210
382	International Clinical Research Institute, Inc	Overland Park	Kansas	United States	66211
383	Arthritis Specialists of Greater KC	Overland Park	Kansas	United States	66215
384	Pinnacle Medical Research	Overland Park	Kansas	United States	66215
385	Quivira Internal Medicine	Overland Park	Kansas	United States	66215
386	Health Science Research Center	Pratt	Kansas	United States	67124
387	Heartland Research Associates, LLC	Wichita	Kansas	United States	67205
388	Via Christi Clinic	Wichita	Kansas	United States	67208
389	Howard L. Feinberg, D.O.	Ashland	Kentucky	United States	41101
390	Graves Gilbert Clinic	Bowling Green	Kentucky	United States	42101-1759
391	Graves Gilbert Clinic	Bowling Green	Kentucky	United States	42101
392	Internal Medicine Research Association	Campbellsville	Kentucky	United States	42718
393	Center for Arthritis and Osteoporosis	Elizabethtown	Kentucky	United States	42701
394	Arthritis Center of Lexington	Lexington	Kentucky	United States	40504
395	Kentuckiana Center for Better Bone and Joint Health	Louisville	Kentucky	United States	40202
396	KY Research PLLC.	Louisville	Kentucky	United States	40202
397	University Medical Associates	Louisville	Kentucky	United States	40202
398	Louisville Metabolic and Atherosclerosis Research Center	Louisville	Kentucky	United States	40213
399	Office of Gaurang B. Shah,MD, PSC	Richmond	Kentucky	United States	40475
400	Richmond Regional Research	Richmond	Kentucky	United States	40475
401	Chandler Family Practice	Bossier City	Louisiana	United States	71111
402	McFarland Family Clinic	Shreveport	Louisiana	United States	71105
403	TFD Research, LLC	Shreveport	Louisiana	United States	71115
404	Maine Research Associates	Auburn	Maine	United States	04210
405	Southern Maine Health Care	Biddeford	Maine	United States	04005
406	Central Maine Heart & Vascular Institute	Lewiston	Maine	United States	04240
407	Chesapeake CardioVascular Associates	Baltimore	Maryland	United States	21204
408	Midatlantic Cardiovascular Associates	Baltimore	Maryland	United States	21204
409	Midatlantic Cardiovascular Associates, PA	Baltimore	Maryland	United States	21208
410	Health Trends Research, LLC	Baltimore	Maryland	United States	21209
411	One Heart, LLC	Baltimore	Maryland	United States	21215
412	Chesapeake CardioVascular Associates	Baltimore	Maryland	United States	21218
413	Midatlantic Cardiovascular Associates, Pa	Baltimore	Maryland	United States	21229
414	Saint Agnes HealthCare Incorporated	Baltimore	Maryland	United States	21229
415	Stephen R Smith, MD FACP	Baltimore	Maryland	United States	21234-4607
416	MidAtlantic Cardiovascular Associates, PA	Baltimore	Maryland	United States	21237
417	Peter A. Holt	Baltimore	Maryland	United States	21239
418	Midatlantic Cardiovascular Associates PA	Bel Air	Maryland	United States	21014
419	Shah Associates MD, LLC	Charlotte Hall	Maryland	United States	20622
420	Cardiovascular Specialists, LLC	Columbia	Maryland	United States	21044-2914
421	Johns Hopkins University	Columbia	Maryland	United States	21044
422	The Osteoporosis & Clinical Trials Center	Cumberland	Maryland	United States	21502
423	Arthritis Treatment Center	Frederick	Maryland	United States	21702
424	The Spine & Joint Center	Greenbelt	Maryland	United States	20770
425	Klein & Associates, MD, PA	Hagerstown	Maryland	United States	21740
426	Community Health Research	North East	Maryland	United States	21901
427	MD Medical Research	Oxon Hill	Maryland	United States	20745
428	Shah Associates	Prince Frederick	Maryland	United States	20678
429	Cardiac Associates, Shady Grove Adventist Hospital	Rockville	Maryland	United States	20850
430	The Center for Rheumatology and Bone Research	Rockville	Maryland	United States	20850
431	Rockville Internal Medicine Group	Rockville	Maryland	United States	20854
432	IRC Clinics	Towson	Maryland	United States	21204
433	Midatlantic Cardiovascular Associates, P.A.	Westminster	Maryland	United States	21157-6160
434	The Center for Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
435	Primary Care Cardiology Research	Ayer	Massachusetts	United States	01432
436	Genesis Clinical Research & Consulting	Fall River	Massachusetts	United States	02720
437	NECCR Internal Medicine and Cardiology Associates, LLC	Fall River	Massachusetts	United States	02720
438	Phase III Clinical Research	Fall River	Massachusetts	United States	02720
439	Pentucket Medical Associates, Incorporated	Haverhill	Massachusetts	United States	01830
440	Clinical Research Center of Cape Cod, Inc.	Hyannis	Massachusetts	United States	02601
441	Charles River Medical Associates, Pchi	Natick	Massachusetts	United States	01760
442	Novex Clinical Research, LLC	New Bedford	Massachusetts	United States	02740
443	Northampton Internal Medicine Associates, PC	Northampton	Massachusetts	United States	01062
444	FutureCare Studies	Springfield	Massachusetts	United States	01105
445	Reliant Medical Group, Inc.	Worcester	Massachusetts	United States	01605
446	Great Lakes Research Group, Incorporated	Bay City	Michigan	United States	48706
447	Professional Clinical Research-Benzonia	Benzonia	Michigan	United States	49616
448	Cadillac Clinical Research	Cadillac	Michigan	United States	49601
449	Livernois Family Medical Services	Detroit	Michigan	United States	48221
450	Office of Dr. Susan Courtnage	Eaton Rapids	Michigan	United States	48827
451	McLaren Regional Medical Center-Research Dept.	Flint	Michigan	United States	48532
452	Grand Valley Medical Specialist, PLC	Grand Rapids	Michigan	United States	49506
453	Spectrum Health Medical Group-Rheumatology	Grand Rapids	Michigan	United States	49506
454	Michigan Medical Cardiovascular PC	Grand Rapids	Michigan	United States	49546
455	Professional Clinical Research	Interlochen	Michigan	United States	49643
456	Justus J Fiechtner, MD	Lansing	Michigan	United States	48910-8595
457	Michigan Cardiovascular Institute	Saginaw	Michigan	United States	48601
458	Synergy Medical Education Alliance	Saginaw	Michigan	United States	48602
459	Shores Rheumatology	Saint Clair Shores	Michigan	United States	48081
460	Oakland Medical Research Center	Troy	Michigan	United States	48085
461	Troy Internal Medicine Research	Troy	Michigan	United States	48098
462	St. Luke's Hospital Association of Duluth, DBA St Luke's Rheumatology Assoc.	Duluth	Minnesota	United States	55805
463	St. Luke's Hospital Association of Duluth, Inc.	Duluth	Minnesota	United States	55805
464	St. Luke's Hospital Association of Duluth	Duluth	Minnesota	United States	55805
465	Central Minnesota Heart Center at St. Cloud Hospital	Saint Cloud	Minnesota	United States	56303-1901
466	St. Paul Heart Clinic	Saint Paul	Minnesota	United States	55102
467	The Center for Clinical Trials	Biloxi	Mississippi	United States	39531
468	Planters Clinic	Port Gibson	Mississippi	United States	39150
469	North Mississippi Medical Clinics, Inc.	Tupelo	Mississippi	United States	38801
470	Cape Girardeau Physicians Associates	Cape Girardeau	Missouri	United States	63703
471	Patterson Medical Clinic / d.b.a. Prime Care Research Associates	Florissant	Missouri	United States	63031
472	Allergy Asthma Immunology Services, LLC	Jefferson City	Missouri	United States	65101
473	Jefferson City Medical Group	Jefferson City	Missouri	United States	65109
474	University of Missouri Kansas City School of Medicine	Kansas City	Missouri	United States	64108-2792
475	Truman Medical Center, Inc.	Kansas City	Missouri	United States	64108
476	Clinical Research Advantage, Inc./Manning Family Care, LLC	Kansas City	Missouri	United States	64133
477	St. Louis Center for Clinical Research	Saint Louis	Missouri	United States	63128
478	Physician Groups, LC, DBA Rheumatology and Internal Medicine Associates	Saint Louis	Missouri	United States	63131
479	Southampton Healthcare, Inc.	Saint Louis	Missouri	United States	63139-2909
480	Barbara A. Caciolo, MD	Saint Louis	Missouri	United States	63139
481	A & A Pain Institute	Saint Louis	Missouri	United States	63141
482	Sundance Clinical Research, LLC	Saint Louis	Missouri	United States	63141
483	Mercy Medical Research Institute	Springfield	Missouri	United States	65807
484	Patients First Health Care, LLC	Washington	Missouri	United States	63090
485	Glacier View Research Institute, Cardiology	Kalispell	Montana	United States	59901
486	Alliance Medical Center	Alliance	Nebraska	United States	69301
487	Cody Medical Associates	Alliance	Nebraska	United States	69301
488	Bellevue Family Practice/Clinical Research Advantage, Inc.	Bellevue	Nebraska	United States	68005
489	Clinical Research Advantage, Inc./ Skyline Medical Center, PC	Elkhorn	Nebraska	United States	68022
490	Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC	Fremont	Nebraska	United States	68025
491	Internal Medicine Associates, PC	Grand Island	Nebraska	United States	68803
492	Physician, Research Collaboration, Southwest Family Health	Lincoln	Nebraska	United States	68512
493	Lincoln Internal Medicine Associates	Lincoln	Nebraska	United States	68516
494	Platte River Nephrology	North Platte	Nebraska	United States	69101
495	Quality Clinical Research LLC	Omaha	Nebraska	United States	68114
496	Westroads Medical Group	Omaha	Nebraska	United States	68114
497	Heartland Clinical Research, Inc.	Omaha	Nebraska	United States	68134
498	Clinical Research Advantage, Inc./Primary Care Physicians, LLP	Omaha	Nebraska	United States	68144
499	Clinical Research Advantage, Inc.	Henderson	Nevada	United States	89014
500	Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC	Henderson	Nevada	United States	89052
501	Sierra Internal Medicine Associates	Incline Village	Nevada	United States	89451
502	Clinical Research Center of Nevada	Las Vegas	Nevada	United States	89104
503	Clinical Research Advantage/Peter Philander, MD	Las Vegas	Nevada	United States	89128
504	Rancho Internal Medicine	Las Vegas	Nevada	United States	89128
505	Steven D. Folkerth, MD	Las Vegas	Nevada	United States	89130
506	Ladner Family Practice	Las Vegas	Nevada	United States	89146
507	VA Southern Nevada Healthcare System	North Las Vegas	Nevada	United States	89086
508	Arthritis Center of Reno	Reno	Nevada	United States	89502
509	New Jersey Physicians, LLC	Clifton	New Jersey	United States	07012
510	Clifton-Wallington Medical Group	Clifton	New Jersey	United States	07013
511	Anderson and Collins, Clinical Research Inc.	Edison	New Jersey	United States	08817
512	Drs. Collins and Uthappa	Edison	New Jersey	United States	08817
513	Central Jersey Health Care	Elizabeth	New Jersey	United States	07202
514	Andron Medical Associates	Englewood	New Jersey	United States	07631-2507
515	Advocare Heights Primary Care	Haddon Heights	New Jersey	United States	08035
516	Hazlet Health Care	Hazlet	New Jersey	United States	07730
517	Family Care Physicians	Lawrenceville	New Jersey	United States	08648
518	Penn Cardiac Care at Mercer Bucks	Lawrenceville	New Jersey	United States	08648
519	Family Medicine of Lindenwold	Lindenwold	New Jersey	United States	08021
520	Rheumatology and Arthritis Associates PC	Medford	New Jersey	United States	08055
521	Adult & Pediatric Rheumatology	Midland Park	New Jersey	United States	07432-1969
522	The Valley Hospital	Ridgewood	New Jersey	United States	07450
523	Maynard Holgado LLC	Sicklerville	New Jersey	United States	08081
524	Shore Health Group	Toms River	New Jersey	United States	08753
525	Hopewell Valley Medical Group, P.A.	Trenton	New Jersey	United States	08618
526	Arthritis, Rheumatic and Back Disease Associates, PA	Voorhees	New Jersey	United States	08043
527	Lourdes Medical Associates	Willingboro	New Jersey	United States	08046
528	Kenneth F. Solinsky, MD	Babylon	New York	United States	11702-2516
529	LifeLine Research Institute	Brooklyn	New York	United States	11214
530	Lee Medical Associates	Dunkirk	New York	United States	14048
531	AMS Research	Elmira	New York	United States	14905
532	Regional Clinical Research, Inc.	Endwell	New York	United States	13760
533	Drug Trials America, Inc.	Hartsdale	New York	United States	10530
534	United Health Service Hospitals, Office of Clinical Trials	Johnson City	New York	United States	13790
535	IMA Medical Research PC	Kew Gardens	New York	United States	11415
536	NYU Langone Medical Center, Laura and Issac Perlmutter Cancer Center, Infusion Center	Lake Success	New York	United States	11042
537	NYU Langone Medical Center, Laura and Issac Perlmutter Cancer Center, Investigational Pharmacy	Lake Success	New York	United States	11042
538	NYU Langone Rheumatology Associates Long Island	Lake Success	New York	United States	11042
539	Office of Dr. Allen Chodock	Mamaroneck	New York	United States	10543
540	Winthrop University Hospital / Clinical Trials Center	Mineola	New York	United States	11501
541	New York University Pain Management Center	New York	New York	United States	10016-4974
542	NYU Pain Research	New York	New York	United States	10016
543	Office of Dr. Richard Stern	New York	New York	United States	10021
544	DiGiovanna Family Care Center	North Massapequa	New York	United States	11758
545	Hudson Valley Heart Center	Poughkeepsie	New York	United States	12601
546	AAIR Research Center	Rochester	New York	United States	14618
547	Institute for Clinical Studies	Rosedale	New York	United States	11422
548	Rheumatology Associates of Long Island	Smithtown	New York	United States	11787-2817
549	Office of Dr. Chadia Morcos	Syosset	New York	United States	11791
550	Arthritis Health Associates	Syracuse	New York	United States	13210-1775
551	Crouse Medical Practice, PLLC d/b/a Internist Associates of Central New York	Syracuse	New York	United States	13210
552	East Meadow Family Practice Associates, PC	Wantagh	New York	United States	11793
553	Southgate Medical Group	West Seneca	New York	United States	14224
554	Great Lakes Medical Research	Westfield	New York	United States	14787
555	Buffalo Cardiology and Pulmonary Associates, PC	Williamsville	New York	United States	14221
556	Upstate Clinical Research Associates	Williamsville	New York	United States	14221
557	Asheville Arthritis & Osteoporosis, PA	Asheville	North Carolina	United States	28803
558	Kernodle Clinic Inc.	Burlington	North Carolina	United States	27215
559	Calabash Medical Center	Calabash	North Carolina	United States	28467
560	PMG Research of Raleigh, LLC d/b/a PMG Research of Cary	Cary	North Carolina	United States	27518
561	Chapel Hill Family Medicine	Chapel Hill	North Carolina	United States	27514
562	Thurston Arthritis Reaserch Ctr	Chapel Hill	North Carolina	United States	27599
563	Mid Carolina Cardiology Research	Charlotte	North Carolina	United States	28204
564	Presbyterian Novant Heart and Wellness	Charlotte	North Carolina	United States	28204
565	Arthritis and Osteoporosis Consultants of the Carolinas	Charlotte	North Carolina	United States	28207-1198
566	PMG Research of Charlotte	Charlotte	North Carolina	United States	28209-3734
567	Barat Research Group, Inc.	Charlotte	North Carolina	United States	28262
568	Sensenbrenner Primary Care	Charlotte	North Carolina	United States	28277
569	Duke Health Center at Pickett Road	Durham	North Carolina	United States	27705
570	Bland Clinic, PA	Greensboro	North Carolina	United States	27401
571	Medication Management, LLC	Greensboro	North Carolina	United States	27408
572	Physicians East P. A.	Greenville	North Carolina	United States	27834
573	Physicians East, PA	Greenville	North Carolina	United States	27834
574	Clinical Trials of America, Inc.	Hickory	North Carolina	United States	28601
575	PMG Research Of Hickory, LLC	Hickory	North Carolina	United States	28602
576	Peters Medical Research	High Point	North Carolina	United States	27262
577	Research Institute of the Carolinas, PLLC	Mooresville	North Carolina	United States	28117
578	Crystal Coast Family Practice	Morehead City	North Carolina	United States	28557
579	Burke Primary Care	Morganton	North Carolina	United States	28655
580	Pinehurst Medical Clinic, Inc.	Pinehurst	North Carolina	United States	28374
581	Pinehurst Medical Clinic. Inc.	Pinehurst	North Carolina	United States	28374
582	Blue Ridge Family Physicians, PPLC	Raleigh	North Carolina	United States	27607
583	PMG Research of Raleigh, LLC	Raleigh	North Carolina	United States	27609
584	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina	United States	27612
585	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
586	Boice-Willis Clinic	Rocky Mount	North Carolina	United States	27804
587	PMG Research of Salisbury	Salisbury	North Carolina	United States	28144
588	Tabor City Family Medicine	Tabor City	North Carolina	United States	28463
589	PMG Research of Wilmington	Wilmington	North Carolina	United States	28401
590	PMG Research Wilmington Research Associates	Wilmington	North Carolina	United States	28401
591	Natalie A. Doyle, MD PA	Wilson	North Carolina	United States	27893
592	Ardmore Family Practice	Winston-Salem	North Carolina	United States	27103
593	Clinical Trials of America, Inc.	Winston-Salem	North Carolina	United States	27103
594	Clinical Trials of America, inc	Winston-Salem	North Carolina	United States	27103
595	PMG Research of Winston-Salem	Winston-Salem	North Carolina	United States	27103
596	Winston-Salem Health Care	Winston-Salem	North Carolina	United States	27103
597	Plains Clinical Research Center	Fargo	North Dakota	United States	58104
598	Daystar Clinical Research	Akron	Ohio	United States	44313
599	CFP Research, Inc.	Cincinnati	Ohio	United States	45242
600	Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
601	Cleveland Clinic	Cleveland	Ohio	United States	44195
602	The Ohio State University	Columbus	Ohio	United States	43210-1228
603	Feldman Family Practice	Columbus	Ohio	United States	43213
604	MidWest Cardiology Research Foundation	Columbus	Ohio	United States	43214
605	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
606	Remington-Davis Incorporated	Columbus	Ohio	United States	43215
607	Midtowne Family Practice Centre	Columbus	Ohio	United States	43228
608	PriMed Clinical Research	Dayton	Ohio	United States	45419
609	HWC Women's Research Center	Englewood	Ohio	United States	45322
610	Cleveland Clinic Fairview Cardiovascular Medicine	Fairview Park	Ohio	United States	44126
611	Prestige Clinical Research	Franklin	Ohio	United States	45005
612	TriPhase Research, Ltd.	Franklin	Ohio	United States	45005
613	Holzer Clinic, Inc	Gallipolis	Ohio	United States	45631
614	Office of Dr. Saleem Khan, MD, Inc	London	Ohio	United States	43140
615	North Central Research	Mansfield	Ohio	United States	44903
616	OhioHealth Research Institute	Mansfield	Ohio	United States	44903
617	R&R Research-Smith Clinic	Marion	Ohio	United States	43302
618	David R. Mandel, MD, Inc	Mayfield	Ohio	United States	44143
619	Paramount Medical Research and Consulting, LLC	Middleburg Heights	Ohio	United States	44130
620	Newark Physician Associates	Newark	Ohio	United States	43055
621	Family Medicine and Occupational Health Center, Inc.	Shaker Heights	Ohio	United States	44120
622	Abner Cordero, M.D.	Tiffin	Ohio	United States	44883
623	Arthritis Associates of Northwest Ohio, Inc.	Toledo	Ohio	United States	43606
624	Mercy St Vincent Medical Center	Toledo	Ohio	United States	43608
625	Toledo Cardiology Consultants c/o Cardiac Research	Toledo	Ohio	United States	43608
626	South Toledo Internists	Toledo	Ohio	United States	43614
627	University of Toledo Health Science Campus	Toledo	Ohio	United States	43614
628	UT Medical Center Medicine Clinic	Toledo	Ohio	United States	43614
629	Trenton Family Medicine	Trenton	Ohio	United States	45067
630	Lake Medical Research, LLC	Willoughby Hills	Ohio	United States	44094
631	Pharmacotherapy Research Associates Incorporated	Zanesville	Ohio	United States	43701
632	LION Research	Norman	Oklahoma	United States	73069
633	Integris Physicians Services	Oklahoma City	Oklahoma	United States	73109
634	Integris Cardiovascular Physicians LLC	Oklahoma City	Oklahoma	United States	73112
635	Integris Family Care Central	Oklahoma City	Oklahoma	United States	73112
636	Integris Physician Services	Oklahoma City	Oklahoma	United States	73112
637	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
638	Healthcare Research Consultants	Tulsa	Oklahoma	United States	74135
639	Integrated Medical Research, PC	Ashland	Oregon	United States	97520
640	Lane Medical Research Group	Eugene	Oregon	United States	97401
641	Oregon Medical Group Adult Medicine Clinic	Eugene	Oregon	United States	97401
642	Oregon Medical Group Clinical Research	Eugene	Oregon	United States	97401
643	Institute of Diabetes and Endocrinology	Medford	Oregon	United States	97501
644	Rogue Valley Physicians-Clinical Research Group	Medford	Oregon	United States	97504
645	Fanno Creek Clinic	Portland	Oregon	United States	97219-1940
646	Affinity Research	Portland	Oregon	United States	97219
647	Portland Rheumatology Clinic, LLC	Portland	Oregon	United States	97219
648	Internal Medicine Research	Portland	Oregon	United States	97225
649	University Orthopedics Center	Altoona	Pennsylvania	United States	16602
650	Tri-State Medical Group	Beaver	Pennsylvania	United States	15009
651	East Penn Rheumatology Associates, PC	Bethlehem	Pennsylvania	United States	18015
652	Buckingham Family Medicine	Buckingham	Pennsylvania	United States	18912
653	Camp Hill Clinical Research Center	Camp Hill	Pennsylvania	United States	17011
654	Butler Medical Associates	Chicora	Pennsylvania	United States	16025
655	Perkiomen Valley Family Practice, PC	Collegeville	Pennsylvania	United States	19426-3626
656	Rheumatology Associates, Ltd	Colmar	Pennsylvania	United States	18915
657	Office of J. Miller Oppy, MD, Youghiogheny Primary Care Practice	Connellsville	Pennsylvania	United States	15425
658	Brandywine Clinical Research	Downingtown	Pennsylvania	United States	19335
659	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
660	Saint Vincent Consultant in Cardiovascular Diseases, LLC	Erie	Pennsylvania	United States	16502
661	Arthritis Associates	Erie	Pennsylvania	United States	16508
662	Center for Assessment and Research of Erie	Erie	Pennsylvania	United States	16508
663	Stan F. Slabic, M.D.	Erie	Pennsylvania	United States	16509
664	AMH Feasterville Family HealthCare Center	Feasterville	Pennsylvania	United States	19053
665	Westmoreland Neurology Associates, Incorporated	Greensburg	Pennsylvania	United States	15601
666	Harleysville Medical Assoc	Harleysville	Pennsylvania	United States	19438-2513
667	Lederach Family Medicine	Harleysville	Pennsylvania	United States	19438
668	Dr. Bruce Morrison, Family Practice	Huntingdon Valley	Pennsylvania	United States	19006
669	Detweiler Family Medicine and Associates, PC	Lansdale	Pennsylvania	United States	19446
670	Green and Seidner Family Practice Associates	Lansdale	Pennsylvania	United States	19446
671	Lansdale Medical Group Family Practice	Lansdale	Pennsylvania	United States	19446
672	Bucks County Clinical Research	Morrisville	Pennsylvania	United States	19067-5008
673	Pearl Clinical Research, Inc.	Norristown	Pennsylvania	United States	19401
674	Lehigh Wellness Center Outpatient Services	Philadelphia	Pennsylvania	United States	19126
675	Founders Research Corporation	Philadelphia	Pennsylvania	United States	19152
676	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania	United States	15206
677	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania	United States	15240
678	Dairyland Medical Center	Red Lion	Pennsylvania	United States	17356
679	Sfm Clinical Trials, PC	Scotland	Pennsylvania	United States	17254
680	Elite Medical Research, Inc.	Sellersville	Pennsylvania	United States	18960
681	Prime Health Network	Springfield	Pennsylvania	United States	19064
682	University Orthopedics Center	State College	Pennsylvania	United States	16801
683	The Office of Dr. Joseph T. Morelli, DO	Stoneboro	Pennsylvania	United States	16153
684	Tipton Medical and Diagnostic Center	Tipton	Pennsylvania	United States	16684
685	Pish Medical Associates	Uniontown	Pennsylvania	United States	15401
686	PEAK Research, LLC	Upper Saint Clair	Pennsylvania	United States	15241
687	Allegheny Rheumatology - WPAHS - ASRI	Wexford	Pennsylvania	United States	15090
688	Clinical Research Center of Reading, LLC	Wyomissing	Pennsylvania	United States	19610
689	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania	United States	19067
690	Jeffry A. Lindenbaum DO, PC	Yardley	Pennsylvania	United States	19067
691	New England Center for Clinical Research	Cranston	Rhode Island	United States	02920
692	Partners in Clinical Research	Cumberland	Rhode Island	United States	02864
693	Hugo M. Yamada, MD	Lincoln	Rhode Island	United States	02865
694	Rheumatology Associates	Pawtucket	Rhode Island	United States	02860
695	Medical Office Center	Providence	Rhode Island	United States	02905
696	Anderson Heart	Anderson	South Carolina	United States	29621
697	AnMed Health	Anderson	South Carolina	United States	29621
698	Low Country Rheumatology, PA/Low Country Research Center	Charleston	South Carolina	United States	29406-9333
699	Clinical Trials of South Carolina	Charleston	South Carolina	United States	29406
700	St. Andrews Medical	Charleston	South Carolina	United States	29407
701	Neem Research Group Inc.	Columbia	South Carolina	United States	29201
702	Columbia Arthritis Center Pa	Columbia	South Carolina	United States	29204
703	MedTrial	Columbia	South Carolina	United States	29204
704	Clinical Research Associates, LLC	Florence	South Carolina	United States	29501
705	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina	United States	29601
706	Paris View Family Practice	Greenville	South Carolina	United States	29601
707	John Milas	Greer	South Carolina	United States	29650
708	Radiant Research, Inc	Greer	South Carolina	United States	29650
709	DeGarmo Institute of Medical Research	Greer	South Carolina	United States	29651
710	Mountain View Clinical Research, Inc.	Greer	South Carolina	United States	29651
711	Palmetto Clinical Trial Services, LLC at the Family Healthcare Center	Laurens	South Carolina	United States	29360
712	Berkeley Medical Center	Moncks Corner	South Carolina	United States	29461
713	PMG Research of Charleston	Mount Pleasant	South Carolina	United States	29464
714	North Myrtle Beach Family Practice	North Myrtle Beach	South Carolina	United States	29582
715	Coulter Clinic	Orangeburg	South Carolina	United States	29115-4931
716	Orangeburg Medical Associates, PA	Orangeburg	South Carolina	United States	29118
717	The Carolina Center for Rheumatology & Arthritis Care, PA	Rock Hill	South Carolina	United States	29732
718	Hillcrest Clinical Research, LLC	Simpsonville	South Carolina	United States	29681
719	Hillcrest Family Practice	Simpsonville	South Carolina	United States	29681
720	Palmetto Research	Spartanburg	South Carolina	United States	29302
721	Palmetto Clinical Research	Summerville	South Carolina	United States	29485
722	Southeastern Research Associates, Inc.	Taylors	South Carolina	United States	29687
723	Odyssey Research/Sanford Clinic - Aberdeen	Aberdeen	South Dakota	United States	57401
724	Sanford Clinic - Aberdeen	Aberdeen	South Dakota	United States	57401
725	Regional Health Clinic Research	Rapid City	South Dakota	United States	57701
726	Regional Medical Clinic-Rheumatology	Rapid City	South Dakota	United States	57701
727	Health Concepts	Rapid City	South Dakota	United States	57702
728	Brown Clinic PLLP	Watertown	South Dakota	United States	57201
729	Odyssey Research	Watertown	South Dakota	United States	57201
730	Holston Medical Group	Bristol	Tennessee	United States	37620
731	Internal Medicine & Pediatric Associates of Bristol	Bristol	Tennessee	United States	37620
732	PMG Research of Bristol	Bristol	Tennessee	United States	37620
733	Parkway Medical Group	Fayetteville	Tennessee	United States	37334
734	Stern Cardiovascular Foundation, inc.	Germantown	Tennessee	United States	38138
735	Arthritis Clinic	Jackson	Tennessee	United States	38305
736	The Jackson Clinic, PA	Jackson	Tennessee	United States	38305
737	State of Franklin Healthcare Associates Clinical Research	Johnson City	Tennessee	United States	37604
738	Holston Medical Group	Kingsport	Tennessee	United States	37660
739	Holston Valley Surgery Center	Kingsport	Tennessee	United States	37660
740	Gupta, Ramesh C MD	Memphis	Tennessee	United States	38119-5214
741	Access Clinical Trials, Inc.	Nashville	Tennessee	United States	37203
742	Premier Orthopaedics	Nashville	Tennessee	United States	37203
743	The Cholesterol Center of Nashville	Nashville	Tennessee	United States	37203
744	Nashville Medical Research Institute	Nashville	Tennessee	United States	37205
745	Quality Medical Research	Nashville	Tennessee	United States	37211
746	Amarillo Medical Specialists, LLP	Amarillo	Texas	United States	79106
747	Pharma Tex Research, LLC	Amarillo	Texas	United States	79106
748	Family Health Care Association	Arlington	Texas	United States	76013
749	South Arlington Primary Care Associates PA	Arlington	Texas	United States	76017
750	DCT - Anchor, LLC dba Discovery Clinical Trials	Arlington	Texas	United States	76018
751	DCT-AACT, LLC dba Discovery Clinical Trials	Austin	Texas	United States	78758
752	Southeast Texas Cardiology Associates	Beaumont	Texas	United States	77702
753	Southeast Texas Clinical Research Center	Beaumont	Texas	United States	77702
754	Kaner Medical Group PA	Bedford	Texas	United States	76021
755	Nexxus Research Group, LLC	Bedford	Texas	United States	76021
756	Texas Orthopedic Specialists, PLLC	Bedford	Texas	United States	76021
757	MedicalEdge Healthcare Group, PA, dba Leading Edge Research, PA	Carrollton	Texas	United States	75007
758	Prentiss Family Medicine	Colleyville	Texas	United States	76034
759	Carlos B. Everett, MD	Corpus Christi	Texas	United States	78405
760	Discovery Clinical Research	Corpus Christi	Texas	United States	78411
761	Texas Health Physicians Group	Dallas	Texas	United States	75220
762	Soltero Cardiovascular Research Center/Baylor University Medical Center	Dallas	Texas	United States	75226
763	Arthritis Care and Diagnostic Center, P.A.	Dallas	Texas	United States	75231
764	Medical Specialists Associated	Dallas	Texas	United States	75231
765	Metroplex Clinical Research Center	Dallas	Texas	United States	75231
766	SouthWest Rheumatology, P.A.	Dallas	Texas	United States	75231
767	DCT - Genesis Neighborhood Research, LLC dba Discovery Clinical Trials	Dallas	Texas	United States	75254
768	Rajendra K. Marwah, MD	El Paso	Texas	United States	79902
769	Kaner Medical Group, PA	Euless	Texas	United States	76039
770	The Medical Group of Texas	Fort Worth	Texas	United States	76104
771	Texas Health Physicians Group	Fort Worth	Texas	United States	76107
772	T & R Clinic, P. A.	Fort Worth	Texas	United States	76117
773	Rheumatology-UTMB	Galveston	Texas	United States	77555
774	Towngate Plaza Medical Center	Garland	Texas	United States	75041
775	ProCare Clinical Trials	Grand Prairie	Texas	United States	75052
776	The Office of Amer Zaheer MD, PA	Houston	Texas	United States	77004
777	Salim Gopalani, MD, PA	Houston	Texas	United States	77008
778	Office of Cyril Wolf, MD	Houston	Texas	United States	77024
779	Village Family Practice	Houston	Texas	United States	77024
780	Kelsey Seybold Clinic	Houston	Texas	United States	77025-1669
781	Oxford Clinical Research, LLC	Houston	Texas	United States	77074
782	MCA Research	Houston	Texas	United States	77079
783	Texas Health Physicians Group	Irving	Texas	United States	75039
784	One World Medical Associates, P.A.	Lewisville	Texas	United States	75057
785	Pri-Med Care	Lewisville	Texas	United States	75067
786	South Texas Institute of Health	McAllen	Texas	United States	78501
787	DCT - Genesis Seidmeyer Research, LLC dba Discovery Clinical Trials	McKinney	Texas	United States	75071
788	Southwest Rheumatology, PA	Mesquite	Texas	United States	75150
789	Midland Clinical Research Center	Midland	Texas	United States	79707
790	Basin Orthopedics Surgical Specialists	Odessa	Texas	United States	79761
791	Center for Hypertension and Internal Medicine	Odessa	Texas	United States	79761
792	Odessa Heart Institute	Odessa	Texas	United States	79761
793	Permian Research Foundation	Odessa	Texas	United States	79761
794	Office of David K. McDonald, M.D.. P.A.	Pasadena	Texas	United States	77504
795	Centex Studies, Inc.	Pharr	Texas	United States	78577-5198
796	Clinical Investigations of Texas, LLC	Plano	Texas	United States	75075
797	DCT-Genesis naini, LLC dba Discovery Clinical Trials	Plano	Texas	United States	75075
798	North Texas Medical Research	Plano	Texas	United States	75093
799	MedicalEdge Healthcare Group, PA	Richardson	Texas	United States	75080
800	Texas Health Physicians Group	Richardson	Texas	United States	75080
801	Ivan N. Mefford, MD, PhD, PA	Richmond	Texas	United States	77469
802	Paragon Research Center, LLC	San Antonio	Texas	United States	78205
803	Quality Assurance Research Center	San Antonio	Texas	United States	78207
804	Quality Research Inc.	San Antonio	Texas	United States	78209
805	Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute	San Antonio	Texas	United States	78212
806	GSA Research	San Antonio	Texas	United States	78213
807	Sun Research Institute	San Antonio	Texas	United States	78215
808	Radiant Research San Antonio Northeast	San Antonio	Texas	United States	78217
809	Briggs Clinical Research, LLC	San Antonio	Texas	United States	78224
810	DCT - Barlite, LLC dba Discovery Clinical Trials	San Antonio	Texas	United States	78224
811	S.A.M. Clinical Research Center	San Antonio	Texas	United States	78229
812	WellMed Clinical Research	San Antonio	Texas	United States	78229
813	DCT-Westover Hills, LLC dba Discovery Clinical Trials	San Antonio	Texas	United States	78251
814	DCT - Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas	United States	78258
815	The Office of Shahbaz Yazdani, MD, PA	San Antonio	Texas	United States	78258
816	Southlake Clinical Trials	Southlake	Texas	United States	76092
817	Sugar Land Med-Ped Clinic, PA	Sugar Land	Texas	United States	77479
818	Crossroads Clinical Research, LLC	Victoria	Texas	United States	77901
819	Crossroads Clinical Research	Victoria	Texas	United States	77901
820	Office of Pamela Dugano-Daphnis	Webster	Texas	United States	77598
821	Advanced Research Institute	Ogden	Utah	United States	84405
822	Advanced Clinical Research	West Jordan	Utah	United States	84088
823	Burke Internal Medicine & Research	Burke	Virginia	United States	22015
824	Burke Internal Medicine	Burke	Virginia	United States	22015
825	Center for Arthritis and Rheumatic Diseases	Chesapeake	Virginia	United States	23320-4985
826	Bayview Physicians oa Cardiovascular Associates, Ltd	Chesapeake	Virginia	United States	23320
827	David Ramstad, MD, MPH and Associates	Chesapeake	Virginia	United States	23320
828	Danville Internal Medicine, Inc.	Danville	Virginia	United States	24541
829	Danville Orthopedic Clinic	Danville	Virginia	United States	24541
830	Seven Corners Medical Research Center	Falls Church	Virginia	United States	22044
831	Hampton Family Practice	Hampton	Virginia	United States	23666
832	Manassas Clinical Research Center	Manassas	Virginia	United States	20110
833	Bruton Avenue Family Practice	Newport News	Virginia	United States	23601
834	Internal Medicine Kidney and Hypertension Center	Norfolk	Virginia	United States	23502
835	National Clinical Research - Norfolk Inc.	Norfolk	Virginia	United States	23502
836	Sentara Medical Group	Norfolk	Virginia	United States	23502
837	Ettrick Health Center	Petersburg	Virginia	United States	23803
838	Arthritis and Rheumatic Research	Portsmouth	Virginia	United States	23701
839	Roanoke Heart Institute	Roanoke	Virginia	United States	24014
840	Harbourview Professional Center	Suffolk	Virginia	United States	23435
841	Chase Research Group, LLC	Virginia Beach	Virginia	United States	23452
842	The Center for Excellence in Aging and Geriatric Health	Williamsburg	Virginia	United States	23185
843	Highline Medical Center Laboratory	Burien	Washington	United States	98166
844	Puget Sound Osteoporosis Center	Seattle	Washington	United States	98144
845	Arthritis Northwest	Seattle	Washington	United States	98166-2967
846	Arthritis Northwest Rheumatology	Spokane	Washington	United States	99204
847	Lawrence S. Eastburn, MD, PS	Spokane	Washington	United States	99204
848	Pulmonary and Research Associates	Spokane	Washington	United States	99204
849	The Office of William Gray, Md, Family Practice	Spokane	Washington	United States	99216
850	John F. Long, D.O.	Spokane	Washington	United States	99218
851	George H. Krick, MD	Tacoma	Washington	United States	98405
852	Northwest Family and Spinal Clinic	Tacoma	Washington	United States	98405
853	Rheumatology Infusion Services	Tacoma	Washington	United States	98405
854	Tacoma Center for Arthritis Research, PS	Tacoma	Washington	United States	98405
855	Wenatchee Valley Medical Center, Research Department	Wenatchee	Washington	United States	98801
856	Clinical Trials Northwest	Yakima	Washington	United States	98902
857	Rheumatology and Pulmonary Clinic	Beckley	West Virginia	United States	25801
858	Mountain State Clinical Research	Clarksburg	West Virginia	United States	26301
859	University Cardiovascular Services. Robert C. Byrd Clinical Center	Huntington	West Virginia	United States	25701
860	WVVA Healthcare Alliance	Lewisburg	West Virginia	United States	24901
861	Parkersburg Cardiology Associates	Parkersburg	West Virginia	United States	26101
862	Meriter Medical Group	Madison	Wisconsin	United States	53713
863	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin	United States	53715
864	UW Health Physicians	Madison	Wisconsin	United States	53715
865	St. Lukes Pain Management Center	Milwaukee	Wisconsin	United States	53215
866	Zablocki VA Medical Center	Milwaukee	Wisconsin	United States	53295
867	Aspirus Cardiovascular Associates - Rhinelander	Rhinelander	Wisconsin	United States	54501
868	Aspirus Cardiovascular Associates	Wausau	Wisconsin	United States	54401
869	Aspirus Heart & Vascular lnstitute--Research & Education)	Wausau	Wisconsin	United States	54401
870	Aspirus Wausau Hospital	Wausau	Wisconsin	United States	54401
871	Allegiance Research Specialists, LLC	Wauwatosa	Wisconsin	United States	53226
872	Hunter Clinical Research	Broadmeadow	New South Wales	Australia	2292
873	Wesley Medical Centre	Auchenflower	Queensland	Australia	4066
874	Australian Clinical Research Organisation	Caboolture	Queensland	Australia	4510
875	Rheumatology Department	Cairns	Queensland	Australia	4870
876	AusTrials Pty Ltd	Kippa Ring	Queensland	Australia	4021
877	Core Research Group	Milton	Queensland	Australia	4064
878	AusTrials Pty Ltd	Sherwood	Queensland	Australia	4075
879	Monash Medical Centre, Department of Rheumatology	Clayton	Victoria	Australia	3168
880	Rheumatology Department	Heidelberg West	Victoria	Australia	3081
881	Emeritus Research	Malvern East	Victoria	Australia	3145
882	The Goatcher Clinical Research Unit	Shenton Park	Western Australia	Australia	6008
883	The Colin Bayliss Research and Teaching Unit	Victoria Park	Western Australia	Australia	6979
884	CLINCOR - Clinica de Exames Cardiologicos e Ecografia S/C Ltda	Maceio	AL	Brazil	57021-500
885	Hospital do Coracao de Alagoas	Maceio	AL	Brazil	57052-580
886	CIP - Centro Internacional de Pesquisas	Goiania	GO	Brazil	74110-120
887	Via Medica - Centro Clinico	Goiania	GO	Brazil	74223-130
888	CMIP - Centro Mineiro de Pesquisa	Juiz de Fora	MG	Brazil	36010-570
889	Hopsital das Clinicas da Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais	Brazil	30150-260
890	Hospital e Maternidade Angelina Caron, Sala Pesquisa Clinica	Campina Grande do Sul	PR	Brazil	83430-000
891	CEPEME-CERHFAC Centro de Estudos e Pesquisas Medicas	Curitiba	PR	Brazil	80030-220
892	Centro de Estudos do Hospital de Clínicas da UFPR	Curitiba	PR	Brazil	80060-240
893	Hospital Universitário Clementino Fraga Filho - UFRJ	Rio de Janeiro	RJ	Brazil	21941-913
894	CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda	Rio de Janeiro	RJ	Brazil	22271-100
895	Hospital Ipanema Plus	Rio de Janeiro	RJ	Brazil	22411-001
896	Clinica de Reumatologia do Centro Médico BarraShopping	Rio de Janeiro	RJ	Brazil	22649-900
897	Centro de Pesquisa Clinica	Porto Alegre	RS	Brazil	90035-903
898	Associação Hospitalar Moinhos de Vento (AHMV) / CMIC	Porto Alegre	RS	Brazil	90560-030
899	Hospital São Lucas - Pontificia	Porto Alegre	RS	Brazil	90610-000
900	Hospital e Maternidade Celso Pierro - Puc Campinas	Campinas	SAO Paulo	Brazil	13059-740
901	Centro de Ensino e Pesquisa Hospital Sao Lucas	Aracaju	SE	Brazil	49015-400
902	PUC Campinas	Campinas	SP	Brazil	13059-740
903	Hospital das Clinicas da UNICAMP	Campinas	SP	Brazil	13083-888
904	Hospital das Clinicas da Faculdade de Medicina de Marilia	Marilia	SP	Brazil	17519-030
905	Hospital de Base - Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto	Sao Jose do Rio Preto	SP	Brazil	15090-000
906	Hospital Alemao Oswaldo Cruz	Sao Paulo	SP	Brazil	01323-903
907	Setor de Lip., Arterosc. e BioVasc. - Disc. de Cardiologia	Sao Paulo	SP	Brazil	04039-030
908	CEPIC - Centro Paulista de Investigacao Clínica	Sao Paulo	SP	Brazil	04266-010
909	IMA Brasil - Instituto de Medicina Avancada	Sao Paulo	SP	Brazil	05437-010
910	CPCLIN - Centro de Pesquisas Clínicas	São Paulo	SP	Brazil	01244-030
911	Hospital Sao Salvador - Medicos Reunidos Ltda.	Goiania-GO		Brazil	74110-020
912	Ambulatorio de Especialidades Mario Covas	Marilia/SP		Brazil	17519-000
913	Hospital Nossa Senhora da Conceicao	Porto Alegre, RS		Brazil	91350-200
914	Hospital das Clinicas da UFPE	Recife - Pernambuco		Brazil	52679-420
915	Hospital Dos Servidores Do Estado do Rio de Janeiro	Rio de Janeiro		Brazil	20221-903
916	Faculdade de Medicina DO ABC	Santo Andre		Brazil	09060-650
917	South Calgary Medical Clinic - Sunpark Professional Center	Calgary	Alberta	Canada	T2X 3X7
918	Allin Clinic	Edmonton	Alberta	Canada	T5K 2A2
919	Dr. MPJ Senaratne Professional Corporation	Edmonton	Alberta	Canada	T6K 4C1
920	Medical Arts Health Research Group	Kelowna	British Columbia	Canada	V1Y 3G8
921	The Medical Arts Health Research Group	Penticton	British Columbia	Canada	V2A 5C8
922	Ocean West Research Clinic Inc.	Surrey	British Columbia	Canada	V3S 2N6
923	Prohealth Clinical Research Inc.	Vancouver	British Columbia	Canada	V5Z 4E1
924	Office of Dr. Milton F. Baker	Victoria	British Columbia	Canada	V8P 5P6
925	The Medical Arts Health Research Group	West Vancouver	British Columbia	Canada	V7T 2Z3
926	Rivergrove Medical Clinic	Winnipeg	Manitoba	Canada	R2V 4W3
927	Manitoba Clinic	Winnipeg	Manitoba	Canada	R3A 1M3
928	G.A. Research Associates Ltd/Ltee	Moncton	New Brunswick	Canada	E1G 1A7
929	Eric N. Grant Professional Corporation	Quispamis	New Brunswick	Canada	E2E 4J8
930	Office of Dr. Brian N. Craig	Saint John	New Brunswick	Canada	E2K 2T8
931	Commonwealth Medical Clinic	Mount Pearl	Newfoundland and Labrador	Canada	A1N 1W7
932	Paradise Medical Clinic	Paradise	Newfoundland and Labrador	Canada	A1L 1C6
933	White Hills Medical Clinic	St. John's	Newfoundland and Labrador	Canada	A1A 3R5
934	Nexus Clinic Research	St. John's	Newfoundland and Labrador	Canada	A1A 5E8
935	The Clinical Trials Centre	St. John's	Newfoundland and Labrador	Canada	A1C 2H5
936	Topsail Road Medical Clinic	St. John's	Newfoundland and Labrador	Canada	A1E 2E2
937	MSHJ Research Associates, Inc.	Halifax	Nova Scotia	Canada	B3K 0A4
938	Colchester Research Group	Truro	Nova Scotia	Canada	B2N 1L2
939	Office of Dr. Rohit Nagpal	Brampton	Ontario	Canada	L6R 3A5
940	Aggarwal and Associates Ltd.	Brampton	Ontario	Canada	L6T 3J1
941	Aviva Clinical Trial Group Inc.	Burlington	Ontario	Canada	L7M 4Y1
942	Corunna Medical Research Center	Corunna	Ontario	Canada	N0N 1G0
943	C & L Research	Fort Erie	Ontario	Canada	L2A 1Z3
944	Office of Dr. Jonathan D. Adachi	Hamilton	Ontario	Canada	L8N 1Y2
945	Office of Dr. John Mutrie	Kitchener	Ontario	Canada	N2E 4H9
946	KW Musculoskeletal Research Inc.	Kitchener	Ontario	Canada	N2M 5N6
947	East London Medical Centre	London	Ontario	Canada	N5W 3C6
948	London East Medical Centre	London	Ontario	Canada	N5W 6A2
949	Office of Dr. Gordon Schacter	London	Ontario	Canada	N5Y 5K7
950	Office of Dr. William Blake Bowler	London	Ontario	Canada	N6A 3H5
951	Office of Dr. Robert G. Luton	London	Ontario	Canada	N6A 5G6
952	Malton Medical Centre	Mississauga	Ontario	Canada	L4T 4J2
953	The Arthritis Program Research Group Inc.	Newmarket	Ontario	Canada	L3Y 3R7
954	SKDS Research Inc.	Newmarket	Ontario	Canada	L3Y 5G8
955	Office of Dr. Azim M. Velji	Niagara Falls	Ontario	Canada	L2E 7H1
956	AIM Health Group Trainyards Health and Wellness Centre	Ottawa	Ontario	Canada	K1G 0Z3
957	London Road Diagnostic Clinic & Medical Center	Sarnia	Ontario	Canada	N7T 4X3
958	London Road Diagnostic Clinic & Medical Centre	Sarnia	Ontario	Canada	N7T 4X3
959	Office of Dr. Swaran K. Syan	Sudbury	Ontario	Canada	P3C 5K7
960	Keele Medical Place	Toronto	Ontario	Canada	M3M 3E5
961	Prime Health Clinical Research	Toronto	Ontario	Canada	M4S 1Y2
962	Office of Dr. Ira Bernstein	Toronto	Ontario	Canada	M6A 3B5
963	Office of Dr. Subodh Kanani	Toronto	Ontario	Canada	M8V 3X8
964	Manna Research	Toronto	Ontario	Canada	M9W 4L6
965	North Walkerville Orthopaedic Associates	Windsor	Ontario	Canada	N8W 1E6
966	Research Office	Windsor	Ontario	Canada	N8W 1E6
967	Clinical Research and Arthritis Centre	Windsor	Ontario	Canada	N8X 5A6
968	Centre de sante et de services sociaux de Chicoutimi	Chicoutimi	Quebec	Canada	G7H 5H6
969	ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi	Chicoutimi	Quebec	Canada	G7H 7P2
970	Clinique de Medicine Familiale de Cowansville	Cowansville	Quebec	Canada	J2K 2X9
971	Centre de recherche clinique Adapra Inc.	L'Ancienne-Lorette	Quebec	Canada	G2E 2X1
972	Centre de Recherche Hochelaga/ Clinique Medicale Hochelaga	Montreal	Quebec	Canada	H1L 2N9
973	Recherche Medicale Appliquee Informatics (AMIR) Inc.	Montreal	Quebec	Canada	H3N 1S4
974	Kells Medical Research Group, Inc.	Pointe-Claire	Quebec	Canada	H9R 4S3
975	Le Manoir de l'Atrium	Quebec City	Quebec	Canada	G1H 7L3
976	Clinique Services Sante Rosemere	Rosemere	Quebec	Canada	J7A 1K7
977	Centre Medical des Carrieres	Saint-Marc-des-Carrieres	Quebec	Canada	G0A 4B0
978	St-Jerome Medical Research Inc.	St-Jerome	Quebec	Canada	J7Z 5T3
979	Centre de Recherche Musculo-Squelettique	Trois-Rivieres	Quebec	Canada	G8Z 1Y2
980	Cardiology and Research	Westmount	Quebec	Canada	H3Z 2M6
981	Downtown Medical Specialists	Saskatoon	Saskatchewan	Canada	S7L 0Y7
982	Recherche Clinique Sigma, Inc.	Quebec		Canada	G1G 3Y8
983	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec		Canada	G1V 4G5
984	Hospital Pablo Tobon Uribe - Unidad de Investigaciones	Medellin	Antioquia	Colombia	050034
985	Reumalab S.A.S.	Medellin	Antioquia	Colombia	0
986	IPS Rodrigo Botero S.A.S.	Medellin	Antioquia	Colombia
987	Fundacion Cardioinfantil	Bogota	Cundinamarca	Colombia	0
988	Clinica Colsanitas Sa	Bogota	Cundinamarca	Colombia
989	Fundacion Cardiovascular de Colombia	Floridablanca	Santander	Colombia
990	Fundacion Valle del Lili	Cali		Colombia	760032
991	Clínica Vía San Juan	La Union De Tres Rios	Cartago	Costa Rica	30303
992	Clinica San Agustin	Desamparados Centro	San Jose	Costa Rica	0000
993	Hospital CIMA San Jose	Escazu	San Jose	Costa Rica
994	Hospital Hotel La Catolica	Goicoechea	San Jose	Costa Rica
995	Consultorio Privado Dr. Alberto Lainez Ventosilla	Moravia	San José	Costa Rica	0000
996	Centro Medico San Rafael	Alajuela		Costa Rica
997	Centro de Reumatologia y Osteoporosis	Cartago		Costa Rica	30101
998	Clínica Garzona	Cartago		Costa Rica
999	Clinica de Especialidades Medicas Drs. Saenz Castro	Heredia		Costa Rica
1000	Clínica Monte Sión	Heredia		Costa Rica
1001	Clínica San Antonio	Heredia		Costa Rica
1002	Centro Medico San Jose	San Jose		Costa Rica
1003	Edificio Panda	San Jose		Costa Rica
1004	Hospital Clinica Biblica	San Jose		Costa Rica
1005	Hospital Clínica Biblica	San Jose		Costa Rica
1006	Oficina Privada	San Jose		Costa Rica
1007	Prince of Wales Hospital	Shatin	NEW Territories	Hong Kong
1008	Centre for Assessment and Treatment of Rheumatic Diseases, Department of Medicine and Geriatrics	New Territories	NT	Hong Kong
1009	Department of Medicine, Queen Mary Hospital	Pokfulam		Hong Kong
1010	Department of Medicine, North District Hospital	Sheung Shui, NT		Hong Kong
1011	Centro de Investigacion del Noroeste SC	Tijuana	BAJA California	Mexico	22010
1012	Comite Mexicano para la Prevencion de la Osteoporosis, A.C.	Mexico	D.f.	Mexico	06100
1013	Instituto Mexicano de Investigación Clínica, S.A. de C.V	Mexico	D.f.	Mexico	06700
1014	CIF-BIOTEC, Medica Sur	Mexico	DF	Mexico	14050
1015	Centro Medico Toluca	Metepec	Estado DE Mexico	Mexico	52140
1016	Hospital Regional ISSSTE	Leon	Guanajuato	Mexico	37520
1017	Instituto Jalisciense de Investigación Clínica SA de CV	Guadalajara	Jalisco	Mexico	44160
1018	Centro de Estudios de Investigacion Basica y Clinica SC.	Guadalajara	Jalisco	Mexico	44690
1019	Unidad de Investigacion Dr. Mario Alvizouri Muñoz Ac Del Hospital General Dr. Miguel Silva	Morelia	Michoacan	Mexico	58000
1020	Hospital Central "Dr. Ignacio Morones Prieto" Unidad Regional de Reumatologia y Osteoporosis	San Luis Potosi	SLP	Mexico	78240
1021	Clinicos Asociados BOCM, S.C.	Mexico City		Mexico	03300
1022	Centro de Investigación Marbella	Panama City		Panama
1023	IPC - Centro de Salud Integral S.A.	San Isidro	Lima	Peru	L 27
1024	Centro Empresarial - Altavista Polo 4	Santiago de Surco	Lima	Peru	00033
1025	Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva	Santiago de Surco	Lima	Peru	00033
1026	Clinica San Felipe	Lima		Peru	11
1027	Centro de Investigaciones Medical	Lima		Peru	L29
1028	Clinica San Juan Bautista	Lima		Peru	Lima 36
1029	Mary Mediatrix Medical Center	Lipa City	Batangas	Philippines	4217
1030	De La Salle Health Sciences Institute	Dasmarinas	Cavite	Philippines	4114
1031	Chong Hua Hospital	Cebu City		Philippines	6000
1032	Southern Philippines Medical Center	Davao City		Philippines	8000
1033	Jose R. Reyes Memorial Medical Center	Manila		Philippines	1003
1034	Chinese General Hospital and Medical Center	Manila		Philippines	1014
1035	Hospital Research Unit, University of Santo Tomas Hospital	Manila		Philippines	1015
1036	St. Luke's Medical Center	Quezon City		Philippines	1102
1037	Chang Gung Memorial Hospital-Kaohsiung branch, Section of Allergy, Immunology	Nio Sung Township	Kaohsiung County	Taiwan	833
1038	Tri-Service General Hospital	Neihu District	Taipei CITY	Taiwan	114
1039	Chang Gung Medical Foundation-Linkou Branch	Gueishan Township	Taoyuan County	Taiwan	333
1040	Chi-Mei Medical Center	Tainan	Yung Kang	Taiwan	71004
1041	Buddhist Tzu Chi Dailin General Hospital	Chia-Yi County		Taiwan	62247
1042	Chung-Ho Memorial Hospital, Kaoshiung Medical University Hospital	Kaohsiung		Taiwan	807
1043	Chung Shan Medical University Hospital	Taichung		Taiwan	402
1044	Taichung Veterans General Hospital	Taichung		Taiwan	40705
1045	Tri-service General Hospital	Taipei City		Taiwan	100
1046	National Taiwan University Hospital	Taipei		Taiwan	10018
1047	Taipei Veterans General Hospital	Taipei		Taiwan	112
1048	CRI "Clinical Territorial Medical Association "University Clinic",	Simferopol	Crimea	Ukraine	95017
1049	Municipal Medical Institution "City Clinical Hospital #3", Department of Rheumatology	Chernivtsi		Ukraine	58022
1050	MI Dnipropetrovsk Regional Clinical Hospital named after I.I Mechnikov	Dnipropetrovsk		Ukraine	49005
1051	State Institution "Dnipropetrovsk Medical Academy of MOH, Ukraine	Dnipropetrovsk		Ukraine	49005
1052	Rheumatology Department, MMI "City Clinical Hospital #5", DNMU n.a. M.Gorkyy,	Donetsk		Ukraine	83001
1053	Donetsk National Med University, Chair of Propaedeutics and Internal Medicine	Donetsk		Ukraine	83003
1054	Municipal Establishment of Health Care	Kharkiv		Ukraine	61002
1055	City Clinical Hospital # 8, Dept of Cardiology and Functional Diagnostics	Kharkiv		Ukraine	61178
1056	City Clinical Hospital #1	Kyiv		Ukraine	02091
1057	National Scientific Center "The Strazhesko Institute of Cardiology"	Kyiv		Ukraine	03680
1058	State Institution "Republican clinical hospital of MOH of Ukraine"	Kyiv		Ukraine	04053
1059	Family Medicine Department of NMAPE named after PL Shupyk,	Kyiv		Ukraine	04107
1060	Lutsk City Clinical Hospital	Lutsk		Ukraine	43024
1061	Municipal City Clinical Hospital #5	Lviv		Ukraine	79013
1062	Center of Reconstructive and Regenerative Medicine (University clinic) of	Odesa		Ukraine	65009
1063	Treatment-and-Diagnostic Center LLC "Desna" Ltd	Ternopil		Ukraine	46010
1064	Municipal enterprise " City Hospital # 7",	Zaporizhzhia		Ukraine	69118
1065	Municipal Institution "Zaporizhzhya City Multiple Discipline Clinical Hospital #9"	Zaporizhzhya		Ukraine	69065
1066	Zhytomyr Regional Clinical Hospital n.a. O.F. Gerbachevs'kyy/ Rheumatology Center	Zhytomyr		Ukraine	10003

Sponsors and Collaborators

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
The Cleveland Clinic

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

ClinicalTrials.gov Identifier:

NCT00346216

Other Study ID Numbers:

A3191172
2004-002441-13
PRECISION TRIAL

First Posted:

Jun 29, 2006

Last Update Posted:

Mar 3, 2021

Last Verified:

Mar 1, 2021

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Ibuprofen

Celecoxib

Naproxen

Study Results

Participant Flow

Recruitment Details	The study was conducted at 950 centers in Australia (11), Brazil (30), Canada (64), Colombia (7), Costa Rica (12), Hong Kong (4), Mexico (11), Panama (2), Peru (5), Philippines (8), Taiwan (10), Ukraine 19), and United States (767); a total of 24 sites were activated but did not randomized any subject.
Pre-assignment Detail	All eligible participants were enrolled in to the study.

Arm/Group Title	Celecoxib	Ibuprofen	Naproxen
Arm/Group Description	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily	Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
Period Title: Overall Study
STARTED	8072	8040	7969
COMPLETED	5664	5580	5621
NOT COMPLETED	2408	2460	2348

Baseline Characteristics

Arm/Group Title	Celecoxib	Ibuprofen	Naproxen	Total
Arm/Group Description	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily	Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.	Total of all reporting groups
Overall Participants	8072	8040	7969	24081
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	63.0 (9.5)	63.2 (9.4)	63.3 (9.4)	63.2 (9.4)
Sex: Female, Male (Count of Participants)
Female	5175 64.1%	5174 64.4%	5096 63.9%	15445 64.1%
Male	2897 35.9%	2866 35.6%	2873 36.1%	8636 35.9%

Outcome Measures

1. Primary Outcome

Title	The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).
Description	APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).
Time Frame	Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months

Outcome Measure Data

Analysis Population Description
ITT - The ITT population will consist of all subjects randomized for participation in the study. MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit.

Arm/Group Title	Celecoxib	Ibuprofen	Naproxen
Arm/Group Description	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily	Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
Measure Participants	8072	8040	7969
ITT (N = 8072, 8040, 7969)	2.3	2.7	2.5
MITT (N = 8030, 7990, 7933)	1.7	1.9	1.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	ITT Population
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Non inferiority required a hazard ratio of 1.12 or lower, as well as an upper 95% confidence limit of 1.33 or lower in the ITT population and of 1.40 or lower in the MITT population.

Statistical Test of Hypothesis	p-Value	0.0002
	Comments	Non inferiority P value, α=0.025
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95% 0.76 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	MITT Population
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.40

Statistical Test of Hypothesis	p-Value	0.0001
	Comments	Non inferiority P value, α=0.025
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95% 0.72 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	ITT Population
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.33

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Non inferiority P value, α=0.025
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95% 0.70 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	MITT Population
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Non-inferiority P-value, α=0.025
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95% 0.64 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	ITT Population
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.33

Statistical Test of Hypothesis	p-Value	0.0182
	Comments	Non-inferiority P-value, α=0.025
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95% 0.89 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	MITT Population
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40

Statistical Test of Hypothesis	p-Value	0.0250
	Comments	Non-inferiority P-value, α=0.025
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95% 0.89 to 1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	The First Occurrence of a Major Adverse Cardiovascular Events (MACE)
Description	MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA
Time Frame	ITT Population - 30 months; MITT Population - 42 months

Outcome Measure Data

Analysis Population Description
ITT - The ITT population will consist of all subjects randomized for participation in the study. MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit.

Arm/Group Title	Celecoxib	Ibuprofen	Naproxen
Arm/Group Description	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily	Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
Measure Participants	8072	8040	7969
ITT (N = 8072, 8040, 7969)	4.2 0.1%	4.8 0.1%	4.3 0.1%
MITT (N = 8030, 7990, 7933)	3.1 0%	3.6 0%	3.2 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	ITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.6427
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95% 0.83 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	ITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0597
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95% 0.75 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	ITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1481
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95% 0.96 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	MITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.5758
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95% 0.80 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	MITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0204
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95% 0.69 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	MITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0751
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95% 0.98 to 1.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)
Description	CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer
Time Frame	ITT Population - 30 months; MITT Population - 42 months

Outcome Measure Data

Analysis Population Description
ITT - The ITT population will consist of all subjects randomized for participation in the study. MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit.

Arm/Group Title	Celecoxib	Ibuprofen	Naproxen
Arm/Group Description	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily	Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
Measure Participants	8072	8040	7969
ITT (N = 8072, 8040, 7969)	0.7 0%	0.9 0%	0.7 0%
MITT (N = 8030, 7990, 7933)	0.3 0%	0.7 0%	0.7 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	ITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8576
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95% 0.67 to 1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	ITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1202
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% 0.53 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	ITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1734
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.27
	Confidence Interval	(2-Sided) 95% 0.90 to 1.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	MITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0041
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95% 0.32 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	MITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95% 0.27 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	MITT Population
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4243
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95% 0.80 to 1.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)
Description	VAS question "How much pain do you have" was graded on a scale from 0 to 100 with 0 indicating "No pain" and 100 indicating "Worst possible pain".
Time Frame	ITT and MITT Population - Baseline to 42 months

Outcome Measure Data

Analysis Population Description
ITT - The ITT population will consist of all subjects randomized for participation in the study. MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit.

Arm/Group Title	Celecoxib	Ibuprofen	Naproxen
Arm/Group Description	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily	Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
Measure Participants	8072	8040	7969
Baseline (ITT) N= 8014, 8001, 7928	54.0 (23.53) 0.7%	54.1 (23.58) 0.7%	54.1 (24.04) 0.7%
Change-Baseline to Mon1 (ITT) N=7382, 7379, 7325	-8.2 (24.69) -0.1%	-9.0 (25.69) -0.1%	-9.9 (25.53) -0.1%
Change-Baseline to Mon2 (ITT) N=7180, 7090, 7149	-10.5 (26.39) -0.1%	-10.6 (26.92) -0.1%	-11.1 (26.83) -0.1%
Change-Baseline to Mon4 (ITT) N=6777, 6696, 6740	-11.4 (27.70) -0.1%	-11.7 (28.10) -0.1%	-12.3 (27.80) -0.2%
Change-Baseline to Mon8 (ITT) N=6230, 6137, 6159	-11.7 (28.92) -0.1%	-12.1 (28.97) -0.2%	-12.1 (28.83) -0.2%
Change-Baseline to Mon12 (ITT) N=5792, 5696, 5846	-11.0 (29.15) -0.1%	-11.6 (29.29) -0.1%	-11.9 (29.30) -0.1%
Change-Baseline to Mon18 (ITT) N=5310, 5181. 5246	-11.3 (29.11) -0.1%	-11.3 (29.10) -0.1%	-11.7 (29.33) -0.1%
Change-Baseline to Mon24 (ITT) N=4818, 4776, 4785	-11.3 (29.44) -0.1%	-11.5 (28.98) -0.1%	-11.4 (29.27) -0.1%
Change-Baseline to Mon30 (ITT) N=4140, 4069, 4086	-10.5 (29.81) -0.1%	-11.2 (29.71) -0.1%	-11.3 (29.71) -0.1%
Change-Baseline to Mon36 (ITT) N=3692, 3627, 3635	-10.1 (29.61) -0.1%	-10.7 (29.62) -0.1%	-11.6 (29.80) -0.1%
Change-Baseline to Mon42 (ITT) N=3469, 3406, 3439	-11.4 (29.78) -0.1%	-11.1 (30.14) -0.1%	-12.1 (30.27) -0.2%
Baseline (MITT) N=7974, 7954, 7894	54.0 (23.53) 0.7%	54.1 (23.58) 0.7%	54.1 (24.02) 0.7%
Change-Baseline to Mon1 MITT N=7372, 7367, 7321	-8.2 (24.69) -0.1%	-9.0 (25.67) -0.1%	-9.9 (25.53) -0.1%
Change-Baseline to Mon2 MITT N=7170, 7078, 7142	-10.5 (26.38) -0.1%	-10.6 (26.92) -0.1%	-11.1 (26.84) -0.1%
Change-Baseline to Mon4 MITT N=6772, 6686, 6732	-11.4 (27.70) -0.1%	-11.7 (28.10) -0.1%	-12.3 (27.81) -0.2%
Change-Baseline to Mon8 MITT N=6224, 6128, 6155	-11.7 (28.93) -0.1%	-12.1 (28.97) -0.2%	-12.1 (28.84) -0.2%
Change-Baseline to Mon12 MITT N=5787, 5689, 5844	-11.0 (29.16) -0.1%	-11.6 (29.30) -0.1%	-11.9 (29.30) -0.1%
Change-Baseline to Mon18 MITT N=5305, 5175, 5242	-11.3 (29.11) -0.1%	-11.3 (29.12) -0.1%	-11.7 (29.33) -0.1%
Change-Baseline to Mon24 MITT N=4815, 4769, 4782	-11.4 (29.44) -0.1%	-11.5 (29.00) -0.1%	-11.3 (29.26) -0.1%
Change-Baseline to Mon30 MITT N=4139, 4067, 4085	-10.5 (29.81) -0.1%	-11.2 (29.71) -0.1%	-11.3 (29.70) -0.1%
Change-Baseline to Mon36 MITT N=3691, 3623, 3635	-10.2 (29.61) -0.1%	-10.7 (29.62) -0.1%	-11.6 (29.80) -0.1%
Change-Baseline to Mon42 MITT N=3468, 3404, 3438	-11.4 (29.78) -0.1%	-11.1 (30.14) -0.1%	-12.1 (30.27) -0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 1 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.77
	Confidence Interval	(2-Sided) 95% 1.01 to 2.53
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 1 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0373
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95% 0.05 to 1.56
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 1 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0129
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95% 0.20 to 1.72
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 2 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1830
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95% -0.25 to 1.29
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 2 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.7777
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95% -0.88 to 0.66
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 2 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1072
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95% -0.14 to 1.40
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 4 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8237
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95% -0.12 to 1.46
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.40
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 4 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8237
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95% -0.88 to 0.70
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.40
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 4 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0587
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% -0.03 to 1.55
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.40
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 8 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3129
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 95% -0.39 to 1.23
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.41
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 8 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.6526
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95% -0.63 to 1.00
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.41
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 8 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.5774
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95% -0.58 to 1.05
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 12 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0632
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% -0.04 to 1.62
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 12 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4540
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95% -0.52 to 1.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.43
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 12 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2705
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95% -0.37 to 1.30
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.43
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 18 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.5225
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 95% -0.58 to 1.14
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.44
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 18 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.5996
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95% -1.10 to 0.63
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.44
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 18 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2461
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95% -0.35 to 1.38
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.44
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 24 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8127
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95% -0.79 to 1.00
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.46
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 24 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.9641
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95% -0.92 to 0.87
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.46
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 24 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.7784
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95% -0.77 to 1.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.46
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 30 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2105
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.61
	Confidence Interval	(2-Sided) 95% -0.34 to 1.56
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.49
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 30 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2909
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95% -0.44 to 1.46
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.49
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 30 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8459
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95% -0.86 to 1.05
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.49
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 36 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1116
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95% -0.19 to 1.80
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 36 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.9751
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95% -0.98 to 1.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 36 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1202
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% -0.21 to 1.79
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 42 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3767
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.46
	Confidence Interval	(2-Sided) 95% -0.56 to 1.48
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.52
	Estimation Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 42 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1123
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.83
	Confidence Interval	(2-Sided) 95% -1.85 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.52
	Estimation Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 42 (ITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0137
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.29
	Confidence Interval	(2-Sided) 95% 0.26 to 2.31
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.52
	Estimation Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from Baseline to Month 1 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.77
	Confidence Interval	(2-Sided) 95% 1.07 to 2.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.36
	Estimation Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from Baseline to Month 1 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0197
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95% 0.13 to 1.54
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.36
	Estimation Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from Baseline to Month 1 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0094
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95% 0.23 to 1.64
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.36
	Estimation Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 2 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1247
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95% -0.16 to 1.31
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 2 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8278
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95% -0.81 to 0.65
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 2 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0802
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95% -0.08 to 1.39
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 4 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0822
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95% -0.09 to 1.46
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 4 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8314
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95% -0.86 to 0.69
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 4 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0516
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95% -0.01 to 1.54
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 8 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3202
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 95% -0.40 to 1.24
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 8 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.5893
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95% -0.60 to 1.05
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 8 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.6510
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95% -0.63 to 1.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 12 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0796
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% -0.09 to 1.62
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.44
	Estimation Comments

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 12 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.5061
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.29
	Confidence Interval	(2-Sided) 95% -0.57 to 1.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.44
	Estimation Comments

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 12 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2796
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95% -0.38 to 1.33
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.44
	Estimation Comments

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 18 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.6725
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95% -0.69 to 1.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.45
	Estimation Comments

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 18 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.6381
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95% -1.10 to 0.67
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.45
	Estimation Comments

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 18 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3737
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 95% -0.49 to 1.29
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.45
	Estimation Comments

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 24 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.9139
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95% -0.87 to 0.97
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.47
	Estimation Comments

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 24 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.9998
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95% -0.92 to 0.92
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.47
	Estimation Comments

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 24 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.9144
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95% -0.88 to 0.98
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.47
	Estimation Comments

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 30 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2250
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95% -0.38 to 1.61
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 53

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 30 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2758
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95% -0.44 to 1.55
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 54

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 30 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.9030
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95% -0.94 to 1.06
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 55

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 36 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0910
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95% -0.14 to 1.94
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.53
	Estimation Comments

Statistical Analysis 56

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 36 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.7668
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 95% -0.88 to 1.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.53
	Estimation Comments

Statistical Analysis 57

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 36 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1653
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95% -0.31 to 1.78
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.53
	Estimation Comments

Statistical Analysis 58

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Naproxen
	Comments	Change from baseline to Month 42 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4323
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95% -0.65 to 1.52
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Statistical Analysis 59

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Ibuprofen
	Comments	Change from baseline to Month 42 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1439
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.81
	Confidence Interval	(2-Sided) 95% -1.89 to 0.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Statistical Analysis 60

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen, Naproxen
	Comments	Change from baseline to Month 42 (MITT)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0251
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 95% 0.16 to 2.33
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Adverse Events

	Celecoxib		Ibuprofen		Naproxen
Time Frame	Adverse events were reported from the signing of the informed consent throughout the entire study period (42 months) and including 30 calendar days after the last administration of the investigational product.
Adverse Event Reporting Description

Arm/Group Title	Celecoxib		Ibuprofen		Naproxen
Arm/Group Description	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily		Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily		Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Celecoxib		Ibuprofen		Naproxen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1473/8030 (18.3%)		1624/7992 (20.3%)		1611/7933 (20.3%)
Blood and lymphatic system disorders
Anaemia	15/8030 (0.2%)		34/7992 (0.4%)		24/7933 (0.3%)
Anaemia vitamin B12 deficiency	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Aplastic anaemia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Coagulopathy	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Haemorrhagic anaemia	2/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Hypochromic anaemia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Iron deficiency anaemia	2/8030 (0%)		10/7992 (0.1%)		11/7933 (0.1%)
Leukocytosis	1/8030 (0%)		2/7992 (0%)		5/7933 (0.1%)
Leukopenia	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Lymphadenopathy mediastinal	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Microcytic anaemia	0/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Pancytopenia	2/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Thrombocytopenia	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Thrombocytosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cardiac disorders
Acute coronary syndrome	7/8030 (0.1%)		7/7992 (0.1%)		3/7933 (0%)
Acute left ventricular failure	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Acute myocardial infarction	22/8030 (0.3%)		20/7992 (0.3%)		18/7933 (0.2%)
Angina pectoris	13/8030 (0.2%)		11/7992 (0.1%)		13/7933 (0.2%)
Angina unstable	45/8030 (0.6%)		41/7992 (0.5%)		60/7933 (0.8%)
Aortic valve disease	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Aortic valve incompetence	0/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Aortic valve stenosis	3/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Arrhythmia	1/8030 (0%)		7/7992 (0.1%)		3/7933 (0%)
Arrhythmia supraventricular	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Arteriosclerosis coronary artery	5/8030 (0.1%)		5/7992 (0.1%)		7/7933 (0.1%)
Arteriospasm coronary	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Atrial fibrillation	35/8030 (0.4%)		39/7992 (0.5%)		36/7933 (0.5%)
Atrial flutter	6/8030 (0.1%)		4/7992 (0.1%)		4/7933 (0.1%)
Atrioventricular block	1/8030 (0%)		3/7992 (0%)		0/7933 (0%)
Atrioventricular block complete	1/8030 (0%)		7/7992 (0.1%)		2/7933 (0%)
Atrioventricular block second degree	2/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Atrioventricular dissociation	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bradyarrhythmia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Bradycardia	10/8030 (0.1%)		11/7992 (0.1%)		6/7933 (0.1%)
Bundle branch block left	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Bundle branch block right	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cardiac aneurysm	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cardiac arrest	6/8030 (0.1%)		9/7992 (0.1%)		6/7933 (0.1%)
Cardiac disorder	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Cardiac failure	2/8030 (0%)		8/7992 (0.1%)		4/7933 (0.1%)
Cardiac failure chronic	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cardiac failure congestive	31/8030 (0.4%)		41/7992 (0.5%)		41/7933 (0.5%)
Cardiac tamponade	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cardiac valve disease	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cardiac ventricular thrombosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cardio-respiratory arrest	6/8030 (0.1%)		5/7992 (0.1%)		4/7933 (0.1%)
Cardiogenic shock	0/8030 (0%)		3/7992 (0%)		2/7933 (0%)
Cardiomyopathy	3/8030 (0%)		4/7992 (0.1%)		2/7933 (0%)
Cardiopulmonary failure	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Cardiovascular disorder	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Congestive cardiomyopathy	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Cor pulmonale chronic	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Coronary artery disease	42/8030 (0.5%)		40/7992 (0.5%)		44/7933 (0.6%)
Coronary artery insufficiency	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Coronary artery occlusion	9/8030 (0.1%)		8/7992 (0.1%)		8/7933 (0.1%)
Coronary artery stenosis	4/8030 (0%)		9/7992 (0.1%)		6/7933 (0.1%)
Coronary artery thrombosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Extrasystoles	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Heart valve incompetence	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hypertensive cardiomyopathy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hypertensive heart disease	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Ischaemic cardiomyopathy	3/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Left ventricular dysfunction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Left ventricular failure	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Mitral valve disease	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Mitral valve incompetence	2/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Myocardial infarction	45/8030 (0.6%)		70/7992 (0.9%)		48/7933 (0.6%)
Myocardial ischaemia	2/8030 (0%)		7/7992 (0.1%)		3/7933 (0%)
Nodal arrhythmia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Palpitations	2/8030 (0%)		3/7992 (0%)		4/7933 (0.1%)
Pericardial effusion	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Pericarditis	0/8030 (0%)		1/7992 (0%)		4/7933 (0.1%)
Pleuropericarditis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Postinfarction angina	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Prinzmetal angina	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Silent myocardial infarction	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Sinus bradycardia	0/8030 (0%)		3/7992 (0%)		3/7933 (0%)
Sinus node dysfunction	2/8030 (0%)		3/7992 (0%)		4/7933 (0.1%)
Sinus tachycardia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Supraventricular extrasystoles	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Supraventricular tachycardia	1/8030 (0%)		8/7992 (0.1%)		4/7933 (0.1%)
Tachyarrhythmia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Tachycardia	2/8030 (0%)		2/7992 (0%)		5/7933 (0.1%)
Tricuspid valve incompetence	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Ventricular extrasystoles	0/8030 (0%)		3/7992 (0%)		3/7933 (0%)
Ventricular fibrillation	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Ventricular tachycardia	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Bradycardia and atrial flutter with hospitalization cardiorespiratory arrest and ischemia dilated	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Cardiomyopathy and non-ST elevation MI and atherosclerosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Congenital, familial and genetic disorders
Arteriovenous malformation	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Atrial septal defect	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Cardiac septal defect	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Cerebrovascular arteriovenous malformation	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Choledochal cyst	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Developmental hip dysplasia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Diverticulitis Meckel's	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Haemorrhagic arteriovenous malformation	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Hypertrophic cardiomyopathy	0/8030 (0%)		3/7992 (0%)		0/7933 (0%)
Renal hypoplasia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Ear and labyrinth disorders
Deafness	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Ear discomfort	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Vertigo	5/8030 (0.1%)		2/7992 (0%)		8/7933 (0.1%)
Vertigo positional	0/8030 (0%)		3/7992 (0%)		3/7933 (0%)
Endocrine disorders
Adrenal haemorrhage	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Adrenal insufficiency	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Autoimmune thyroiditis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Goitre	2/8030 (0%)		4/7992 (0.1%)		0/7933 (0%)
Hyperparathyroidism	3/8030 (0%)		4/7992 (0.1%)		0/7933 (0%)
Hyperparathyroidism primary	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hyperthyroidism	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hypogonadism	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hypoparathyroidism	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Inappropriate antidiuretic hormone secretion	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Myxoedema	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Parathyroid disorder	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Thyroid mass	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Eye disorders
Cataract	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Diplopia	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Eye haemorrhage	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Glaucoma	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Optic neuropathy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Retinal detachment	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Retinal haemorrhage	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Retinal vein occlusion	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Vision blurred	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Visual impairment	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Vitreous detachment	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastrointestinal disorders
Abdominal adhesions	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Abdominal discomfort	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Abdominal hernia	5/8030 (0.1%)		4/7992 (0.1%)		7/7933 (0.1%)
Abdominal incarcerated hernia	3/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Abdominal pain	14/8030 (0.2%)		7/7992 (0.1%)		13/7933 (0.2%)
Abdominal pain lower	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Abdominal pain upper	2/8030 (0%)		3/7992 (0%)		2/7933 (0%)
Abdominal wall haematoma	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Ascites	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Autoimmune pancreatitis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Chronic gastritis	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Colitis	6/8030 (0.1%)		3/7992 (0%)		3/7933 (0%)
Colitis ischaemic	1/8030 (0%)		4/7992 (0.1%)		4/7933 (0.1%)
Colitis ulcerative	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Colonic fistula	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Colonic pseudo-obstruction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Constipation	1/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Crohn's disease	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Diarrhoea	3/8030 (0%)		8/7992 (0.1%)		5/7933 (0.1%)
Diarrhoea haemorrhagic	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Diverticular perforation	0/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Diverticulum	6/8030 (0.1%)		0/7992 (0%)		2/7933 (0%)
Diverticulum intestinal	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Diverticulum intestinal haemorrhagic	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Duodenal ulcer	2/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Duodenal ulcer haemorrhage	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Duodenal ulcer perforation	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Duodenitis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Dysphagia	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Enteritis	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Enterocele	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Enterovesical fistula	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Erosive duodenitis	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Erosive oesophagitis	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Faecaloma	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Femoral hernia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Food poisoning	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastric perforation	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gastric ulcer	1/8030 (0%)		12/7992 (0.2%)		5/7933 (0.1%)
Gastric ulcer haemorrhage	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastric varices	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gastric varices haemorrhage	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gastric volvulus	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Gastritis	3/8030 (0%)		6/7992 (0.1%)		5/7933 (0.1%)
Gastritis erosive	1/8030 (0%)		6/7992 (0.1%)		1/7933 (0%)
Gastritis haemorrhagic	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Gastroduodenal haemorrhage	0/8030 (0%)		3/7992 (0%)		2/7933 (0%)
Gastroduodenitis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastrointestinal haemorrhage	7/8030 (0.1%)		8/7992 (0.1%)		8/7933 (0.1%)
Gastrointestinal hypomotility	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gastrointestinal necrosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastrointestinal stenosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastrointestinal ulcer	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gastrooesophageal reflux disease	1/8030 (0%)		3/7992 (0%)		4/7933 (0.1%)
Haematochezia	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Haemorrhoidal haemorrhage	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Haemorrhoids	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hernial eventration	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hiatus hernia	2/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Ileal ulcer	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Ileus	1/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Ileus paralytic	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Incarcerated inguinal hernia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Incarcerated umbilical hernia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Inflammatory bowel disease	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Inguinal hernia	5/8030 (0.1%)		2/7992 (0%)		0/7933 (0%)
Intestinal dilatation	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Intestinal ischaemia	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Intestinal obstruction	2/8030 (0%)		2/7992 (0%)		5/7933 (0.1%)
Intestinal perforation	0/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Intestinal ulcer	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Intra-abdominal haemorrhage	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Irritable bowel syndrome	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Large intestinal haemorrhage	4/8030 (0%)		3/7992 (0%)		0/7933 (0%)
Large intestinal obstruction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Large intestinal ulcer	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Large intestine perforation	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Large intestine polyp	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Localised intraabdominal fluid collection	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Lower gastrointestinal haemorrhage	2/8030 (0%)		3/7992 (0%)		3/7933 (0%)
Megacolon	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Melaena	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Mesenteric artery stenosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Nausea	5/8030 (0.1%)		3/7992 (0%)		6/7933 (0.1%)
Necrotising colitis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Neutropenic colitis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Obstruction gastric	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Oedematous pancreatitis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Oesophageal spasm	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Oesophageal stenosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Oesophageal ulcer	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Oesophagitis	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Oesophagitis ulcerative	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pancreatic cyst	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pancreatic necrosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Pancreatitis	8/8030 (0.1%)		12/7992 (0.2%)		12/7933 (0.2%)
Pancreatitis acute	3/8030 (0%)		4/7992 (0.1%)		6/7933 (0.1%)
Pancreatitis chronic	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pancreatitis necrotising	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Peptic ulcer haemorrhage	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Rectal haemorrhage	4/8030 (0%)		4/7992 (0.1%)		2/7933 (0%)
Retroperitoneal haematoma	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Retroperitoneal mass	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Salivary gland calculus	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Small intestinal obstruction	7/8030 (0.1%)		9/7992 (0.1%)		8/7933 (0.1%)
Umbilical hernia	4/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Upper gastrointestinal haemorrhage	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Volvulus	0/8030 (0%)		3/7992 (0%)		0/7933 (0%)
Vomiting	5/8030 (0.1%)		7/7992 (0.1%)		7/7933 (0.1%)
General disorders
Adverse drug reaction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Asthenia	4/8030 (0%)		5/7992 (0.1%)		4/7933 (0.1%)
Cardiac death	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Chest discomfort	2/8030 (0%)		5/7992 (0.1%)		4/7933 (0.1%)
Chest pain	52/8030 (0.6%)		84/7992 (1.1%)		73/7933 (0.9%)
Complication associated with device	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Cyst rupture	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Death	4/8030 (0%)		3/7992 (0%)		7/7933 (0.1%)
Device related thrombosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Drowning	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Drug interaction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Electrocution	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Fatigue	2/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Feeling hot	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
General physical health deterioration	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Generalised oedema	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Granuloma	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hernia	0/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Ill-defined disorder	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Impaired healing	1/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Incarcerated hernia	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Influenza like illness	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Local swelling	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Malaise	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Multiple organ dysfunction syndrome	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Necrosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Non-cardiac chest pain	23/8030 (0.3%)		19/7992 (0.2%)		23/7933 (0.3%)
Oedema peripheral	4/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Organ failure	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pain	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pelvic mass	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Peripheral swelling	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Polyp	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pyrexia	0/8030 (0%)		4/7992 (0.1%)		3/7933 (0%)
Sudden cardiac death	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Sudden death	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Surgical failure	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Systemic inflammatory response syndrome	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Vascular stent stenosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Vascular stent thrombosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hepatobiliary disorders
Acute hepatic failure	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Bile duct obstruction	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bile duct stone	1/8030 (0%)		0/7992 (0%)		5/7933 (0.1%)
Biliary colic	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Biliary dyskinesia	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Biliary tract disorder	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cholangitis	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Cholecystitis	8/8030 (0.1%)		10/7992 (0.1%)		11/7933 (0.1%)
Cholecystitis acute	9/8030 (0.1%)		11/7992 (0.1%)		5/7933 (0.1%)
Cholecystitis chronic	1/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Cholelithiasis	24/8030 (0.3%)		23/7992 (0.3%)		12/7933 (0.2%)
Cholestasis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Drug-induced liver injury	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gallbladder disorder	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Hepatic cyst	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hepatic failure	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Hepatic function abnormal	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hepatic lesion	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hepatic vein thrombosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hepatitis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hepatitis alcoholic	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Jaundice cholestatic	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Jaundice hepatocellular	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Liver disorder	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Portal vein thrombosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Immune system disorders
Allergy to arthropod bite	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Anaphylactic reaction	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Anaphylactic shock	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Drug hypersensitivity	0/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Hypersensitivity	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Sarcoidosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Infections and infestations
Abdominal abscess	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Abdominal infection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Abdominal wall abscess	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Abscess intestinal	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Abscess limb	2/8030 (0%)		3/7992 (0%)		2/7933 (0%)
Abscess neck	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Acute sinusitis	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Anal abscess	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Appendiceal abscess	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Appendicitis	7/8030 (0.1%)		7/7992 (0.1%)		7/7933 (0.1%)
Appendicitis perforated	2/8030 (0%)		3/7992 (0%)		2/7933 (0%)
Arthritis bacterial	5/8030 (0.1%)		2/7992 (0%)		2/7933 (0%)
Arthritis infective	0/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Atypical pneumonia	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Bacteraemia	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bacterial diarrhoea	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Bacterial disease carrier	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bacterial infection	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Bacterial sepsis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Beta haemolytic streptococcal infection	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bone tuberculosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Breast abscess	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Bronchitis	10/8030 (0.1%)		16/7992 (0.2%)		17/7933 (0.2%)
Bronchitis bacterial	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bursitis infective	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Campylobacter gastroenteritis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Cellulitis	29/8030 (0.4%)		32/7992 (0.4%)		32/7933 (0.4%)
Cellulitis of male external genital organ	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cellulitis staphylococcal	1/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Cholecystitis infective	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Chronic pulmonary histoplasmosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Chronic sinusitis	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Clostridium difficile colitis	2/8030 (0%)		4/7992 (0.1%)		4/7933 (0.1%)
Clostridium difficile infection	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Cystitis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Cytomegalovirus infection	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Dengue fever	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Device related infection	1/8030 (0%)		4/7992 (0.1%)		3/7933 (0%)
Diabetic foot infection	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Diverticulitis	12/8030 (0.1%)		13/7992 (0.2%)		17/7933 (0.2%)
Embolic pneumonia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Empyema	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Encephalitis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Endocarditis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Epididymitis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Erysipelas	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Escherichia bacteraemia	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Escherichia infection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Escherichia sepsis	1/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Escherichia urinary tract infection	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Extradural abscess	2/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Gangrene	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Gastroenteritis	12/8030 (0.1%)		21/7992 (0.3%)		7/7933 (0.1%)
Gastroenteritis bacterial	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastroenteritis viral	4/8030 (0%)		4/7992 (0.1%)		3/7933 (0%)
Gastrointestinal infection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastrointestinal viral infection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Genitourinary tract infection	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Groin abscess	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
H1N1 influenza	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
HIV infection	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Haemophilus infection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Helicobacter gastritis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hepatic infection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Herpes oesophagitis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Herpes simplex	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Herpes zoster	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Incision site infection	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Infected skin ulcer	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Infection	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Infectious colitis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Infectious pleural effusion	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Infective exacerbation of chronic obstructive airways disease	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Infective tenosynovitis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Influenza	2/8030 (0%)		4/7992 (0.1%)		1/7933 (0%)
Intervertebral discitis	1/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Joint abscess	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Kidney infection	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Klebsiella bacteraemia	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Klebsiella infection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Liver abscess	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Localised infection	4/8030 (0%)		2/7992 (0%)		5/7933 (0.1%)
Lower respiratory tract infection	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Lung infection	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Lymphangitis	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Meningitis bacterial	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Meningitis pneumococcal	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Necrotising fasciitis	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Nosocomial infection	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Ophthalmic herpes zoster	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Oral candidiasis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Orchitis	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Osteomyelitis	9/8030 (0.1%)		6/7992 (0.1%)		8/7933 (0.1%)
Osteomyelitis acute	1/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Osteomyelitis chronic	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Otitis media	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pancreatic abscess	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Pancreatitis bacterial	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Pancreatitis viral	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Parametritis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Paraspinal abscess	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Parotitis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Periodontitis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Perirectal abscess	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Peritonitis	1/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Peritonitis bacterial	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Peritonsillar abscess	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pharyngitis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pharyngitis streptococcal	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pleurisy viral	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pneumococcal sepsis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pneumonia	64/8030 (0.8%)		79/7992 (1%)		69/7933 (0.9%)
Pneumonia bacterial	3/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pneumonia fungal	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pneumonia haemophilus	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pneumonia klebsiella	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pneumonia pseudomonal	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pneumonia staphylococcal	2/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pneumonia streptococcal	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Post procedural infection	2/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Postoperative abscess	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Postoperative wound infection	3/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Prostate infection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Proteus infection	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pulmonary tuberculosis	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pyelonephritis	5/8030 (0.1%)		9/7992 (0.1%)		8/7933 (0.1%)
Pyelonephritis acute	5/8030 (0.1%)		3/7992 (0%)		3/7933 (0%)
Pyelonephritis chronic	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pyometra	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Respiratory tract infection	0/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Sepsis	19/8030 (0.2%)		20/7992 (0.3%)		12/7933 (0.2%)
Septic arthritis staphylococcal	1/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Septic shock	2/8030 (0%)		5/7992 (0.1%)		4/7933 (0.1%)
Sinusitis	0/8030 (0%)		5/7992 (0.1%)		0/7933 (0%)
Skin infection	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Spinal cord abscess	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Staphylococcal abscess	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Staphylococcal bacteraemia	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Staphylococcal infection	4/8030 (0%)		2/7992 (0%)		4/7933 (0.1%)
Staphylococcal sepsis	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Staphylococcal skin infection	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Stenotrophomonas infection	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Subcutaneous abscess	4/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Tinea pedis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Tonsillitis	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Tooth abscess	0/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Tooth infection	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Tuberculosis	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Upper respiratory tract infection	3/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Urinary tract infection	16/8030 (0.2%)		22/7992 (0.3%)		20/7933 (0.3%)
Urinary tract infection bacterial	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Urosepsis	9/8030 (0.1%)		8/7992 (0.1%)		6/7933 (0.1%)
Viral diarrhoea	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Viral infection	1/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Viral upper respiratory tract infection	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Vulval abscess	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Wound infection	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Wound infection staphylococcal	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
MRSA	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pyelonephritis with sepsis NFI	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Injury, poisoning and procedural complications
Accidental exposure to product	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Acetabulum fracture	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Alcohol poisoning	2/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Anaemia postoperative	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Anastomotic leak	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Animal bite	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Ankle fracture	10/8030 (0.1%)		5/7992 (0.1%)		9/7933 (0.1%)
Arterial injury	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Arthropod bite	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Back injury	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Brain contusion	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Burns second degree	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Burns third degree	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cartilage injury	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cervical vertebral fracture	4/8030 (0%)		0/7992 (0%)		5/7933 (0.1%)
Chest injury	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Clavicle fracture	0/8030 (0%)		1/7992 (0%)		3/7933 (0%)
Compression fracture	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Concussion	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Contusion	0/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Craniocerebral injury	1/8030 (0%)		2/7992 (0%)		4/7933 (0.1%)
Delayed spinal fusion	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Extradural haematoma	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Eye contusion	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Face injury	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Facial bones fracture	4/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Fall	8/8030 (0.1%)		11/7992 (0.1%)		10/7933 (0.1%)
Fat embolism	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Femoral neck fracture	4/8030 (0%)		3/7992 (0%)		3/7933 (0%)
Femur fracture	11/8030 (0.1%)		7/7992 (0.1%)		18/7933 (0.2%)
Fibula fracture	3/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Foetal exposure during pregnancy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Foot fracture	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Forearm fracture	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Foreign body	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Gastrointestinal stoma complication	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gun shot wound	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Hand fracture	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Head injury	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Heat exhaustion	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hepatic rupture	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hip fracture	8/8030 (0.1%)		11/7992 (0.1%)		16/7933 (0.2%)
Humerus fracture	4/8030 (0%)		5/7992 (0.1%)		5/7933 (0.1%)
Incisional hernia	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Injury	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Intentional overdose	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Intervertebral disc injury	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Jaw fracture	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Joint dislocation	6/8030 (0.1%)		5/7992 (0.1%)		3/7933 (0%)
Joint injury	1/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Laceration	3/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Ligament injury	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Ligament rupture	1/8030 (0%)		4/7992 (0.1%)		0/7933 (0%)
Limb crushing injury	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Lower limb fracture	3/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Meniscus injury	1/8030 (0%)		4/7992 (0.1%)		3/7933 (0%)
Multiple fractures	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Multiple injuries	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Muscle rupture	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Nerve injury	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Overdose	0/8030 (0%)		3/7992 (0%)		3/7933 (0%)
Patella fracture	0/8030 (0%)		4/7992 (0.1%)		1/7933 (0%)
Pelvic fracture	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Periprosthetic fracture	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Perirenal haematoma	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Post concussion syndrome	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Post procedural complication	2/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Post procedural constipation	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Post procedural haemorrhage	3/8030 (0%)		3/7992 (0%)		3/7933 (0%)
Post procedural oedema	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Post procedural swelling	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Post-traumatic neck syndrome	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Postoperative ileus	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Postoperative thoracic procedure complication	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Procedural complication	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Procedural pain	0/8030 (0%)		3/7992 (0%)		0/7933 (0%)
Procedural pneumothorax	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Pubis fracture	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pulmonary contusion	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Radius fracture	9/8030 (0.1%)		1/7992 (0%)		0/7933 (0%)
Respiratory fume inhalation disorder	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Rib fracture	4/8030 (0%)		5/7992 (0.1%)		8/7933 (0.1%)
Road traffic accident	4/8030 (0%)		9/7992 (0.1%)		6/7933 (0.1%)
Scapula fracture	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Seroma	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Skeletal injury	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Skin abrasion	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Skull fracture	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Spinal column injury	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Spinal compression fracture	2/8030 (0%)		0/7992 (0%)		10/7933 (0.1%)
Spinal fracture	0/8030 (0%)		0/7992 (0%)		4/7933 (0.1%)
Spinal shock	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Splenic rupture	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Subdural haematoma	1/8030 (0%)		6/7992 (0.1%)		1/7933 (0%)
Subdural haemorrhage	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Tendon rupture	4/8030 (0%)		6/7992 (0.1%)		2/7933 (0%)
Thermal burn	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Thoracic vertebral fracture	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Tibia fracture	1/8030 (0%)		0/7992 (0%)		6/7933 (0.1%)
Toxicity to various agents	1/8030 (0%)		2/7992 (0%)		4/7933 (0.1%)
Traumatic arthritis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Traumatic haemothorax	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Traumatic renal injury	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Ulna fracture	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Upper limb fracture	2/8030 (0%)		2/7992 (0%)		4/7933 (0.1%)
Urinary retention postoperative	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Urostomy complication	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Vascular graft occlusion	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Vascular graft thrombosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Vascular pseudoaneurysm	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Wound	0/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Wound decomposition	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Wound dehiscence	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Wound necrosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Wound secretion	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Wrist fracture	4/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Investigations
Alanine aminotransferase increased	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Aspartate aminotransferase increased	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Aspiration bronchial	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Biopsy anus	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Biopsy breast	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Blood bilirubin increased	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Blood chromium increased	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Blood creatine abnormal	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Blood creatinine increased	0/8030 (0%)		1/7992 (0%)		3/7933 (0%)
Blood glucose abnormal	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Blood glucose increased	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Blood iron decreased	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Blood pressure increased	1/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Blood pressure systolic increased	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Blood triglycerides increased	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Clostridium test positive	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Ejection fraction	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Ejection fraction decreased	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Electrocardiogram abnormal	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Endoscopy gastrointestinal	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Fibrin D dimer increased	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Haemoglobin decreased	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Heart rate irregular	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hepatic enzyme increased	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Liver function test increased	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Occult blood positive	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Oxygen saturation decreased	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Platelet count decreased	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Platelet function test abnormal	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Staphylococcus test positive	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Transaminases increased	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Troponin increased	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Weight decreased	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Dehydration	10/8030 (0.1%)		20/7992 (0.3%)		13/7933 (0.2%)
Diabetes mellitus	5/8030 (0.1%)		2/7992 (0%)		6/7933 (0.1%)
Diabetes mellitus inadequate control	2/8030 (0%)		1/7992 (0%)		4/7933 (0.1%)
Diabetic ketoacidosis	2/8030 (0%)		4/7992 (0.1%)		4/7933 (0.1%)
Electrolyte imbalance	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Gout	0/8030 (0%)		1/7992 (0%)		3/7933 (0%)
Hypercalcaemia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hyperglycaemia	3/8030 (0%)		3/7992 (0%)		7/7933 (0.1%)
Hyperkalaemia	1/8030 (0%)		4/7992 (0.1%)		2/7933 (0%)
Hypernatraemia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hyperosmolar hyperglycaemic state	2/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Hypocalcaemia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hypoglycaemia	6/8030 (0.1%)		7/7992 (0.1%)		8/7933 (0.1%)
Hypokalaemia	7/8030 (0.1%)		9/7992 (0.1%)		5/7933 (0.1%)
Hypomagnesaemia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hyponatraemia	7/8030 (0.1%)		8/7992 (0.1%)		5/7933 (0.1%)
Hypophosphataemia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hypovolaemia	0/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Iron deficiency	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Ketoacidosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Lactic acidosis	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Malnutrition	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Metabolic acidosis	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Obesity	5/8030 (0.1%)		5/7992 (0.1%)		5/7933 (0.1%)
Type 2 diabetes mellitus	1/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	44/8030 (0.5%)		33/7992 (0.4%)		39/7933 (0.5%)
Arthrofibrosis	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Arthropathy	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Back pain	14/8030 (0.2%)		17/7992 (0.2%)		20/7933 (0.3%)
Bone cyst	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Bone disorder	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Bone erosion	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Bursitis	2/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Cervical spinal stenosis	8/8030 (0.1%)		7/7992 (0.1%)		2/7933 (0%)
Chondropathy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Compartment syndrome	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Costochondritis	3/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Exostosis	0/8030 (0%)		3/7992 (0%)		0/7933 (0%)
Facet joint syndrome	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Felty's syndrome	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Fistula	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Flank pain	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Foot deformity	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Fracture malunion	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Gouty arthritis	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Intervertebral disc degeneration	7/8030 (0.1%)		13/7992 (0.2%)		11/7933 (0.1%)
Intervertebral disc disorder	3/8030 (0%)		0/7992 (0%)		5/7933 (0.1%)
Intervertebral disc displacement	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Intervertebral disc protrusion	19/8030 (0.2%)		16/7992 (0.2%)		16/7933 (0.2%)
Joint ankylosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Joint effusion	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Joint instability	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Joint swelling	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Knee deformity	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Kyphosis	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Lumbar spinal stenosis	13/8030 (0.2%)		15/7992 (0.2%)		20/7933 (0.3%)
Meniscal degeneration	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Arthritis	31/8030 (0.4%)		33/7992 (0.4%)		32/7933 (0.4%)
Mobility decreased	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Muscle spasms	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Muscular weakness	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Musculoskeletal chest pain	2/8030 (0%)		4/7992 (0.1%)		7/7933 (0.1%)
Musculoskeletal pain	4/8030 (0%)		5/7992 (0.1%)		6/7933 (0.1%)
Myalgia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Neck pain	5/8030 (0.1%)		3/7992 (0%)		0/7933 (0%)
Osteoarthritis	201/8030 (2.5%)		206/7992 (2.6%)		189/7933 (2.4%)
Osteoarthropathy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Osteolysis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Osteonecrosis	2/8030 (0%)		1/7992 (0%)		3/7933 (0%)
Osteoporosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pain in extremity	1/8030 (0%)		7/7992 (0.1%)		1/7933 (0%)
Pain in jaw	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pathological fracture	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Periarthritis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Polyarthritis	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Polymyositis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pseudarthrosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Rhabdomyolysis	3/8030 (0%)		4/7992 (0.1%)		1/7933 (0%)
Rheumatoid arthritis	8/8030 (0.1%)		5/7992 (0.1%)		3/7933 (0%)
Rotator cuff syndrome	10/8030 (0.1%)		7/7992 (0.1%)		10/7933 (0.1%)
Scoliosis	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Spinal column stenosis	13/8030 (0.2%)		12/7992 (0.2%)		7/7933 (0.1%)
Spinal osteoarthritis	4/8030 (0%)		16/7992 (0.2%)		4/7933 (0.1%)
Spinal pain	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Spondylitis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Spondylolisthesis	7/8030 (0.1%)		7/7992 (0.1%)		10/7933 (0.1%)
Synovial cyst	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Tendon disorder	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Tendon pain	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Tendonitis	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Vertebral foraminal stenosis	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Vertebral osteophyte	2/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Osteoarthritis with tibial component loosening	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Acute myeloid leukaemia	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Adenocarcinoma	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Adenocarcinoma of colon	2/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Adenocarcinoma of the cervix	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Adenocarcinoma pancreas	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Adenoma benign	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
B-cell lymphoma	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Basal cell carcinoma	3/8030 (0%)		8/7992 (0.1%)		4/7933 (0.1%)
Benign lung neoplasm	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Benign neoplasm	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Benign ovarian tumour	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Bladder cancer	3/8030 (0%)		3/7992 (0%)		2/7933 (0%)
Bladder cancer recurrent	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bladder neoplasm	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Bladder transitional cell carcinoma	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Bone cancer	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Bowen's disease	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Brain neoplasm	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Brain neoplasm malignant	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Breast cancer	20/8030 (0.2%)		11/7992 (0.1%)		10/7933 (0.1%)
Breast cancer in situ	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Breast cancer recurrent	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Breast cancer stage I	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Breast cancer stage IV	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Breast neoplasm	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Bronchioloalveolar carcinoma	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Carcinoid tumour	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Carcinoid tumour of the duodenum	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Carcinoid tumour of the small bowel	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Carcinoid tumour of the stomach	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Central nervous system lymphoma	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Cervix carcinoma stage 0	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cholangiocarcinoma	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Chronic lymphocytic leukaemia	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Clear cell renal cell carcinoma	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Colon adenoma	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Colon cancer	3/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Colon cancer metastatic	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Colon cancer recurrent	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Colon cancer stage III	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Colon neoplasm	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Diffuse large B-cell lymphoma stage II	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Endometrial adenocarcinoma	2/8030 (0%)		1/7992 (0%)		4/7933 (0.1%)
Endometrial cancer recurrent	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Endometrial cancer stage III	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Female reproductive neoplasm	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Follicle centre lymphoma, follicular grade I, II, III	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Follicular thyroid cancer	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gastric cancer	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Gastric neoplasm	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastrointestinal melanoma	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Gastrointestinal stromal cancer	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Gastrointestinal stromal tumour	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastrointestinal tract adenoma	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Glioblastoma multiforme	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hairy cell leukaemia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Head and neck cancer	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hepatic cancer	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Hepatic cancer metastatic	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Hodgkin's disease	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Intraductal proliferative breast lesion	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Invasive ductal breast carcinoma	4/8030 (0%)		3/7992 (0%)		5/7933 (0.1%)
Large cell lung cancer stage 0	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Laryngeal squamous cell carcinoma	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Leiomyoma	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Leukaemia	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Lip neoplasm malignant stage unspecified	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Lipoma	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Lobular breast carcinoma in situ	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Lung adenocarcinoma	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Lung adenocarcinoma stage III	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Lung cancer metastatic	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Lung carcinoma cell type unspecified stage I	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Lung carcinoma cell type unspecified stage IV	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Lung neoplasm malignant	14/8030 (0.2%)		7/7992 (0.1%)		12/7933 (0.2%)
Lung squamous cell carcinoma stage II	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Lymphocytic leukaemia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Lymphoma	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Malignant mediastinal neoplasm	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Malignant melanoma	4/8030 (0%)		1/7992 (0%)		3/7933 (0%)
Malignant melanoma in situ	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Malignant neoplasm of unknown primary site	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Malignant pleural effusion	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Mantle cell lymphoma	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Meningioma	0/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Mesothelioma	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Metastases to liver	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Metastatic gastric cancer	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Metastatic malignant melanoma	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Metastatic squamous cell carcinoma	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Myelodysplastic syndrome	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Neoplasm malignant	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Non-Hodgkin's lymphoma	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Non-Hodgkin's lymphoma stage III	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Non-small cell lung cancer	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Oesophageal adenocarcinoma	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Oesophageal carcinoma	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Oropharyngeal cancer	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Ovarian cancer	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Ovarian cancer stage III	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pancreatic carcinoma	2/8030 (0%)		7/7992 (0.1%)		3/7933 (0%)
Pancreatic carcinoma metastatic	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pancreatic carcinoma stage II	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Pancreatic carcinoma stage III	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Papillary cystadenoma lymphomatosum	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Paraproteinaemia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Parathyroid tumour	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Parathyroid tumour benign	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Pituitary tumour	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pituitary tumour benign	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Plasma cell myeloma	2/8030 (0%)		1/7992 (0%)		3/7933 (0%)
Prostate cancer	8/8030 (0.1%)		19/7992 (0.2%)		20/7933 (0.3%)
Prostate cancer recurrent	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Rectal cancer	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Renal cancer	1/8030 (0%)		4/7992 (0.1%)		2/7933 (0%)
Renal cancer metastatic	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Renal cell carcinoma	1/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Renal neoplasm	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Small cell lung cancer	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Small cell lung cancer metastatic	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Squamous cell carcinoma	3/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Squamous cell carcinoma of lung	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Squamous cell carcinoma of skin	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Superficial spreading melanoma stage unspecified	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Sweat gland tumour	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Testis cancer	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Throat cancer	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Thyroid cancer	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Transitional cell cancer of the renal pelvis and ureter	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Transitional cell carcinoma	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Triple negative breast cancer	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Ureteric cancer	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Uterine cancer	0/8030 (0%)		4/7992 (0.1%)		1/7933 (0%)
Uterine leiomyoma	0/8030 (0%)		5/7992 (0.1%)		3/7933 (0%)
Large granular lymphocyte	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Metastatic hepatic adenocarcinoma	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Metastatic tumor possibly from squamous cell lung cancer and metastatic tumor cerebral tumor	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Nervous system disorders
Altered state of consciousness	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Amnesia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Aphasia	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Ataxia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Autonomic neuropathy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Balance disorder	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Basal ganglia infarction	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Basal ganglia stroke	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Brachial plexopathy	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Brain oedema	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Carotid arteriosclerosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Carotid artery disease	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Carotid artery dissection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Carotid artery occlusion	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Carotid artery stenosis	5/8030 (0.1%)		5/7992 (0.1%)		3/7933 (0%)
Carotid artery thrombosis	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Carpal tunnel syndrome	2/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Central nervous system lesion	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Central-alveolar hypoventilation	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cerebellar infarction	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Cerebral cyst	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cerebral haematoma	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cerebral haemorrhage	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cerebral infarction	1/8030 (0%)		4/7992 (0.1%)		1/7933 (0%)
Cerebral ischaemia	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Cerebrospinal fluid leakage	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cerebrovascular accident	39/8030 (0.5%)		34/7992 (0.4%)		34/7933 (0.4%)
Cerebrovascular disorder	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cervical cord compression	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Cervical myelopathy	3/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Cervical radiculopathy	1/8030 (0%)		5/7992 (0.1%)		2/7933 (0%)
Chorea	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Cognitive disorder	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Complex regional pain syndrome	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Dementia	2/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Dementia Alzheimer's type	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Depressed level of consciousness	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Diabetic hyperosmolar coma	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Diabetic neuropathy	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Dizziness	6/8030 (0.1%)		5/7992 (0.1%)		6/7933 (0.1%)
Dural arteriovenous fistula	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Dysarthria	2/8030 (0%)		0/7992 (0%)		3/7933 (0%)
Dyskinesia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Embolic stroke	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Encephalomalacia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Encephalopathy	0/8030 (0%)		1/7992 (0%)		3/7933 (0%)
Epidural lipomatosis	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Epilepsy	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Facial paralysis	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Facial paresis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Generalised tonic-clonic seizure	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Guillain-Barre syndrome	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Haemorrhage intracranial	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Haemorrhagic stroke	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Headache	4/8030 (0%)		6/7992 (0.1%)		0/7933 (0%)
Hemiparesis	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Hydrocephalus	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hypertensive encephalopathy	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hypoaesthesia	2/8030 (0%)		4/7992 (0.1%)		0/7933 (0%)
Hypoxic-ischaemic encephalopathy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
IIIrd nerve paralysis	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Intracranial aneurysm	1/8030 (0%)		4/7992 (0.1%)		3/7933 (0%)
Ischaemic cerebral infarction	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Ischaemic stroke	2/8030 (0%)		3/7992 (0%)		8/7933 (0.1%)
Lacunar infarction	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Lacunar stroke	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Loss of consciousness	6/8030 (0.1%)		1/7992 (0%)		1/7933 (0%)
Lumbar radiculopathy	1/8030 (0%)		4/7992 (0.1%)		3/7933 (0%)
Mental impairment	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Metabolic encephalopathy	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Migraine	5/8030 (0.1%)		2/7992 (0%)		1/7933 (0%)
Migraine with aura	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Monoparesis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Multiple sclerosis relapse	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Myelopathy	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Nerve compression	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Nerve root compression	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Nervous system disorder	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Neurological symptom	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Neuromyopathy	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Neuropathy peripheral	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Normal pressure hydrocephalus	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Paraesthesia	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Paraplegia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Parkinsonism	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Presyncope	2/8030 (0%)		6/7992 (0.1%)		4/7933 (0.1%)
Quadriparesis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Quadriplegia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Radial nerve palsy	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Radicular pain	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Radiculopathy	1/8030 (0%)		3/7992 (0%)		0/7933 (0%)
Sacral radiculopathy	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Sciatica	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Seizure	6/8030 (0.1%)		8/7992 (0.1%)		4/7933 (0.1%)
Senile dementia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Spinal claudication	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Spinal cord compression	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Spondylitic myelopathy	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Status epilepticus	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Subarachnoid haemorrhage	3/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Syncope	19/8030 (0.2%)		21/7992 (0.3%)		31/7933 (0.4%)
Thalamic infarction	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Toxic encephalopathy	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Transient global amnesia	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Transient ischaemic attack	22/8030 (0.3%)		29/7992 (0.4%)		28/7933 (0.4%)
Tremor	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Trigeminal neuralgia	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Unresponsive to stimuli	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Vascular encephalopathy	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Product Issues
Device breakage	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Device connection issue	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Device dislocation	1/8030 (0%)		1/7992 (0%)		4/7933 (0.1%)
Device failure	1/8030 (0%)		1/7992 (0%)		4/7933 (0.1%)
Device loosening	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Device malfunction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Device material issue	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Lead dislodgement	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Stent malfunction	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Psychiatric disorders
Acute psychosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Alcohol withdrawal syndrome	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Anxiety	1/8030 (0%)		0/7992 (0%)		4/7933 (0.1%)
Bipolar I disorder	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bipolar disorder	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Confusional state	3/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Delirium	0/8030 (0%)		1/7992 (0%)		4/7933 (0.1%)
Depression	3/8030 (0%)		5/7992 (0.1%)		3/7933 (0%)
Depression suicidal	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Disorientation	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Drug abuse	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Dysphoria	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hallucination, auditory	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hypomania	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Major depression	2/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Mental status changes	10/8030 (0.1%)		5/7992 (0.1%)		8/7933 (0.1%)
Panic attack	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Paranoia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Post-traumatic stress disorder	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Schizoaffective disorder	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Schizophrenia	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Substance abuse	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Suicidal ideation	1/8030 (0%)		4/7992 (0.1%)		4/7933 (0.1%)
Suicide attempt	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Renal and urinary disorders
Acute kidney injury	36/8030 (0.4%)		39/7992 (0.5%)		31/7933 (0.4%)
Acute prerenal failure	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bladder outlet obstruction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Bladder prolapse	2/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Bladder spasm	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Calculus bladder	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Calculus urethral	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Calculus urinary	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Chronic kidney disease	1/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Cystitis haemorrhagic	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Dysuria	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Haematuria	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hydronephrosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hypertensive nephropathy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Incontinence	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Nephrolithiasis	7/8030 (0.1%)		10/7992 (0.1%)		11/7933 (0.1%)
Nephropathy	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Nephrotic syndrome	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Renal artery stenosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Renal colic	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Renal cyst haemorrhage	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Renal failure	7/8030 (0.1%)		21/7992 (0.3%)		18/7933 (0.2%)
Renal haematoma	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Renal impairment	2/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Renal injury	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Renal mass	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Stag horn calculus	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Stress urinary incontinence	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Tubulointerstitial nephritis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Ureterolithiasis	2/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Urethral stenosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Urinary incontinence	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Urinary retention	1/8030 (0%)		3/7992 (0%)		0/7933 (0%)
Urine flow decreased	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Reproductive system and breast disorders
Adnexa uteri mass	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Atrophic vulvovaginitis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Benign prostatic hyperplasia	4/8030 (0%)		5/7992 (0.1%)		4/7933 (0.1%)
Breast disorder	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Breast mass	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Colpocele	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cystocele	4/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Dysfunctional uterine bleeding	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Endometrial hyperplasia	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Erectile dysfunction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Female genital tract fistula	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Menorrhagia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Metrorrhagia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Ovarian cyst	3/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Ovarian mass	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pelvic adhesions	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pelvic floor muscle weakness	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pelvic prolapse	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Postmenopausal haemorrhage	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Prostatic obstruction	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Prostatitis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Prostatomegaly	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Rectocele	2/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Spermatocele	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Uterine haemorrhage	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Uterine prolapse	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Uterovaginal prolapse	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Vaginal haemorrhage	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Vaginal prolapse	4/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Acute respiratory failure	7/8030 (0.1%)		11/7992 (0.1%)		4/7933 (0.1%)
Asphyxia	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Aspiration	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Asthma	9/8030 (0.1%)		13/7992 (0.2%)		10/7933 (0.1%)
Asthma-chronic obstructive pulmonary disease overlap syndrome	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Asthmatic crisis	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Atelectasis	0/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Bronchial hyperreactivity	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Bronchiectasis	0/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Bronchitis chronic	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Bronchospasm	3/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Choking	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Chronic obstructive pulmonary disease	29/8030 (0.4%)		30/7992 (0.4%)		31/7933 (0.4%)
Cough	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Dyspnoea	16/8030 (0.2%)		24/7992 (0.3%)		24/7933 (0.3%)
Dyspnoea exertional	1/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Dyspnoea paroxysmal nocturnal	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Emphysema	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Eosinophilic pneumonia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Epistaxis	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Haemoptysis	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Hydrothorax	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hypercapnia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hypoventilation	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hypoxia	0/8030 (0%)		6/7992 (0.1%)		6/7933 (0.1%)
Idiopathic pulmonary fibrosis	1/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Interstitial lung disease	1/8030 (0%)		4/7992 (0.1%)		4/7933 (0.1%)
Laryngeal stenosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Lung consolidation	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Lung infiltration	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Mediastinal mass	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Nasal congestion	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Nasal polyps	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Nasal septum deviation	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Obstructive airways disorder	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Pickwickian syndrome	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pleural effusion	6/8030 (0.1%)		2/7992 (0%)		6/7933 (0.1%)
Pleurisy	1/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Pneumonia aspiration	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pneumonitis	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pneumothorax	2/8030 (0%)		4/7992 (0.1%)		4/7933 (0.1%)
Pulmonary arterial hypertension	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Pulmonary embolism	18/8030 (0.2%)		10/7992 (0.1%)		21/7933 (0.3%)
Pulmonary fibrosis	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Pulmonary hypertension	0/8030 (0%)		2/7992 (0%)		4/7933 (0.1%)
Pulmonary mass	3/8030 (0%)		3/7992 (0%)		2/7933 (0%)
Pulmonary oedema	1/8030 (0%)		4/7992 (0.1%)		3/7933 (0%)
Pulmonary thrombosis	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Respiratory arrest	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Respiratory disorder	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Respiratory distress	3/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Respiratory failure	8/8030 (0.1%)		14/7992 (0.2%)		10/7933 (0.1%)
Sleep apnoea syndrome	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Status asthmaticus	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Tachypnoea	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Tracheal stenosis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Vocal cord inflammation	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Skin and subcutaneous tissue disorders
Angioedema	3/8030 (0%)		4/7992 (0.1%)		1/7933 (0%)
Dermal cyst	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Dermatitis bullous	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Diabetic foot	3/8030 (0%)		5/7992 (0.1%)		1/7933 (0%)
Diabetic ulcer	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Drug eruption	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Erythema multiforme	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Erythema nodosum	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Hyperhidrosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Hypersensitivity vasculitis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Leukoplakia	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Melanocytic hyperplasia	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Panniculitis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Pruritus	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Rash	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Rash vesicular	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Skin ulcer	2/8030 (0%)		4/7992 (0.1%)		1/7933 (0%)
Stasis dermatitis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Swelling face	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Urticaria	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Social circumstances
Activities of daily living impaired	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Immobile	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Physical assault	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Surgical and medical procedures
Bladder operation	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Cardiac pacemaker replacement	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Colporrhaphy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Coronary arterial stent insertion	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Coronary revascularisation	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Cystocele repair	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Gastric banding	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hernia repair	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Hip arthroplasty	2/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Hysterectomy	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Inguinal hernia repair	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Joint fluid drainage	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Knee arthroplasty	1/8030 (0%)		1/7992 (0%)		3/7933 (0%)
Ligament operation	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Medical device removal	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Oophorectomy	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Parovarian cystectomy	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Renal artery stent placement	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Renal stone removal	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Shoulder arthroplasty	0/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Shoulder operation	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Spinal decompression	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Spinal fusion surgery	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Spinal operation	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Tenoplasty	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Thyroidectomy	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Vascular operation	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Wound drainage	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Left hip surgical error	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Worsening osteoarthritis right hip replacement	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Vascular disorders
Accelerated hypertension	1/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Aneurysm	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Angiopathy	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Aortic aneurysm	10/8030 (0.1%)		4/7992 (0.1%)		4/7933 (0.1%)
Aortic aneurysm rupture	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Aortic arteriosclerosis	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Aortic calcification	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Aortic dilatation	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Aortic dissection	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Aortic stenosis	2/8030 (0%)		3/7992 (0%)		7/7933 (0.1%)
Arterial occlusive disease	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Arteriosclerosis	1/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Arteriovenous fistula	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Bleeding varicose vein	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Blue toe syndrome	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Deep vein thrombosis	12/8030 (0.1%)		11/7992 (0.1%)		12/7933 (0.2%)
Extravasation blood	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Extremity necrosis	3/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Haematoma	2/8030 (0%)		1/7992 (0%)		4/7933 (0.1%)
Hypertension	18/8030 (0.2%)		35/7992 (0.4%)		21/7933 (0.3%)
Hypertensive crisis	4/8030 (0%)		7/7992 (0.1%)		14/7933 (0.2%)
Hypertensive emergency	1/8030 (0%)		2/7992 (0%)		2/7933 (0%)
Hypotension	7/8030 (0.1%)		13/7992 (0.2%)		9/7933 (0.1%)
Hypovolaemic shock	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Intermittent claudication	2/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Internal haemorrhage	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Ischaemia	1/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Labile hypertension	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Leriche syndrome	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Lymphoedema	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Malignant hypertension	1/8030 (0%)		2/7992 (0%)		3/7933 (0%)
Neurogenic shock	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Orthostatic hypertension	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Orthostatic hypotension	2/8030 (0%)		3/7992 (0%)		3/7933 (0%)
Arterial thrombosis	0/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Penetrating aortic ulcer	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Peripheral arterial occlusive disease	2/8030 (0%)		2/7992 (0%)		4/7933 (0.1%)
Peripheral artery aneurysm	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Peripheral artery occlusion	2/8030 (0%)		3/7992 (0%)		1/7933 (0%)
Peripheral artery stenosis	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Peripheral artery thrombosis	2/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Peripheral ischaemia	3/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Peripheral vascular disorder	4/8030 (0%)		3/7992 (0%)		5/7933 (0.1%)
Peripheral venous disease	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Phlebitis	1/8030 (0%)		0/7992 (0%)		2/7933 (0%)
Shock	2/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Subclavian vein thrombosis	0/8030 (0%)		1/7992 (0%)		0/7933 (0%)
Systolic hypertension	0/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Temporal arteritis	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Thrombophlebitis	2/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Thrombophlebitis superficial	1/8030 (0%)		1/7992 (0%)		2/7933 (0%)
Thrombosis	3/8030 (0%)		2/7992 (0%)		1/7933 (0%)
Varicose vein	1/8030 (0%)		1/7992 (0%)		1/7933 (0%)
Vascular stenosis	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Venous thrombosis	0/8030 (0%)		2/7992 (0%)		0/7933 (0%)
Venous thrombosis limb	0/8030 (0%)		0/7992 (0%)		1/7933 (0%)
Femoral popliteal occlusive disease	1/8030 (0%)		0/7992 (0%)		0/7933 (0%)
Other (Not Including Serious) Adverse Events
	Celecoxib		Ibuprofen		Naproxen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4268/8030 (53.2%)		4363/7992 (54.6%)		4337/7933 (54.7%)
Blood and lymphatic system disorders
Anaemia	207/8030 (2.6%)		405/7992 (5.1%)		310/7933 (3.9%)
Gastrointestinal disorders
Constipation	274/8030 (3.4%)		344/7992 (4.3%)		408/7933 (5.1%)
Diarrhoea	641/8030 (8%)		538/7992 (6.7%)		566/7933 (7.1%)
Dyspepsia	393/8030 (4.9%)		424/7992 (5.3%)		436/7933 (5.5%)
Gastrooesophageal reflux disease	401/8030 (5%)		404/7992 (5.1%)		387/7933 (4.9%)
Nausea	425/8030 (5.3%)		482/7992 (6%)		502/7933 (6.3%)
Infections and infestations
Bronchitis	465/8030 (5.8%)		471/7992 (5.9%)		427/7933 (5.4%)
Sinusitis	373/8030 (4.6%)		421/7992 (5.3%)		375/7933 (4.7%)
Upper respiratory tract infection	584/8030 (7.3%)		595/7992 (7.4%)		560/7933 (7.1%)
Urinary tract infection	416/8030 (5.2%)		452/7992 (5.7%)		414/7933 (5.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	764/8030 (9.5%)		659/7992 (8.2%)		764/7933 (9.6%)
Back pain	542/8030 (6.7%)		516/7992 (6.5%)		547/7933 (6.9%)
Osteoarthritis	958/8030 (11.9%)		859/7992 (10.7%)		880/7933 (11.1%)
Pain in extremity	455/8030 (5.7%)		422/7992 (5.3%)		422/7933 (5.3%)
Nervous system disorders
Headache	361/8030 (4.5%)		409/7992 (5.1%)		365/7933 (4.6%)
Vascular disorders
Hypertension	762/8030 (9.5%)		1008/7992 (12.6%)		855/7933 (10.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer Clinical Trials.gov Call Center
Organization	Pfizer, Inc
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

ClinicalTrials.gov Identifier:

NCT00346216

Other Study ID Numbers:

A3191172
2004-002441-13
PRECISION TRIAL

First Posted:

Jun 29, 2006

Last Update Posted:

Mar 3, 2021

Last Verified:

Mar 1, 2021