SPIRE-2: The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01975389
• Collaborator: (none)
• Enrollment: 10,564
• Locations: 1596
• Arms: 2
• Actual Duration (Months): 41.1
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: bococizumab (PF-04950615); Drug: Placebo	Phase 3

Detailed Description

The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10564 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
• Actual Study Start Date: Oct 29, 2013
• Actual Primary Completion Date: Apr 3, 2017
• Actual Study Completion Date: Apr 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bococizumab (PF-04950615) 150 mg, every 2 weeks, subcutaneous.	Drug: bococizumab (PF-04950615); 150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.; Other Names: RN316
Placebo Comparator: Placebo Placebo comparator, every 2 weeks, subcutaneous.	Drug: Placebo; Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.

Outcome Measures

Primary Outcome Measures

1. Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event [From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death [defined as sudden cardiac death, fatal myocardial infarction (MI), death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes] non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. Event rate was calculated as the number of events per 100 participant-years at risk.

Secondary Outcome Measures

1. Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infraction (MI) or Non-fatal Stroke [From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for first occurrence of composite endpoint of CV Death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.

2. Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infraction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization [From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.

3. Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke [From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.

4. Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization [From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

5. Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina [From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for first occurrence of composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.

6. Event Rate Per 100 Participant-years for Cardiovascular (CV) Death [From baseline until the date of adjudicated and confirmed occurrence of CV death (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for occurrence of CV death (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.

7. Event Rate Per 100 Participant-years for First Occurrence of Any Myocardial Infarction (Fatal or Non-fatal) [From baseline until the date of first adjudicated and confirmed occurrence of any myocardial infarction (fatal or non-fatal) (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for first occurrence of any myocardial infarction (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

8. Event Rate Per 100 Participant-years for Fatal Myocardial Infarction (MI) [From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for occurrence of fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

9. Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Myocardial Infarction (MI) [From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years)]

   Event rate per 100 participant-years for first occurrence of non-fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

10. Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal) [From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

11. Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal), of Any Etiology [From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) of any etiology (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) of any etiology (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

12. Event Rate Per 100 Participant-years for Fatal Stroke [From baseline until the date of adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for occurrence of fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

13. Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Stroke [From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of non-fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

14. Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina [From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

15. Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF) [From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for CHF (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of hospitalization for CHF (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

16. Event Rate Per 100 Participant-years for First Occurrence of Coronary Revascularization [From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of coronary revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

17. Event Rate Per 100 Participant-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG) [From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of CABG (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

18. Event Rate Per 100 Participant-years for First Occurrence of Percutaneous Coronary Intervention (PCI) [From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of PCI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

19. Event Rate Per 100 Participant-years for First Occurrence of Any Arterial Revascularizations [From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for first occurrence of any arterial revascularizations (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.

20. Event Rate Per 100 Participant-years for All-cause Death [From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years)]

    Event rate per 100 participant-years for occurrence of all-cause death (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.

21. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14 [Baseline, Week 14]

22. Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14 [Baseline, Week 14]

23. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement [Baseline, last post-baseline measurement (any time up to Week 140)]

24. Percent Change From Baseline in Lipid Levels at Week 14 [Baseline, Week 14]

    Lipids included non-high density lipoprotein cholesterol (non-HDL-C), very low density lipoprotein cholesterol (VLDL-C), remnant lipoprotein cholesterol (RLP-C), apolipoprotein B (Apo B), HDL-C, apolipoprotein A-I (Apo A-I) and total cholesterol.

25. Percent Change From Baseline in Log-transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14 [Baseline, Week 14]

26. Percent Change From Baseline in Log-transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14 [Baseline, Week 14]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be on background lipid lowering treatment.

• Must be at high risk of a CV event.

• Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).

Exclusion Criteria:

• Planned coronary (PCI or CABG) or other arterial revascularization.

• New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.

• Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis.

• History of hemorrhagic stroke.

• Prior exposure to bococizumab or other investigational PCSK9 inhibitor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ernest Hendrix, MD, PC	Athens	Alabama	United States	35611
2	North Alabama Research Center, LLC	Athens	Alabama	United States	35611
3	Central Alabama Research	Birmingham	Alabama	United States	35209
4	Clinical Research Advantage, Inc./Simon Williamson Clinic	Birmingham	Alabama	United States	35211
5	The Kirklin Clinic	Birmingham	Alabama	United States	35233
6	Birmingham Heart Clinic, P.C.	Birmingham	Alabama	United States	35235
7	University of Alabama at Birmingham (Drug Shipment)	Birmingham	Alabama	United States	35294
8	Appalachian Cardiovascular Associates	Fort Payne	Alabama	United States	35967
9	Fundamental Research, LLC	Gulf Shores	Alabama	United States	36542
10	Avant Research Associates, LLC	Guntersville	Alabama	United States	35976
11	Boyett Health Services	Hamilton	Alabama	United States	35570
12	The Office of Saadat Ansari MD LLC	Huntsville	Alabama	United States	35801
13	CB Flock Research Corporation	Mobile	Alabama	United States	36608
14	Alaska Heart Institute	Anchorage	Alaska	United States	99508
15	Phoenix Heart, PLLC	Glendale	Arizona	United States	85306
16	Arrowhead Internal Medicine	Glendale	Arizona	United States	85308
17	Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.	Phoenix	Arizona	United States	85018
18	Cochise Clinical Research	Sierra Vista	Arizona	United States	85635
19	Clinical Research Advantage, Inc. (Administrative Mailing Only)	Tempe	Arizona	United States	85282
20	Southwest Heart Group	Tucson	Arizona	United States	85710
21	Arizona Endocrine and Rheumatology Associates	Tucson	Arizona	United States	85715
22	Arkansas Heart Hospital Clinic	Little Rock	Arkansas	United States	72211
23	Arkansas Site Management Services, LLC	Little Rock	Arkansas	United States	72211
24	Cardiology Consultants of Orange County Medical Group, Inc.	Anaheim	California	United States	92801
25	Premier Valley Medical Group	Bakersfield	California	United States	93309
26	Cardiovascular Research Foundation of Southern California	Beverly Hills	California	United States	90210
27	Westside Medical Associates of Los Angeles	Beverly Hills	California	United States	90211
28	Southbay Pharma Research	Buena Park	California	United States	90620
29	Pioneer Medical Group	Cerritos	California	United States	90703
30	John Muir Physician Network Clinical Research Center	Concord	California	United States	94520
31	Atlantic Ave Medical Clinic Inc.	Cudahy	California	United States	90201
32	Multani Medical Group	Downey	California	United States	90241
33	Triwest Research Associates, LLC	El Cajon	California	United States	92020
34	Diagnamics Inc.	Encinitas	California	United States	92024
35	T. Joseph Raoof, Md, Inc/Encino Research Center	Encino	California	United States	91436
36	Aviva Research	Escondido	California	United States	92025
37	Valley Research	Fresno	California	United States	93720
38	St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare	Fullerton	California	United States	92835
39	Omnibus Clinical Research	La Palma	California	United States	90623
40	Alliance Research Centers	Laguna Hills	California	United States	92653
41	Prime Care Clinical Research Center	Laguna Hills	California	United States	92653
42	Clinical Trials Research	Lincoln	California	United States	95648
43	Long Beach Memorial Medical Center	Long Beach	California	United States	90806
44	American Institute of Research	Los Angeles	California	United States	90017
45	Intermed Group	Los Angeles	California	United States	90017
46	Academic Medical Research Institute	Los Angeles	California	United States	90022
47	Eastside Clinical Research Associates	Los Angeles	California	United States	90022
48	Richard S. Cherlin, MD	Los Gatos	California	United States	95032
49	Facey Medical Foundation	Mission Hills	California	United States	91345
50	California Medical Research Associates Inc.	Northridge	California	United States	91324
51	Valley Clinical Trials, Inc.	Northridge	California	United States	91325
52	Diabetes Associates Medical Group	Orange	California	United States	92868
53	Saviers Medical Group	Port Hueneme	California	United States	93041
54	California Research Foundation	San Diego	California	United States	92103-6204
55	San Diego Family Care dba Linda Vista Health Center	San Diego	California	United States	92111
56	San Diego Family Care	San Diego	California	United States	92111
57	Ritchken & First Md's	San Diego	California	United States	92117
58	Wetlin Research Associates, Inc.	San Diego	California	United States	92120
59	West Coast Research LLC	San Ramon	California	United States	94582
60	Syrentis Clinical Research	Santa Ana	California	United States	92705
61	Coastal Biomedical Research, Inc.	Santa Monica	California	United States	90404
62	Encompass Clinical Research	Spring Valley	California	United States	91978
63	St. Joseph's Medical Associates	Stockton	California	United States	95204
64	Westlake Medical Research	Thousand Oaks	California	United States	91360
65	Harbor-UCLA Medical Center - Torrance	Torrance	California	United States	90502-2004
66	Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center	Torrance	California	United States	90502
67	Bayview Research Group	Valley Village	California	United States	91607
68	Coastal Metabolic Research Centre	Ventura	California	United States	93003
69	Ventura Clinical Trials	Ventura	California	United States	93003
70	Clinical Research Advantage, Inc. / Cassidy Medical Group - Vista	Vista	California	United States	92083
71	Allianz Research Institute	Westminster	California	United States	92683
72	American Institute of Research Studies	Whittier	California	United States	90603
73	American Institute of Research	Whittier	California	United States	90603
74	Elite Clinical Trials, Inc.	Wildomar	California	United States	92595
75	Elite Clinical Trials, Incorporated	Wildomar	California	United States	92595
76	Colorado Springs Health Partners	Colorado Springs	Colorado	United States	80906
77	Lynn Institute of the Rockies	Colorado Springs	Colorado	United States	80909
78	Memorial Hospital: University of Colorado Health	Colorado Springs	Colorado	United States	80909
79	Lynn Institute of Denver	Denver	Colorado	United States	80246
80	Western Colorado Research, LLC	Glenwood Springs	Colorado	United States	81601
81	South Denver Cardiology Associates, PC	Littleton	Colorado	United States	80120
82	Connecticut Clinical Research, LLC	Bridgeport	Connecticut	United States	06606
83	Bridgeport Hospital	Bridgeport	Connecticut	United States	06610
84	Cardiology Associates of Fairfield County, PC	Stamford	Connecticut	United States	06905
85	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
86	Christiana Care Health Services, Inc.	Newark	Delaware	United States	19713
87	Alfieri Cardiology	Wilmington	Delaware	United States	19803
88	ACRC - Cardiology	Atlantis	Florida	United States	33462
89	GulfCoast Endocrine and Diabetes Center	Clearwater	Florida	United States	33756
90	Morton Plant Mease Health Care, Inc. Cardiovascular Research	Clearwater	Florida	United States	33756
91	Team Medical Research	Coral Gables	Florida	United States	33134
92	The Heart Group, PA	Daytona Beach	Florida	United States	32114
93	Cardiology Associates Research Company	Daytona Beach	Florida	United States	32117
94	The Cardiology Center	Delray Beach	Florida	United States	33484
95	Continental Research Corp	Doral	Florida	United States	33126
96	Care Research Center Inc	Doral	Florida	United States	33166
97	Integrity Clinical Research, LLC	Doral	Florida	United States	33166
98	Moonshine Research Center, Inc.	Doral	Florida	United States	33166
99	Invesclinic, LLC	Fort Lauderdale	Florida	United States	33308
100	The Office of Dr. Alan Graff, MD, PA	Fort Lauderdale	Florida	United States	33308
101	Broward Health Medical Center	Fort Lauderdale	Florida	United States	33316
102	The Office of Maxine E. Hamilton, MD, PA	Fort Lauderdale	Florida	United States	33316
103	State Of The Art Research, LLC	Hialeah	Florida	United States	33010
104	Direct Helpers Medical Center Inc	Hialeah	Florida	United States	33012
105	Research Physicians Network Alliance	Hollywood	Florida	United States	33021
106	Pines Clinical Research, Inc.	Hollywood	Florida	United States	33024
107	East Coast Institute for Research, LLC	Jacksonville	Florida	United States	32204
108	Westside Center for Clinical Research	Jacksonville	Florida	United States	32205
109	River City Clinical Research	Jacksonville	Florida	United States	32207
110	East Coast Institute for Research, LLC	Jacksonville	Florida	United States	32216
111	East Coast Institute for Reserach, LLC	Jacksonville	Florida	United States	32216
112	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
113	The Office of Rachel Day	Jacksonville	Florida	United States	32216
114	Baker-Gilmore Cardiovascular Institute	Jacksonville	Florida	United States	32223
115	Solutions Through Advanced Research, Inc.	Jacksonville	Florida	United States	32256
116	Meridien Research	Lakeland	Florida	United States	33805
117	The Heart Institute at Largo	Largo	Florida	United States	33770
118	South Florida Clinical Research Institute	Margate	Florida	United States	33063
119	Research Physicians Network Alliance	Miami Beach	Florida	United States	33140
120	G & I Medical Research LLC	Miami Lakes	Florida	United States	33014
121	Ocean Blue Medical Research Center, Inc.	Miami Springs	Florida	United States	33166
122	Future Clinical Research, Inc.	Miami	Florida	United States	33122
123	Advanced Clinical Research of Miami (ACROM) International	Miami	Florida	United States	33125
124	Project4Research, Inc	Miami	Florida	United States	33125
125	A & L Clinical Research	Miami	Florida	United States	33126
126	Finlay Medical Research	Miami	Florida	United States	33126
127	Pharmax Research Clinic, Inc.	Miami	Florida	United States	33126
128	Team Medical Research, Inc.	Miami	Florida	United States	33134
129	Team Medical Research	Miami	Florida	United States	33134
130	South Florida Research Center, Inc.	Miami	Florida	United States	33135
131	Florida Medical Center & Research, Inc.	Miami	Florida	United States	33142
132	Medical Research Center	Miami	Florida	United States	33144
133	Nuren Medical & Research Center	Miami	Florida	United States	33144
134	Doctors Research Institute	Miami	Florida	United States	33145
135	Advanced Pharma CR, LLC	Miami	Florida	United States	33147
136	Coast Research Institute	Miami	Florida	United States	33155
137	My Community Research Center, Inc.	Miami	Florida	United States	33155
138	Columbus Clinical Services LLC	Miami	Florida	United States	33165
139	Cardiovascular Research Center of South Florida	Miami	Florida	United States	33173
140	Research Institute of South Florida, Inc.	Miami	Florida	United States	33173
141	A & O Research Center, Inc.	Miami	Florida	United States	33174
142	BWell Research Center	Miami	Florida	United States	33175
143	Pharmacology International Research, Inc.	Miami	Florida	United States	33175
144	Advanced Clinical Research	Miami	Florida	United States	33176
145	South Florida Research Group, LLC	Miami	Florida	United States	33176
146	International Research Associates, LLC	Miami	Florida	United States	33183
147	Kendall South Medical Center, Inc.	Miami	Florida	United States	33185
148	Kendall South Medical Center, Inc	Miami	Florida	United States	33185
149	M & M Medical Center, Inc	Miami	Florida	United States	33185
150	Med Research Of Florida, LLC	Miami	Florida	United States	33186
151	Southwest Florida Research, LLC	Naples	Florida	United States	34102
152	BayCare Medical Group	New Port Richey	Florida	United States	34653
153	The Heart & Vascular Institute of Florida	New Port Richey	Florida	United States	34653
154	Bravo Health Care Center	North Bay Village	Florida	United States	33141
155	Harmony Clinical Research, Inc.	North Miami Beach	Florida	United States	33162
156	Florida Hospital	Orlando	Florida	United States	32803
157	Omega Research Consultants, LLC	Orlando	Florida	United States	32806
158	Aba Family Medicine, LLC	Ormond Beach	Florida	United States	32174
159	Millennium Research	Ormond Beach	Florida	United States	32174
160	Ribo Research, LLC dba Peninsula Research	Ormond Beach	Florida	United States	32174
161	A and R Research Group LLC	Pembroke Pines	Florida	United States	33024
162	Research Physicians Network Alliance	Pembroke Pines	Florida	United States	33025
163	South Broward Research	Pembroke Pines	Florida	United States	33027
164	DBC Research USA	Pembroke Pines	Florida	United States	33029
165	DBC Research	Pembroke Pines	Florida	United States	33029
166	Cardiology Consultants	Pensacola	Florida	United States	32501
167	DMI Research, Inc.	Pinellas Park	Florida	United States	33782
168	Clinical Research of Central Florida	Plant City	Florida	United States	33563
169	Clinical Research of Florida	Plant City	Florida	United States	33563
170	Jeffrey D Greff,MD	Plantation	Florida	United States	33313-6066
171	St. Johns Center for Clinical Research	Ponte Vedra	Florida	United States	32081
172	Charlotte Heart Group Research Center	Port Charlotte	Florida	United States	33952
173	Meridien Research	Saint Petersburg	Florida	United States	33709
174	Advance Medical Research	Saint Petersburg	Florida	United States	33713
175	Intercoastal Medical Group	Sarasota	Florida	United States	34232
176	Intercoastal Medical Group	Sarasota	Florida	United States	34233
177	Cardiovascular Center Of Sarasota	Sarasota	Florida	United States	34239
178	Heart & Vascular Center Research	Sarasota	Florida	United States	34239
179	Intercoastal Medical Group (Drug Shipment Address and Administrative)	Sarasota	Florida	United States	34239
180	The Office of Bridget Bellingar, DO	Seminole	Florida	United States	33777
181	Vita Health & Medical Center, Inc./Concept Clinical Trials, LLC	Tamarac	Florida	United States	33319
182	Interventional Cardiac Consultants	Trinity	Florida	United States	34655
183	Cardiology Partners Clinical Research Institute	Wellington	Florida	United States	33449
184	Cleveland Clinic Cardiology Associates	West Palm Beach	Florida	United States	33401
185	Metabolic Research Institute, Inc.	West Palm Beach	Florida	United States	33401
186	Clinical Research of Central Florida	Winter Haven	Florida	United States	33880
187	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
188	Emory University Hospital	Atlanta	Georgia	United States	30322
189	Atlanta Center For Medical Research	Atlanta	Georgia	United States	30331
190	Columbus Regional Research Institute	Columbus	Georgia	United States	31904
191	Rockdale Medical Research Associates	Conyers	Georgia	United States	30094
192	Georgia Heart Specialists, LLC	Covington	Georgia	United States	30014
193	Neurostudies.net, LLC	Decatur	Georgia	United States	30033
194	Alta Pharmaceutical Research Center	Dunwoody	Georgia	United States	30338
195	In-Quest Medical Research, LLC	Norcross	Georgia	United States	30071
196	Atlanta Center for Clinical Research / Internal Medicine	Roswell	Georgia	United States	30075
197	Dr. B. Abraham, P.C.	Snellville	Georgia	United States	30039
198	Georgia Clinical Research, LLC	Snellville	Georgia	United States	30078
199	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
200	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
201	Elite Clinial Trials, LLLP	Blackfoot	Idaho	United States	83221
202	Elite Clinical Trials (Additional Administrative Room / Exam Rooms)	Blackfoot	Idaho	United States	83221
203	St. Luke's Idaho Cardiology Associates	Caldwell	Idaho	United States	83605
204	Solaris Clinical Research	Meridian	Idaho	United States	83646
205	Saltzer Medical Group, PA	Nampa	Idaho	United States	83686-6011
206	Northwest Heart Clinical Research, LLC	Arlington Heights	Illinois	United States	60005
207	Clinical Research Advantage, Inc./Michigan Avenue Internists	Chicago	Illinois	United States	60604
208	Apex Medical Research, AMR, Inc.	Chicago	Illinois	United States	60616
209	Clinical Research Advantage,Inc./Medical and Procedural Specilaists of Illinois	Chicago	Illinois	United States	60631
210	Evanston Premier Healthcare Research, LLC	Evanston	Illinois	United States	60201
211	Clinical Investigation Specialists, Inc	Gurnee	Illinois	United States	60031
212	Heart Care Centers of Illinois	Mokena	Illinois	United States	60448
213	Advanced CardioVascular Consultants	Rock Island	Illinois	United States	61201
214	Investigators Research Group, LLC	Brownsburg	Indiana	United States	46112
215	Investigative Clinical Research of Indiana, LLC	Elwood	Indiana	United States	46036
216	Deaconess Clinic Downtown	Evansville	Indiana	United States	47713
217	Clinical Research Advantage, Inc.	Evansville	Indiana	United States	47714
218	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
219	Clinical Research Advantage, Inc. / Family Medicine Associates	Evansville	Indiana	United States	47725
220	Deaconess Clinic Mt. Pleasant	Evansville	Indiana	United States	47725
221	American Health Network of Indiana LLC	Franklin	Indiana	United States	46131
222	American Health Network of Indiana LLC	Greenfield	Indiana	United States	46140
223	American Health Network of Indiana, LLC	Muncie	Indiana	United States	47304
224	Cardiovascular Research of Northwest Indiana, LLC	Munster	Indiana	United States	46321
225	Buynak Clinical Research, P.C.	Valparaiso	Indiana	United States	46383
226	West Broadway Clinic	Council Bluffs	Iowa	United States	51501
227	Clinical Research Advantage, Inc.	Council Bluffs	Iowa	United States	51503
228	Midwest Cardiovascular Research Foundation	Davenport	Iowa	United States	52803
229	University of Iowa-College of Public Health-Preventive Intervention Center	Iowa City	Iowa	United States	52242
230	Northeast Iowa Medical Education Foundation	Waterloo	Iowa	United States	50702
231	The Iowa Clinic, PC	West Des Moines	Iowa	United States	50266
232	Hutchinson Clinic, P.A	Hutchinson	Kansas	United States	67502
233	University Of Kansas Medical Center	Kansas City	Kansas	United States	66160
234	Midwest Heart & Vascular Specialists, LLC	Overland Park	Kansas	United States	66209
235	Women's & Family Care D.B.A. GTC Research	Shawnee Mission	Kansas	United States	66218
236	Women's & Family Care, LLC D.B.A GTC Research	Shawnee Mission	Kansas	United States	66218
237	Women's & Family Care, LLC D.B.A. GTC Research	Shawnee Mission	Kansas	United States	66218
238	Central Cardiology Associates Research	Elizabethtown	Kentucky	United States	42701
239	The Research Group of Lexington, LLC	Lexington	Kentucky	United States	40503
240	L-MARC	Louisville	Kentucky	United States	40213
241	Research Integrity, LLC.	Owensboro	Kentucky	United States	42303
242	Grace Research, LLC	Bossier City	Louisiana	United States	71111
243	Avant Research Associates, LLC	Crowley	Louisiana	United States	70526
244	Centex Studies	Lake Charles	Louisiana	United States	70601
245	Imperial Health, LLP	Lake Charles	Louisiana	United States	70601
246	American Clinical Research, LLC	Marrero	Louisiana	United States	70072
247	West Jefferson Heart Clinic of Louisiana New Orleans Physician Services, Inc.	Marrero	Louisiana	United States	70072
248	Clinical Trials of America LA	Monroe	Louisiana	United States	71201
249	KAMP Medical Research Inc.	Natchitoches	Louisiana	United States	71457
250	Clinical and Translation Research Center (CTRC) University Medical Center of New Orleans, Diagnostic	New Orleans	Louisiana	United States	70112
251	Section of Nephrology and Hypertension, LSU Health Sciences Center-New Orleans	New Orleans	Louisiana	United States	70112
252	Maine Research Associates	Auburn	Maine	United States	04210
253	Acadia Clinical Research, LLC	Bangor	Maine	United States	04401
254	Acadia Clinical Research	Bangor	Maine	United States	04401
255	Cranbrook Cardiology Research Associates	Cape Elizabeth	Maine	United States	04107
256	Anne Arundel Medical Center	Annapolis	Maryland	United States	21401
257	MedStar Cardiology Associates	Annapolis	Maryland	United States	21401
258	MedStar Chesapeake CardioVascular Associates	Baltimore	Maryland	United States	21204
259	MedStar Union Memorial Heart Specialists	Baltimore	Maryland	United States	21218
260	Maryland Cardiovascular Specialists	Baltimore	Maryland	United States	21229
261	Overlea Personal Physicians	Baltimore	Maryland	United States	21236
262	Shahid Saeed, MD, PC	Baltimore	Maryland	United States	21237
263	Maryland Heart Associates, LLC	Glen Burnie	Maryland	United States	21061
264	Lutherville Personal Physicians	Lutherville	Maryland	United States	21093
265	MD Medical Research	Oxon Hill	Maryland	United States	20745
266	MetroWest Medical Center - Pharmacy Department	Framingham	Massachusetts	United States	01702
267	MetroWest Medical Center Research Clinic	Framingham	Massachusetts	United States	01702
268	MetroWest Medical Center	Framingham	Massachusetts	United States	01702
269	ActivMed Practices and Research, Inc.	Methuen	Massachusetts	United States	01844
270	Charles River Medical Associates	Natick	Massachusetts	United States	01760
271	Endeavor Medical Research	Alpena	Michigan	United States	49707
272	St. Joseph Mercy Health System (Drug shipment Only)	Ann Arbor	Michigan	United States	48106
273	University of Michigan - Domino Farms	Ann Arbor	Michigan	United States	48106
274	Quest Research Institute	Bingham Farms	Michigan	United States	48025
275	IHA Chelsea Family & Internal Medicine	Chelsea	Michigan	United States	48118
276	Healthy Heart Cardiology	Grandville	Michigan	United States	49418
277	Westside Family Medical Center, Pc	Kalamazoo	Michigan	United States	49009
278	Sparrow Clinical Research Institute	Lansing	Michigan	United States	48912
279	Sparrow Thoracic & Cardiovascular Institute	Lansing	Michigan	United States	48912
280	Detroit Clinical Research Center, PC	Livonia	Michigan	United States	48154
281	MidMichigan Medical Center Midland	Midland	Michigan	United States	48670
282	Michigan Cardio Vascular Institute	Saginaw	Michigan	United States	48601
283	Tri-County Research, Inc.	Sterling Heights	Michigan	United States	48310
284	Medical Research Associates, Inc.	Traverse City	Michigan	United States	49684
285	Oakland Medical Research Center	Troy	Michigan	United States	48085
286	Arcturus Healthcare, PLC, Troy Internal Medicine Research Division	Troy	Michigan	United States	48098
287	Michigan Heart & Vascular Institute	Ypsilanti	Michigan	United States	48197
288	Duluth Clinic, dba Essentia Health Duluth Clinic Investigational Drug Room	Duluth	Minnesota	United States	55805
289	St. Mary's Medical Center dba Essentia Health St. Mary's Medical Center	Duluth	Minnesota	United States	55805
290	St. Mary's Medical Center	Duluth	Minnesota	United States	55805
291	The Duluth Clinic, Ltd.	Duluth	Minnesota	United States	55805
292	Radiant Research, Inc.	Edina	Minnesota	United States	55435
293	Minneapolis Clinic of Neurology	Golden Valley	Minnesota	United States	55422
294	Allina Health System, dba Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
295	Lillehei Clinical Research Unit, University of Minnesota	Minneapolis	Minnesota	United States	55455
296	CentraCare Heart and Vascular Center	Saint Cloud	Minnesota	United States	56303
297	HealthEast St. Joseph's Hospital inpatient Pharmacy	Saint Paul	Minnesota	United States	55102
298	Olive Branch Family Medical Center	Olive Branch	Mississippi	United States	38654
299	Cardiology Associates Research, LLC	Tupelo	Mississippi	United States	38801
300	Missouri Cardiovascular Specialists, LLP	Columbia	Missouri	United States	65201
301	Saint Luke's Lipid and Diabetes Research Center	Kansas City	Missouri	United States	64111
302	Kansas City VA Medical Center	Kansas City	Missouri	United States	64128-2226
303	Mercy Research	Saint Louis	Missouri	United States	63141
304	Glacier View Research Institute, Cardiology	Kalispell	Montana	United States	59901
305	Montana Medical Research Inc.	Missoula	Montana	United States	59808
306	Bryan Heart	Lincoln	Nebraska	United States	68506
307	Creighton Diabetes Research Center	Omaha	Nebraska	United States	68131
308	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
309	AB Clinical Trials	Las Vegas	Nevada	United States	89119
310	Clinical Research of South Nevada	Las Vegas	Nevada	United States	89121
311	Clinical Research Advantage, Inc.	Las Vegas	Nevada	United States	89128
312	John V. Bernard, MD dba Wellness and Research Center	Belvidere	New Jersey	United States	07823
313	Advanced Heart Care LLC	Bridgewater	New Jersey	United States	08807
314	Lourdes Cardiology Services	Cherry Hill	New Jersey	United States	08034
315	USMA Clinical Research	Elizabeth	New Jersey	United States	07201
316	Lourdes Cardiology Services	Hammonton	New Jersey	United States	08037
317	NJ Heart	Linden	New Jersey	United States	07036
318	Arysmed LLC	Lodi	New Jersey	United States	07644
319	Amici Clinical Research, LLC	Martinsville	New Jersey	United States	08836
320	Rutgers Biomedical and Health Sciences-Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901
321	Cardiac & Endovascular Associates	Ridgewood	New Jersey	United States	07450
322	The Valley Hospital	Ridgewood	New Jersey	United States	07450
323	Cardio Metabolic Institute	Somerset	New Jersey	United States	08873
324	TLB Research LLC	Trenton	New Jersey	United States	08611
325	Lourdes Cardiology Services	Voorhees	New Jersey	United States	08043
326	Westwood Cardiology Associates, P.A.	Westwood	New Jersey	United States	07675
327	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico	United States	87102
328	Albany Medical College, Division of Community Endocrinology	Albany	New York	United States	12206
329	Sorin Medical, P.C.	Brooklyn	New York	United States	11214
330	NY Total Medical Care, PC	Brooklyn	New York	United States	11215
331	NY Scientific	Brooklyn	New York	United States	11235
332	Buffalo Heart Group, Llp	Buffalo	New York	United States	14215
333	NYU Hudson Valley Cardiology	Cortlandt Manor	New York	United States	10567
334	Scott Research,Inc	Laurelton	New York	United States	11413
335	SJH Cardiology Associates	Liverpool	New York	United States	13088
336	Long Island Heart Associates	Mineola	New York	United States	11501
337	Mid Hudson Medical Research, PLLC	New Windsor	New York	United States	12553
338	Manhattan Medical Research Practice	New York	New York	United States	10016
339	Peters Medical Research NY, LLC	New York	New York	United States	10016
340	Weill Cornell Medical College	New York	New York	United States	10065
341	DiGiovanna Institute for Medical Education And Research	North Massapequa	New York	United States	11758-1802
342	Hudson Valley Cardiovascular Practice, PC	Poughkeepsie	New York	United States	12601
343	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
344	Institute for Clinical Studies	Rosedale	New York	United States	11422
345	Saratoga Clinical Research, LLC	Saratoga Springs	New York	United States	12866
346	Central New York Cardiology	Utica	New York	United States	13501
347	Great Lakes Medical Research	Westfield	New York	United States	14787
348	Buffalo Medical Group	Williamsville	New York	United States	14221
349	Novant Health Clinical Research	Charlotte	North Carolina	United States	28204
350	Novant Health Heart and Vascular Institute	Charlotte	North Carolina	United States	28204
351	Sensenbrenner Primary Care	Charlotte	North Carolina	United States	28277
352	NC Heart and Vascular	Clayton	North Carolina	United States	27520
353	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina	United States	27401
354	Clinical Trials of America, Inc.	Hickory	North Carolina	United States	28601
355	Carolina Cardiology Cornerstone	High Point	North Carolina	United States	27262
356	Clinical Trials of America- NC, LLC	Lenoir	North Carolina	United States	28645
357	Research Institute of the Carolinas of Piedmont Healthcare, PA	Mooresville	North Carolina	United States	28117
358	Burke Primary Care	Morganton	North Carolina	United States	28655
359	Eastern Nephrology Associates	New Bern	North Carolina	United States	28562
360	Boice Willis Clinic	Rocky Mount	North Carolina	United States	27804
361	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina	United States	27804
362	NC Heart and Vascular Research	Smithfield	North Carolina	United States	27577
363	Piedmont Healthcare/Research	Statesville	North Carolina	United States	28625
364	Wake Forest University Health Sciences Institutional Review Board	Winston-Salem	North Carolina	United States	27157
365	Lillestol Research LLC	Fargo	North Dakota	United States	58103
366	Radiant Research, Inc	Akron	Ohio	United States	44311
367	The Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio	United States	45219
368	Metabolic and Atherosclerosis Research Center	Cincinnati	Ohio	United States	45227
369	Sterling Research Group, Ltd.	Cincinnati	Ohio	United States	45246
370	Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
371	Cleveland Clinic - Taussig Cancer Institute	Cleveland	Ohio	United States	44195
372	Radiant Research, Inc.	Columbus	Ohio	United States	43212
373	Optimed Research, LTD	Columbus	Ohio	United States	43235
374	Dayton Heart Center	Dayton	Ohio	United States	45414
375	Premier Health Specialists, Inc. (dba Dayton Heart Center)	Dayton	Ohio	United States	45414
376	PriMed Clinical Research	Dayton	Ohio	United States	45419
377	Delaware Research Group, LLC	Delaware	Ohio	United States	43015
378	North Ohio Heart Center (Administrative Only)	Elyria	Ohio	United States	44035
379	North Ohio Heart Center	Elyria	Ohio	United States	44035
380	North Ohio Heart Center	Lorain	Ohio	United States	44053
381	SV Research LLC	Marion	Ohio	United States	43302
382	Office of Daniel G. Williams, MD	Perrysburg	Ohio	United States	43551
383	North Ohio Heart Center, Inc.	Sandusky	Ohio	United States	44870
384	ProMedica Northwest Ohio Cardiology Consultants	Toledo	Ohio	United States	43615
385	Mercy Health Youngstown, LLC d/b/a St. Elizabeth Youngstown Hospital	Youngstown	Ohio	United States	44501
386	LION Research	Norman	Oklahoma	United States	73069
387	LION Research	Norman	Oklahoma	United States	73072
388	COR Clinical Research LLC	Oklahoma City	Oklahoma	United States	73103
389	Oklahoma Heart Hospital Physicians	Oklahoma City	Oklahoma	United States	73120
390	Oklahoma Heart Hospital Research Foundation	Oklahoma City	Oklahoma	United States	73120
391	South Oklahoma Heart Research, LLC	Oklahoma City	Oklahoma	United States	73135
392	Integrated Medical Research PC	Ashland	Oregon	United States	97520
393	Hillsboro Cardiology, PC	Hillsboro	Oregon	United States	97123
394	Portland Preventive Cardiology LLC	Portland	Oregon	United States	97225
395	Abington Hosptial	Abington	Pennsylvania	United States	19001
396	Clinical Research Associates of Central PA	Altoona	Pennsylvania	United States	16602
397	Brandywine Clinical Research	Downingtown	Pennsylvania	United States	19335-2620
398	Doylestown Cardiology Associates - VIAA	Doylestown	Pennsylvania	United States	18901
399	Doylestown Health Cardiology, a division of Doylestown Health Physicians	Doylestown	Pennsylvania	United States	18901
400	Amh/Feasterville Family Health Care Center	Feasterville-Trevose	Pennsylvania	United States	19053
401	Greater Pittsburgh Vascular	Jefferson Hills	Pennsylvania	United States	15025
402	Detweiler Family Medicine and Associates, PC	Lansdale	Pennsylvania	United States	19446
403	Green and Seidner Family Practice Associates	Lansdale	Pennsylvania	United States	19446
404	Family Medical Associates	Levittown	Pennsylvania	United States	19056
405	Mercer Bucks Cardiology	Newtown	Pennsylvania	United States	18940
406	Philadelphia Health Associates-Adult Medicine	Philadelphia	Pennsylvania	United States	19146
407	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania	United States	15212
408	Preferred Primary Care Physicians	Pittsburgh	Pennsylvania	United States	15236
409	Guthrie Medical Group, PC	Sayre	Pennsylvania	United States	18840
410	SFM Clinical Trials, Inc.	Scotland	Pennsylvania	United States	17254
411	Fay-West Family Practice	Scottdale	Pennsylvania	United States	15683
412	Grand View - Lehigh Valley Health Services, Buxmont Cardiology Division	Sellersville	Pennsylvania	United States	18960
413	Montgomery Medical, Inc.	Smithfield	Pennsylvania	United States	15478
414	Preferred Primary Care Physicians	Uniontown	Pennsylvania	United States	15401
415	Berks Cardiologists, Ltd.	Wyomissing	Pennsylvania	United States	19610
416	Coastal Cardiology	Charleston	South Carolina	United States	29407
417	Upstate Pharmaceutical Research	Greenville	South Carolina	United States	29615
418	Mountain View Clinical Research, Inc.	Greer	South Carolina	United States	29651
419	The Diabetes Center, LLC	Murrells Inlet	South Carolina	United States	29576
420	Black Hills Cardiovascular-Regional Health Research	Rapid City	South Dakota	United States	57701
421	Mid-Cumberland Infectious Disease Consultants, PLC	Clarksville	Tennessee	United States	37043
422	Collierville Medical Specialists	Collierville	Tennessee	United States	38017
423	Stern Cardiovascular Foundation, Inc.	Germantown	Tennessee	United States	38138
424	Holston Medical Group	Kingsport	Tennessee	United States	37660
425	New Phase Research & Development	Knoxville	Tennessee	United States	37909
426	PMG Research,Inc d/b/a PMG Research of Knoxville	Knoxville	Tennessee	United States	37912
427	Cardiovascular Research of Knoxville	Knoxville	Tennessee	United States	37917
428	New Orleans Center for Clinical Research	Knoxville	Tennessee	United States	37920
429	Volunteer Research Group	Knoxville	Tennessee	United States	37920
430	Baptist Memorial Medical Group, Inc.	Memphis	Tennessee	United States	38119
431	The Green Clinic, PC	Memphis	Tennessee	United States	38119
432	Southwind Medical Specialists	Memphis	Tennessee	United States	38125
433	Tennessee Center for Clinical Trials	Tullahoma	Tennessee	United States	37388
434	Trinity Clinical Research, LLC	Tullahoma	Tennessee	United States	37388
435	PharmaTex Research	Amarillo	Texas	United States	79106
436	Arlington Family Research Center, Inc.	Arlington	Texas	United States	76012
437	Texas Diabetes & Endocrinology	Austin	Texas	United States	78731
438	Austin Heart, PLLC	Austin	Texas	United States	78756
439	Aztec Medical Research, LLC	Channelview	Texas	United States	77530
440	Corsicana Medical Research, PLLC	Corsicana	Texas	United States	75110
441	Protenium Clinical Research, LLC	Dallas	Texas	United States	75208
442	VA North Texas Health Care System - Dallas VAMC	Dallas	Texas	United States	75216
443	Baylor Heart and Vascular Institute	Dallas	Texas	United States	75226
444	Dallas Diabetes and Endocrine Center	Dallas	Texas	United States	75230
445	Cardiovascular Research Institute of Dallas	Dallas	Texas	United States	75231
446	Radiant Research, Inc.	Dallas	Texas	United States	75231
447	Research Institute of Dallas	Dallas	Texas	United States	75231
448	Doctors Hospital At Renaissance	Edinburg	Texas	United States	78539
449	Amir Malik Research	Fort Worth	Texas	United States	76104
450	The Medical Group Of Texas	Fort Worth	Texas	United States	76104
451	Rockwood Medical Clinic	Fort Worth	Texas	United States	76164
452	San Gabriel Clinical Research, LLC	Georgetown	Texas	United States	78626
453	East Texas Cardiology PA	Houston	Texas	United States	77002
454	Spring Clinical Research	Houston	Texas	United States	77002
455	Med Tech Research, LP	Houston	Texas	United States	77024
456	Prime Care Medical Group	Houston	Texas	United States	77024
457	Associates in Medicine, PA	Houston	Texas	United States	77027
458	Alan S. Hoffman, M.D.	Houston	Texas	United States	77030
459	Baylor College of Medicine	Houston	Texas	United States	77030
460	Investigational Product Shipment Address TO: Investigational Drug Services (IDS),	Houston	Texas	United States	77030
461	Centex Studies, Inc.	Houston	Texas	United States	77058
462	Northwest Houston Cardiology	Houston	Texas	United States	77070
463	Texas Center For Drug Development, Inc.	Houston	Texas	United States	77081
464	Private Practice Leadership, LLC	Houston	Texas	United States	77094
465	Protenium Clinical Research	Hurst	Texas	United States	76054
466	South Texas Cardiovascular Consultants, PLLC	Kerrville	Texas	United States	78028
467	Caprock Cardiac Center Research Institute Inc.	Lubbock	Texas	United States	79410
468	Midland Clinical Research Center	Midland	Texas	United States	79707
469	Hill Country Medical Associates	New Braunfels	Texas	United States	78130
470	North Hills Medical Research, Inc.	North Richland Hills	Texas	United States	76180
471	Grace Research, LLC	Palestine	Texas	United States	75801
472	Med-Olam Clinical Research	Pasadena	Texas	United States	77504
473	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas	United States	78660
474	Austin Institute for Clinical Research,Inc.	Pflugerville	Texas	United States	78660
475	Centex Studies, Inc	Pharr	Texas	United States	78577
476	Legacy Heart Center	Plano	Texas	United States	75024
477	South Texas Cardiovascular Consultants, PLLC	San Antonio	Texas	United States	78201
478	Sun Research Institute	San Antonio	Texas	United States	78215
479	Southwest Clinic	San Antonio	Texas	United States	78221
480	Victorium Clinical Research	San Antonio	Texas	United States	78231
481	Bandera Family Health Care, LLC	San Antonio	Texas	United States	78249
482	Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)	Schertz	Texas	United States	78154
483	Acacia Medical Research Institute, LLC	Sugar Land	Texas	United States	77478
484	IP + Dry ice deliveries Sugar Lakes Family Practice	Sugar Land	Texas	United States	77478
485	Sugar Lakes Family Practice	Sugar Land	Texas	United States	77479
486	Northwest Houston Heart Center	Tomball	Texas	United States	77375-4536
487	Admin & Storage only:Northwest Heart Center	Tomball	Texas	United States	77375
488	Northwest Heart Center	Tomball	Texas	United States	77375
489	Northwest Houston Clinical Research, PLLC	Tomball	Texas	United States	77375
490	Victoria Heart and Vascular Center, PA	Victoria	Texas	United States	77901
491	Utah Cardiology, PC	Bountiful	Utah	United States	84010
492	Utah Cardiology, P.C.	Layton	Utah	United States	84041
493	Paramount Medical Care	Ogden	Utah	United States	84405
494	Aspen Clinical Research LLC	Orem	Utah	United States	84058
495	Revere Health	Provo	Utah	United States	84604
496	Optimum Clinical Research, Inc.	Salt Lake City	Utah	United States	84102
497	Wasatch Clinical Research, LLC	Salt Lake City	Utah	United States	84107
498	Holladay Family Practice	Salt Lake City	Utah	United States	84117
499	Heart Center at St. Mark's Hospital	Salt Lake City	Utah	United States	84124
500	Burke Internal Medicine & Research	Burke	Virginia	United States	22015
501	Clinical Research Institute of Northern Virginia	Burke	Virginia	United States	22015
502	Virginia Heart	Falls Church	Virginia	United States	22042
503	Seven Corners Medical Research Center	Falls Church	Virginia	United States	22044
504	Heart Care Associates, P.C.	Hopewell	Virginia	United States	23860
505	Virginia Research Center	Midlothian	Virginia	United States	23114
506	Chippenham and Johnston Willis Hospitals, Inc. dba CJW Medical Center	Richmond	Virginia	United States	23225
507	Retreat Cardiology LLC, dba Cardiology Associates of Richmond	Richmond	Virginia	United States	23225
508	Roanoke Heart Institute	Roanoke	Virginia	United States	24014
509	Hampton Roads Center for Clinical Research	Suffolk	Virginia	United States	23435
510	Office of Daniel W. Gottlieb, MD, PS	Burien	Washington	United States	98166
511	Premier Clinical Research	Spokane	Washington	United States	99202
512	Universal Research Group, LLC	Tacoma	Washington	United States	98405
513	Walla Walla Clinic	Walla Walla	Washington	United States	99362
514	Wenatchee Valley Hospital & Clinics	Wenatchee	Washington	United States	98801
515	Exemplar Research Inc	Fairmont	West Virginia	United States	26554
516	Prevea Clinic, Inc.	Green Bay	Wisconsin	United States	54303
517	Clinical Investigation Specialists, Inc.	Kenosha	Wisconsin	United States	53142
518	Waukesha Heart Foundation	Waukesha	Wisconsin	United States	53188
519	Instituto de Investigaciones Clinicas Bahia Blanca	Bahia Blanca	Buenos Aires	Argentina	B8000FTD
520	Hospital Italiano Regional del Sur	Bahia Blanca	Buenos Aires	Argentina	B8001HXM
521	CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A.	C.a.b.a.	Buenos Aires	Argentina	C1119ACN
522	Hospital Britanico De Buenos Aires	Ciudad Autonoma de B. Aires	Buenos Aires	Argentina	C1280AEB
523	Investigaciones Medicas IMOBA S.R.L.	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1179AAB
524	CEDIC - Consultorios Medicos	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1425DES
525	Clinica Coronel Suarez S.A.	Coronel Suarez	Buenos Aires	Argentina	B7540GHD
526	Framingham Centro Medico	La Plata	Buenos Aires	Argentina	B1902COS
527	CIMeL CHAHIN CHAHIN S.A.	Lanus Este	Buenos Aires	Argentina	B1824KAJ
528	Instituto de Investigaciones Clinicas Mar del Plata	Mar del Plata	Buenos Aires	Argentina	B7600FZN
529	DIM Clinica Privada	Ramos Mejia	Buenos Aires	Argentina	B1704ETD
530	Instituto de Investigaciones Clinicas Zarate	Zarate	Buenos Aires	Argentina	B2800DGH
531	Consultorios Asociados de Endocrinologia e Investigacion Clinica Aplicada	C.a.b.a	C.a.b.a.	Argentina	C1425AGC
532	STAT Research S.A.	C.a.b.a	Caba	Argentina	C1023AAB
533	Clinica Privada de Especialidades Medicas	Villa Maria	Cordoba	Argentina	5901
534	CIPADI Centro Integral de Prevencion y Atencion en Diabetes	Godoy Cruz	Mendoza	Argentina	M5501ARP
535	IMEP Instituto Medico Elsa Perez	Ciudadela	PCIA DE Buenos Aires	Argentina	1702
536	Instituto Medico Aguero	Moron	PCIA DE Buenos Aires	Argentina	B1708CGU
537	Cordis - Instituto del Corazon	Resistencia	PCIA DE Chaco	Argentina	H3500CDM
538	Hospital de Alta Complejidad "Pte. Juan Domingo Peron"	Formosa	PCIA DE Formosa	Argentina	3600
539	Hospital Provincial Dr. Jose Maria Cullen	Santa Fe	PCIA DE Santa FE	Argentina	S3000EOZ
540	Centro De Investigaciones Clinicas Del Litoral S.R.L.	Santa Fe	PCIA DE Santa FE	Argentina	S3000FWO
541	Cedir S.A - Centro De Diagnostico Y Rehabilitacion S.A.	Santa Fe	PCIA DE Santa FE	Argentina	S3004CVS
542	Centro Modelo de Cardiologia	San Miguel De Tucuman	PCIA DE Tucuman	Argentina	T4000IFL
543	Instituto de Hematologia y Medicina Clinica "Dr. Ruben A. Davoli"	Rosario	Pcia. DE Santa FE	Argentina	S2000CFK
544	Instituto Medico Ceniclar - Central De Investigaciones Clinicas Argentina - Sanatorio De La Mujer	Rosario	Provincia DE Santa FE	Argentina	S2000QID
545	Centro Medico CCBR Tucuman	San Miguel de Tucuman	Tucuman	Argentina	T4000IAF
546	Cicemo - Consultorio de Investigaciones Clinicas E.M.O. S.R.L.	Ciudad Autonoma De B. Aires		Argentina	C1405BUB
547	Instituto Cardiovascular De Buenos Aires	Ciudad Autonoma de B. Aires		Argentina	C1428ART
548	Universidad Maimonides	Ciudad Autonoma De Buenos Aires		Argentina	C1405BCK
549	Centro de Investigacion: AXISMED S.R.L.	Ciudad Autonoma de Buenos Aires		Argentina	C1430CKE
550	ILAIM Instituto Latinoamericano de Investigaciones Medicas	Cordoba		Argentina	X5000BNB
551	Clinico Chutro SRL	Cordoba		Argentina	X5000EPU
552	Centro de Investigaciones Clinicas "Instituto del Corazon"	Cordoba		Argentina	X5000EVQ
553	Clinica Privada Colombo	Cordoba		Argentina	x5002AOQ
554	Instituto Medico DAMIC S.R.L.	Cordoba		Argentina	X5003DCE
555	Centro Medico Luquez	Cordoba		Argentina	X5006IKK
556	IPAC Caraffa	Cordoba		Argentina	X5008KKF
557	Instituto de Cardiologia de Corrientes "Juana Fca. Cabral"	Corrientes		Argentina	3400
558	Hospital Central de Mendoza	Mendoza		Argentina	5500
559	Cordis S.A.	Salta		Argentina	4400
560	Centro Cardiovascular Salta	Salta		Argentina	A4406BPF
561	Instituto Cardiovascular San Luis A.E.	San Luis		Argentina	D5702JRS
562	Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders	Camperdown	New South Wales	Australia	2050
563	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
564	Central Coast Neurosciences Research	Erina	New South Wales	Australia	2250
565	Central Coast Local Health District, Gosford Hospital	Gosford	New South Wales	Australia	2250
566	Australian Clinical Research Network	Maroubra	New South Wales	Australia	2035
567	Holy Spirit Northside Private Hospital Limited	Chermside	Queensland	Australia	4032
568	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4029
569	Core Research Group Pty Ltd	Milton	Queensland	Australia	4064
570	Redcliffe Hospital	Redcliffe	Queensland	Australia	4020
571	Austrials Pty Ltd	Sherwood	Queensland	Australia	4075
572	Gold Coast University Hospital	Southport	Queensland	Australia	4215
573	Adelaide Medical Research	Ashford	South Australia	Australia	5035
574	SA Heart	Ashford	South Australia	Australia	5035
575	Southern Adelaide Diabetes and Endocrine Service	Daws Park	South Australia	Australia	5041
576	Department of Cardiology, Lyell McEwin Hospital	Elizabeth Vale	South Australia	Australia	5112
577	Heart and Vascular Research	Fullarton	South Australia	Australia	5063
578	Launceston General Hospital	Launceston	Tasmania	Australia	7250
579	Eastern Health - Box Hill Hospital	Box Hill	Victoria	Australia	3128
580	The Northern Hospital	Epping	Victoria	Australia	3076
581	Barwon Health-The Geelong Hospital	Geelong	Victoria	Australia	3220
582	Austin Health - Heidelberg Repatriation Hospital	Heidelberg West	Victoria	Australia	3081
583	Alfred Hospital	Melbourne	Victoria	Australia	3004
584	Fremantle Hospital	Fremantle	Western Australia	Australia	6160
585	HPS Pharmacies	Joondalup	Western Australia	Australia	6027
586	Joondalup Cardiovascular Trials Foundation Inc.	Joondalup	Western Australia	Australia	6027
587	VZW Algemeen Ziekenhuis KLINA	Brasschaat	Antwerpen	Belgium	2930
588	AZ Sint-Maarten	Mechelen	Antwerp	Belgium	2800
589	Algemeen Stedelijk Ziekenhuis	Aalst	Oost-vlaanderen	Belgium	9300
590	Az Sint Blasius	Dendermonde	Oost-vlaanderen	Belgium	9200
591	AZ Sint Lucas Gent	Gent	Oost-vlaanderen	Belgium	9000
592	Universitair Ziekenhuis Gent	Gent	Oost-vlaanderen	Belgium	9000
593	Az Glorieux	Ronse	Oost-vlaanderen	Belgium	9600
594	AZ Nikolaas, Campus Moerland	Sint-Niklaas	Oost-vlaanderen	Belgium	9100
595	AZ Groeninge-Campus Loofstraat	Kortrijk	West-vlaanderen	Belgium	8500
596	Az Damiaan	Oostende	West-vlaanderen	Belgium	8400
597	ZNA Campus Middelheim	Antwerpen		Belgium	2020
598	Imeldaziekenhuis Bonheiden	Bonheiden		Belgium	2820
599	A.Z. St.Jan AV Brugge	Brugge		Belgium	8000
600	University Hospital Brussels - Centrum voor hart- en vaatziekten	Brussels		Belgium	1090
601	University Hospital Brussels- Diabeteskliniek	Brussels		Belgium	1090
602	Private Practice 'Cardiovascular Detection Center'	De Pinte		Belgium	9840
603	ZOL Campus Sint-Jan	Genk		Belgium	3600
604	AZ Maria Middelares	Gent		Belgium	9000
605	Grand Hopital de Charleroi, Site St-Joseph	Gilly		Belgium	6060
606	Hygeia	Hasselt		Belgium	3500
607	Jessa Ziekenhuis	Hasselt		Belgium	3500
608	Sint-Franciskusziekenhuis	Heusden-Zolder		Belgium	3550
609	Centre Hospitalier Regional de Huy	Huy		Belgium	4500
610	Jan Yperman Ziekenhuis, Cardiology	Ieper		Belgium	8900
611	Centre Hospitalier De Jolimont - Lobbes	La Louviere (Haine-Saint-Paul)		Belgium	7100
612	Centre Hospitalier de Jolimont-Lobbes	La Louviere (Haine-Saint-Paul)		Belgium	7100
613	University hospitals Leuven - Neurology department	Leuven		Belgium	3000
614	University hospitals Leuven	Leuven		Belgium	3000
615	Centre Hospitalier Universitaire (CHU) de Liege	Liege		Belgium	4000
616	Huisartsenpraktijk Medilink	Linkebeek		Belgium	1630
617	Huisartsenpraktijk Luc Capiau	Massemen		Belgium	9230
618	C.H.U. Ambroise Pare	Mons		Belgium	7000
619	Mariaziekenhuis vzw	Overpelt		Belgium	3900
620	Dr. Luc De Wolf - Private Practice	Tienen		Belgium	3300
621	Fundacao Bahiana De Cardiologia	Salvador	BA	Brazil	41810-010
622	HBA S/A ASSISTENCIA MEDICA E HOSPITALAR-Hospital da Bahia	Salvador	BA	Brazil	41810-011
623	Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas Ltda	Fortaleza	CE	Brazil	60430-140
624	Covance Central Laboratory Services	Indianapolis	Indiana	Brazil	46214-2985
625	CARDSEARCH/CARDRESEARCH - Cardiologia Assistencial e de Pesquisa LTDA	Belo Horizonte	Minas Gerais	Brazil	30150-240
626	Nucleo de Pesquisa Clínica	Curitiba	Parana	Brazil	80730-150
627	Universidade Federal do Para - Hospital Universitario Joao de Barros Barreto	Belem	PA	Brazil	66073-000
628	Hospital Agamenon Magalhaes	Recife	Pernambuco	Brazil	52051-380
629	Centro de Pesquisas Medicas Basica e Clinica LTDA	Recife	PE	Brazil	52020-010
630	Sociedade Hospitalar Angelina Caron/Hospital e Maternidade Angelina Caron	Campina Grande do Sul	PR	Brazil	83430-000
631	Hospital Santa Casa de Curitiba	Curitiba	PR	Brazil	80010-030
632	Quanta Diagnostico e Terapia / Medicina Nuclear Alto da XV	Curitiba	PR	Brazil	80045-170
633	Hospital Universitario - Associacao Educadora Sao Carlos - AESC	Canoas	RIO Grande DO SUL	Brazil	92425-055
634	Irmandade Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RIO Grande DO SUL	Brazil	90020-090
635	Hospital Mae de Deus/Associacao Educadora Sao Carlos AESC / IMV - Instituto de Medicina Vascular	Porto Alegre	RIO Grande DO SUL	Brazil	90110-270
636	Instituto de Cardiologia do Rio Grande do Sul / Fundacao Universitaria de Cardiologia	Porto Alegre	RIO Grande DO SUL	Brazil	90620-001
637	Hospital Mae de Deus - Instituto do Cancer	Porto Alegre	RIO Grande DO SUL	Brazil	90840-440
638	Hospital Mae de Deus-Associacao Educadora de Sao Carlos-AESC/IMV - Instituto de Medicina Vascular	Porto Alegre	RIO Grande DO SUL	Brazil	90840-440
639	Mae de Deus - Centro de Oncologia Radioterapica (COR)	Porto Alegre	RIO Grande DO SUL	Brazil	90840-440
640	CCBR Brasil - Centro de Pesquisa e Analises Clinicas LTDA	Rio de Janeiro	RJ	Brazil	22271-100
641	Hospital Santa Isabel	Blumenau	Santa Catarina	Brazil	89010-906
642	Loema Medicina e Bem Estar- Centro Especializado em Cardiologia Ltda.	Campinas	SAO Paulo	Brazil	13010-001
643	IMC - Instituto de Molestias Cardiovasculares/Equipamentos Cardiovasculares Rio Preto Ltda	Sao Jose do Rio Preto	SAO Paulo	Brazil	15015210
644	CAEP - Centro Avançado de Estudos e Pesquisas Ltda.	Campinas	SP	Brazil	13087-567
645	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)	Sao Paulo	SP	Brazil	05403-010
646	CARDSEARCH/CARDRESEARCH - Cardiologia Assistencial e de Pesquisa LTDA	Minas Gerais		Brazil	30150-240
647	CPClin- Centro de Pesquisas Clinicas Ltda./Clinica Dr. Freddy Goldberg Eliaschewitz	Sao Paulo		Brazil	01244-030
648	FGM-Clinica Paulista de Doencas Cardiovasculares	Sao Paulo		Brazil	01327-010
649	CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda	Sao Paulo		Brazil	04266-010
650	LMC Diabetes & Endocrinology (Calgary)	Calgary	Alberta	Canada	T2H 2G4
651	Foothills Hospital/University of Calgary	Calgary	Alberta	Canada	T2N 4Z6
652	Nanji Professional Corporation	Calgary	Alberta	Canada	T2V 4J2
653	The Medical Arts Health Research Group	Kelowna	British Columbia	Canada	V1Y 1V6
654	Kelowna Cardiology Associates	Kelowna	British Columbia	Canada	VlY 1V6
655	Dr. Raymond Dong Inc.	Surrey	British Columbia	Canada	V3V 0C6
656	Dr. Richard Bon Inc. & Dr. Adam Yeung Inc.	Surrey	British Columbia	Canada	V3V 0C6
657	Dr. Stephen S. Cheung Inc.	Surrey	British Columbia	Canada	V3V 0C6
658	SMH Cardiology Clinical Trials	Surrey	British Columbia	Canada	V3V 0C6
659	Dr. Dante E. Manyari Inc.	Surrey	British Columbia	Canada	V3V 1N1
660	Dr. Stephanie Au, Inc.	Surrey	British Columbia	Canada	V3V 1N1
661	Dr. Stephen Pearce Inc. & Dr. Peter K.H. Tan Inc.	Surrey	British Columbia	Canada	V3V 1N1
662	SMH Cardiology Clinical Trials Inc	Surrey	British Columbia	Canada	V3V 1N1
663	Dr. Adam Yeung Inc.	Surrey	British Columbia	Canada	V3V OC6
664	Dr. Michael Kanakos Inc.	Surrey	British Columbia	Canada	V3V OC6
665	Dr. Stephen S. Cheung Inc.	Surrey	British Columbia	Canada	V3VOC6
666	Dr. Kapil M. Bhagirath Medical Services Corporation	Surrey	British Columbia	Canada	V3W 3C3
667	Victoria Heart Institute Foundation	Victoria	British Columbia	Canada	V8R 4R2
668	Discovery Clinical Services Ltd.	Victoria	British Columbia	Canada	V8T 5G4
669	St. Boniface Hospital	Winnipeg	Manitoba	Canada	R2H 2A6
670	G.A. Research Associates Ltd.	Moncton	New Brunswick	Canada	E1G 1A7
671	Cardiology Research Associates of New Brunswick	Saint John	New Brunswick	Canada	E2L 4L2
672	Health Sciences Centre	St. John's	NF	Canada	A1B 3V6
673	Health Science Centre	St. John's	NF	Canada	A1B3V6
674	LMC Diabetes & Endocrinology (Brampton)	Brampton	Ontario	Canada	L6S 0C9
675	Aviva Clinical Trial Group Inc.	Burlington	Ontario	Canada	L7M 4Y1
676	JBN Medical Diagnostic Services Inc.	Burlington	Ontario	Canada	L7M 4Y1
677	Philippe R. Beaudry Medicine Professional Corporation	Burlington	Ontario	Canada	L7R 4E2
678	Cambridge Cardiac Care Centre	Cambridge	Ontario	Canada	N1R 6V6
679	Vizel Cardiac Research - Saul Vizel Professional Medicine Corporation	Cambridge	Ontario	Canada	N1R 7R1
680	Moran Medical Centre	Collingwood	Ontario	Canada	L9Y 1W3
681	C & L Research	Fort Erie	Ontario	Canada	L2A 1Z3
682	Parkdale Medical Centre	Hamilton	Ontario	Canada	L8K 3P3
683	Stroke Prevention & Atherosclerosis Research Centre (SPARC)	London	Ontario	Canada	N6G 2V2
684	Western University - WCPHFM	London	Ontario	Canada	N6G2Ml
685	LMC Diabetes & Endocrinology (Markham)	Markham	Ontario	Canada	L6B 0P9
686	Newmarket Cardiology Research Group	Newmarket	Ontario	Canada	L3Y 8C3
687	LMC Clinical Research Inc. (Oakville)	Oakville	Ontario	Canada	L6M 1M1
688	The Office of Dr. James Cha	Oshawa	Ontario	Canada	L1J 2K1
689	Kawartha Cardiology Clinical Trials	Peterborough	Ontario	Canada	K9J 0B2
690	London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario	Canada	N7T 4X3
691	Sarnia Institute of Clinical Research	Sarnia	Ontario	Canada	N7T 4X3
692	Scarborough Cardiology Research Associates Inc.	Scarborough	Ontario	Canada	M1E 5E9
693	Canadian Centre for Research on Diabetes	Smiths Falls	Ontario	Canada	K7A 4W8
694	Brian Y.L. Wong Medicine Professional Corporation	Sudbury	Ontario	Canada	P3E 2N8
695	LMC Diabetes & Endocrinology (Thornhill)	Thornhill	Ontario	Canada	L4J 8L7
696	JJ Dig Research LTD	Toronto	Ontario	Canada	M3J 1N2
697	Canadian Phase Onward, Inc.	Toronto	Ontario	Canada	M3J 2C5
698	LMC Diabetes & Endocrinology (Bayview)	Toronto	Ontario	Canada	M4G 3E8
699	Dr. Anil K. Gupta Medicine Professional Corporation	Toronto	Ontario	Canada	M9V 4B4
700	Dr. Mohan Babapulle Medicine Professional Cooperation	Waterloo	Ontario	Canada	N2T 0C1
701	Dr. Louis Yao, MD Office of	Weston	Ontario	Canada	M9N 1W4
702	Ecogene-21	Chicoutimi	Quebec	Canada	G7H 7K9
703	Q & T Research Chicoutimi	Chicoutimi	Quebec	Canada	G7H 7Y8
704	Q&T Recherche Outaouais Inc.	Gatineau	Quebec	Canada	J8Y 6S8
705	Omnispec Recherche Clinique Inc.	Mirabel	Quebec	Canada	J7J 2K8
706	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
707	Diex Research Montreal, Inc.	Montreal	Quebec	Canada	H2Y 1S1
708	Centre Hospitalier Universitaire de Sherbrooke - Hotel-Dieu	Sherbrooke	Quebec	Canada	J1G 2E8
709	Centre integre de sante et de services sociaux de Lanaudiere (CISSSL)	St-Charles-Borromee	Quebec	Canada	J6E 6J2
710	Centre Integre de Sante et de services sociaux de Chaudiere-Appalaches (CISSA-CA) -	St-Georges, Beauce	Quebec	Canada	G5Y 4T8
711	CISSS des Laurentides-Point de Service de St-Jerome- Comite d'ethique de la recherche	St-Jerome	Quebec	Canada	J7Z 5T3
712	St-Jerome Medical Research Inc.	St-Jerome	Quebec	Canada	J7Z 5T3
713	C.I.C. Mauricie Inc.	Trois-Rivieres	Quebec	Canada	G8T 7A1
714	LMC Clinical Research Inc. (Montreal)	Ville Saint-Laurent	Quebec	Canada	H4T 1Z9
715	Recherche Clinique Sigma inc	Quebec		Canada	G1G 3Y8
716	Clinique des maladies lipidiques de Quebec	Quebec		Canada	G1V 4W2
717	Biomedica Research Group	Providencia Santiago	Metropolitana	Chile	7500710
718	CICAB	Santiago	Metropolitana	Chile	7500021
719	SMOLAM	Santiago	Metropolitana	Chile	7500739
720	Complejo Asitencial Dr. Sotero del Rio	Santiago	Metropolitana	Chile	8207257
721	Centro de Investigacion Clínica del Sur	Temuco	Region DE LA Araucania	Chile	4781156
722	Corporacion de Beneficencia Osorno	Osorno	Region DE LOS Lagos	Chile	5311092
723	Servicios Medicos Godoy	Santiago	Region Metropolitana	Chile	7500710
724	Quantum Research	Puerto Varas		Chile	5550170
725	Hospital y CRS El Pino	Santiago		Chile	8053095
726	Hospital Pablo Tobon Uribe	Medellin	Antioquia	Colombia	00000
727	Rodrigo Botero S.A.S	Medellin	Antioquia	Colombia	50012
728	Centro de Investigacion Clinica Avanzada y Multidisciplinaria CICLAM	Medellin	Antioquia	Colombia
729	Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.	Medellin	Antioquia	Colombia
730	Clinica de la Costa LTDA	Barranquila	Atlantico	Colombia
731	Centro Cientifico Asistencial Jose Luis Accini S.A.S.	Barranquilla	Atlantico	Colombia	80020
732	Corazon Ips S.A.S.	Barranquilla	Atlantico	Colombia	80020
733	Corozan Ips Sas	Barranquilla	Atlantico	Colombia
734	Fundacion del Caribe para la Investigacion Biomedica - Fundacion BIOS	Barranquilla	Atlantico	Colombia
735	Centro de Diagnostico Cardiologico LTDA.	Cartagena	Bolivar	Colombia
736	Asociacion IPS Medicos Internistas de Caldas	Manizales	Caldas	Colombia
737	MedPlus Medicina Prepagada S.A.	Bogota D.C.	Cundinamarca	Colombia	110911
738	Solano & Terront Servicios Medicos Ltda-Establecimiento Comercial UNIENDO	Bogota D.C.	Cundinamarca	Colombia
739	Dexadiab Servicios Medicos LTDA	Bogota D.C	Cundinamarca	Colombia	110221
740	Caja de Compensacion Familiar CAFAM, Sede Centro de Atencion en Salud CAFAM FLORESTA	Bogota D.C	Cundinamarca	Colombia	111211
741	Hospital Universitario San Ignacio	Bogota D.C	Cundinamarca	Colombia
742	Instituto de Investigacion Endocrinologia y Prevencion Metabolica - ENDOCARE LTDA.	Bogota D.C	Cundinamarca	Colombia
743	Instituto del Corazon de Bucaramanga S.A.	Bucaramanga	Santander	Colombia
744	Fundación Cardiovacular de Colombia - Instituto del Corazón de Floridablanca	Floridablanca	Santander	Colombia
745	Fundacion Reina Isabel	Cali	Valle DEL Cauca	Colombia	760001
746	FREMLOVA APHOTECA s.r.o.	Litovel	Czech Republic	Czechia	78401
747	BENU Lekarna	Pardubice	Czech Republic	Czechia	530 02
748	Kardiologicka Ambulance	Brno	Jihomoravsky KRAJ	Czechia	638 00
749	EDUMED s.r.o.	Broumov	Kralovehradecky KRAJ	Czechia	55001
750	Edumed S.R.O.	Jaromer	Kralovehradecky KRAJ	Czechia	550 01
751	Kardiologicka ambulance	Trutnov	Kralovehradecky KRAJ	Czechia	54101
752	Lekarna na Poliklinice	Trutnov	Kralovehradecky KRAJ	Czechia	54101
753	MUDr. Jan Vrkoc s.r.o.	Ostrava	Moravskoslezsky KRAJ	Czechia	70200
754	Pv-Kardiologie S.R.O.	Pardubice	Pardubicky KRAJ	Czechia	53002
755	CCBR Czech Brno, s.r.o.	Brno		Czechia	602 00
756	DIKa centrum s.r.o., Kardiologicka a interni ambulance	Havirov		Czechia	73601
757	Fakultni nemocnice Hradec Kralove, III. Interni gerontometabolicka klinika	Hradec Kralove		Czechia	500 05
758	Fakultni nemocnice Hradec Kralove	Hradec Kralove		Czechia	500 05
759	Kardio interna s.r.o.	Litovel		Czechia	784 01
760	Fakultni Nemocnice Olomouc	Olomouc		Czechia	775 00
761	Fakultni Nemocnice Olomouc	Olomouc		Czechia	77520
762	CCBR Czech a.s.	Pardubice		Czechia	530 02
763	Kardiologie Plzen s.r.o.	Plzen		Czechia	326 00
764	Fakultni poliklinika Vseobecne fakultni nemocnice v Praze	Praha 2		Czechia	128 08
765	CCBR Czech Prague, s.r.o	Praha 3		Czechia	130 00
766	Kardiologie a interni lekarstvi	Praha 5		Czechia	158 00
767	NEFROMED, s.r.o.	Praha 6		Czechia	160 00
768	Centrum kardiovaskularni prevence 1. LF UK a TN	Praha		Czechia	14059
769	Interna a kardiologie s.r.o.	Roznov pod Radhostem		Czechia	756 61
770	Nemocnice Pardubickeho kraje, a.s., Svitavska nemocnice	Svitavy		Czechia	568 25
771	Vseobecna kardiologicka ambulance s.r.o.	Tabor		Czechia	390 03
772	Lekarna U Nemocnice	Tabor		Czechia	39003
773	MUDr. Antonin Dufka, kardiologicka ambulance	Uherske Hradiste 1		Czechia	686 01
774	MUDr. Nina Zemkova s.r.o.	Uherske Hradiste 1		Czechia	686 01
775	Lekarna Hradebni s.r.o.	Uherske Hradiste		Czechia	686 01
776	KIGE s.r.o.	Znojmo		Czechia	66902
777	Sygehus Sonderjylland Aabenraa	Aabenraa		Denmark	6200
778	Aalborg Universitetshospital, Lipidklinikken	Aalborg		Denmark	9000
779	CCBR Aalborg	Aalborg		Denmark	9000
780	Aarhus Universitetshospital	Aarhus N		Denmark	8250
781	Aarhus Universitetshospital Skejby, Hjertesygdomme ¿ Klinisk Forskning	Aarhus		Denmark	8200
782	CCBR Ballerup	Ballerup		Denmark	2750
783	Bispebjerg og Frederiksberg Hospital	Copenhagen NV		Denmark	2400
784	Rigshospitalet	Copenhagen Oe		Denmark	2100
785	Sydvestjysk Sygehus	Esbjerg		Denmark	6700
786	Frederiksberg Hospital	Frederiksberg		Denmark	2000
787	Glostrup Hospital	Glostrup		Denmark	2600
788	Herlev Universitetshospital, Kardiologisk afdeling S	Herlev		Denmark	2730
789	Regionshospitalet Herning	Herning		Denmark	7400
790	Hillerod Hospital	Hillerod		Denmark	3400
791	Hvidovre Universitetshospital, Hjerte-lungemedicinsk afdeling	Hvidovre		Denmark	2650
792	Amager Hospital	Kobenhavn S.		Denmark	2300
793	Region Sjaelland Sygehus Nord, Koge Sygehus	Koge		Denmark	4600
794	Kolding Sygehus	Kolding		Denmark	6000
795	Region Sjaelland Naestved Sygehus	Naestved		Denmark	4700
796	Nykobing F. Sygehus-Medicinsk afdeling	Nykobing F.		Denmark	4800
797	Regionshospitalet Randers	Randers		Denmark	8930
798	Regionshospitalet Silkeborg, Hjerte Projektkontor	Silkeborg		Denmark	8600
799	Slagelse Sygehus	Slagelse		Denmark	4200
800	Svendborg Sygehus	Svendborg		Denmark	5700
801	CCBR Vejle	Vejle		Denmark	DK 7100
802	Hospitalsenheden Midt, Regionshospital Viborg	Viborg		Denmark	8800
803	Linnan Klinikka Oy	Hameenlinna		Finland	13100
804	Mehilainen Toolo	Helsinki		Finland	00260
805	Helsinki University Central Hospital	Helsinki		Finland	00290
806	Helsingin yliopistollinen keskussairaala, Sisaetaudit ja kuntoutus, Biomedicum 2U	Helsinki		Finland	FI-00290
807	Ita-Suomen laakarikeskus Oy	Joensuu		Finland	80100
808	Studycor Oy	Jyvaskyla		Finland	40620
809	Laeaekaerikeskus Aava Kerava	Kerava		Finland	04200
810	Menoa oy	Kinkomaa		Finland	40930
811	Kokkolan Keskussairaala	Kokkola		Finland	67200
812	Mewell liikuntaklinikka	Kotka		Finland	48600
813	Itae-Suomen Laeaekaeritalo Oy	Kuopio		Finland	70100
814	Terveystalo Kuopio	Kuopio		Finland	70100
815	Oulu Mentalcare Oy	Oulu		Finland	90100
816	Terveystalo Oulu, Diapolis	Oulu		Finland	90100
817	Oulu University Hospital	Oulu		Finland	90220
818	Porin Laakaritalo Oy	Pori		Finland	28100
819	Terveystalo Siilinjarvi	Siilinjarvi		Finland	71800
820	FinnMedi Oy	Tampere		Finland	33520
821	Terveystalo Pulssi	Turku		Finland	20100
822	Turku University Hospital	Turku		Finland	20520
823	Vantaan Tutkimuskeskus	Vantaa		Finland	01600
824	CHU Jean Minjoz Cardiologie	Besancon		France	25000
825	Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat	Bourg En Bresse Cedex 10000		France	01012
826	CHU de Caen	Caen cedex 9		France	14033
827	Centre Hospitalier de Cannes- Service de Cardiologie	Cannes Cedex		France	06414
828	Centre Hospitalier Sud-Francilien	Corbeil-Essonnes		France	91106
829	Scp Cardiovasculaire De L'Est	Essey-Les-Nancy		France	54270
830	Centre Hospitalier Louis Pasteur	Le Coudray		France	28630
831	Hopital La Louviere	Lille		France	59000
832	Centre Hospitalier Saint Philibert	Lomme		France	59462
833	Hopital Cardiovasculaire Et Pneumologique Louis Pradel	Lyon Cedex 03		France	69394
834	Hopital Arnaud de Villeneuve	Montpellier cedex 5		France	34295
835	CHU de Nantes - Hopital Nord Laennec	Nantes		France	44093
836	Nouvelles Cliniques Nantaises	Nantes		France	44200
837	CHU Caremeau	Nimes cedex 9		France	30029
838	CHU Caremeau	Nimes		France	30000
839	Centre Hospitalier de PAU	PAU		France	64046
840	Hopital Cardiologique	Pessac cedex		France	33604
841	CHU de Poitiers	Poitiers cedex		France	86021
842	CHU de Renes Hopital de Pontchaillou	Rennes Cedex 9		France	35033
843	CHU de Toulouse	Toulouse cedex 9		France	31059
844	Hopital Guy Chatiliez	Tourcoing		France	59200
845	Hopital Trousseau	Tours Cedex 9		France	37044
846	Centre Hospitalier (CH) de Valenciennes	Valenciennes		France	59300
847	Polyclinique Vauban	Valenciennes		France	59300
848	Universitaets Herzzentrum Freiburg Bad Krozingen	Bad Krozingen	Baden-wuerttemberg	Germany	79189
849	Medizinische Universtatsklinik Heidelberg	Heidelberg	Baden-wurttemberg	Germany	69120
850	Ze:ro Arztpraxen	Mannheim	Baden-wurttemberg	Germany	68165
851	Gemeinschaftspraxis im Altstadt Carree	Fulda	Hessen	Germany	36037
852	Klinische Forschung Schwerin GmbH	Schwerin	Mecklenburg-vorpommern	Germany	19055
853	Zentrum Klinische Studien Neuwied (ZKSN)	Neuwied	Rheinland Pfalz	Germany	56564
854	Gemeinschaftspraxis Schwabenheim	Schwabenheim	Rhineland-palatinate	Germany	55270
855	Klinikum Altenburger Land Gmbh	Altenburg		Germany	04600
856	Zentralklinik Bad Berka GmbH	Bad Berka		Germany	99437
857	Forschungszentrum Dr. med Irma Schoell	Bad Homburg		Germany	61348
858	Institut fuer Klinische Forschung und Entwicklung(IKFE) Berlin GmbH	Berlin		Germany	10115
859	Klinische Forschung Berlin-Mitte GmbH	Berlin		Germany	10117
860	POLIKUM Institut GmbH	Berlin		Germany	12157
861	DRK Kliniken Kopenick, Zentrum Klinische Forschung	Berlin		Germany	12559
862	Berlin Research Centre-Synexus Clinical Research GmbH	Berlin		Germany	12627
863	Synexus Clinical Research GmbH	Berlin		Germany	12627
864	Deutsches Herzzentrum Berlin	Berlin		Germany	13353
865	Medizinisches Versorgungszentrum am Bahnhof Spandau	Berlin		Germany	13597
866	Klinikum Bielefeld	Bielefeld		Germany	33604
867	Bochum Research Centre-Synexus Clinical Research GmbH	Bochum		Germany	44787
868	MediClin Reha-Zentrum Spreewald	Burg-Spreewald		Germany	03096
869	Klinikum Coburg	Coburg		Germany	96450
870	HELIOS Amper-Klinikum Dachau	Dachau		Germany	85221
871	Kardiologische Praxisgemeinschaft	Dortmund		Germany	44137
872	St. Johannes-Hospital	Dortmund		Germany	44137
873	Gemeinschaftspraxis fuer Kardiologie Dres. Med. Willgeroth/Wetzel	Dortmund		Germany	44141
874	Klinsche Forschung Dresden GmbH	Dresden		Germany	01069
875	Praxis Dr. med. Christoph Axthelm	Dresden		Germany	01277
876	GWT-TUD GmbH, Studienzentrum Professor Hanefeld	Dresden		Germany	01307
877	Gemeinschaftspraxis Dr. Hagemann/Breiderhoff/Durfeld	Essen		Germany	45355
878	Medizentrum Essen Borbeck	Essen		Germany	45355
879	Studienzentrum	Essen		Germany	45355
880	Gemeinschaftspraxis Dres. Dirk Weber, Ulrich Weber, Heiner Saueressig, Birte Turner und Georg	Essen		Germany	45359
881	Schwerpunktpraxis Dr. Luedemann fuer Diabetes Gefaess- und Ernaehrungsmedizin	Falkensee		Germany	14612
882	IKF Institut fuer klinische Forschung Frankfurt	Frankfurt am Main		Germany	60596
883	Clinphenomics Gmbh & Co Kg, Studienzentrum	Frankfurt		Germany	60 594
884	Synexus Clinical research GmbH	Frankfurt		Germany	60596
885	Klinik und Poliklinik fuer Innere Medizin B-Kardiologie, Angiologie, Pulmologie, Internistische	Greifswald		Germany	17475
886	Cardiologicum Hamburg	Hamburg		Germany	22041
887	Praxis Dr. med Cornelia Brauer	Hamburg		Germany	22415
888	Klinische Forschung Hannover-Mitte GmbH	Hannover		Germany	30159
889	Universitatsklinikum des Saarlandes Klinik fur Innere Medizin III	Homburgsaar		Germany	66421
890	Praxis Dr. Heister	Kamp-Lintfort		Germany	47475
891	Studienzentrum Dr. Appel	Kassel		Germany	34121
892	Zentrum fuer klinische Forschung	Koeln		Germany	51069
893	Gemeinschaftspraxis Dr. Klein / Minnich	Kuenzing		Germany	94550
894	Klinik fur Innere Medizin, Kardiologie und Angiologie MediClin Herzzentrum Lahr/Baden.	Lahr		Germany	77933
895	Synexus Clinical research GmbH	Leipzig		Germany	04103
896	Synexus Leipzig Clinical Research Centre	Leipzig		Germany	04103
897	Polikum Institut Leipzig GmbH	Leipzig		Germany	04109
898	Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut	Leipzig		Germany	04249
899	Maerkische Kliniken GmbH, Klinikum Luedenscheid, Innere III	Luedenscheid		Germany	58515
900	Klinikum Lunen, St. Marienhospital	Lunen		Germany	44534
901	SMO.MD GmbH - Zentrum für klinische Studien	Magdeburg		Germany	39120
902	SMO.MD GmbH, Zentrum fuer klinische Studien Site Management and Clinical Research Unit	Magdeburg		Germany	39120
903	Pfuetzner Science & Health Institute-Gmbh	Mainz		Germany	55116
904	Klinikum fuer Herz- & Kreislauferkrankungen	Muenchen		Germany	80636
905	Klinikum Der Universitat Munchen	Munchen		Germany	80336
906	Staedtisches Klinikum Muenchen GmbH	Munich		Germany	81737
907	Kardiologische Praxis Northeim	Northeim		Germany	37154
908	Gemeinschaftspraxis Drs Haggenmiller/Jeserich, Kardiologie, Angiologie, Innere Medizin	Nurnberg		Germany	90402
909	Allgemeinmedizinisch-Internistische Praxisgemeinschaft	Offenbach		Germany	63071
910	Praxis Dres. Med Naudts und Nowack	Rodgau		Germany	63110
911	Klinik am See Rehabilitationszentrum fur Innere Medizin	Rudersdorf		Germany	15562
912	Kardiologische Gemeinschaftspraxis Dres Med. Gerke/Burger	Soest		Germany	59494
913	Praxisgemeinschaft Stuhr-Brinkum	Stuhr-Brinkum		Germany	28816
914	Robert-Bosch-Krankenhaus	Stuttgart		Germany	70376
915	Josephs-Hospital Warendorf Med. Klinik II, Kardiologie/Angiologie	Warendorf		Germany	48231
916	Kardiologische Praxis	Wermsdorf		Germany	04779
917	ForschungszentrumRuhr KliFoCenter GmbH	Witten		Germany	58455
918	Bacs-Kiskun Megyei Korhaz	Kecskemet	Bacs-kiskun	Hungary	6000
919	Pecsi Tudomanyegyetem AOK, II.	Pecs	Baranya	Hungary	7624
920	Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika	Szeged	Csongrad	Hungary	6720
921	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar	Fejer	Hungary	8000
922	DRC Kft.	Balatonfured		Hungary	8230
923	DRC Kft.	Balatongyorok		Hungary	8313
924	Kardiologiai Maganrendelo	Bekescsaba		Hungary	5600
925	Grof Tisza Istvan Korhaz Berettyoujfalu	Berettyoujfalu		Hungary	4100
926	Budapesti Szent Ferenc Korhaz	Budapest		Hungary	1021
927	Synexus Magyarorszag Kft	Budapest		Hungary	1036
928	Szent Rokus Korhaz	Budapest		Hungary	1085
929	Semmelweis Egyetem	Budapest		Hungary	1088
930	Gottsegen Gyorgy Orszagos Kardiologiai Intezet	Budapest		Hungary	1096
931	Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet	Budapest		Hungary	1097
932	Egyesitett Szent Istvan Korhaz es Szent Laszlo Korhaz	Budapest		Hungary	1097
933	Semmelweis Egyetem	Budapest		Hungary	1125
934	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, III. Belgyogyaszat-Kardiologiai Osztaly	Budapest		Hungary	1125
935	Debreceni Egyetem	Debrecen		Hungary	4032
936	Synexus Magyarorszag Kft.	Gyula		Hungary	5700
937	Edes Szivunk Egeszsegkozpont Kft.	Hajduszoboszlo		Hungary	4200
938	BKS Research Kft., Albert Schweitzer Korhaz	Hatvan		Hungary	3000
939	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvar		Hungary	7400
940	Jutrix Egeszsegugyi Kft	Kecskemet		Hungary	6000
941	Megyei Flor Ferenc Korhaz	Kistarcsa		Hungary	2143
942	Pest Megyei Flor Ferenc Korhaz	Kistarcsa		Hungary	2143
943	Josa Andras Oktatokorhaz	Nyiregyhaza		Hungary	4400
944	Medifarma-98 Kft.	Nyiregyhaza		Hungary	4400
945	Pecsi Tudomanyegyetem AOK, I. Belgyogyaszati Klinika	Pecs		Hungary	7624
946	Mentahaz Maganorvosi Kozpont	Szekesfehervar		Hungary	8000
947	Hetenyi Geza Korhaz	Szolnok		Hungary	5000
948	Markusovszky Egyetemi Oktatokarhaz	Szombathely		Hungary	9700
949	Dr. Sydo es Tsa Kft.	Veszprem		Hungary	8200
950	Zala Megyei Korhaz, Diabetológiai Szakrendelés	Zalaegerszeg		Hungary	8900
951	Zala Megyei Korhaz	Zalaegerszeg		Hungary	8900
952	Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre	Ahmedabad	Gujarat	India	380007
953	Apex Heart Institute (A Unit of TCVS Pvt. Ltd)	Ahmedabad	Gujarat	India	380054
954	SAL Hospital	Ahmedabad	Gujarat	India	380054
955	Apple Hospital	Surat	Gujarat	India	395 002
956	Unicare Heart Institute & Research Center	Surat	Gujarat	India	395002
957	BAPS - Pramukh Swami Hospital	Surat	Gujarat	India	395009
958	Rhythm Heart Institute	Vadodara	Gujarat	India	390022
959	Jehangir Clinical Development Centre Pvt. Ltd.	Pune	Maharashtra	India	411001
960	M.V. Hospital And Research Centre	Lucknow	Uttar Pradesh	India	226003
961	Beaumont Hospital	Dublin	Leinster	Ireland	9
962	St James's Hospital	Dublin		Ireland	8
963	Tel Aviv Sourasky Medical Center	Tel Aviv	Tel-aviv	Israel	64239
964	Barzilai Medical Center	Ashkelon		Israel	7830604
965	Ben Yair Community Clinic - Clalit Health Services	Beer Sheva		Israel	84350
966	Heart Institute, Hillel Yaffe Medical Center	Hadera		Israel	38100
967	Rambam Medical Center	Haifa		Israel	31096
968	Cardiovascular Clinical Research Institute	Haifa		Israel	34362
969	Edith Wolfson Medical Center	Holon		Israel	58100
970	Hadassah Ein Kerem Medical Center	Jerusalem		Israel	91120
971	Meir Medical Center	Kfar Sava		Israel	44281
972	Meir Medical Center	Kfar-Saba		Israel	44281
973	Galilee Medical Center, Cardiology Department	Nahariya		Israel	22100
974	E.M.M.S Nazareth Hospital	Nazareth		Israel	16100
975	Sha'aria Clinic, Clalit Health Services	Petach Tikva		Israel	4958202
976	Rabin Medical Center, Beilinson Hospital	Petah Tikva		Israel	49100
977	Rabin Medical Center-Beilinson Hospital	Petah Tikva		Israel	49100
978	Rabin Medical Center	Petah Tikva		Israel	49100
979	Shuali Community Clinic, Clalit Health Services	Raanana		Israel	43452
980	Department of Neurology & Sagol Neuroscience Center	Ramat Gan		Israel	52621
981	Heart Institute, Kaplan Medical Center	Rehovot		Israel	76100
982	Kaplan Medical Center Metabolism and Diabetes Clinic, Kaplan Medical Center	Rehovot		Israel	76100
983	Internal Medicine A, Ziv Medical Center	Safed		Israel	13100
984	Ziv Medical Center	Safed		Israel	13100
985	Assuta Medical Center	Tel Aviv		Israel	6789140
986	The Chaim Sheba Medical Center	Tel Hashomer		Israel	5265601
987	Tel Aviv Sourasky Medical Center	Tel-Aviv		Israel	64239
988	A.O. Treviglio e Caravaggio	Treviglio (BG)	Bergamo	Italy	24047
989	AOU Policlinico "Mater Domini" UOC di Medicina Interna	Catanzaro	CZ	Italy	88100
990	Covance Central Laboratory Services	Meyrin/Geneve	Geneve	Italy	1217
991	Ospedale S. L. Mandic di Merate	Merate	Lecco	Italy	23807
992	Dipartimento delle Patologie Emergenti, Unita di Medicina Interna e Dislipidemie Genetiche	Palermo	PA	Italy	90127
993	Ospedale S. Maria della Misericordia -Dipartimento di Medicina, Medicina Interna,	Perugia	PG	Italy	06132
994	Azienda Ospedaliera Della Provincia Di Lecco - Ospedale Manzoni	Lecco	Province OF Lecco	Italy	23900
995	Dip Medicina Interna e Specialita Mediche, Policlinico Umberto I	Roma	RM	Italy	00161
996	Policlinico Umberto I di Roma	Rome	RM	Italy	00161
997	Azienda Ospedaliera S'Andrea di Roma - UOC Cardiologia	Rome	RM	Italy	00189
998	Ospedale G. Fracastoro	San Bonifacio	Verona	Italy	37047
999	AOUI di Verona - Ospedale Civile Maggiore Borgo Trento	Verona	VR	Italy	37126
1000	S. C. Cardiologia INRCA	Ancona		Italy	60124
1001	Ospedale Civile Regionale San Martino, Belluno	Belluno		Italy	32100
1002	Azienda Ospedaliera G. Brotzu	Cagliari		Italy	09124
1003	Unità Operativa Solventi e Unità Poliambulatorio	Milan		Italy	20138
1004	Department of Clinical Medicines and Cardiovascular Sciences, Universita "Federico II" di Napoli	Napoli		Italy	80131
1005	Divisione di Cardiologia con Utic ed Emodinamica - AOU Federico II di Napoli	Napoli		Italy	80131
1006	A.O. di Reggio Emilia Arcispedale "S. Maria Nuova"/IRCCS	Reggio Emilia		Italy	42123
1007	AUSL Della Romagna-Ospedale Infermi	Rimini		Italy	47923
1008	Ospedale Santa Maria della Misericordia Azienda ULSS 18 of Rovigo	Rovigo		Italy	45100
1009	Azienda Ospedaliera Universitaria Santa Maria della Misericordia	Udine		Italy	33100
1010	Chungbuk National University Hospital	Cheongju-si	Chungcheonbuk-do	Korea, Republic of	362-711
1011	Kangwon National University Hospital	Chuncheon-si	Gangwon-do	Korea, Republic of	24289
1012	Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital	Wonju-Si	Gangwon-do	Korea, Republic of	26426
1013	Yonsei University Wonju Severance Christian Hospital	Wonju-si	Gangwon-do	Korea, Republic of	26426
1014	Donguk University Gyeongju Hospital	Gyeongju-si	Gyeongbuk	Korea, Republic of	780-350
1015	Dongguk University Ilsan Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10326
1016	Inje University Ilsan Paik Hospital	Goyang-Si	Gyeonggi-do	Korea, Republic of	10380
1017	Myongji Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10475
1018	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
1019	Ajou University Hospital	Suwon-si	Gyeonggi-do	Korea, Republic of	443-380
1020	Uijeongbu St. Mary's Hospital-The Catholic University of Korea	Uijeongbu-si	Gyeonggi-do	Korea, Republic of	11765
1021	Inje University Busan Paik Hospital	Busan		Korea, Republic of	47392
1022	Dong-A University Hospital	Busan		Korea, Republic of	49201
1023	Daegu Catholic University Medical Center	Daegu		Korea, Republic of	42472
1024	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565
1025	Asan Medical Center	Seoul		Korea, Republic of	05505
1026	Seoul Medical Center	Seoul		Korea, Republic of	131-795
1027	Hallym University Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of	134-701
1028	Gangnam Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	135-720
1029	The Catholic University Of Korea Seoul St.Marys Hospital	Seoul		Korea, Republic of	137-701
1030	Seoul Metropolitan Government - Seoul National University Boramae Medical Center	Seoul		Korea, Republic of	156-707
1031	Consultorio Dr. Leocadio Gerardo Munoz Beltran	Cd. Juarez	Chihuahua	Mexico	32472
1032	Centro Especializado en Diabetes Obesidad y Prevencion de Enfermedades Cardiovasculares, SC.	Mexico	DF	Mexico	11650
1033	Consultorio de Endocrinologia y Nutriologia	Mexico	Distrito Federal	Mexico	07760
1034	Operadora de Hospitales Angeles S.A. de C.V. (Emergencies)	Mexico	Distrito Federal	Mexico	07760
1035	Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran"	Mexico	Distrito Federal	Mexico	14000
1036	Centro de Investigacion Clinica del Pacifico, S.A. de C.V.	Acapulco de Juarez	Guerrero	Mexico	39670
1037	Hospital Del Pacifico,Centro De Investigacion Clinica Del Pacifico Cicpa,Torre Medica Del Pacifico	Acapulco	Guerrero	Mexico	39670
1038	Clinical Trials Mexico, S.A. de C.V.	Pachuca de Soto	Hidalgo	Mexico	42070
1039	Investigacion Biomedica Aplicada de Hidalgo S.A. de C.V.	Pachuca	Hidalgo	Mexico	42090
1040	Centro de Investigacion Medica Integral S.C.	Guadalajara	Jalisco	Mexico	44160
1041	Icle S.C.	Guadalajara	Jalisco	Mexico	44600
1042	Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez	Guadalajara	Jalisco	Mexico	44657
1043	Unidad de Investigacion Clinica y Atencion Medica Hepa S.C.	Guadalajara	Jalisco	Mexico	44760
1044	Instituto de Diabetes Obesidad y Nutricion, S.C.	Cuernavaca	Morelos	Mexico	62250
1045	Hospital Inovamed Cuernavaca (Emergencies)	Cuernavaca	Morelos	Mexico	62270
1046	Cardiolink Clin Trials, S.C.	Monterrey	Nuevo LEON	Mexico	64060
1047	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEON	Mexico	64460
1048	CRI Centro Regiomontano de Investigacion SC	Monterrey	Nuevo LEON	Mexico	64710
1049	Global Trial Research Center S.A. de C.V.	Monterrey	Nuevo LEON	Mexico	64718
1050	Centro Integral Medico SJR S.C	San Juan del Rio	Queretaro	Mexico	76800
1051	Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.	Culiacan	Sinaloa	Mexico	80020
1052	Hospital Angeles Culiacan	Culiacan	Sinaloa	Mexico	80020
1053	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares S.C.	Tampico	Tamaulipas	Mexico	89000
1054	Centro De Especialidades Medicas Del Estado De Veracruz	Xalapa	Veracruz	Mexico	91020
1055	Instituto Biomedico De Investigacion A.C.	Aguascalientes		Mexico	20127
1056	Hospital Cardiologica Aguascalientes	Aguascalientes		Mexico	20230
1057	Unidad De Investigacion En Salud De Chihuahua S.C.	Chihuahua		Mexico	31203
1058	Consultorio Medico de Especialidad Dr. Demetrio Kosturakis Garcia	Chihuahua		Mexico	31217
1059	Investigacion en Salud y Metabolismo S.C	Chihuahua		Mexico	31217
1060	Instituto Nacional de Ciencia Medicas y Nutricion Salvador Zubiran	Distrito Federal		Mexico	14000
1061	Lahoja Asociacion para la Investigacion y Farmacovigilancia S.C.	Durango		Mexico	34000
1062	Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiovasculares, S.C.	Mexico		Mexico	11650
1063	Pharmacology and Clinical Research S.A. de C.V.	Queretaro		Mexico	76000
1064	Cardioarritmias e Investigacion S.C.	San Luis Potosi		Mexico	78200
1065	Hospital Lomas de San Luis lntemacional (Emergencies)	San Luis Potosi		Mexico	78218
1066	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi		Mexico	78240
1067	Centro Especializado En Diabetes Y Metabolismo	Veracruz		Mexico	91910
1068	Tjongerschans Ziekenhuis	Heerenveen	Friesland	Netherlands	8441 PW
1069	Zuyderland MC	Sittard-Geleen	Limburg	Netherlands	6162 BG
1070	Isala	Zwolle	Overijssel	Netherlands	8025 AB
1071	St. Franciscus Gasthuis	Rotterdam	Zuid-holland	Netherlands	3045 PM
1072	Het Lange Land Ziekenhuis	Zoetermeer	Zuid-holland	Netherlands	2725 NA
1073	Noordwest Ziekenhuisgroep	Alkmaar		Netherlands	1815 JD
1074	EB Flevoresearch	Almere		Netherlands	1311 RL
1075	Meander Medical Center	Amersfoort		Netherlands	3813 TZ
1076	Meander Medisch Centrum	Amersfoort		Netherlands	3813 TZ
1077	Amstelland Hospital	Amstelveen		Netherlands	1186 AM
1078	Bovenij Ziekenhuis	Amsterdam		Netherlands	1034 CS
1079	OLVG, locatie West	Amsterdam		Netherlands	1061 AE
1080	VU University Medical Center	Amsterdam		Netherlands	1081 HV
1081	Onze Lieve Vrouwe Gasthuis	Amsterdam		Netherlands	1091 AC
1082	Academic Medical Center	Amsterdam		Netherlands	1105 AZ
1083	Gelre Hospitals	Apeldoorn		Netherlands	7334 DZ
1084	Rode Kruis Ziekenhuis	Beverwijk		Netherlands	1942 LE
1085	Tergooi Ziekenhuis	Blaricum		Netherlands	1261 AN
1086	Andro Medical Research B.V.	Breda		Netherlands	4811 SW
1087	Amphia Ziekenhuis	Breda		Netherlands	4818 CK
1088	Reinier de Graaf Ziekenhuis	Delft		Netherlands	2625 AD
1089	Hedramed	Den Haag		Netherlands	2526 HW
1090	Hagaziekenhuis	Den Haag		Netherlands	2545 CH
1091	Bronovo Ziekenhuis	Den Haag		Netherlands	2597 AX
1092	Deventer Ziekenhuis	Deventer		Netherlands	7416SE
1093	Van Weel Bethesda Hospital	Dirksland		Netherlands	3247 BW
1094	Slingeland Ziekenhuis	Doetinchem		Netherlands	7009 BL
1095	Albert Schweitzer Ziekenhuis-Albert Schweitzer Hospital	Dordrecht		Netherlands	3318 AT
1096	Ziekenhuis Gelderse Vallei	Ede		Netherlands	6716 RP
1097	Andromed Eindhoven	Eindhoven		Netherlands	5611 NV
1098	Heartcentre Catharina Hospital	Eindhoven		Netherlands	5623 EJ
1099	Medisch Spectrum Twente	Enschede		Netherlands	7512 KZ
1100	Beatrix Hospital	Gorinchem		Netherlands	4204 AA
1101	Beatrix Ziekenhuis	Gorinchem		Netherlands	4204 AA
1102	Groene Hart Ziekenhuis	Gouda		Netherlands	2803 HH
1103	University Medical Center Groningen	Groningen		Netherlands	9713 GZ
1104	Martini Ziekenhuis	Groningen		Netherlands	9728 NT
1105	Spaarne Gasthuis	Haarlem		Netherlands	2035 RC
1106	Ropcke Zweers Hospital	Hardenberg		Netherlands	7772 SE
1107	St. Jansdal Ziekenhuis	Harderwijk		Netherlands	3844 DG
1108	Zuyderland Medisch Centrum	Heerlen		Netherlands	6419 PC
1109	Zuyderland	Heerlen		Netherlands	6419PC
1110	Treant Zorggroep, location Bethesda	Hoogeveen		Netherlands	7909 AA
1111	Vascular Research Centre	Hoorn		Netherlands	1624 NP
1112	Quality Care Research	Kloosterhaar		Netherlands	7694 AC
1113	Medisch Centrum Leeuwarden	Leeuwarden		Netherlands	8934 AD
1114	Leiden University Medical Center	Leiden		Netherlands	2333 ZA
1115	Alrijne Ziekenhuis	Leiden		Netherlands	2334 CK
1116	Alrijne Ziekenhuis	Leiderdorp		Netherlands	2353 GA
1117	GCM Maarssenbroek	Maarssen		Netherlands	3607 KN
1118	Maastricht University Medical Center	Maastricht		Netherlands	6229 HX
1119	Isala Diaconessenhuis	Meppel		Netherlands	7943 KA
1120	St Antonius Hospital	Nieuwegein		Netherlands	3435 CM
1121	Radboud University Nijmegen Medical Centre	Nijmegen		Netherlands	6525 GA
1122	Canisius Wilhelmina Ziekenhuis	Nijmegen		Netherlands	6532 SZ
1123	Waterland Hospital	Purmerend		Netherlands	1441 RN
1124	Andro Medical Research B.V.	Rotterdam		Netherlands	3021 HC
1125	Hedramed	Rotterdam		Netherlands	3037 AN
1126	Rotterdam Research Institute	Rotterdam		Netherlands	3039 BD
1127	Ikazia Ziekenhuis	Rotterdam		Netherlands	3083AN
1128	D&A Research and Genetics	Sneek		Netherlands	8601 ZR
1129	Ziekenhuis Rivierenland	Tiel		Netherlands	4002 WP
1130	Elisabeth-TweeSteden Ziekenhuis (previously named St. Elisabeth Ziekenhuis)	Tilburg		Netherlands	5022 GC
1131	St. Elisabeth Ziekenhuis	Tilburg		Netherlands	5022 GC
1132	Elisabeth TweeSteden Ziekenhuis (ETZ)	Tilburg		Netherlands	5042 AD
1133	Bernhoven Ziekenhuis	Uden		Netherlands	5406 PT
1134	EB Utrecht	Utrecht		Netherlands	3511 NH
1135	Universitair Medisch Centrum (UMC) Utrecht - Locatie AZU	Utrecht		Netherlands	3584 CX
1136	University Medical Center Utrecht	Utrecht		Netherlands	3584 CX
1137	Maxima Medisch Centrum	Veldhoven		Netherlands	5504 DB
1138	VieCuri Medisch Centrum	Venlo		Netherlands	5912 BL
1139	Twee Steden Ziekenhuis	Waalwijk		Netherlands	5141 BM
1140	Klinisch Onderzoek Praktijk Zoetermeer	Zoetermeer		Netherlands	2712 AB
1141	Albert Schweitzer Hospital	Zwijndrecht		Netherlands	3331 LZ
1142	Henderson Medical Centre	Henderson	Auckland	New Zealand	0612
1143	North Shore Hospital	Takapuna	Auckland	New Zealand	0622
1144	Hawke's Bay Hospital	Frimley	Hastings	New Zealand	4120
1145	North Shore Hospital, Laboratory	Auckland		New Zealand	0622
1146	North Shore Hospital- Inpatient Pharmacy	Auckland		New Zealand	0622
1147	Optimal Clinical Trials	Auckland		New Zealand	1010
1148	Auckland City Hospital	Auckland		New Zealand	1023
1149	Middlemore Clinical Trials	Auckland		New Zealand	2025
1150	Lipid and Diabetes Research Group	Christchurch		New Zealand	8011
1151	Southern Clinical Trials Shirley Ltd Don Beavan Medical Research Centre	Christchurch		New Zealand	8011
1152	Southern Clinical Trials Riccarton	Christchurch		New Zealand	8041
1153	Taranaki Base Hospital	New Plymouth		New Zealand	4310
1154	Papamoa Pines Medical Centre	Papamoa		New Zealand	3118
1155	Rotorua Hospital	Rotorua		New Zealand	3010
1156	Clinical Horizons NZ Ltd	Tauranga		New Zealand	3112
1157	Clinical Trials Unit,Bay of Plenty(BOP) Clinical School	Tauranga		New Zealand	3112
1158	CCDHB, Wellington Hospital, Clinical Measurement Unit	Wellington		New Zealand	6021
1159	Wellington Hospital	Wellington		New Zealand	6021
1160	Wellington Regional Hospital	Wellington		New Zealand	6242
1161	Jeleniogorskie Centrum Chorob Serca, Przychodnia Kardiologiczna, Poradnia Kardiologiczna	Jelenia Gora	Dolnoslaskie	Poland	58-506
1162	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw	Dolnoslaskie	Poland	50-088
1163	Wojewodzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo-Rozwojowy	Wroclaw	Dolnoslaskie	Poland	51-124
1164	Zdrowie s.c. Agnieszka i Donald Drozdz	Wroclaw	Dolnoslaskie	Poland	51-314
1165	Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED	Zarow	Dolnoslaskie	Poland	58-130
1166	SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego	Lodz	Iodzkie	Poland	92-213
1167	NZOZ Vitamed	Bydgoszcz	Kujawsko-pomorskie	Poland	85-079
1168	Nzoz Centrum Medyczne Kermed	Bydgoszcz	Kujawsko-pomorskie	Poland	85-231
1169	Specjalistyczna Praktyka Lekarska Piotr Kubalski	Grudziadz	Kujawsko-pomorskie	Poland	86-300
1170	Specjalistyczne Gabinety Lekarskie "Medicor Plus" - Jerzy Kopaczewski	Wloclawek	Kujawsko-pomorskie	Poland	87-800
1171	Gabinet Lekarski Malgorzata Saryusz-Wolska	Lodz	Lodzkie	Poland	90-132
1172	Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.	Lodz	Lodzkie	Poland	90-368
1173	"Prywatny Gabinet Kardiologiczny" Dr N.Med. Maciej Kosmider	Lodz	Lodzkie	Poland	91-490
1174	Prywatny Gabinet Lekarski Dr n. med. Michal Ogorek	Piotrkow Trybunalski	Lodzkie	Poland	97-300
1175	Centrum Medyczne Ogrodowa Sp. z o.o.	Skierniewice	Lodzkie	Poland	96-100
1176	Clinical Best Solutions	Lublin	Lubelskie	Poland	20-045
1177	Optimamed Specjalistyczne Gabinety Lekarskie	Lublin	Lubelskie	Poland	20-091
1178	KO-MED Centra Kliniczne Lublin II	Lublin	Lubelskie	Poland	20-362
1179	KO-MED Centra Kliniczne Pulawy	Pulawy	Lubelskie	Poland	24-100
1180	KO-MED Centra Kliniczne Zamosc	Zamosc	Lubelskie	Poland	22-400
1181	Landa Specjalistyczne Gabinety Lekarskie	Krakow	Malopolskie	Poland	30-015
1182	Szpital Specjalistyczny im. J. Dietla w Krakowie, Oddzial Kardiologii	Krakow	Malopolskie	Poland	31-121
1183	Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Szybkiej Diagnostyki	Krakow	Malopolskie	Poland	31-202
1184	Centrum Medyczne Zdrowa J. Trebacz, W. Zajdel Spolka Jawna	Krakow	Malopolskie	Poland	31-216
1185	CENTRUM MEDYCZNE A-Z Clinic	Krakow	Malopolskie	Poland	31-315
1186	Krakowskie Centrum Medyczne Sp. z o.o.	Krakow	Malopolskie	Poland	31-501
1187	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie,	Krakow	Malopolskie	Poland	31-531
1188	NeuroCor Banaszkiewicz, Kulaga, Ostrowska, Tomaszewski lekarze spolka partnerska	Myslenice	Malopolskie	Poland	32-400
1189	INTERCARD Sp. z. o. o. Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Nowym Targu	Nowy Targ	Malopolskie	Poland	34-400
1190	Centrum Szybkiej Diagnostyki Kardiologicznej Kardiomed M. Zabowka E. Zabowka	Tarnow	Malopolskie	Poland	33-100
1191	Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny Boguslaw Derlaga	Tarnow	Malopolskie	Poland	33-100
1192	Synexus Polska Sp. z o.o. Oddzial w Katowicach	Katowice	Mazowieckie	Poland	40-040
1193	Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD"	Plock	Mazowieckie	Poland	09-402
1194	Centrum Medyczne Piaski Filia Nr 9	Warszawa	Mazowieckie	Poland	01-875
1195	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie	Warszawa	Mazowieckie	Poland	02-507
1196	CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego	Warszawa	Mazowieckie	Poland	02-507
1197	Wojskowy Instytut Medyczny, Klinika Kardiologii i Chorob Wewnetrznych, Centralny Szpital Kliniczny	Warszawa	Mazowieckie	Poland	04-141
1198	Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego	Warszawa	Mazowieckie	Poland	04-628
1199	Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.	Warszawa	Mazowieckie	Poland	04-730
1200	Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza Oddzial	Brzozow	Podkarpackie	Poland	36-200
1201	INTERCARD Sp. z o.o. Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Krosnie	Krosno	Podkarpackie	Poland	38400
1202	EMED Centrum Uslug Medycznych Ewa Smialek	Rzeszow	Podkarpackie	Poland	35205
1203	"""OSTEO-MEDIC"" s.c. Artur Racewicz, Jerzy Supronik"	Bialystok	Podlaskie	Poland	15-351
1204	Podlaski Osrodek Kardiologii Janusz Korecki	Bialystok	Podlaskie	Poland	15-875
1205	Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdansk	Pomorskie	Poland	80-382
1206	Niepubliczny Zaklad Opieki Zdrowotnej Gdanskie Centrum Zdrowia, Poradnia Kardiologiczna	Gdansk	Pomorskie	Poland	80-542
1207	Centrum Badan Klinicznych Pi-House, Poradnia Diabetologiczna	Gdansk	Pomorskie	Poland	80-546
1208	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia	Pomorskie	Poland	81-384
1209	NZOZ "PRO CORDIS" Sopockie Centrum Badan Kardiologicznych	Gdynia	Pomorskie	Poland	81-423
1210	Gabinet Kardiologiczno - lnternistyczny	Gdynia	Pomorskie	Poland	81-472
1211	Centrum Medyczne "SOPMED" Sp. z o.o.	Sopot	Pomorskie	Poland	81-756
1212	Indywidualna Specjalistyczna Praktyka Lekarska Malgorzata Biedrzycka	Starogard Gdanski	Pomorskie	Poland	83-200
1213	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu,	Bytom	Slaskie	Poland	41-902
1214	Bogna Gabrylewicz Andrzej Ochala Unimed s.c.	Katowice	Slaskie	Poland	40-083
1215	Pro Familia Altera Poradnia Wielospecjalistyczna	Katowice	Slaskie	Poland	40-648
1216	NZOZ Terapia Optima	Katowice	Slaskie	Poland	40-752
1217	Przychodnia Specjalistyczna Samodzielny Publiczny ZOZ w Rudzie Slaskiej, Poradnie Specjalistyczne,	Ruda Slaska	Slaskie	Poland	41-709
1218	NZOZ "Medyk"Sp. z o. o.	Wola	Slaskie	Poland	43-225
1219	Prywatny Gabinet Lekarski Marianna Janion	Kielce	Swietokrzyskie	Poland	25-315
1220	Wojewodzki Szpital Zespolony w Elblagu, Oddzial Kardiologiczny z Pododdzialem Kardiologii Inwazyjnej	Elblag	Warminsko-mazurskie	Poland	82-300
1221	Synexus Polska Sp. z o.o Oddzial w Poznaniu	Poznan	Wielkopolskie	Poland	60-702
1222	Nzoz "Twoja Przychodnia"	Poznan	Wielkopolskie	Poland	61-006
1223	"OSTEO-MEDIC" s.c. Artur Racewicz, Jerzy Supronik	Bialystok		Poland	15-351
1224	NZOZ Vitamed -Ga¿aj I Cichomski sp.j	Bydgoszcz		Poland	85-079
1225	Medica Pro Familia Sp. z o.o. Spolka Komandytowo Akcyjna, Oddzial w Gdyni	Gdynia		Poland	81-338
1226	Nzoz Gall-Med	Krakow		Poland	30-053
1227	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie,	Krakow		Poland	31-501
1228	SP ZOZ Szpital Uniwersytecki w Krakowie	Krakow		Poland	31-501
1229	NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp. z.o.o.	Krakow		Poland	31-567
1230	Specjalistyczny Osrodek Medycyny Wieku Dojrzalego	Lodz		Poland	90-368
1231	"TWOJA PRZYCHODNIA" Sp. Z o.o	Lublin		Poland	20-857
1232	NeuroCor Banaszkiewicz, Kulaga, Ostrowska, Tomaszewski lekarze spolka partnerska	Myslenice		Poland	32-400
1233	Medicus w Opolu Sp z o. o.	Opole		Poland	45-706
1234	Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota	Ostroda		Poland	14-100
1235	Medicome Sp. z o.o.	Oswiecim		Poland	32-600
1236	Centrum Zdrowia Metabolicznego Pawel Bogdanski	Poznan		Poland	60-592
1237	NZOZ Przychodnia Specjalistyczna Andrzej wittek Henryk Rudzki S.C.	Ruda Slaska		Poland	41-709
1238	KO-MED Centra Kliniczne Staszow	Staszow		Poland	28-200
1239	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa		Poland	01-192
1240	Instytut Kardiologii, Ii Klinika Choroby WieCowej	Warszawa		Poland	02-637
1241	Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego	Warszawa		Poland	04-628
1242	Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala	Warszawa		Poland	04-628
1243	Dobrostan Michal Bogacki	Wroclaw		Poland	53-301
1244	The Office of Roberto J. Ayala-Rios, MD - Research Center and Private Practice (DMRA LLC)	Anasco		Puerto Rico	00610
1245	Cardiometabolic Research Center, Inc.	Ponce		Puerto Rico	00717
1246	Endocrine Lipid Diabetes Research Institute	Ponce		Puerto Rico	00717
1247	Pradnet Inc.	San Juan		Puerto Rico	00917
1248	Altamira Family Medicine And Research Institute	San Juan		Puerto Rico	00920
1249	Miguel Sosa-Padilla, MD-Private Practice	San Juan		Puerto Rico	00926-2832
1250	Centro de Diabetes para Puerto Rico	San Juan		Puerto Rico	00935
1251	Pitesti-Arges County Emergency Hospital	Pitesti	Arges	Romania	110084
1252	Medical Practice SRL	Oradea	Bihor	Romania	410032
1253	County Clinical Emergency Hospital Oradea	Oradea	Bihor	Romania	410169
1254	County Emergency Hospital Deva	Deva	Hunedoara	Romania	330084
1255	CMI Pop Calin Florin	Baia Mare	JUD Maramures	Romania	430123
1256	Centrul Medical Dr. Negrisanu SRL, Diabet Zaharat Nutritie si Boli Metabolice	Timisoara	Judet Timis	Romania	300456
1257	Dr. Pop Calin Florin - Cabinet Cardiologie	Baia Mare	Maramures	Romania	430130
1258	Podoleanu G. Cristian-Gheorghe-Calin - Cardiology Medical Practice	Targu Mures	Mures	Romania	540143
1259	Diabmed Dr. Popescu Alexandrina SRL, Diabet, Nutritie, Boli Metabolice	Ploiesti	Prahova	Romania	100163
1260	Dr. Busegeanu Mihaela Private Practice	Ploiesti	Prahova	Romania	100342
1261	Clinica Medicala Synexus Ltd.	Bucharest	Sectorul 2	Romania	021611
1262	Institute of Cardiovascular Diseases Timisoara	Timisoara	Timis	Romania	300310
1263	Euromedica Hospital	Baia Mare		Romania	430032
1264	Spitalul Clinic Judetean De Urgenta Braila(Braila County Clincal Emergency Hospital)	Braila		Romania	810249
1265	S.C. Polimed Dacia S.R.L.	Brasov		Romania	500209
1266	Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL, Medicina Interna	Brasov		Romania	500283
1267	Data Plus Medical Clinic	Bucharest		Romania	010192
1268	"Prof. Dr. N.C. Paulescu" National Institute of Diabetes, Nutrition and Metabolic Diseases,	Bucharest		Romania	020045
1269	Med Plus SRL (Med Plus Ltd.)	Bucharest		Romania	061118
1270	S.C. Centrul Medical "Sanatatea Ta" S.R.L.	Bucharest		Romania	20614
1271	Med Plus Srl	Bucharest		Romania	61118
1272	Spitalul Universitar De Urgenta Militar Central, Dr. Carol Davila	Bucuresti		Romania	010825
1273	Spitalul Clinic Colentina, Departament Cardiologie	Bucuresti		Romania	020125
1274	SC Centrul Medical Policlinico Di Monza SRL, Cardiologie	Bucuresti		Romania	021967
1275	SC Policlinica CCBR SRL	Bucuresti		Romania	030463
1276	Spitalul Clinic Judetean De Urgenta Cluj-Napoca, Diabet Zabarat	Cluj-Napoca		Romania	400006
1277	Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Diabet Zaharat, Nutritie si Boli Metabolice	Cluj-Napoca		Romania	400006
1278	Dr. Mistodie Cristina Victoria MD, Office of	Galati		Romania	800098
1279	S.C. Diamed Obesity S.R.L.	Galati		Romania	800291
1280	County Emergency Hospital Satu Mare Diabetes, Nutrition And Metabolic Diseases Department	Satu Mare		Romania	440055
1281	County Clinical Emergency Hospital Sibiu	Sibiu		Romania	550245
1282	Cardio Med SRL, Cardiologie	Tg. Mures		Romania	540124
1283	Centrul Medical Sf. Stefan	Timisoara		Romania	300125
1284	Institution Centrul Medical Sf. Stefan SRL, Diabet Nutritie si Boli Metabolice	Timisoara		Romania	300125
1285	State Budgetary Healthcare Institution "Research Institution - Regional Clinical Hospital #1	Krasnodar	Krasnodar Region	Russian Federation	350086
1286	State Budgetary Healthcare Institution of Moscow Region "Lubertsy Regional Hospital #2"	Lubertsy	Moscow Region	Russian Federation	140006
1287	Federal State Budgetary Institution of Healthcare Hospital of Russian Academy of Sciences	Troitsk	Moscow Region	Russian Federation	142190
1288	1st Pavlov State Medical University of St. Petersburg	St. Petersburg	Sankt-peterburg	Russian Federation	197022
1289	Saint Petersburg State Budgetary Institution of Healthcare	St. Petersburg	Sestroretsk	Russian Federation	197706
1290	FSBEI of HE Kazan State Medical University on the base of SBHI Clinical Hospital No.2	Kazan	Tatarstan Republic	Russian Federation	420033
1291	Municipal Budgetary State Healthcare Institution "City Clinical Hospital #6"	Chelyabinsk		Russian Federation	454047
1292	Non-State Institution of Healthcare	Chelyabinsk		Russian Federation	454092
1293	State Budgetary Healthcare Institution ¿Region Clinical Hospital #3¿	Chelyabinsk		Russian Federation	454136
1294	Municipal Autonomous Institution "City Clinical Hospital #14"	Ekaterinburg		Russian Federation	620039
1295	Regional Budgetary Healthcare Institution "Cardiology Dispensary"	Ivanovo		Russian Federation	153012
1296	State Budgetary Institution of Healthcare of Kaluga Region "Kaluga Regional Hospital"	Kaluga		Russian Federation	428007
1297	Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University"	Kazan		Russian Federation	420012
1298	State Autonomous Healthcare Institution "Republic Clinical Hospital"	Kazan		Russian Federation	420064
1299	"SAHI of Kemerovo ""Regional Clinical Hospital of Emergency Medical Care n.a. M.A Podgorbunsky """	Kemerovo		Russian Federation	650000
1300	Municipal Budgetary Institution of Healthcare Municipal Clinical Hospital #3 n.a. M.A. Podgorbunsky	Kemerovo		Russian Federation	650000
1301	FSBI "Research institute of complex problems of cardio-vascular diseases" of	Kemerovo		Russian Federation	650002
1302	FSHI "Medical and Sanitary Unit of the Ministry of Internal Affairs of Russia across	Kemerovo		Russian Federation	650099
1303	Kirov Regional State Budgetary Healthcare Institution "Kirov City Clinical Hospital #1"	Kirov		Russian Federation	610014
1304	Regional Budgetary Healthcare Institution "Kursk City Clinical Emergency Hospital"	Kursk		Russian Federation	305035
1305	Non-State Institution of Healthcare "Central Clinical Hospital #6 OAO "RZhD"	Moscow		Russian Federation	109388
1306	SBHI Moscow city "City Clinical Hospital #15 n.a. O.M. Filatova" of Moscow Healthcare Department	Moscow		Russian Federation	111539
1307	Federal State Budgetary Institution "Central Clinical Hospital with Polyclinic"	Moscow		Russian Federation	121359
1308	"Federal State Budgetary Institution "Russian Cardiology Research And Production Complex" Of	Moscow		Russian Federation	121552
1309	Moscow State Healthcare Institution "City clinical hospital n.a. S.P.Botkin"	Moscow		Russian Federation	125284
1310	State Budget Institution of Healthcare (SBIH) of Moscow "City Clinical Hospital #81	Moscow		Russian Federation	127644
1311	Federal State Budget Institution "Out-patient Clinic #3" of Russian Federation, President's	Moscow		Russian Federation	129090
1312	State Regional Budgetary Healthcare Institution	Murmansk		Russian Federation	183047
1313	State Budgetary Healthcare Institution of Nizhegorodskaya Region	Nizhniy Novgorod		Russian Federation	603076
1314	Federal State Budgetary Institution "Research Institute of Therapy and Preventive Medicine"	Novosibirsk		Russian Federation	630089
1315	"Reafan" LLC	Novosibirsk		Russian Federation	630099
1316	Municipal Budgetary Institution of Healthcare of Novosibirsk	Novosibirsk		Russian Federation	630102
1317	State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital of Emergency	Novosibirsk		Russian Federation	630102
1318	State Budgetary Healthcare Institution (SBHI) N.N. Burdenko Regional Clinical Hospital of Penza	Penza		Russian Federation	440026
1319	SBHI of Saint-Petersburg "City Hospital # 38 n.a. N.A. Semashko"	Pushkin		Russian Federation	196601
1320	State Budgetary Educational Institution Of Higher Professional Education	Rostov-on-Don		Russian Federation	344022
1321	State Budgetary Educational Institution of Higher Professional Education	Rostov-on-Don		Russian Federation	344068
1322	State Budgetary Institution "Ryazan Regional Clinical Hospital"	Ryazan		Russian Federation	390039
1323	Limited Liability Company "Reavita"	Saint Petersburg		Russian Federation	194354
1324	LLC "Institution of medical studies"	Saint Petersburg		Russian Federation	196084
1325	Federal State Budgetary Institution "Federal Almazov Medical Research Centre" of	Saint Petersburg		Russian Federation	197341
1326	Limited Liability Company International Medical Centre SOGAZ	Saint-Petersberg		Russian Federation	191186
1327	Saint-Petersburg State Budgetary Institution of Healthcare "City Hospital #23"	Saint-Petersburg		Russian Federation	192148
1328	Saint-Petersburg State Budgetary Healthcare Institution "City Alexandrovskaya Hospital"	Saint-Petersburg		Russian Federation	193312
1329	Saint-Petersburg State Budgetary Institution of Healthcare "City Hospital #26"	Saint-Petersburg		Russian Federation	196247
1330	SBEI of HPE "First Pavlov State Medical University of St. Petersburg" of the MoH of the RF	Saint-Petersburg		Russian Federation	197022
1331	Federal State Budgetary Institution "Advisory Diagnostic Center and Polyclinic"	Saint-Petersburg		Russian Federation	197110
1332	Saint-Petersburg State Budgetary Healthcare Institution "City Hospital #15"	Saint-Petersburg		Russian Federation	198205
1333	State Budgetary Healthcare Institution "Samara Regional Clinical Cardiology Dispensary"	Samara		Russian Federation	443070
1334	MHI "City Clinical Hospital 12"of the Healthcare Committee of	Saratov		Russian Federation	410039
1335	State Institution of Healthcare "Regional Clinical Hospital"	Saratov		Russian Federation	410053
1336	Federal State Budgetary Educational Institution of Higher Education "Academician I.P. Pavlov First	St. Petersburg		Russian Federation	197022
1337	Tyumen Cardiology Research Center-branch of the Tomsk NRMC	Tomsk		Russian Federation	634009
1338	State Budgetary Educational Institution of Highest Professional Education	Tomsk		Russian Federation	634050
1339	State Autonomous Healthcare Institution of Tyumen region "Scientific-Practical Medical Center"	Tyumen		Russian Federation	625000
1340	"Tyumen Cardiology Center" Affiliate of the FSBSI "Scientific and Research Institution of Cardiology	Tyumen		Russian Federation	625026
1341	State Autonomous Healthcare Institution of Yaroslavl region Clinical Emergency Hospital n.a..N.V.So	Yaroslavl		Russian Federation	150003
1342	State Autonomous Healthcare Institution of Yaroslavl Region	Yaroslavl		Russian Federation	150003
1343	FSBEI of HE "Yaroslavl State Medical University" MH of the Russian Federation based on Clinical	Yaroslavl		Russian Federation	150010
1344	State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital No. 10"	Yaroslavl		Russian Federation	150023
1345	State Healthcare Institution of Yaroslavl Region "Clinical Hospital #8"	Yaroslavl		Russian Federation	150030
1346	Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)	Bratislava	Bratislavsky	Slovakia	826 06
1347	Stredoslovensky ustav srdcovych a cievnych chorob a.s.	Banska Bystrica		Slovakia	974 01
1348	Fakultna nemocnica F. D. Roosevelta	Banska Bystrica		Slovakia	97517
1349	Alian s.r.o., kardiologicka ambulancia	Bardejov		Slovakia	08501
1350	Metabol KLINIK s.r.o., Ambulancia pre diabetologiu, poruchy latkovej premeny a vyzivy	Bratislava		Slovakia	811 08
1351	Univerzitna nemocnica Bmtislava, Nemocnica Stare Mesto	Bratislava		Slovakia	81369
1352	Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto, l.interna klinika	Bratislava		Slovakia	81369
1353	Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto	Bratislava		Slovakia	81369
1354	UN Bratislava, Nemocnica Ruzinov, V. interna klinika LFUK a UN Bratislava	Bratislava		Slovakia	826 06
1355	Kardiovaskularne Centrum S.R.O.	Bratislava		Slovakia	83101
1356	Metabolicke Centrum MUDr. Katariny Raslovej, S.R.O.	Bratislava		Slovakia	83101
1357	Narodny ustav srdcovych a cievnych chorob, a.s.	Bratislava		Slovakia	833 48
1358	Univerzitna Nemocnica Bratislava	Bratislava		Slovakia	83305
1359	Narodny ustav srdcovych a cievnych chorob, a.s.	Bratislava		Slovakia	83348
1360	KARDIO-SANUS spol.,s.r.o.,Kardiologicka, interna a sonograficka ambulancia	Bratislava		Slovakia	841 08
1361	KARDIO-SANUS spol. s.r.o.	Bratislava		Slovakia	84107
1362	VERIA, s.r.o. -Kardiologicka ambulancia	Bratislava		Slovakia	85101
1363	UN Bratislava Nemocnica Sv.Cyrila a Metoda, kardiologicka ambulancia 1	Bratislava		Slovakia	85107
1364	Endiamed s.r.o. Nestatna diabetologicka a endokrinologicka ambulancia	Dolny Kubin		Slovakia	02601
1365	JM-Interna s.r.o., interna ambulancia	Dolny Kubin		Slovakia	02601
1366	CARDIO D&R s.r.o., Kardiologicka ambulancia	Kosice		Slovakia	040 01
1367	AGTO., spol. s r. o.	Kosice		Slovakia	04011
1368	Cardio D&R spol.s.r.o., kardiologicka ambulancia	Kosice		Slovakia	04022
1369	Medicentrum Heart, Spol. S.R.O	Kralovsky Chlmec		Slovakia	077 01
1370	CELL-B s.r.o. interna ambulancia	Levice		Slovakia	93405
1371	Liptovska nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovsky Mikulas	Liptovsky Mikulas		Slovakia	031 23
1372	Narodny Endokrinologicky A Diabetologicky Ustav N.O.	Lubochna		Slovakia	034 91
1373	KARDIO 1 s.r.o.	Lucenec		Slovakia	984 39
1374	Klinika hematologie a transfuziologie, Univerzitna nemocnica Martin	Martin		Slovakia	036 59
1375	MEDI M&M s.r.o., Ambulancia vnutorneho lekarstva	Moldava nad Bodvou		Slovakia	045 01
1376	MUDr. Kanderkova s.r.o., Diabetologicka ambulancia	Namestovo		Slovakia	02901
1377	Kardiocentrum Nitra s.r.o., kardiologicka ambulancia	Nitra		Slovakia	94901
1378	Fakultna nemocnica s poliklinikou Nove Zamky, I. interna klinika	Nove Zamky		Slovakia	940 34
1379	Mediab s.r.o. Diabetologicka ambulancia	Pezinok		Slovakia	90201
1380	BENIMED s.r.o.	Piestany		Slovakia	921 01
1381	Medispol S.R.O.	Presov		Slovakia	08001
1382	Medilex s.r.o. Interna ambulancia	Rimavska Sobota		Slovakia	979 01
1383	Kardioamb S.R.O.	Rimavska Sobota		Slovakia	97901
1384	DIAMEL, s.r.o., Diabetologicka ambulancia	Trencin		Slovakia	911 01
1385	BV Medical, s.r.o. Diabetologicka ambulancia,	Trnava		Slovakia	917 01
1386	Kardiologicka ambulancia	Trnava		Slovakia	917 01
1387	Medivasa S.R.O., Diabetologicka Ambulancia	Zilina		Slovakia	01001
1388	IATROS International	Bloemfontein	FREE State	South Africa	9301
1389	JOSHA Research	Bloemfontein	FREE State	South Africa	9301
1390	Welkom Clinical Trial Centre	Welkom	FREE State	South Africa	9460
1391	Midrand Medical Centre	Halfway House	Gauteng	South Africa	1685
1392	Centre for Diabetes and Endocrinology	Houghton	Gauteng	South Africa	2198
1393	Sunninghill Hospital	Johannesburg	Gauteng	South Africa	2157
1394	I Engelbrecht Research (Pty) Ltd	Lyttelton	Gauteng	South Africa	0157
1395	Charlotte Maxeke Johannesburg Academic Hospital	Parktown	Gauteng	South Africa	2193
1396	Jongaie Research	Pretoria West	Gauteng	South Africa	0183
1397	Medipark Centre for Clinical Research	Pretoria	Gauteng	South Africa	0158
1398	Synexus Watermeyer Clinical Research Centre	Pretoria	Gauteng	South Africa	0184
1399	Roodepoort Medicross Clinical Research Centre	Roodepoort	Gauteng	South Africa	1724
1400	Wits Clinical Research-Chris Hani Baragwanath Hospital	Soweto	Gauteng	South Africa	2013
1401	Medi-Clinic Heart Hospital	Sunnyside	Gauteng	South Africa	0083
1402	Nash Ranjith Research Centre	Merebank, Durban	KWA ZULU Natal	South Africa	4052
1403	Suite 502	Durban	Kwazulu-natal	South Africa	4001
1404	Dr Ganesh c/o Dr NB Maharaj	Durban	Kwazulu-natal	South Africa	4091
1405	Limpopo Clinical Research Initiative	Thabazimbi	Limpopo	South Africa	0380
1406	Zinakekele Medical Centre	Moloto	Mpumalanga	South Africa	1022
1407	Drs Joynt Venter & Associates	Witbank (eMalahleni)	Mpumalanga	South Africa	1035
1408	Dr JM Engelbrecht Trial Site-Vergelegen Mediclinic	Cape Town	Western CAPE	South Africa	7130
1409	Tiervlei Trial Centre	Cape Town	Western CAPE	South Africa	7530
1410	Synopsis Research cc	Cape Town	Western CAPE	South Africa	7700
1411	Helderberg Research Institute	Somerset West	Western CAPE	South Africa	7130
1412	Synexus Helderberg Clinical Research Centre	Somerset West	Western CAPE	South Africa	7130
1413	Vergelegen Mediclinic-Helderberg Research Institute	Somerset West	Western CAPE	South Africa	7130
1414	Unitas Hospital.	Centurion		South Africa	0157
1415	Clinresco Centres (Pty) Ltd-Central Professional Suits	Gauteng		South Africa	1619
1416	Paarl Research Centre	Paarl		South Africa	7646
1417	TREAD Research cc	Parow		South Africa	7500
1418	Clinical Projects Research SA (Pty) Ltd	Worcester		South Africa	6850
1419	Hospital Clinico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruna	Spain	15706
1420	Hospital Virgen De Los Lirios	Alcoy	Alicante	Spain	03804
1421	Hospital Regional Universitario de Malaga	Malaga	Andalucia	Spain	29010
1422	Hospital Universitario Virgen del Rocio	Sevilla	Andalucia	Spain	41013
1423	Centro de Salud El Cristo	Oviedo	Asturias	Spain	33006
1424	Centro Salud Paulino Prieto	Oviedo	Asturias	Spain	33009
1425	Cap Florida	L'Hospitalet De Llobregat	Barcelona-cataluna	Spain	08905
1426	CAP Disset De Setembre (Sant Cosme I Sant Damia)	El Prat De Llobregat	Barcelona/cataluna	Spain	08820
1427	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona	Spain	08907
1428	CAP La Mina	Sant Adria De Besos	Barcelona	Spain	08930
1429	EAP Vic	Vic	Barcelona	Spain	08500
1430	Hospital Universitario Marques De Valdecilla	Santander	Cantabria	Spain	39008
1431	Hospital Universitari de Tarragona Joan XXIII	Tarragona	Catalonia	Spain	43007
1432	Hospital Universitario San Juan de Alicante	Alicante	Comunidad Valenciana	Spain	03550
1433	Albera Salut	Peralada	Gerona	Spain	17491
1434	Hospital De Figueres	Figueres	Girona-catalonia	Spain	17600
1435	Hospital Santa Caterina	Salt, Girona	Girona	Spain	17190
1436	Hospital Comarcal d'Inca	Inca	Illes Balears	Spain	07300
1437	Hospital Arquitecto Marcide	El Ferrol	LA Coruna	Spain	15405
1438	Hospital Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid	Spain	28222
1439	Hospital Universitario Quiron Madrid	Pozuelo de Alarcon	Madrid	Spain	28223
1440	Hospital Universitario de Cruces	Barakaldo	PAIS Vasco	Spain	48903
1441	Hospital Universitario Sant Joan de Reus	Reus	Tarragona	Spain	43204
1442	Hospital General De Requena	Requena	Valencia	Spain	46340
1443	Gerencia de Gestion integrada de A Coruna	A Coruna		Spain	15006
1444	Complejo Hospitalario Universitario de Albacete	Albacete		Spain	02006
1445	Hospital General Universitario de Alicante; Servicio Cardiologia	Alicante		Spain	03010
1446	Hospital Virgen del Mar	Almeria		Spain	04120
1447	Parc de Salut mar ¿ Hospital del Mar	Barcelona		Spain	08003
1448	Parc de Salut Mar- Hospital del Mar	Barcelona		Spain	08003
1449	Centre Teknon	Barcelona		Spain	08022
1450	EAP Sardenya	Barcelona		Spain	08025
1451	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
1452	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
1453	CAP Centelles	Barcelona		Spain	08540
1454	CAP Amadeu Torner	Barcelona		Spain	08902
1455	Hospital Universitario de Bellvitge	Barcelona		Spain	08907
1456	Fundacio Hospital de I'Esperit Sant	Barcelona		Spain	08923
1457	Hospital Universitario Reina Sofia	Cordoba		Spain	14004
1458	Complexo Hospitalario Universitario Arquitecto Marcide-Profesor Novoa Santos De Ferrol	Ferrol		Spain	15401
1459	Hospital Universitario San Cecilio	Granada		Spain	18012
1460	Hospital Universitario Virgen de las Nieves (HUVN)	Granada		Spain	18014
1461	Hospital Universitari Arnau de Vilanova (HUAV)	Lleida		Spain	25198
1462	Hospital Universitari Arnau de Vilanova	Lleida		Spain	25198
1463	Pharmacy - Hospital Universitari Arnau de Vilanova (HUAV)	Lleida		Spain	25198
1464	Hospital Universitario Lucus Augusti	Lugo		Spain	27003
1465	Hospital Universitario de La Princesa	Madrid		Spain	28006
1466	Hospital General Universitario Gregorio Maranon	Madrid		Spain	28007
1467	Hospital Carlos III	Madrid		Spain	28029
1468	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
1469	Fundacion Jimenez Diaz	Madrid		Spain	28040
1470	Hospital Universitario Fundacion Jimenez Diaz	Madrid		Spain	28040
1471	Hospital Universitario La Paz; Unidad Metabolico-Vascular	Madrid		Spain	28046
1472	Hospital Universitario Infanta Sofía	Madrid		Spain	28702
1473	Carretera Alcala-Meco s/n	Madrid		Spain	28805
1474	H. U. Principe de Asturias	Madrid		Spain	28805
1475	Hospital Universitario Virgen de la Victoria. CE San Jose Obrero	Malaga		Spain	29006
1476	Hospital Regional Universitario de Malaga	Malaga		Spain	29009
1477	Hospital Universitario Virgen De La Victoria	Malaga		Spain	29010
1478	Hospital General Universitario Morales Meseguer	Murcia		Spain	30008
1479	Hospital Universitario Sant Joan de Reus	Reus (Tarragona)		Spain	43204
1480	Clinica Nuevas Tecnologias En Diabetes Y Endocrinologia	Sevilla		Spain	41003
1481	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
1482	Hospital Universitario Virgen de Valme	Sevilla		Spain	41014
1483	CAP Muralles	Tarragona		Spain	43002
1484	Hospital General Universitario de Valencia	Valencia		Spain	46014
1485	Hospital Clinico Universitario Miguel Servet; Medicina Interna	Zaragoza		Spain	50009
1486	Karolinska universitetssjukhuset Huddinge	Stockholm	Huddinge	Sweden	141 86
1487	Kasernens Läkarservice AB	Eksjö		Sweden	57535
1488	Sahlgrenska Universitetssjukhuset	Goteborg		Sweden	41345
1489	Pharmasite AB	Helsingborg		Sweden	252 20
1490	Medicinklinikens forskningsenhet	Kristianstad		Sweden	291 85
1491	Hjartmottagningen, Capio Citykliniken	Lund		Sweden	222 21
1492	Probar E Lund AB	Lund		Sweden	222 22
1493	Karlkliniken, Skanes Universitetssjukhus i Malmo	Malmo		Sweden	205 02
1494	Pharmasite AB	Malmo		Sweden	211 52
1495	Forskningsenheten, Medicinmottagningen Sahlgrenska Universitetssjukhuset/Molndal, Hus J	Molndal		Sweden	431 80
1496	Ostersunds Sjukhus	Ostersund		Sweden	83183
1497	Dalecarlia Clinical Research Center	Rattvik		Sweden	79530
1498	Skelleftea Lasarett	Skelleftea		Sweden	93186
1499	A+Science City site	Stockholm		Sweden	111 57
1500	Karolinska Universitetssjukhuset	Stockholm		Sweden	17176
1501	Hjartkliniken	Stockholm		Sweden	182 82
1502	Akademiska Sjukhuset	Uppsala		Sweden	75185
1503	Vastmanlands Sjukhus Vasteras	Vasteras		Sweden	721 89
1504	Universitatsspital	Basel	Basel Stadt	Switzerland	4031
1505	Diagene Laboratories Inc.	Reinach	Basel	Switzerland	4153
1506	Hospitaux Universitaires de Geneve (HUG)	Geneve	Geneva	Switzerland	1211
1507	Policlinique Medicale Universitaire	Lausanne	Vaud	Switzerland	1011
1508	Kantonsspital Winterthur	Winterthur	Zurich	Switzerland	8401
1509	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland	1011
1510	Cardiocentro Ticino	Lugano		Switzerland	CH-6900
1511	Fondazione Diabete Lugano	Lugano		Switzerland	CH-6900
1512	Luzerner Kantonsspital Luzern	Luzern 16		Switzerland	CH-6000
1513	Kantonsspital St. Gallen	St. Gallen		Switzerland	CH-9007
1514	China Medical University Hospital	Taichung	Taiwan R O C	Taiwan	40447
1515	National Taiwan University Hospital	Taipei	Taiwan R O C	Taiwan	10002
1516	Kaohsiung Medical University Chung-Ho Memorial Hospital - New	Kaohsiung		Taiwan	807
1517	Cardinal Tien Hospital	New Taipei City		Taiwan	23148
1518	Chung Shan Medical University Hospital	Taichung		Taiwan	402
1519	National Cheng Kung University (NCKU) Hospital	Tainan		Taiwan	70428
1520	National Taiwan University Hospital	Taipei		Taiwan	10041
1521	MacKay Memorial Hospital	Taipei		Taiwan	10449
1522	Taipei Veterans General Hospital	Taipei		Taiwan	11217
1523	Division of Cardiology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,	Bangkoknoi	Bangkok	Thailand	10700
1524	Faculty of Medicine, Srinagarind Hospital, Khon Kaen University	Muang	Khon Kaen	Thailand	40002
1525	Heart Center, Songklanagarind Prince of Songkla University	Hat Yai	Songkla	Thailand	90110
1526	Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,	Bangkok		Thailand	10400
1527	Division Of cardiology,Department of Medicine,Faculty Of Medicine,Chulalongkorn University	Bangkok		Thailand	10400
1528	Baskent University, Adana Yuregir Training & Research Hospital	Adana		Turkey	01250
1529	A.karahisar Kocatepe Universitesi Hastanesi Ahmet Needet Sezer Uygulama ve	Afyonkarahisar		Turkey	03200
1530	Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi	Ankara		Turkey	06110
1531	Ufuk University School of Medicine, Dr. Ridvan Ege Training & Research Hospital	Ankara		Turkey	06520
1532	Akdeniz Universitesi Tip Fakultesi	Antalya		Turkey	07059
1533	Antalya Training & Research Hospital	Antalya		Turkey	07100
1534	Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi	Aydin		Turkey	09100
1535	Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi	Bursa		Turkey	16320
1536	Firat Universitesi	Elazig		Turkey	23119
1537	Gaziantep Universitesi Tip Fakultesi Sahinbey Egitim ve Arastirma Hastanesi	Gaziantep		Turkey	27310
1538	Bezmialem Vakif Universitesi Tip Fakultesi Kardiyoloji Bolurnu	Istanbul		Turkey	34093
1539	Istanbul Universitesi Istanbul Tip Fakultesi	Istanbul		Turkey	34093
1540	Istanbul Universitesi Kardiyoloji Enstitusu	Istanbul		Turkey	34096
1541	Ege University, School of Medicine	Izmir		Turkey	35100
1542	Izmir Tepecik Egitim ve Arastirma Hastanesi	Izmir		Turkey	35170
1543	Dokuz Eylul Universitesi Tip Fakultesi Hastanesi	Izmir		Turkey	35340
1544	Dokuz Eylul Universitesi Tip Fakultesi	Izmir		Turkey	35340
1545	Kocaeli University School Of Medicine-Kocaeli Universitesi Tip Fakultesi	Kocaeli		Turkey	41380
1546	Mersin University, School of Medicine	Mersin		Turkey	33343
1547	Recep Tayyip Erdogan University School of Medicine, Training & Research Hospital	Rize		Turkey	53020
1548	Synexus Thames Valley Clinical Research Centre	Reading	Berkshire	United Kingdom	RG2 0TG
1549	Peterborough and Stamford Hospitals NHS Foundation Trust	Peterborough	Cambridgeshire	United Kingdom	PE3 9GZ
1550	Brannel Surgery	St Austell	Cornwall	United Kingdom	PL26 7RL
1551	Queens Hospital	Romford	Essex	United Kingdom	RM7 0AG
1552	Synexus Manchester Clinical Research Centre-Manchester Science Park	Manchester	Greater Manchester	United Kingdom	M15 6SX
1553	Royal Oldham Hospital	Oldham	Greater Manchester	United Kingdom	OL1 2JH
1554	Salford Royal NHS Foundation Trust	Salford	Greater Manchester	United Kingdom	M6 8HD
1555	Lister Hospital	Stevenage	Hertfordshire	United Kingdom	SG1 4AB
1556	Queen Elizabeth II Hospital, East and North Hertfordshire NHS Trust	Welwyn Garden City	Hertfordshire	United Kingdom	AL7 4HQ
1557	Medway Maritime Hospital	Gillingham	Kent	United Kingdom	ME7 5NY
1558	Synexus Scotland Clinical Research Centre	Glasgow	Lanarkshire	United Kingdom	G20 0SP
1559	Bolton NHS Foundation Trust	Bolton	Lancashire	United Kingdom	BL4 0JR
1560	Synexus Lancashire Clinical Research Centre	Chorley	Lancashire	United Kingdom	PR7 7NA
1561	Layton Medical Centre	Layton, Blackpool	Lancashire	United Kingdom	FY3 7EN
1562	Synexus Merseyside Clinical Research Centre	Liverpool	Merseyside	United Kingdom	L22 0LG
1563	Whitby Group Practice	Whitby	North Yorkshire	United Kingdom	YO21 1SD
1564	Albany House Medical Centre	Wellingborough	Northants	United Kingdom	NN84RW
1565	Southern Health & Social Care Trust, Craigavon Area Hospital	Portadown	Northern Ireland	United Kingdom	BT63 5QQ
1566	Synexus North East Clinical Research Centre - Hexham General Hospital	Hexham	Northumberland	United Kingdom	NE46 1QJ
1567	South Axholme Practice	Doncaster	South Yorkshire	United Kingdom	DN9 2HY
1568	Central Manchester University Hospitals NHS Foundation Trust	Manchester	South Yorkshire	United Kingdom	M13 9WL
1569	The Crouch Oak Family Practice	Addlestone	Surrey	United Kingdom	KT15 2BH
1570	Ely Bridge Surgery	Cardiff	Wales	United Kingdom	CF5 4AD
1571	Synexus Midlands Clinical Research Centre	Birmingham	WEST Midlands	United Kingdom	B15 2SQ
1572	City Hospital	Birmingham	WEST Midlands	United Kingdom	B18 7QH
1573	Prince Philip Hospital	Llanelli	WEST Wales	United Kingdom	SF14 8QF
1574	Royal Free London NHS Foundation Trust	Barnet		United Kingdom	EN5 3DJ
1575	Laurie Pike Health Centre	Birmingham		United Kingdom	B6 6BB
1576	Heart of England NHS Foundation Trust, Dept. of Clinical Biochemistry & Immunology	Birmingham		United Kingdom	B9 5SS
1577	Synexus Wales Clinical Research Centre	Cardiff		United Kingdom	CF14 5GJ
1578	Ashgate Medical Practice	Chesterfield		United Kingdom	S404AA
1579	Little Common Surgery	East Sussex		United Kingdom	TN39 4SP
1580	Sea Road Surgery	East Sussex		United Kingdom	TN40 1JJ
1581	Staploe Medical Centre	Ely		United Kingdom	CB7 5JD
1582	McGlone Practice - Ballieston Health Centre	Glasgow		United Kingdom	G69 7AD
1583	The Queen Elizabeth University Hospital- NHS Greater Glasgow and Clyde	Glosgow		United Kingdom	G51 4TF
1584	Burbage Surgery	Hinckley		United Kingdom	LE10 2SE
1585	The Royal Liverpool and Broadgreen -University Hospitals NHS	Liverpool		United Kingdom	L7 8XP
1586	Barts Health NHS Trust	London		United Kingdom	EC1M 6BQ
1587	Royal Free Hospital	London		United Kingdom	NW3 2QG
1588	Peart-Rose Research Unit, Hammersmith Hospital, Imperial College NHS Trust	London		United Kingdom	W12 OHS
1589	The Red Porto cabin, The James Cook University Hospital	Middlesbrough		United Kingdom	TS4 3BW
1590	St Mary's Hospital	Newport		United Kingdom	PO30 5TG
1591	Wansford And Kings Cliffe Practice	Peterborough		United Kingdom	PE8 6PL
1592	Rothwell and Desborough Healthcare Group	Rothwell, Northants		United Kingdom	NN14 6JQ
1593	Abertawe Bro Morgannwg University Local Health Board Joint	Swansea		United Kingdom	SA2 8PP
1594	Western Sussex Hosptials NHS Trust	Worthing		United Kingdom	BN11 2DH
1595	York Medical Group	York		United Kingdom	YO30 6AE
1596	Strensall Healthcare Centre	York		United Kingdom	YO32 5UA

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Feb 12, 2016
• Statistical Analysis Plan - Dec 20, 2016

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01975389
• Other Study ID Numbers: B1481038; CV OUTCOMES 2; 2013-002795-41
• First Posted: Nov 3, 2013
• Last Update Posted: May 1, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: myocardial infarction; stroke; hyperlipidemia
• Additional relevant MeSH terms: Cardiovascular Diseases; Bococizumab

Study Results

Participant Flow

Pre-assignment Detail	The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Period Title: Overall Study
STARTED	5283	5281
Treated	5279	5276
COMPLETED	5031	5045
NOT COMPLETED	252	236

Baseline Characteristics

Arm/Group Title	Placebo	Bococizumab (PF-04950615)	Total
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Total of all reporting groups
Overall Participants	5283	5281	10564
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	62.5 (9.5)	62.2 (9.6)	62.4 (9.6)
Sex: Female, Male (Count of Participants)
Female	1849 35%	1792 33.9%	3641 34.5%
Male	3434 65%	3489 66.1%	6923 65.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	852 16.1%	892 16.9%	1744 16.5%
Not Hispanic or Latino	4430 83.9%	4387 83.1%	8817 83.5%
Unknown or Not Reported	1 0%	2 0%	3 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	118 2.2%	105 2%	223 2.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	246 4.7%	252 4.8%	498 4.7%
White	4776 90.4%	4784 90.6%	9560 90.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	143 2.7%	140 2.7%	283 2.7%

Outcome Measures

1. Primary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event
Description	Event rate per 100 participant-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death [defined as sudden cardiac death, fatal myocardial infarction (MI), death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes] non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	4.19	3.33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.021469
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infraction (MI) or Non-fatal Stroke
Description	Event rate per 100 participant-years for first occurrence of composite endpoint of CV Death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	3.58	2.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007597
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infraction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization
Description	Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	4.59	3.76

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.035958
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.68 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke
Description	Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	3.97	3.09

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.015694
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.64 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization
Description	Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.77	0.73

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.814224
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina
Description	Event rate per 100 participant-years for first occurrence of composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	4.35	3.45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.018053
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Event Rate Per 100 Participant-years for Cardiovascular (CV) Death
Description	Event rate per 100 participant-years for occurrence of CV death (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of adjudicated and confirmed occurrence of CV death (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.62	0.51

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.446033
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Any Myocardial Infarction (Fatal or Non-fatal)
Description	Event rate per 100 participant-years for first occurrence of any myocardial infarction (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of any myocardial infarction (fatal or non-fatal) (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	2.39	1.79

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.029977
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Event Rate Per 100 Participant-years for Fatal Myocardial Infarction (MI)
Description	Event rate per 100 participant-years for occurrence of fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.16	0.07

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.162615
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95%; 0.14 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Myocardial Infarction (MI)
Description	Event rate per 100 participant-years for first occurrence of non-fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	2.26	1.74

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.051534
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal)
Description	Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.72	0.48

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.104998
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95%; 0.41 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal), of Any Etiology
Description	Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) of any etiology (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) of any etiology (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.77	0.61

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.294331
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Event Rate Per 100 Participant-years for Fatal Stroke
Description	Event rate per 100 participant-years for occurrence of fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.00	0.00

14. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Stroke
Description	Event rate per 100 participant-years for first occurrence of non-fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.72	0.48

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.104998
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95%; 0.41 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina
Description	Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.94	0.85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.601200
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF)
Description	Event rate per 100 participant-years for first occurrence of hospitalization for CHF (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for CHF (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.75	0.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.678061
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Coronary Revascularization
Description	Event rate per 100 participant-years for first occurrence of coronary revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	4.18	3.23

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.010457
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)
Description	Event rate per 100 participant-years for first occurrence of CABG (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	0.48	0.57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.509847
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 0.71 to 2.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Percutaneous Coronary Intervention (PCI)
Description	Event rate per 100 participant-years for first occurrence of PCI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	3.73	2.70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002981
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Event Rate Per 100 Participant-years for First Occurrence of Any Arterial Revascularizations
Description	Event rate per 100 participant-years for first occurrence of any arterial revascularizations (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	1.51	1.44

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.748975
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Event Rate Per 100 Participant-years for All-cause Death
Description	Event rate per 100 participant-years for occurrence of all-cause death (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.
Time Frame	From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years)

Outcome Measure Data

Analysis Population Description

FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Number (95% Confidence Interval) [Events per 100 participant-years]	1.06	0.97

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.626157
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.63 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

Analysis was performed on FAS. Here, "Number of participants analyzed" (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	4712	4654
Least Squares Mean (Standard Error) [Percent change]	2.13 (0.36)	-54.77 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Least square (LS) mean differences, associated 95% CI, and p-values were from an mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-56.90
	Confidence Interval	(2-Sided) 95%; -57.91 to -55.89
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.51
	Estimation Comments

23. Secondary Outcome

Title	Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

Analysis was performed on FAS. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	4712	4654
Least Squares Mean (Standard Error) [mg/dL]	0.69 (0.47)	-73.11 (0.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	LS mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-73.80
	Confidence Interval	(2-Sided) 95%; -75.11 to -72.50
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.67
	Estimation Comments

24. Secondary Outcome

Title	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement
Time Frame	Baseline, last post-baseline measurement (any time up to Week 140)

Outcome Measure Data

Analysis Population Description

Analysis was performed on FAS. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5242	5246
Least Squares Mean (Standard Error) [Percent change]	2.90 (0.45)	-36.41 (0.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	LS-mean difference, associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-39.31
	Confidence Interval	(2-Sided) 95%; -40.55 to -38.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.64
	Estimation Comments

25. Secondary Outcome

Title	Percent Change From Baseline in Lipid Levels at Week 14
Description	Lipids included non-high density lipoprotein cholesterol (non-HDL-C), very low density lipoprotein cholesterol (VLDL-C), remnant lipoprotein cholesterol (RLP-C), apolipoprotein B (Apo B), HDL-C, apolipoprotein A-I (Apo A-I) and total cholesterol.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

FAS population. Here, number analyzed "n" signifies number of participants who were evaluable for the specified categories.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Non-HDL-C	1.82 (0.34)	-50.05 (0.34)
VLDL-C	4.88 (0.56)	-13.54 (0.56)
RLP-C	8.76 (0.81)	-20.44 (0.81)
Apo B	1.89 (0.35)	-49.51 (0.35)
HDL-C	1.05 (0.21)	7.96 (0.21)
Apo A-I	0.07 (0.18)	4.46 (0.18)
Total cholesterol	1.26 (0.28)	-36.72 (0.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Non-HDLC: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-51.87
	Confidence Interval	(2-Sided) 95%; -52.81 to -50.94
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.48
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	VLDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-18.41
	Confidence Interval	(2-Sided) 95%; -19.96 to -16.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.79
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	RLP-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-29.20
	Confidence Interval	(2-Sided) 95%; -31.44 to -26.96
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.14
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Apo B: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-51.40
	Confidence Interval	(2-Sided) 95%; -52.37 to -50.42
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.50
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	HDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	6.91
	Confidence Interval	(2-Sided) 95%; 6.33 to 7.50
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Apo A-I: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	4.40
	Confidence Interval	(2-Sided) 95%; 3.90 to 4.90
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Total cholesterol: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-37.99
	Confidence Interval	(2-Sided) 95%; -38.75 to -37.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.39
	Estimation Comments

26. Secondary Outcome

Title	Percent Change From Baseline in Log-transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

FAS population. Here, number analyzed "n" signifies number of participants who were evaluable for the specified categories.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	5283	5281
Triglycerides	-1.4 (34.55)	-19.7 (30.71)
Lp(a)	-2.0 (31.03)	-33.3 (31.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Triglycerides: LS-mean differences, associated 95% CI and p-values were from an MMRM model including observations through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.81 to 0.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	Lp(a): LS-mean differences, associated 95% CI and p-values were from an MMRM model on the Difference of log-transformed observations with fixed effects for treatment group, visit, a treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.67 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Secondary Outcome

Title	Percent Change From Baseline in Log-transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

Analysis was performed on FAS. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.	Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Measure Participants	4655	4620
Mean (Standard Deviation) [Percent change]	-4.8 (83.68)	0.3 (90.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bococizumab (PF-04950615)
	Comments	LS-mean differences, associated 95% CI and p-values were from an MMRM model on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline up to 3.4 years
Adverse Event Reporting Description	Safety analysis set: all participants who randomized, had atleast 1 dose of study drug, excluding those attempted to randomize more than once in a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to randomize in more than 1 CV outcomes trial, and all participants enrolled at study Site 3027 where a quality-related event was identified
Arm/Group Title	Placebo		Bococizumab (PF-04950615)
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.		Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
All Cause Mortality
	Placebo		Bococizumab (PF-04950615)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/5279 (1.2%)		54/5276 (1%)
Serious Adverse Events
	Placebo		Bococizumab (PF-04950615)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	994/5279 (18.8%)		934/5276 (17.7%)
Blood and lymphatic system disorders
Anaemia	4/5279 (0.1%)		6/5276 (0.1%)
Autoimmune haemolytic anaemia	0/5279 (0%)		1/5276 (0%)
Haemorrhagic anaemia	2/5279 (0%)		3/5276 (0.1%)
Hypochromic anaemia	0/5279 (0%)		1/5276 (0%)
Iron deficiency anaemia	1/5279 (0%)		1/5276 (0%)
Leukocytosis	1/5279 (0%)		0/5276 (0%)
Pancytopenia	1/5279 (0%)		0/5276 (0%)
Cardiac disorders
Acute coronary syndrome	7/5279 (0.1%)		9/5276 (0.2%)
Acute left ventricular failure	2/5279 (0%)		0/5276 (0%)
Acute myocardial infarction	40/5279 (0.8%)		30/5276 (0.6%)
Angina pectoris	92/5279 (1.7%)		64/5276 (1.2%)
Angina unstable	93/5279 (1.8%)		73/5276 (1.4%)
Anginal equivalent	0/5279 (0%)		1/5276 (0%)
Aortic valve incompetence	0/5279 (0%)		1/5276 (0%)
Aortic valve stenosis	3/5279 (0.1%)		3/5276 (0.1%)
Arrhythmia	3/5279 (0.1%)		4/5276 (0.1%)
Arrhythmia supraventricular	1/5279 (0%)		0/5276 (0%)
Arteriosclerosis coronary artery	3/5279 (0.1%)		3/5276 (0.1%)
Arteriospasm coronary	0/5279 (0%)		1/5276 (0%)
Atrial fibrillation	34/5279 (0.6%)		26/5276 (0.5%)
Atrial flutter	9/5279 (0.2%)		5/5276 (0.1%)
Atrial thrombosis	1/5279 (0%)		0/5276 (0%)
Atrioventricular block	3/5279 (0.1%)		4/5276 (0.1%)
Atrioventricular block complete	1/5279 (0%)		4/5276 (0.1%)
Atrioventricular block second degree	3/5279 (0.1%)		1/5276 (0%)
Bradycardia	7/5279 (0.1%)		1/5276 (0%)
Cardiac arrest	5/5279 (0.1%)		4/5276 (0.1%)
Cardiac failure	15/5279 (0.3%)		16/5276 (0.3%)
Cardiac failure acute	0/5279 (0%)		3/5276 (0.1%)
Cardiac failure chronic	3/5279 (0.1%)		2/5276 (0%)
Cardiac failure congestive	31/5279 (0.6%)		24/5276 (0.5%)
Cardiac valve disease	1/5279 (0%)		0/5276 (0%)
Cardio-respiratory arrest	2/5279 (0%)		0/5276 (0%)
Cardiogenic shock	1/5279 (0%)		0/5276 (0%)
Cardiomyopathy	1/5279 (0%)		1/5276 (0%)
Cardiopulmonary failure	0/5279 (0%)		1/5276 (0%)
Cardiorenal syndrome	1/5279 (0%)		0/5276 (0%)
Conduction disorder	1/5279 (0%)		0/5276 (0%)
Congestive cardiomyopathy	2/5279 (0%)		1/5276 (0%)
Coronary artery disease	31/5279 (0.6%)		29/5276 (0.5%)
Coronary artery insufficiency	0/5279 (0%)		1/5276 (0%)
Coronary artery occlusion	5/5279 (0.1%)		5/5276 (0.1%)
Coronary artery stenosis	17/5279 (0.3%)		7/5276 (0.1%)
Coronary artery thrombosis	1/5279 (0%)		0/5276 (0%)
Diastolic dysfunction	1/5279 (0%)		0/5276 (0%)
Dressler's syndrome	1/5279 (0%)		0/5276 (0%)
Ischaemic cardiomyopathy	0/5279 (0%)		1/5276 (0%)
Left ventricular dysfunction	2/5279 (0%)		0/5276 (0%)
Left ventricular failure	3/5279 (0.1%)		1/5276 (0%)
Left ventricular hypertrophy	1/5279 (0%)		0/5276 (0%)
Mitral valve incompetence	2/5279 (0%)		0/5276 (0%)
Myocardial infarction	52/5279 (1%)		34/5276 (0.6%)
Myocardial ischaemia	10/5279 (0.2%)		9/5276 (0.2%)
Palpitations	2/5279 (0%)		1/5276 (0%)
Pericarditis	0/5279 (0%)		1/5276 (0%)
Sinus arrhythmia	1/5279 (0%)		0/5276 (0%)
Sinus node dysfunction	4/5279 (0.1%)		4/5276 (0.1%)
Sinus tachycardia	0/5279 (0%)		1/5276 (0%)
Supraventricular tachycardia	2/5279 (0%)		3/5276 (0.1%)
Systolic dysfunction	1/5279 (0%)		0/5276 (0%)
Tachycardia	2/5279 (0%)		0/5276 (0%)
Tachycardia paroxysmal	1/5279 (0%)		0/5276 (0%)
Torsade de pointes	1/5279 (0%)		0/5276 (0%)
Trifascicular block	0/5279 (0%)		1/5276 (0%)
Ventricular arrhythmia	1/5279 (0%)		1/5276 (0%)
Ventricular extrasystoles	3/5279 (0.1%)		6/5276 (0.1%)
Ventricular fibrillation	0/5279 (0%)		1/5276 (0%)
Ventricular tachycardia	5/5279 (0.1%)		5/5276 (0.1%)
Congenital, familial and genetic disorders
Hydrocele	0/3434 (0%)		1/3489 (0%)
Phimosis	1/3434 (0%)		0/3489 (0%)
Ear and labyrinth disorders
Sudden hearing loss	0/5279 (0%)		1/5276 (0%)
Tinnitus	0/5279 (0%)		1/5276 (0%)
Vertigo	2/5279 (0%)		3/5276 (0.1%)
Vertigo positional	1/5279 (0%)		1/5276 (0%)
Vestibular disorder	1/5279 (0%)		1/5276 (0%)
Endocrine disorders
Addison's disease	0/5279 (0%)		1/5276 (0%)
Goitre	1/5279 (0%)		0/5276 (0%)
Hyperparathyroidism	0/5279 (0%)		1/5276 (0%)
Hyperthyroidism	0/5279 (0%)		1/5276 (0%)
Hypothyroidism	0/5279 (0%)		2/5276 (0%)
Thyroid mass	0/5279 (0%)		2/5276 (0%)
Eye disorders
Amaurosis fugax	1/5279 (0%)		0/5276 (0%)
Cataract	1/5279 (0%)		2/5276 (0%)
Diabetic retinopathy	0/5279 (0%)		1/5276 (0%)
Diplopia	1/5279 (0%)		0/5276 (0%)
Macular fibrosis	1/5279 (0%)		1/5276 (0%)
Retinal detachment	1/5279 (0%)		1/5276 (0%)
Retinal haemorrhage	1/5279 (0%)		0/5276 (0%)
Retinal infarction	0/5279 (0%)		1/5276 (0%)
Vitreous haemorrhage	1/5279 (0%)		0/5276 (0%)
Gastrointestinal disorders
Abdominal adhesions	0/5279 (0%)		1/5276 (0%)
Abdominal hernia	0/5279 (0%)		3/5276 (0.1%)
Abdominal pain	5/5279 (0.1%)		3/5276 (0.1%)
Abdominal pain upper	3/5279 (0.1%)		4/5276 (0.1%)
Acute abdomen	1/5279 (0%)		0/5276 (0%)
Anal fistula	0/5279 (0%)		1/5276 (0%)
Anal incontinence	1/5279 (0%)		1/5276 (0%)
Coeliac artery stenosis	1/5279 (0%)		0/5276 (0%)
Colitis	1/5279 (0%)		2/5276 (0%)
Colitis ischaemic	0/5279 (0%)		1/5276 (0%)
Constipation	0/5279 (0%)		2/5276 (0%)
Crohn's disease	1/5279 (0%)		0/5276 (0%)
Diarrhoea	3/5279 (0.1%)		2/5276 (0%)
Diverticular perforation	0/5279 (0%)		1/5276 (0%)
Diverticulum	0/5279 (0%)		1/5276 (0%)
Diverticulum intestinal	0/5279 (0%)		1/5276 (0%)
Diverticulum oesophageal	0/5279 (0%)		1/5276 (0%)
Duodenal ulcer	1/5279 (0%)		1/5276 (0%)
Dyspepsia	2/5279 (0%)		0/5276 (0%)
Dysphagia	1/5279 (0%)		1/5276 (0%)
Enteritis	1/5279 (0%)		1/5276 (0%)
Erosive oesophagitis	0/5279 (0%)		2/5276 (0%)
Faecaloma	0/5279 (0%)		1/5276 (0%)
Gastric disorder	0/5279 (0%)		1/5276 (0%)
Gastric haemorrhage	1/5279 (0%)		0/5276 (0%)
Gastric ulcer	1/5279 (0%)		3/5276 (0.1%)
Gastric ulcer haemorrhage	1/5279 (0%)		1/5276 (0%)
Gastritis	5/5279 (0.1%)		5/5276 (0.1%)
Gastritis haemorrhagic	0/5279 (0%)		2/5276 (0%)
Gastrointestinal haemorrhage	4/5279 (0.1%)		6/5276 (0.1%)
Gastrooesophageal reflux disease	3/5279 (0.1%)		1/5276 (0%)
Haematochezia	1/5279 (0%)		0/5276 (0%)
Haemorrhagic erosive gastritis	0/5279 (0%)		1/5276 (0%)
Ileus	1/5279 (0%)		1/5276 (0%)
Ileus paralytic	0/5279 (0%)		1/5276 (0%)
Impaired gastric emptying	1/5279 (0%)		0/5276 (0%)
Incarcerated umbilical hernia	1/1849 (0.1%)		0/1792 (0%)
Inguinal hernia	2/5279 (0%)		4/5276 (0.1%)
Intestinal haemorrhage	0/5279 (0%)		1/5276 (0%)
Intestinal ischaemia	1/5279 (0%)		0/5276 (0%)
Intestinal obstruction	1/5279 (0%)		2/5276 (0%)
Intestinal perforation	0/5279 (0%)		1/5276 (0%)
Irritable bowel syndrome	0/5279 (0%)		1/5276 (0%)
Large intestinal obstruction	1/5279 (0%)		0/5276 (0%)
Large intestine polyp	1/5279 (0%)		1/5276 (0%)
Lip disorder	1/5279 (0%)		0/5276 (0%)
Lower gastrointestinal haemorrhage	0/5279 (0%)		4/5276 (0.1%)
Mallory-Weiss syndrome	1/5279 (0%)		1/5276 (0%)
Nausea	3/5279 (0.1%)		1/5276 (0%)
Oesophageal food impaction	1/5279 (0%)		0/5276 (0%)
Oesophageal spasm	0/5279 (0%)		1/5276 (0%)
Pancreatitis	4/5279 (0.1%)		6/5276 (0.1%)
Pancreatitis acute	4/5279 (0.1%)		3/5276 (0.1%)
Pancreatitis chronic	0/5279 (0%)		1/5276 (0%)
Reactive gastropathy	1/5279 (0%)		0/5276 (0%)
Rectal haemorrhage	3/5279 (0.1%)		3/5276 (0.1%)
Rectal polyp	1/5279 (0%)		0/5276 (0%)
Retroperitoneal haematoma	1/5279 (0%)		0/5276 (0%)
Small intestinal obstruction	2/5279 (0%)		5/5276 (0.1%)
Strangulated umbilical hernia	0/1849 (0%)		1/1792 (0.1%)
Ulcerative gastritis	1/5279 (0%)		0/5276 (0%)
Umbilical hernia	2/1849 (0.1%)		1/1792 (0.1%)
Umbilical hernia, obstructive	0/1849 (0%)		1/1792 (0.1%)
Upper gastrointestinal haemorrhage	0/5279 (0%)		2/5276 (0%)
Vomiting	2/5279 (0%)		4/5276 (0.1%)
General disorders
Adverse drug reaction	1/5279 (0%)		0/5276 (0%)
Asthenia	3/5279 (0.1%)		1/5276 (0%)
Cardiac death	1/5279 (0%)		0/5276 (0%)
Chest discomfort	3/5279 (0.1%)		1/5276 (0%)
Chest pain	14/5279 (0.3%)		8/5276 (0.2%)
Complication associated with device	1/5279 (0%)		1/5276 (0%)
Death	6/5279 (0.1%)		9/5276 (0.2%)
Drug withdrawal syndrome	0/5279 (0%)		1/5276 (0%)
Fatigue	1/5279 (0%)		0/5276 (0%)
Hernia	1/5279 (0%)		0/5276 (0%)
Ill-defined disorder	0/5279 (0%)		1/5276 (0%)
Impaired healing	1/5279 (0%)		1/5276 (0%)
Inflammation	1/5279 (0%)		0/5276 (0%)
Multi-organ disorder	0/5279 (0%)		1/5276 (0%)
Multiple organ dysfunction syndrome	1/5279 (0%)		2/5276 (0%)
Non-cardiac chest pain	50/5279 (0.9%)		32/5276 (0.6%)
Oedema peripheral	0/5279 (0%)		1/5276 (0%)
Pain	2/5279 (0%)		0/5276 (0%)
Peripheral swelling	2/5279 (0%)		0/5276 (0%)
Polyp	1/5279 (0%)		0/5276 (0%)
Pyrexia	3/5279 (0.1%)		1/5276 (0%)
Stenosis	0/5279 (0%)		1/5276 (0%)
Sudden cardiac death	8/5279 (0.2%)		5/5276 (0.1%)
Sudden death	3/5279 (0.1%)		2/5276 (0%)
Systemic inflammatory response syndrome	1/5279 (0%)		0/5276 (0%)
Vascular stent restenosis	2/5279 (0%)		1/5276 (0%)
Vascular stent stenosis	1/5279 (0%)		2/5276 (0%)
Vascular stent thrombosis	0/5279 (0%)		1/5276 (0%)
Hepatobiliary disorders
Alcoholic liver disease	0/5279 (0%)		1/5276 (0%)
Bile duct obstruction	0/5279 (0%)		1/5276 (0%)
Bile duct stone	1/5279 (0%)		0/5276 (0%)
Biliary colic	1/5279 (0%)		0/5276 (0%)
Biliary fistula	0/5279 (0%)		1/5276 (0%)
Cholangitis	1/5279 (0%)		1/5276 (0%)
Cholecystitis	6/5279 (0.1%)		5/5276 (0.1%)
Cholecystitis acute	4/5279 (0.1%)		4/5276 (0.1%)
Cholecystitis chronic	2/5279 (0%)		0/5276 (0%)
Cholelithiasis	7/5279 (0.1%)		5/5276 (0.1%)
Drug-induced liver injury	1/5279 (0%)		0/5276 (0%)
Gallbladder perforation	0/5279 (0%)		1/5276 (0%)
Gallbladder polyp	1/5279 (0%)		0/5276 (0%)
Jaundice	1/5279 (0%)		0/5276 (0%)
Liver injury	0/5279 (0%)		1/5276 (0%)
Immune system disorders
Anaphylactic reaction	1/5279 (0%)		2/5276 (0%)
Drug hypersensitivity	0/5279 (0%)		1/5276 (0%)
Food allergy	1/5279 (0%)		0/5276 (0%)
Hypersensitivity	0/5279 (0%)		1/5276 (0%)
Immunosuppression	0/5279 (0%)		1/5276 (0%)
Infections and infestations
Abdominal wall abscess	0/5279 (0%)		1/5276 (0%)
Abscess	1/5279 (0%)		1/5276 (0%)
Abscess intestinal	0/5279 (0%)		1/5276 (0%)
Abscess limb	1/5279 (0%)		2/5276 (0%)
Anal abscess	0/5279 (0%)		4/5276 (0.1%)
Appendicitis	5/5279 (0.1%)		4/5276 (0.1%)
Arteriovenous graft site infection	2/5279 (0%)		0/5276 (0%)
Arthritis infective	0/5279 (0%)		1/5276 (0%)
Bacteraemia	2/5279 (0%)		0/5276 (0%)
Bacterial diarrhoea	1/5279 (0%)		0/5276 (0%)
Biliary sepsis	0/5279 (0%)		1/5276 (0%)
Bronchitis	7/5279 (0.1%)		5/5276 (0.1%)
Campylobacter gastroenteritis	0/5279 (0%)		1/5276 (0%)
Cardiac valve vegetation	1/5279 (0%)		0/5276 (0%)
Cellulitis	10/5279 (0.2%)		8/5276 (0.2%)
Cholecystitis infective	0/5279 (0%)		1/5276 (0%)
Chronic sinusitis	2/5279 (0%)		0/5276 (0%)
Clostridium difficile colitis	3/5279 (0.1%)		2/5276 (0%)
Clostridium difficile infection	2/5279 (0%)		1/5276 (0%)
Cystitis	0/5279 (0%)		2/5276 (0%)
Device related infection	0/5279 (0%)		2/5276 (0%)
Diabetic foot infection	2/5279 (0%)		2/5276 (0%)
Diabetic gangrene	1/5279 (0%)		0/5276 (0%)
Diverticulitis	5/5279 (0.1%)		6/5276 (0.1%)
Endocarditis	2/5279 (0%)		2/5276 (0%)
Epididymitis	0/5279 (0%)		1/5276 (0%)
Epstein-Barr virus infection	0/5279 (0%)		1/5276 (0%)
Erysipelas	2/5279 (0%)		2/5276 (0%)
Escherichia bacteraemia	0/5279 (0%)		1/5276 (0%)
Gangrene	1/5279 (0%)		0/5276 (0%)
Gastritis viral	0/5279 (0%)		1/5276 (0%)
Gastroenteritis	6/5279 (0.1%)		2/5276 (0%)
Gastroenteritis clostridial	1/5279 (0%)		0/5276 (0%)
Gastroenteritis viral	3/5279 (0.1%)		3/5276 (0.1%)
Groin abscess	1/5279 (0%)		1/5276 (0%)
Groin infection	1/5279 (0%)		0/5276 (0%)
Haematoma infection	0/5279 (0%)		1/5276 (0%)
Hepatic cyst infection	0/5279 (0%)		1/5276 (0%)
Hepatitis A	1/5279 (0%)		0/5276 (0%)
Hepatitis C	1/5279 (0%)		0/5276 (0%)
Herpes zoster	2/5279 (0%)		0/5276 (0%)
Incision site infection	1/5279 (0%)		0/5276 (0%)
Infected skin ulcer	0/5279 (0%)		1/5276 (0%)
Infection	0/5279 (0%)		3/5276 (0.1%)
Infectious colitis	0/5279 (0%)		1/5276 (0%)
Infectious pleural effusion	1/5279 (0%)		1/5276 (0%)
Influenza	1/5279 (0%)		0/5276 (0%)
Kidney infection	1/5279 (0%)		0/5276 (0%)
Laryngitis	1/5279 (0%)		1/5276 (0%)
Localised infection	1/5279 (0%)		4/5276 (0.1%)
Lower respiratory tract infection	4/5279 (0.1%)		1/5276 (0%)
Lung abscess	1/5279 (0%)		0/5276 (0%)
Medical device site abscess	0/5279 (0%)		1/5276 (0%)
Muscle abscess	1/5279 (0%)		0/5276 (0%)
Necrotising fasciitis	0/5279 (0%)		1/5276 (0%)
Osteomyelitis	3/5279 (0.1%)		4/5276 (0.1%)
Otitis externa	0/5279 (0%)		1/5276 (0%)
Pelvic abscess	1/5279 (0%)		0/5276 (0%)
Peritonitis	0/5279 (0%)		1/5276 (0%)
Pneumonia	35/5279 (0.7%)		28/5276 (0.5%)
Pneumonia bacterial	0/5279 (0%)		2/5276 (0%)
Pneumonia influenzal	1/5279 (0%)		0/5276 (0%)
Pneumonia legionella	1/5279 (0%)		0/5276 (0%)
Post procedural pneumonia	1/5279 (0%)		0/5276 (0%)
Postoperative wound infection	1/5279 (0%)		0/5276 (0%)
Pulmonary sepsis	1/5279 (0%)		0/5276 (0%)
Pyelocystitis	0/5279 (0%)		1/5276 (0%)
Pyelonephritis	1/5279 (0%)		5/5276 (0.1%)
Pyelonephritis acute	0/5279 (0%)		2/5276 (0%)
Rectal abscess	0/5279 (0%)		1/5276 (0%)
Respiratory tract infection	1/5279 (0%)		2/5276 (0%)
Scrotal abscess	1/5279 (0%)		1/5276 (0%)
Sebaceous gland infection	1/5279 (0%)		0/5276 (0%)
Sepsis	5/5279 (0.1%)		13/5276 (0.2%)
Septic shock	3/5279 (0.1%)		2/5276 (0%)
Sinusitis	1/5279 (0%)		2/5276 (0%)
Sinusitis bacterial	1/5279 (0%)		0/5276 (0%)
Staphylococcal bacteraemia	1/5279 (0%)		0/5276 (0%)
Staphylococcal infection	0/5279 (0%)		1/5276 (0%)
Staphylococcal sepsis	1/5279 (0%)		0/5276 (0%)
Subcutaneous abscess	1/5279 (0%)		1/5276 (0%)
Tick-borne viral encephalitis	1/5279 (0%)		0/5276 (0%)
Tooth abscess	1/5279 (0%)		0/5276 (0%)
Tracheobronchitis	0/5279 (0%)		1/5276 (0%)
Upper respiratory tract infection	0/5279 (0%)		1/5276 (0%)
Urinary tract infection	15/5279 (0.3%)		9/5276 (0.2%)
Urosepsis	1/5279 (0%)		3/5276 (0.1%)
Viral infection	1/5279 (0%)		0/5276 (0%)
Viral sepsis	0/5279 (0%)		1/5276 (0%)
Wound infection	2/5279 (0%)		2/5276 (0%)
Injury, poisoning and procedural complications
Acoustic shock	1/5279 (0%)		0/5276 (0%)
Ankle fracture	2/5279 (0%)		1/5276 (0%)
Arterial bypass thrombosis	0/5279 (0%)		1/5276 (0%)
Arterial restenosis	0/5279 (0%)		1/5276 (0%)
Arthropod sting	1/5279 (0%)		0/5276 (0%)
Cardiac procedure complication	1/5279 (0%)		0/5276 (0%)
Clavicle fracture	1/5279 (0%)		0/5276 (0%)
Concussion	0/5279 (0%)		1/5276 (0%)
Contusion	3/5279 (0.1%)		0/5276 (0%)
Craniocerebral injury	1/5279 (0%)		0/5276 (0%)
Dural tear	1/5279 (0%)		0/5276 (0%)
Fall	6/5279 (0.1%)		7/5276 (0.1%)
Femoral neck fracture	3/5279 (0.1%)		5/5276 (0.1%)
Femur fracture	5/5279 (0.1%)		3/5276 (0.1%)
Fibula fracture	0/5279 (0%)		1/5276 (0%)
Foot fracture	3/5279 (0.1%)		2/5276 (0%)
Fractured sacrum	1/5279 (0%)		0/5276 (0%)
Gallbladder injury	0/5279 (0%)		1/5276 (0%)
Gastrointestinal stoma complication	0/5279 (0%)		1/5276 (0%)
Hand fracture	0/5279 (0%)		1/5276 (0%)
Hip fracture	2/5279 (0%)		2/5276 (0%)
Humerus fracture	2/5279 (0%)		0/5276 (0%)
Incarcerated incisional hernia	1/5279 (0%)		0/5276 (0%)
Incisional hernia	1/5279 (0%)		0/5276 (0%)
Injury	1/5279 (0%)		0/5276 (0%)
Intentional overdose	1/5279 (0%)		0/5276 (0%)
Joint dislocation	0/5279 (0%)		1/5276 (0%)
Kidney rupture	0/5279 (0%)		1/5276 (0%)
Ligament injury	0/5279 (0%)		2/5276 (0%)
Ligament rupture	0/5279 (0%)		1/5276 (0%)
Limb injury	4/5279 (0.1%)		2/5276 (0%)
Lower limb fracture	2/5279 (0%)		2/5276 (0%)
Lumbar vertebral fracture	1/5279 (0%)		0/5276 (0%)
Meniscus injury	1/5279 (0%)		1/5276 (0%)
Muscle rupture	1/5279 (0%)		0/5276 (0%)
Neck injury	0/5279 (0%)		1/5276 (0%)
Overdose	0/5279 (0%)		1/5276 (0%)
Patella fracture	0/5279 (0%)		1/5276 (0%)
Pelvic fracture	1/5279 (0%)		1/5276 (0%)
Peripheral artery restenosis	1/5279 (0%)		1/5276 (0%)
Post procedural complication	0/5279 (0%)		1/5276 (0%)
Post procedural haemorrhage	1/5279 (0%)		2/5276 (0%)
Postoperative fever	1/5279 (0%)		0/5276 (0%)
Postoperative ileus	1/5279 (0%)		0/5276 (0%)
Postoperative respiratory failure	0/5279 (0%)		1/5276 (0%)
Postoperative wound complication	1/5279 (0%)		0/5276 (0%)
Procedural haemorrhage	0/5279 (0%)		1/5276 (0%)
Procedural pain	2/5279 (0%)		1/5276 (0%)
Radius fracture	1/5279 (0%)		1/5276 (0%)
Rib fracture	1/5279 (0%)		1/5276 (0%)
Road traffic accident	2/5279 (0%)		2/5276 (0%)
Skull fracture	0/5279 (0%)		1/5276 (0%)
Spinal compression fracture	0/5279 (0%)		2/5276 (0%)
Subarachnoid haemorrhage	0/5279 (0%)		2/5276 (0%)
Subdural haematoma	1/5279 (0%)		1/5276 (0%)
Subdural haemorrhage	0/5279 (0%)		1/5276 (0%)
Suture related complication	0/5279 (0%)		1/5276 (0%)
Tendon rupture	0/5279 (0%)		1/5276 (0%)
Tibia fracture	1/5279 (0%)		2/5276 (0%)
Traumatic liver injury	1/5279 (0%)		0/5276 (0%)
Traumatic renal injury	1/5279 (0%)		0/5276 (0%)
Upper limb fracture	1/5279 (0%)		0/5276 (0%)
Urinary tract stoma complication	1/5279 (0%)		0/5276 (0%)
Vascular graft occlusion	2/5279 (0%)		0/5276 (0%)
Vascular procedure complication	1/5279 (0%)		0/5276 (0%)
Vascular pseudoaneurysm	2/5279 (0%)		2/5276 (0%)
Wound	2/5279 (0%)		2/5276 (0%)
Wound dehiscence	0/5279 (0%)		1/5276 (0%)
Wound necrosis	0/5279 (0%)		1/5276 (0%)
Investigations
Alanine aminotransferase increased	2/5279 (0%)		1/5276 (0%)
Anticoagulation drug level above therapeutic	1/5279 (0%)		0/5276 (0%)
Aspartate aminotransferase increased	2/5279 (0%)		1/5276 (0%)
Blood creatine phosphokinase increased	2/5279 (0%)		1/5276 (0%)
Blood glucose increased	2/5279 (0%)		1/5276 (0%)
Blood ketone body increased	0/5279 (0%)		1/5276 (0%)
Blood magnesium decreased	0/5279 (0%)		1/5276 (0%)
Blood pressure increased	1/5279 (0%)		0/5276 (0%)
ECG signs of myocardial ischaemia	2/5279 (0%)		0/5276 (0%)
Ejection fraction abnormal	1/5279 (0%)		0/5276 (0%)
Electrocardiogram ST segment elevation	1/5279 (0%)		0/5276 (0%)
Electrocardiogram T wave inversion	1/5279 (0%)		0/5276 (0%)
Exercise test abnormal	0/5279 (0%)		1/5276 (0%)
Gamma-glutamyltransferase increased	1/5279 (0%)		0/5276 (0%)
Hepatic enzyme increased	2/5279 (0%)		2/5276 (0%)
Liver function test abnormal	1/5279 (0%)		0/5276 (0%)
Liver function test increased	2/5279 (0%)		1/5276 (0%)
Myocardial necrosis marker increased	0/5279 (0%)		1/5276 (0%)
Neurological examination	0/5279 (0%)		1/5276 (0%)
Prostatic specific antigen increased	1/5279 (0%)		0/5276 (0%)
Renal function test abnormal	0/5279 (0%)		1/5276 (0%)
Staphylococcus test positive	0/5279 (0%)		1/5276 (0%)
Stress echocardiogram abnormal	0/5279 (0%)		1/5276 (0%)
Transaminases increased	0/5279 (0%)		1/5276 (0%)
Troponin increased	0/5279 (0%)		1/5276 (0%)
Metabolism and nutrition disorders
Dehydration	5/5279 (0.1%)		4/5276 (0.1%)
Diabetes mellitus	5/5279 (0.1%)		4/5276 (0.1%)
Diabetes mellitus inadequate control	4/5279 (0.1%)		5/5276 (0.1%)
Diabetic ketoacidosis	0/5279 (0%)		3/5276 (0.1%)
Electrolyte imbalance	2/5279 (0%)		0/5276 (0%)
Failure to thrive	1/5279 (0%)		0/5276 (0%)
Fluid overload	0/5279 (0%)		1/5276 (0%)
Hyperglycaemia	6/5279 (0.1%)		7/5276 (0.1%)
Hyperkalaemia	2/5279 (0%)		1/5276 (0%)
Hyperosmolar hyperglycaemic state	1/5279 (0%)		1/5276 (0%)
Hypertriglyceridaemia	1/5279 (0%)		0/5276 (0%)
Hypoglycaemia	5/5279 (0.1%)		2/5276 (0%)
Hypokalaemia	2/5279 (0%)		2/5276 (0%)
Hyponatraemia	1/5279 (0%)		1/5276 (0%)
Hypovolaemia	0/5279 (0%)		1/5276 (0%)
Metabolic acidosis	0/5279 (0%)		1/5276 (0%)
Metabolic disorder	0/5279 (0%)		1/5276 (0%)
Obesity	0/5279 (0%)		3/5276 (0.1%)
Type 2 diabetes mellitus	5/5279 (0.1%)		3/5276 (0.1%)
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis	0/5279 (0%)		1/5276 (0%)
Arthralgia	2/5279 (0%)		1/5276 (0%)
Arthritis	1/5279 (0%)		1/5276 (0%)
Back disorder	1/5279 (0%)		0/5276 (0%)
Back pain	3/5279 (0.1%)		9/5276 (0.2%)
Bone pain	1/5279 (0%)		0/5276 (0%)
Bursitis	1/5279 (0%)		1/5276 (0%)
Cervical spinal stenosis	0/5279 (0%)		1/5276 (0%)
Compartment syndrome	1/5279 (0%)		1/5276 (0%)
Costochondritis	1/5279 (0%)		0/5276 (0%)
Fibromyalgia	0/5279 (0%)		1/5276 (0%)
Flank pain	1/5279 (0%)		0/5276 (0%)
Haemarthrosis	1/5279 (0%)		1/5276 (0%)
Intervertebral disc degeneration	1/5279 (0%)		1/5276 (0%)
Intervertebral disc disorder	2/5279 (0%)		1/5276 (0%)
Intervertebral disc protrusion	8/5279 (0.2%)		7/5276 (0.1%)
Jaw cyst	0/5279 (0%)		1/5276 (0%)
Lumbar spinal stenosis	1/5279 (0%)		2/5276 (0%)
Meniscal degeneration	1/5279 (0%)		0/5276 (0%)
Muscle disorder	0/5279 (0%)		1/5276 (0%)
Muscle spasms	1/5279 (0%)		1/5276 (0%)
Muscular weakness	3/5279 (0.1%)		6/5276 (0.1%)
Musculoskeletal chest pain	2/5279 (0%)		0/5276 (0%)
Musculoskeletal pain	3/5279 (0.1%)		2/5276 (0%)
Myalgia	3/5279 (0.1%)		1/5276 (0%)
Myopathy	0/5279 (0%)		1/5276 (0%)
Neck pain	1/5279 (0%)		0/5276 (0%)
Osteoarthritis	16/5279 (0.3%)		17/5276 (0.3%)
Osteochondrosis	0/5279 (0%)		1/5276 (0%)
Osteonecrosis	1/5279 (0%)		0/5276 (0%)
Osteonecrosis of jaw	1/5279 (0%)		0/5276 (0%)
Osteoporosis	1/5279 (0%)		0/5276 (0%)
Pain in extremity	1/5279 (0%)		3/5276 (0.1%)
Periarthritis	1/5279 (0%)		1/5276 (0%)
Peripheral arthritis	1/5279 (0%)		0/5276 (0%)
Polyarthritis	1/5279 (0%)		0/5276 (0%)
Polymyalgia rheumatica	2/5279 (0%)		0/5276 (0%)
Psoriatic arthropathy	1/5279 (0%)		0/5276 (0%)
Rhabdomyolysis	0/5279 (0%)		3/5276 (0.1%)
Rotator cuff syndrome	4/5279 (0.1%)		1/5276 (0%)
Soft tissue mass	0/5279 (0%)		1/5276 (0%)
Spinal column stenosis	3/5279 (0.1%)		3/5276 (0.1%)
Spinal disorder	0/5279 (0%)		1/5276 (0%)
Spinal osteoarthritis	1/5279 (0%)		3/5276 (0.1%)
Synovial cyst	2/5279 (0%)		0/5276 (0%)
Tenosynovitis	1/5279 (0%)		0/5276 (0%)
Tenosynovitis stenosans	0/5279 (0%)		1/5276 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	2/5279 (0%)		0/5276 (0%)
Adenocarcinoma	3/5279 (0.1%)		0/5276 (0%)
Adenocarcinoma gastric	2/5279 (0%)		0/5276 (0%)
Adenocarcinoma of colon	1/5279 (0%)		2/5276 (0%)
Anal cancer	1/5279 (0%)		0/5276 (0%)
Basal cell carcinoma	0/5279 (0%)		1/5276 (0%)
Benign breast neoplasm	1/5279 (0%)		0/5276 (0%)
Benign lymph node neoplasm	0/5279 (0%)		1/5276 (0%)
Bladder neoplasm	0/5279 (0%)		2/5276 (0%)
Bladder papilloma	1/5279 (0%)		0/5276 (0%)
Bladder transitional cell carcinoma	1/5279 (0%)		5/5276 (0.1%)
Bone cancer	0/5279 (0%)		1/5276 (0%)
Bowen's disease	2/5279 (0%)		0/5276 (0%)
Brain cancer metastatic	1/5279 (0%)		0/5276 (0%)
Brain neoplasm	1/5279 (0%)		1/5276 (0%)
Breast cancer	4/5279 (0.1%)		2/5276 (0%)
Breast cancer metastatic	0/5279 (0%)		1/5276 (0%)
Breast neoplasm	1/5279 (0%)		0/5276 (0%)
Cardiac myxoma	1/5279 (0%)		0/5276 (0%)
Cervix carcinoma	0/1849 (0%)		2/1792 (0.1%)
Clear cell renal cell carcinoma	1/5279 (0%)		0/5276 (0%)
Colon adenoma	1/5279 (0%)		0/5276 (0%)
Colon cancer	1/5279 (0%)		0/5276 (0%)
Colon cancer metastatic	0/5279 (0%)		1/5276 (0%)
Colorectal cancer	0/5279 (0%)		1/5276 (0%)
Duodenal neoplasm	1/5279 (0%)		0/5276 (0%)
Endometrial adenocarcinoma	1/1849 (0.1%)		0/1792 (0%)
Follicular thyroid cancer	1/5279 (0%)		0/5276 (0%)
Gastric adenoma	0/5279 (0%)		1/5276 (0%)
Gastric cancer	1/5279 (0%)		1/5276 (0%)
Gastric cancer stage IV	0/5279 (0%)		1/5276 (0%)
Gastric neoplasm	0/5279 (0%)		1/5276 (0%)
Glioblastoma multiforme	1/5279 (0%)		0/5276 (0%)
Hypopharyngeal cancer	0/5279 (0%)		1/5276 (0%)
Invasive ductal breast carcinoma	1/5279 (0%)		0/5276 (0%)
Invasive lobular breast carcinoma	0/5279 (0%)		1/5276 (0%)
Laryngeal squamous cell carcinoma	1/5279 (0%)		0/5276 (0%)
Lentigo maligna	0/5279 (0%)		1/5276 (0%)
Leukaemia	1/5279 (0%)		0/5276 (0%)
Lipoma	0/5279 (0%)		1/5276 (0%)
Lung adenocarcinoma	6/5279 (0.1%)		2/5276 (0%)
Lung adenocarcinoma stage I	1/5279 (0%)		0/5276 (0%)
Lung cancer metastatic	2/5279 (0%)		1/5276 (0%)
Lung carcinoma cell type unspecified stage IV	0/5279 (0%)		1/5276 (0%)
Lung neoplasm	1/5279 (0%)		1/5276 (0%)
Lung neoplasm malignant	6/5279 (0.1%)		3/5276 (0.1%)
Malignant ascites	0/5279 (0%)		1/5276 (0%)
Malignant haemangiopericytoma	0/5279 (0%)		1/5276 (0%)
Malignant melanoma	3/5279 (0.1%)		2/5276 (0%)
Meningioma	0/5279 (0%)		1/5276 (0%)
Meningioma benign	1/5279 (0%)		0/5276 (0%)
Metastases to bone	1/5279 (0%)		0/5276 (0%)
Metastases to central nervous system	1/5279 (0%)		0/5276 (0%)
Metastases to liver	1/5279 (0%)		1/5276 (0%)
Metastases to lung	0/5279 (0%)		1/5276 (0%)
Metastases to spine	1/5279 (0%)		0/5276 (0%)
Metastasis	0/5279 (0%)		1/5276 (0%)
Metastatic bronchial carcinoma	1/5279 (0%)		0/5276 (0%)
Metastatic neoplasm	1/5279 (0%)		0/5276 (0%)
Metastatic renal cell carcinoma	1/5279 (0%)		1/5276 (0%)
Neoplasm malignant	0/5279 (0%)		1/5276 (0%)
Neoplasm skin	1/5279 (0%)		0/5276 (0%)
Neuroendocrine carcinoma	1/5279 (0%)		0/5276 (0%)
Non-Hodgkin's lymphoma	1/5279 (0%)		0/5276 (0%)
Non-small cell lung cancer metastatic	1/5279 (0%)		0/5276 (0%)
Oesophageal carcinoma	1/5279 (0%)		1/5276 (0%)
Pancreatic carcinoma	0/5279 (0%)		1/5276 (0%)
Pancreatic neoplasm	0/5279 (0%)		1/5276 (0%)
Papillary thyroid cancer	1/5279 (0%)		0/5276 (0%)
Parathyroid tumour benign	0/5279 (0%)		1/5276 (0%)
Penile squamous cell carcinoma	0/3434 (0%)		1/3489 (0%)
Prostate cancer	13/3434 (0.4%)		11/3489 (0.3%)
Rectal adenocarcinoma	1/5279 (0%)		0/5276 (0%)
Renal cancer	2/5279 (0%)		1/5276 (0%)
Renal cell carcinoma	3/5279 (0.1%)		0/5276 (0%)
Renal cell carcinoma recurrent	0/5279 (0%)		1/5276 (0%)
Renal neoplasm	0/5279 (0%)		2/5276 (0%)
Respiratory tract neoplasm	1/5279 (0%)		0/5276 (0%)
Salivary gland neoplasm	1/5279 (0%)		1/5276 (0%)
Small cell lung cancer	1/5279 (0%)		1/5276 (0%)
Small cell lung cancer metastatic	1/5279 (0%)		0/5276 (0%)
Squamous cell carcinoma	1/5279 (0%)		1/5276 (0%)
Thyroid cancer	1/5279 (0%)		0/5276 (0%)
Transitional cell carcinoma	1/5279 (0%)		1/5276 (0%)
Uterine leiomyoma	1/1849 (0.1%)		1/1792 (0.1%)
Nervous system disorders
Amputation stump pain	0/5279 (0%)		1/5276 (0%)
Ataxia	1/5279 (0%)		0/5276 (0%)
Balance disorder	0/5279 (0%)		1/5276 (0%)
Basal ganglia stroke	0/5279 (0%)		1/5276 (0%)
Brain stem haemorrhage	0/5279 (0%)		1/5276 (0%)
Brain stem infarction	0/5279 (0%)		1/5276 (0%)
Carotid artery disease	2/5279 (0%)		0/5276 (0%)
Carotid artery stenosis	14/5279 (0.3%)		12/5276 (0.2%)
Carpal tunnel syndrome	1/5279 (0%)		0/5276 (0%)
Cerebellar infarction	2/5279 (0%)		0/5276 (0%)
Cerebral haemorrhage	1/5279 (0%)		1/5276 (0%)
Cerebral infarction	2/5279 (0%)		1/5276 (0%)
Cerebral ischaemia	1/5279 (0%)		0/5276 (0%)
Cerebrovascular accident	10/5279 (0.2%)		7/5276 (0.1%)
Cervical radiculopathy	0/5279 (0%)		1/5276 (0%)
Cervicobrachial syndrome	1/5279 (0%)		0/5276 (0%)
Cognitive disorder	1/5279 (0%)		0/5276 (0%)
Diabetic neuropathy	1/5279 (0%)		0/5276 (0%)
Dizziness	6/5279 (0.1%)		3/5276 (0.1%)
Embolic cerebral infarction	1/5279 (0%)		0/5276 (0%)
Embolic stroke	0/5279 (0%)		1/5276 (0%)
Encephalopathy	0/5279 (0%)		2/5276 (0%)
Epilepsy	1/5279 (0%)		1/5276 (0%)
Facial paralysis	0/5279 (0%)		1/5276 (0%)
Fahr's disease	1/5279 (0%)		0/5276 (0%)
Haemorrhage intracranial	1/5279 (0%)		3/5276 (0.1%)
Haemorrhagic stroke	2/5279 (0%)		5/5276 (0.1%)
Headache	2/5279 (0%)		4/5276 (0.1%)
Hemiparesis	1/5279 (0%)		0/5276 (0%)
Hemiplegic migraine	0/5279 (0%)		1/5276 (0%)
Hypoaesthesia	0/5279 (0%)		1/5276 (0%)
Hypoglycaemic coma	0/5279 (0%)		1/5276 (0%)
Hypoxic-ischaemic encephalopathy	3/5279 (0.1%)		0/5276 (0%)
Intracranial aneurysm	1/5279 (0%)		1/5276 (0%)
Ischaemic cerebral infarction	0/5279 (0%)		2/5276 (0%)
Ischaemic neuropathy	1/5279 (0%)		0/5276 (0%)
Ischaemic stroke	23/5279 (0.4%)		16/5276 (0.3%)
Lacunar infarction	1/5279 (0%)		0/5276 (0%)
Lethargy	0/5279 (0%)		1/5276 (0%)
Lumbar radiculopathy	1/5279 (0%)		0/5276 (0%)
Lumbosacral radiculopathy	0/5279 (0%)		1/5276 (0%)
Memory impairment	0/5279 (0%)		2/5276 (0%)
Migraine	1/5279 (0%)		1/5276 (0%)
Monoplegia	0/5279 (0%)		1/5276 (0%)
Nerve root compression	0/5279 (0%)		1/5276 (0%)
Nervous system disorder	1/5279 (0%)		0/5276 (0%)
Neuralgia	1/5279 (0%)		0/5276 (0%)
Neuritis	0/5279 (0%)		1/5276 (0%)
Paraesthesia	1/5279 (0%)		0/5276 (0%)
Paralysis recurrent laryngeal nerve	0/5279 (0%)		1/5276 (0%)
Parkinson's disease	0/5279 (0%)		1/5276 (0%)
Partial seizures	1/5279 (0%)		0/5276 (0%)
Peripheral motor neuropathy	1/5279 (0%)		0/5276 (0%)
Polyneuropathy	1/5279 (0%)		0/5276 (0%)
Presyncope	0/5279 (0%)		3/5276 (0.1%)
Radicular syndrome	0/5279 (0%)		1/5276 (0%)
Radiculopathy	1/5279 (0%)		1/5276 (0%)
Sciatica	2/5279 (0%)		3/5276 (0.1%)
Seizure	2/5279 (0%)		2/5276 (0%)
Sensory disturbance	0/5279 (0%)		2/5276 (0%)
Serotonin syndrome	0/5279 (0%)		1/5276 (0%)
Speech disorder	0/5279 (0%)		1/5276 (0%)
Spinal cord compression	1/5279 (0%)		0/5276 (0%)
Spondylitic myelopathy	0/5279 (0%)		1/5276 (0%)
Subarachnoid haematoma	0/5279 (0%)		1/5276 (0%)
Syncope	16/5279 (0.3%)		18/5276 (0.3%)
Thrombotic stroke	1/5279 (0%)		0/5276 (0%)
Transient global amnesia	1/5279 (0%)		2/5276 (0%)
Transient ischaemic attack	16/5279 (0.3%)		14/5276 (0.3%)
Vertebral artery stenosis	1/5279 (0%)		0/5276 (0%)
Visual field defect	0/5279 (0%)		1/5276 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion missed	0/1849 (0%)		1/1792 (0.1%)
Product Issues
Device dislocation	1/5279 (0%)		1/5276 (0%)
Device malfunction	1/5279 (0%)		0/5276 (0%)
Device material issue	0/5279 (0%)		1/5276 (0%)
Manufacturing issue	0/5279 (0%)		1/5276 (0%)
Thrombosis in device	0/5279 (0%)		1/5276 (0%)
Psychiatric disorders
Alcohol abuse	1/5279 (0%)		0/5276 (0%)
Alcohol withdrawal syndrome	0/5279 (0%)		2/5276 (0%)
Alcoholism	0/5279 (0%)		2/5276 (0%)
Anxiety	1/5279 (0%)		1/5276 (0%)
Confusional state	1/5279 (0%)		0/5276 (0%)
Delirium	0/5279 (0%)		1/5276 (0%)
Delirium tremens	0/5279 (0%)		1/5276 (0%)
Delusional disorder, unspecified type	0/5279 (0%)		1/5276 (0%)
Depression	4/5279 (0.1%)		6/5276 (0.1%)
Drug abuse	0/5279 (0%)		1/5276 (0%)
Major depression	1/5279 (0%)		0/5276 (0%)
Mental disorder	1/5279 (0%)		0/5276 (0%)
Mental status changes	1/5279 (0%)		2/5276 (0%)
Neurologic somatic symptom disorder	1/5279 (0%)		0/5276 (0%)
Psychotic disorder	0/5279 (0%)		1/5276 (0%)
Suicidal ideation	0/5279 (0%)		3/5276 (0.1%)
Suicide attempt	0/5279 (0%)		2/5276 (0%)
Renal and urinary disorders
Acute kidney injury	15/5279 (0.3%)		10/5276 (0.2%)
Acute prerenal failure	0/5279 (0%)		1/5276 (0%)
Anuria	0/5279 (0%)		1/5276 (0%)
Bladder diverticulum	1/5279 (0%)		0/5276 (0%)
Bladder outlet obstruction	0/5279 (0%)		1/5276 (0%)
Bladder spasm	1/5279 (0%)		0/5276 (0%)
Calculus urinary	1/5279 (0%)		0/5276 (0%)
Chronic kidney disease	1/5279 (0%)		1/5276 (0%)
Diabetic nephropathy	1/5279 (0%)		1/5276 (0%)
Dysuria	1/5279 (0%)		0/5276 (0%)
Haematuria	3/5279 (0.1%)		0/5276 (0%)
Hydronephrosis	0/5279 (0%)		1/5276 (0%)
Nephrolithiasis	6/5279 (0.1%)		0/5276 (0%)
Nephropathy	0/5279 (0%)		1/5276 (0%)
Nephropathy toxic	1/5279 (0%)		0/5276 (0%)
Obstructive uropathy	0/5279 (0%)		1/5276 (0%)
Proteinuria	0/5279 (0%)		1/5276 (0%)
Renal artery stenosis	0/5279 (0%)		1/5276 (0%)
Renal artery thrombosis	0/5279 (0%)		1/5276 (0%)
Renal colic	2/5279 (0%)		2/5276 (0%)
Renal failure	3/5279 (0.1%)		3/5276 (0.1%)
Renal impairment	0/5279 (0%)		2/5276 (0%)
Stress urinary incontinence	1/5279 (0%)		1/5276 (0%)
Ureterolithiasis	3/5279 (0.1%)		2/5276 (0%)
Urethral disorder	0/5279 (0%)		1/5276 (0%)
Urethral stenosis	1/5279 (0%)		0/5276 (0%)
Urinary incontinence	1/5279 (0%)		2/5276 (0%)
Urinary retention	4/5279 (0.1%)		3/5276 (0.1%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	2/3434 (0.1%)		2/3489 (0.1%)
Breast hyperplasia	1/5279 (0%)		0/5276 (0%)
Cervical dysplasia	1/1849 (0.1%)		0/1792 (0%)
Cystocele	0/1849 (0%)		1/1792 (0.1%)
Dysfunctional uterine bleeding	0/1849 (0%)		1/1792 (0.1%)
Endometrial hyperplasia	0/1849 (0%)		1/1792 (0.1%)
Genital haemorrhage	0/5279 (0%)		1/5276 (0%)
Ovarian cyst	1/1849 (0.1%)		0/1792 (0%)
Prostatitis	5/3434 (0.1%)		2/3489 (0.1%)
Rectocele	1/1849 (0.1%)		1/1792 (0.1%)
Uterine haemorrhage	0/1849 (0%)		1/1792 (0.1%)
Uterine prolapse	0/1849 (0%)		1/1792 (0.1%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	1/5279 (0%)		1/5276 (0%)
Acute respiratory failure	3/5279 (0.1%)		7/5276 (0.1%)
Asthma	1/5279 (0%)		3/5276 (0.1%)
Asthma-chronic obstructive pulmonary disease overlap syndrome	1/5279 (0%)		1/5276 (0%)
Bronchitis chronic	1/5279 (0%)		0/5276 (0%)
Chronic obstructive pulmonary disease	14/5279 (0.3%)		17/5276 (0.3%)
Dyspnoea	12/5279 (0.2%)		5/5276 (0.1%)
Dyspnoea exertional	1/5279 (0%)		2/5276 (0%)
Epistaxis	1/5279 (0%)		2/5276 (0%)
Haemoptysis	2/5279 (0%)		2/5276 (0%)
Haemothorax	1/5279 (0%)		1/5276 (0%)
Hyperventilation	1/5279 (0%)		0/5276 (0%)
Hypoxia	1/5279 (0%)		0/5276 (0%)
Idiopathic pulmonary fibrosis	1/5279 (0%)		0/5276 (0%)
Interstitial lung disease	1/5279 (0%)		0/5276 (0%)
Laryngeal dysplasia	1/5279 (0%)		0/5276 (0%)
Lung disorder	0/5279 (0%)		1/5276 (0%)
Nasal septum deviation	0/5279 (0%)		1/5276 (0%)
Obstructive airways disorder	0/5279 (0%)		1/5276 (0%)
Pleural effusion	0/5279 (0%)		1/5276 (0%)
Pleurisy	1/5279 (0%)		0/5276 (0%)
Pneumonia aspiration	3/5279 (0.1%)		2/5276 (0%)
Pneumothorax	3/5279 (0.1%)		2/5276 (0%)
Pulmonary embolism	8/5279 (0.2%)		9/5276 (0.2%)
Pulmonary haemorrhage	1/5279 (0%)		0/5276 (0%)
Pulmonary hypertension	0/5279 (0%)		1/5276 (0%)
Pulmonary mass	2/5279 (0%)		2/5276 (0%)
Pulmonary oedema	3/5279 (0.1%)		2/5276 (0%)
Pulmonary thrombosis	0/5279 (0%)		1/5276 (0%)
Respiratory acidosis	1/5279 (0%)		0/5276 (0%)
Respiratory distress	0/5279 (0%)		1/5276 (0%)
Respiratory failure	5/5279 (0.1%)		7/5276 (0.1%)
Sleep apnoea syndrome	3/5279 (0.1%)		1/5276 (0%)
Stridor	0/5279 (0%)		1/5276 (0%)
Vocal cord leukoplakia	0/5279 (0%)		1/5276 (0%)
Skin and subcutaneous tissue disorders
Angioedema	1/5279 (0%)		1/5276 (0%)
Diabetic foot	1/5279 (0%)		3/5276 (0.1%)
Idiopathic angioedema	1/5279 (0%)		0/5276 (0%)
Neuropathic ulcer	1/5279 (0%)		1/5276 (0%)
Peau d'orange	1/5279 (0%)		0/5276 (0%)
Rash	0/5279 (0%)		1/5276 (0%)
Rash generalised	1/5279 (0%)		0/5276 (0%)
Skin ulcer	2/5279 (0%)		2/5276 (0%)
Social circumstances
Immobile	0/5279 (0%)		1/5276 (0%)
Vascular disorders
Accelerated hypertension	1/5279 (0%)		0/5276 (0%)
Aortic aneurysm	2/5279 (0%)		4/5276 (0.1%)
Aortic occlusion	1/5279 (0%)		0/5276 (0%)
Aortic stenosis	8/5279 (0.2%)		4/5276 (0.1%)
Aortic thrombosis	1/5279 (0%)		0/5276 (0%)
Arterial disorder	1/5279 (0%)		0/5276 (0%)
Arterial rupture	0/5279 (0%)		1/5276 (0%)
Arterial stenosis	2/5279 (0%)		0/5276 (0%)
Arteriosclerosis	1/5279 (0%)		2/5276 (0%)
Axillary vein thrombosis	1/5279 (0%)		0/5276 (0%)
Circulatory collapse	1/5279 (0%)		1/5276 (0%)
Deep vein thrombosis	3/5279 (0.1%)		2/5276 (0%)
Diabetic vascular disorder	1/5279 (0%)		0/5276 (0%)
Dry gangrene	0/5279 (0%)		1/5276 (0%)
Embolism	0/5279 (0%)		1/5276 (0%)
Embolism venous	1/5279 (0%)		0/5276 (0%)
Femoral artery embolism	1/5279 (0%)		0/5276 (0%)
Granulomatosis with polyangiitis	1/5279 (0%)		0/5276 (0%)
Haematoma	4/5279 (0.1%)		2/5276 (0%)
Hypertension	6/5279 (0.1%)		4/5276 (0.1%)
Hypertensive crisis	5/5279 (0.1%)		7/5276 (0.1%)
Hypertensive emergency	0/5279 (0%)		2/5276 (0%)
Hypotension	5/5279 (0.1%)		7/5276 (0.1%)
Iliac artery occlusion	0/5279 (0%)		2/5276 (0%)
Infarction	1/5279 (0%)		0/5276 (0%)
Intermittent claudication	4/5279 (0.1%)		3/5276 (0.1%)
Internal haemorrhage	1/5279 (0%)		0/5276 (0%)
Labile hypertension	1/5279 (0%)		0/5276 (0%)
Microangiopathy	1/5279 (0%)		1/5276 (0%)
Orthostatic hypotension	2/5279 (0%)		1/5276 (0%)
Peripheral arterial occlusive disease	13/5279 (0.2%)		14/5276 (0.3%)
Peripheral artery occlusion	6/5279 (0.1%)		1/5276 (0%)
Peripheral artery stenosis	3/5279 (0.1%)		8/5276 (0.2%)
Peripheral embolism	0/5279 (0%)		1/5276 (0%)
Peripheral ischaemia	8/5279 (0.2%)		4/5276 (0.1%)
Peripheral vascular disorder	14/5279 (0.3%)		10/5276 (0.2%)
Shock	1/5279 (0%)		0/5276 (0%)
Temporal arteritis	1/5279 (0%)		0/5276 (0%)
Thrombosis	1/5279 (0%)		1/5276 (0%)
Varicose vein	1/5279 (0%)		1/5276 (0%)
Vascular pain	0/5279 (0%)		1/5276 (0%)
Vasculitis	0/5279 (0%)		1/5276 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Bococizumab (PF-04950615)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2128/5279 (40.3%)		2453/5276 (46.5%)
Cardiac disorders
Angina pectoris	120/5279 (2.3%)		104/5276 (2%)
Gastrointestinal disorders
Diarrhoea	136/5279 (2.6%)		133/5276 (2.5%)
General disorders
Injection site reaction	68/5279 (1.3%)		617/5276 (11.7%)
Fatigue	134/5279 (2.5%)		141/5276 (2.7%)
Injection site erythema	23/5279 (0.4%)		164/5276 (3.1%)
Non-cardiac chest pain	111/5279 (2.1%)		89/5276 (1.7%)
Infections and infestations
Bronchitis	159/5279 (3%)		167/5276 (3.2%)
Influenza	112/5279 (2.1%)		157/5276 (3%)
Nasopharyngitis	227/5279 (4.3%)		236/5276 (4.5%)
Upper respiratory tract infection	170/5279 (3.2%)		180/5276 (3.4%)
Urinary tract infection	107/5279 (2%)		137/5276 (2.6%)
Injury, poisoning and procedural complications
Fall	156/5279 (3%)		141/5276 (2.7%)
Metabolism and nutrition disorders
Diabetes mellitus	167/5279 (3.2%)		147/5276 (2.8%)
Type 2 diabetes mellitus	126/5279 (2.4%)		109/5276 (2.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	182/5279 (3.4%)		211/5276 (4%)
Back pain	180/5279 (3.4%)		182/5276 (3.4%)
Muscle spasms	109/5279 (2.1%)		108/5276 (2%)
Myalgia	208/5279 (3.9%)		233/5276 (4.4%)
Pain in extremity	120/5279 (2.3%)		125/5276 (2.4%)
Nervous system disorders
Dizziness	143/5279 (2.7%)		136/5276 (2.6%)
Headache	163/5279 (3.1%)		171/5276 (3.2%)
Respiratory, thoracic and mediastinal disorders
Cough	104/5279 (2%)		118/5276 (2.2%)
Dyspnoea	124/5279 (2.3%)		96/5276 (1.8%)
Vascular disorders
Hypertension	242/5279 (4.6%)		226/5276 (4.3%)

Limitations/Caveats

As specified in statistical analysis plan, due to discontinuation of the bococizumab clinical development program, health care resource utilization endpoints were not evaluated.

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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.