A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
Primary Purpose
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Background care
Placebo
dalcetrapib
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/= 45 years of age
- Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
- Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
- Receiving evidence-based medical and dietary management of dyslipidemia
Exclusion Criteria:
- Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
- Uncontrolled hypertension
- Uncontrolled diabetes
- Concomitant treatment with any other drug raising HDL-C
- Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dalcetrapib
Placebo
Arm Description
Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
Outcomes
Primary Outcome Measures
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
Secondary Outcome Measures
All cause mortality
Safety: Incidence of adverse events
Change in blood lipid and lipoprotein levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01516541
Brief Title
A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
Official Title
A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dalcetrapib
Arm Type
Experimental
Arm Description
Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
Intervention Type
Other
Intervention Name(s)
Background care
Intervention Description
Guidelines-based medical care
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching dalcetrapib placebo orally daily
Intervention Type
Drug
Intervention Name(s)
dalcetrapib
Intervention Description
600 mg orally daily
Primary Outcome Measure Information:
Title
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
Time Frame
approximately 4 years
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
approximately 4 years
Title
Safety: Incidence of adverse events
Time Frame
approximately 4 years
Title
Change in blood lipid and lipoprotein levels
Time Frame
from baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/= 45 years of age
Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
Receiving evidence-based medical and dietary management of dyslipidemia
Exclusion Criteria:
Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
Uncontrolled hypertension
Uncontrolled diabetes
Concomitant treatment with any other drug raising HDL-C
Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
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United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
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United States
City
Torrance
State/Province
California
ZIP/Postal Code
90503
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United States
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Torrance
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California
ZIP/Postal Code
90509
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United States
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Colorado Springs
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Colorado
ZIP/Postal Code
80909
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United States
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Denver
State/Province
Colorado
ZIP/Postal Code
80218
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United States
City
Lonetree
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Colorado
ZIP/Postal Code
80124
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United States
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
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United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
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United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
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United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
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United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
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United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
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United States
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
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United States
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Plantation
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Florida
ZIP/Postal Code
33317
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United States
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Port Charlotte
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Florida
ZIP/Postal Code
33952
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United States
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Tallahassee
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Florida
ZIP/Postal Code
32308
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United States
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Tampa
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Florida
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33613
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United States
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West Palm Beach
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Florida
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33401
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United States
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Covington
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Georgia
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30014
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United States
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Cumming
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Georgia
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30041
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United States
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Decatur
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Georgia
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30033
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United States
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Aurora
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Illinois
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60504
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United States
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Rock Island
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Illinois
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61201
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United States
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Winfield
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Illinois
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60190
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United States
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Elkhart
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Indiana
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46617
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United States
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Hammond
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Indiana
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46320-1942
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United States
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Indianapolis
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Indiana
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46237
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United States
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Indianapolis
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Indiana
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46250
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United States
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Muncie
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Indiana
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47303
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United States
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South Bend
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Indiana
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46601
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United States
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Overland Park
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Kansas
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66215
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United States
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Louisville
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Kentucky
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40205
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Maine
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04401
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20705
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United States
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21804
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Boston
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02111
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01830
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Hyannis
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02601
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02747
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Jackson
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49201
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Kalamazoo
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49048
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Marquette
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49855
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48670
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Rochester Hills
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48307
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United States
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Saginaw
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48602
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Ypsilanti
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48197
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Rochester
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Camden
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08103
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Haddon Heights
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08035
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Mine Hill
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07803
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Wayne
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Westwood
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Albany
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New York
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Albany
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New York
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12211
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New York
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New York
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New York
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10567
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New York
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12601
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New York
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12866
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New York
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New York
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Troy
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New York
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Asheville
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North Carolina
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28803
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United States
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Durham
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North Carolina
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27710
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United States
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Elizabeth City
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27909
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United States
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Hickory
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28602
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Morehead City
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28557
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United States
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Rocky Mount
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North Carolina
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27804
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United States
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Statesville
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North Carolina
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28625
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28401
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58103
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Cincinnati
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45227
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Cleveland
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44195
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Mansfield
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44827
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44060
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Thornville
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Toledo
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43623
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Zanesville
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Ohio
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43701
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Allentowm
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18105
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United States
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Altoona
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16602
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United States
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Camp Hill
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17011
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United States
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Doylestown
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18901
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Erie
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Pennsylvania
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16502
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United States
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Erie
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Pennsylvania
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16550
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United States
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Langhorne
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Pennsylvania
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19047
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United States
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Lansdale
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Pennsylvania
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19446
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United States
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North Wales
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Pennsylvania
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19454-2053
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United States
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Philadelphia
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Pennsylvania
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19114
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United States
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Philadelphia
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Pennsylvania
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19153
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United States
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Pottstown
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Pennsylvania
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19464
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United States
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Tipton
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Pennsylvania
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16684
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United States
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West Chester
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Pennsylvania
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19380
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United States
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Anderson
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South Carolina
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29621
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United States
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Greer
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South Carolina
ZIP/Postal Code
29651
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United States
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Rapid City
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South Dakota
ZIP/Postal Code
57701
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United States
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Johnson City
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Tennessee
ZIP/Postal Code
37604
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United States
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Dallas
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Texas
ZIP/Postal Code
75251
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United States
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Humble
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Texas
ZIP/Postal Code
77338
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United States
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Odessa
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Texas
ZIP/Postal Code
79761
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United States
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Tyler
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Texas
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75701
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United States
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Provo
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Utah
ZIP/Postal Code
84004
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United States
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Charlottesville
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Virginia
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22908
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United States
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Danville
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Virginia
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24541-4160
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United States
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Lynchburg
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Virginia
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24501
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United States
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Manassas
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Virginia
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20109
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Richmond
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Virginia
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23249
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Winchester
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Virginia
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22601
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Milton
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Queensland
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4064
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Australia
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Geelong
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Victoria
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3220
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Australia
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Joondalup
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Western Australia
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6027
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Australia
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Coquitlam
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British Columbia
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V3K 3P4
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Canada
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Kelowna
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British Columbia
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V1Y 1T2
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Canada
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Vancouver
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British Columbia
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V5Z 1M9
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Canada
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Moncton
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New Brunswick
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E1C 4B7
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Canada
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Ajax
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Ontario
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L1S 7K8
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Canada
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Barrie
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Ontario
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L4M 7G1
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Canada
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Burlington
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Ontario
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L7M 4Y1
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Canada
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Cambridge
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Ontario
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N1R 7R1
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Canada
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London
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Ontario
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N6A 5G6
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Canada
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Oakville
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Ontario
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L6K 3W7
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Canada
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Oshawa
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Ontario
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L1H 1B9
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Canada
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Oshawa
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Ontario
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L1J 2K1
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Canada
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Sudbury
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Ontario
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P3E 2N8
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Canada
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Sudbury
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Ontario
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Thunder Bay
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Ontario
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P7B 6V4
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Toronto
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Ontario
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Canada
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Granby
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Quebec
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J2G 8Z9
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Canada
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Greenfield Park
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Quebec
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J4V 3G8
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Canada
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Lachine
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Quebec
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H8S 2E4
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Canada
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Longueuil
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Quebec
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J4M 2X1
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Canada
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Longueuil
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Quebec
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J4N 1C2
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Canada
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Mirabel
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Quebec
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J7J 2K8
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Canada
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Montreal
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Quebec
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H1T 1C8
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Canada
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Montreal
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Quebec
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H1T 3Y7
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Canada
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Montréal
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Quebec
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H2K 4L5
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Canada
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Montréal
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Quebec
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H3J 2V5
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Canada
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Québec
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Quebec
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G1V 4M6
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Canada
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St-Lambert
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Quebec
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J4P 2H4
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Canada
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Trois-Rivières
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Quebec
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G8T 7A1
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Canada
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Val D'Or
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Quebec
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J9P 3Y1
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Canada
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Quebec
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G1J 1Z4
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Canada
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Beijing
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100050
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China
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Nanchang
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330006
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China
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Shijiazhuang
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050035
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China
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Benatky nad Jizerou
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29471
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Czech Republic
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Jindrichuv Hradec
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377 01
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Czech Republic
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Ostrava
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722 00
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Czech Republic
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Pardubice
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530 02
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Czech Republic
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Praha 4
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140 00
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Czech Republic
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Slany
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274 01
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Czech Republic
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Trutnov
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541 01
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Czech Republic
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Ballerup
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2750
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Denmark
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Hvidovre
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2650
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Denmark
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Vejle
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7100
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Denmark
City
Århus N
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8200
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Denmark
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Pessac
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33604
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France
City
Budapest
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1036
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Hungary
City
Budapest
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1133
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Hungary
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Debrecen
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4025
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Hungary
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Kisvarda
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4600
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Hungary
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Komarom
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2900
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Hungary
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Nagykanizsa
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8800
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Hungary
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Pecs
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7621
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Hungary
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Urhida
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8142
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Hungary
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Aguascalientes
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20230
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Mexico
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Aguascaliente
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20230
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Mexico
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Celaya
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38000
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Mexico
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Chihuahua
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31217
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Mexico
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Cuernavaca
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62250
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Mexico
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D. F.
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14380
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Mexico
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Durango
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34080
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Mexico
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
City
Mexico City
ZIP/Postal Code
11650
Country
Mexico
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
City
Monterrey
ZIP/Postal Code
64060
Country
Mexico
City
Pachuca
ZIP/Postal Code
42086
Country
Mexico
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
City
San Luis Potosi S.L.P.
ZIP/Postal Code
78240
Country
Mexico
City
San Luis Potosí
ZIP/Postal Code
78200
Country
Mexico
City
San Luís Potosí
ZIP/Postal Code
78200
Country
Mexico
City
Tampico
ZIP/Postal Code
89000
Country
Mexico
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5611 NJ
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5632 EJ
Country
Netherlands
City
Gouda
ZIP/Postal Code
2803 HH
Country
Netherlands
City
Groningen
ZIP/Postal Code
9711 SG
Country
Netherlands
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
City
Velp
ZIP/Postal Code
6883 ES
Country
Netherlands
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
City
Zoetermeer
ZIP/Postal Code
2724 EK
Country
Netherlands
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
City
Gdansk
ZIP/Postal Code
80-286
Country
Poland
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
City
Krakow
ZIP/Postal Code
30-069
Country
Poland
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
City
Lodz
ZIP/Postal Code
91-425
Country
Poland
City
Lublin
ZIP/Postal Code
20-015
Country
Poland
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
City
Poznan
ZIP/Postal Code
61-655
Country
Poland
City
Pulway
ZIP/Postal Code
24-100
Country
Poland
City
Ruda Slaska
ZIP/Postal Code
41-709
Country
Poland
City
Warsawa
ZIP/Postal Code
01-192
Country
Poland
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
City
Almeria
ZIP/Postal Code
04009
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Madrid
ZIP/Postal Code
28009
Country
Spain
City
Madrid
ZIP/Postal Code
280146
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G20 0SP
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
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