NCT00239681

Brief Summary

The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
17,802

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_3

Geographic Reach
26 countries

848 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

March 24, 2014

Completed
Last Updated

March 24, 2014

Status Verified

February 1, 2014

Enrollment Period

5.6 years

First QC Date

October 13, 2005

Results QC Date

August 20, 2009

Last Update Submit

February 6, 2014

Conditions

Keywords

Primary preventionCardiovascular diseaseStatin therapyC-reactive protein

Outcome Measures

Primary Outcomes (1)

  • Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)

    Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean

    up to 5 years

Secondary Outcomes (5)

  • Time to Death Due to Any Cause

    up to 5 years

  • Time to Non-cardiovascular Death

    up to 5 years

  • Time to Development of Diabetes Mellitus

    up to 5 years

  • Time to Venous Thromboembolic Event

    up to 5 years

  • Time to Bone Fracture

    Up to 5 years

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

Rosuvastatin 20 mg once daily

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

Placebo once daily

Other: Placebo

Interventions

Oral

Also known as: Crestor
Rosuvastatin
PlaceboOTHER

Oral

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men 50 years or older, women 60 years or older
  • Low to normal levels of low density lipoprotein (LDL) cholesterol (\< 130mg/dL)
  • Elevated levels of C-Reactive Protein (CRP) \> 2.0 mg/L

You may not qualify if:

  • History of cardiovascular or cerebrovascular events
  • Active liver disease
  • Diabetes mellitus
  • Uncontrolled hypertension or hypothyroidism
  • History of certain malignancies
  • Chronic inflammatory conditions
  • History of alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (856)

Research Site

Birmingham, Alabama, United States

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Calera, Alabama, United States

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Columbiana, Alabama, United States

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Decatur, Alabama, United States

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Graysville, Alabama, United States

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Haleyville, Alabama, United States

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Hartselle, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Muscle Shoals, Alabama, United States

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South Birmingham, Alabama, United States

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Tuscumbia, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Fayetteville, Arkansas, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Pine Bluff, Arkansas, United States

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Alhambra, California, United States

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Azusa, California, United States

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Berkeley, California, United States

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Beverly Hills, California, United States

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Burlingame, California, United States

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Carmichael, California, United States

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Concord, California, United States

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Culver City, California, United States

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Daly City, California, United States

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Folsom, California, United States

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Foothill Ranch, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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Garden Grove, California, United States

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Inglewood, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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La Mesa, California, United States

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Languna Niguel, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Gatos, California, United States

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Mission Hills, California, United States

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Mission Viejo, California, United States

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Modesto, California, United States

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Newport Beach, California, United States

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Norwalk, California, United States

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Orange, California, United States

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Orangevale, California, United States

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Palm Desert, California, United States

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Pasadena, California, United States

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Pismo Beach, California, United States

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Pomona, California, United States

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Riverside, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Jose, California, United States

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San Ramon, California, United States

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Santa Ana, California, United States

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Santa Monica, California, United States

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Thousand Oaks, California, United States

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Torrance, California, United States

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Upland, California, United States

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Ventura, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Westlake Village, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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Golden, Colorado, United States

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Highlands Ranch, Colorado, United States

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Littleton, Colorado, United States

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Loveland, Colorado, United States

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Avon, Connecticut, United States

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Bristol, Connecticut, United States

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Hartford, Connecticut, United States

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Stamford, Connecticut, United States

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Trumbull, Connecticut, United States

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West Hartford, Connecticut, United States

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Newark, Delaware, United States

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Wlimington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Apopka, Florida, United States

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Beverly Hills, Florida, United States

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Cape Coral, Florida, United States

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Clearwater, Florida, United States

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Cooper City, Florida, United States

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Crystal River, Florida, United States

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Davie, Florida, United States

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Deerfield Beach, Florida, United States

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Delray Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Largo, Florida, United States

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Margate, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Palm Harbor, Florida, United States

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Pensacola, Florida, United States

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Port Charlotte, Florida, United States

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Port Orange, Florida, United States

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Sarasota, Florida, United States

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Sebastian, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Blue Ridge, Georgia, United States

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Brunswick, Georgia, United States

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Columbus, Georgia, United States

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Conyers, Georgia, United States

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Decatur, Georgia, United States

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Fayetteville, Georgia, United States

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Suwanee, Georgia, United States

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Woodstock, Georgia, United States

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Idaho Falls, Idaho, United States

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Meridian, Idaho, United States

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Aurora, Illinois, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Gurnee, Illinois, United States

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Lake Road, Illinois, United States

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Melrose Park, Illinois, United States

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Morton, Illinois, United States

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O'Fallon, Illinois, United States

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Orland Park, Illinois, United States

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Springfield, Illinois, United States

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Sterling, Illinois, United States

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Vernon Hills, Illinois, United States

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Avon, Indiana, United States

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Evansville, Indiana, United States

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Granger, Indiana, United States

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Indianapolis, Indiana, United States

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Jeffersonville, Indiana, United States

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Munster, Indiana, United States

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Newburgh, Indiana, United States

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Valparaiso, Indiana, United States

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Des Moines, Iowa, United States

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Dubuque, Iowa, United States

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Iowa City, Iowa, United States

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West Des Moines, Iowa, United States

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Leavenworth, Kansas, United States

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Olathe, Kansas, United States

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Overland Park, Kansas, United States

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Shawnee Mission, Kansas, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Evansville, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Covington, Louisiana, United States

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Houma, Louisiana, United States

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Lake Charles, Louisiana, United States

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Marrero, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Auburn, Maine, United States

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Bangor, Maine, United States

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Portland, Maine, United States

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Sanford, Maine, United States

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South Portland, Maine, United States

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Baltimore, Maryland, United States

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Charlotte Hall, Maryland, United States

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Glen Burnie, Maryland, United States

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Hagerstown, Maryland, United States

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Prince Frederick, Maryland, United States

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Rockville, Maryland, United States

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Towson, Maryland, United States

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Ayer, Massachusetts, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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East Bridgewater, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Natick, Massachusetts, United States

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Newton, Massachusetts, United States

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Springfield, Massachusetts, United States

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West Yarmouth, Massachusetts, United States

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Worcester, Massachusetts, United States

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Berkley, Michigan, United States

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Dearborn, Michigan, United States

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Grand Rapids, Michigan, United States

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Livonia, Michigan, United States

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Petoskey, Michigan, United States

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Portage, Michigan, United States

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Saint Joseph, Michigan, United States

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Troy, Michigan, United States

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Warren, Michigan, United States

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Chaska, Minnesota, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Saint Paul, Minnesota, United States

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Gulfport, Mississippi, United States

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Jackson, Mississippi, United States

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Olive Branch, Mississippi, United States

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Picayune, Mississippi, United States

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Port Gibson, Mississippi, United States

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Chesterfield, Missouri, United States

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Excelsior Springs, Missouri, United States

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Jefferson City, Missouri, United States

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Kansas City, Missouri, United States

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Manchester, Missouri, United States

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Mexico, Missouri, United States

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Rolla, Missouri, United States

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Saint Charles, Missouri, United States

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Shawnee Mission, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Washington, Missouri, United States

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Wentzville, Missouri, United States

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Anaconda, Montana, United States

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Butte, Montana, United States

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Kalispell, Montana, United States

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Missoula, Montana, United States

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Grand Island, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Pahrump, Nevada, United States

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Nashua, New Hampshire, United States

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Bloomfield, New Jersey, United States

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Brick, New Jersey, United States

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Cherry Hill, New Jersey, United States

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Elizabeth, New Jersey, United States

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Englewood Cliffs, New Jersey, United States

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Morristown, New Jersey, United States

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Newark, New Jersey, United States

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Northbrunswick, New Jersey, United States

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Passaic, New Jersey, United States

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Teaneck, New Jersey, United States

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Trenton, New Jersey, United States

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West Caldwell, New Jersey, United States

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Albuquerque, New Mexico, United States

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Los Alamos, New Mexico, United States

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Rio Rancho, New Mexico, United States

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Albany, New York, United States

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Binghamton, New York, United States

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Bowmansville, New York, United States

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Bronxville, New York, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Camillus, New York, United States

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East Islip, New York, United States

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East Syracuse, New York, United States

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Fayetteville, New York, United States

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Lake Success, New York, United States

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Mamaroneck, New York, United States

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Mount Vernon, New York, United States

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New Hartford, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Niagara Falls, New York, United States

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Poughkeepsie, New York, United States

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Riverhead, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Tonawanda, New York, United States

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Williamsville, New York, United States

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Asheville, North Carolina, United States

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Burlington, North Carolina, United States

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Cary, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Fayetteville, North Carolina, United States

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Lenoir, North Carolina, United States

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Lexington, North Carolina, United States

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Raleigh, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Akron, Ohio, United States

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Athens, Ohio, United States

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Bellbrook, Ohio, United States

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Canal Fulton, Ohio, United States

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Centerville, Ohio, United States

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Chesterland, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Mansfield, Ohio, United States

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Massillon, Ohio, United States

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Maumee, Ohio, United States

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Wadsworth, Ohio, United States

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Warren, Ohio, United States

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Zanesville, Ohio, United States

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Guthrie, Oklahoma, United States

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Muskogee, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Yukon, Oklahoma, United States

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Corvallis, Oregon, United States

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Dallas, Oregon, United States

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Eugene, Oregon, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Milwaukie, Oregon, United States

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Portland, Oregon, United States

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Springfield, Oregon, United States

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Altoona, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Bloomsburg, Pennsylvania, United States

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Broomall, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Connellsville, Pennsylvania, United States

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Downingtown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Feasterville, Pennsylvania, United States

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Fleetwood, Pennsylvania, United States

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Harleysville, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Jersey Shore, Pennsylvania, United States

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King of Prussia, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Lansdowne, Pennsylvania, United States

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Lewisburg, Pennsylvania, United States

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Lewistown, Pennsylvania, United States

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Lock Haven, Pennsylvania, United States

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McMurray, Pennsylvania, United States

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Melrose Park, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Plymouth Meeting, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Souderton, Pennsylvania, United States

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Springfield, Pennsylvania, United States

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State College, Pennsylvania, United States

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Stoneboro, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Wallingford, Pennsylvania, United States

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Warminster, Pennsylvania, United States

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West Grove, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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York, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Johnston, Rhode Island, United States

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Pawtucket, Rhode Island, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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Greer, South Carolina, United States

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Hampton, South Carolina, United States

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Moncks Corner, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Orangeburg, South Carolina, United States

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Simpsonville, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Clarksville, Tennessee, United States

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Fayetteville, Tennessee, United States

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Germantown, Tennessee, United States

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Hendersonville, Tennessee, United States

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Jefferson City, Tennessee, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, United States

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Morristown, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Colleyville, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Friendswood, Texas, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Lake Jackson, Texas, United States

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Lubbock, Texas, United States

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New Braunfels, Texas, United States

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North Richland Hills, Texas, United States

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Pharr, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Seguin, Texas, United States

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Sugar Land, Texas, United States

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The Woodlands, Texas, United States

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Tyler, Texas, United States

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Bountiful, Utah, United States

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Nephi, Utah, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Alexandria, Virginia, United States

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Arlington, Virginia, United States

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Burke, Virginia, United States

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Charlottesville, Virginia, United States

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Hampton, Virginia, United States

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Hayes, Virginia, United States

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Norfolk, Virginia, United States

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Quinton, Virginia, United States

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Richmond, Virginia, United States

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Springfield, Virginia, United States

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Stuart, Virginia, United States

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Suffolk, Virginia, United States

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Weber City, Virginia, United States

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Yorktown, Virginia, United States

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Burien, Washington, United States

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Everett, Washington, United States

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Gig Harbor, Washington, United States

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Olympia, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Wenatchee, Washington, United States

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Charleston, West Virginia, United States

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Lewisburg, West Virginia, United States

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Beloit, Wisconsin, United States

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Green Bay, Wisconsin, United States

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Madison, Wisconsin, United States

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Menomonee Falls, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Capital Federal, Buenos Aires, Argentina

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Pilar, Buenos Aires, Argentina

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Quilmes, Buenos Aires - Argentina, Argentina

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Ramos Mejía, Buenos Aires Argentina, Argentina

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San Isidro, Buenos Aires- Argentina, Argentina

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Córdoba, Cordoba - Argentina, Argentina

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Salta, Salta Province, Argentina

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Rosario, Santa Fe- Argentina, Argentina

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San Miguel de Tucumán, Tucuman / Argentina, Argentina

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San Miguel de Tucumán, Tucuman-argentina, Argentina

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Alsemberg, Belgium, Belgium

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Anthée, Belgium, Belgium

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Auvelais, Belgium, Belgium

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Baisy-Thy, Belgium, Belgium

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Bertrix, Belgium, Belgium

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Betekom, Belgium, Belgium

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Boechout, Belgium, Belgium

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Braine-l'Alleud, Belgium, Belgium

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Burdinne, Belgium, Belgium

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Cerexhe-Heuseux, Belgium, Belgium

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Champion, Belgium, Belgium

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Chênée, Belgium, Belgium

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Comines, Belgium, Belgium

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Deurne (antwerpen), Belgium, Belgium

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Dour, Belgium, Belgium

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Embourg, Belgium, Belgium

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Genk, Belgium, Belgium

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Genly, Belgium, Belgium

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Gozée, Belgium, Belgium

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Grivegnée, Belgium, Belgium

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Halen, Belgium, Belgium

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Hasselt, Belgium, Belgium

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Heurne, Belgium, Belgium

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Heusden, Belgium, Belgium

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Hove, Belgium, Belgium

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Kessel-Lo, Belgium, Belgium

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Kraainem, Belgium, Belgium

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Landen, Belgium, Belgium

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Leopoldsburg, Belgium, Belgium

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Leuven, Belgium, Belgium

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Libin, Belgium, Belgium

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Linkebeek, Belgium, Belgium

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Lommel, Belgium, Belgium

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Marchienne-au-Pont, Belgium, Belgium

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Marchovelette, Belgium, Belgium

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Mechelen-aan-de-Maas, Belgium, Belgium

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Melsbroek, Belgium, Belgium

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Mont-sur-Marchienne, Belgium, Belgium

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Moorsel, Belgium, Belgium

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Mouscron, Belgium, Belgium

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Natoye, Belgium, Belgium

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Oostham, Belgium, Belgium

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Opgrimbie (maasmechelen), Belgium, Belgium

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Paal, Belgium, Belgium

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Puurs, Belgium, Belgium

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Ronquières, Belgium, Belgium

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Ronse, Belgium, Belgium

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Rumst, Belgium, Belgium

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Saint-Médard, Belgium, Belgium

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Sint-Gillis-Waas, Belgium, Belgium

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Steenokkerzeel, Belgium, Belgium

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Tavier, Belgium, Belgium

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Tessenderlo, Belgium, Belgium

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Thuin, Belgium, Belgium

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Tremelo, Belgium, Belgium

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Trois-Ponts, Belgium, Belgium

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Turnhout, Belgium, Belgium

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Vilvoorde, Belgium, Belgium

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Waremme, Belgium, Belgium

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Weerde, Belgium, Belgium

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Wezembeek-Oppem, Belgium, Belgium

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Zoersel, Belgium, Belgium

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Ans, Belgium

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Brussels, Belgium

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De Pinte, Belgium

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Ekeren, Belgium

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Evergem, Belgium

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Lauwe, Belgium

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Massemen, Belgium

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Moerkerke, Belgium

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Oudenaarde, Belgium

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Schoonaarde, Belgium

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Schuiferskapelle, Belgium

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Tielt, Belgium

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Maceió, Alagoas, Brazil

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Fortaleza, Ceará, Brazil

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Salvador, Estado de Bahia, Brazil

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Goiagoianiania, Goiás, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Passo Fundo, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Botucatu, São Paulo, Brazil

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S.j.rio Preto, São Paulo, Brazil

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Santos, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Campinas, Brazil

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Dimitrovgrad, Bulgaria

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Haskovo, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Veliko Tarnovo, Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Chilliwack, British Columbia, Canada

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Coquitlam, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Langley, British Columbia, Canada

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New Westminster, British Columbia, Canada

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Penticton, British Columbia, Canada

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Surrey, British Columbia, Canada

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Victoria, British Columbia, Canada

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Portage la Prairie, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Grand Bay-Westfield, New Brunswick, Canada

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Moncton, New Brunswick, Canada

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Nackawic, New Brunswick, Canada

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Saint John, New Brunswick, Canada

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Woodstock, New Brunswick, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Carbonear, Newfoundland and Labrador, Canada

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Conception Bay South, Newfoundland and Labrador, Canada

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Holyrood, Newfoundland and Labrador, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Amherst, Nova Scotia, Canada

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Antigonish, Nova Scotia, Canada

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Digby, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Windsor, Nova Scotia, Canada

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Bolton, Ontario, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Cambridge, Ontario, Canada

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Corunna, Ontario, Canada

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Courtice, Ontario, Canada

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Etobicoke, Ontario, Canada

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Exeter, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Ingersoll, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Newmarket, Ontario, Canada

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Niagara Falls, Ontario, Canada

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North Bay, Ontario, Canada

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North York, Ontario, Canada

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Orléans, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Perth, Ontario, Canada

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Peterborough, Ontario, Canada

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Renfrew, Ontario, Canada

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Saint Catherines, Ontario, Canada

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Sarnia, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Smith Falls, Ontario, Canada

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Stirling, Ontario, Canada

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Thornhill, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Tillsonburg, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Woodstock, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Chicoutimi, Quebec, Canada

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Courcelette, Quebec, Canada

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Drummonville, Quebec, Canada

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Gatineau, Quebec, Canada

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Granby, Quebec, Canada

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Greenfield Park, Quebec, Canada

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LaSalle, Quebec, Canada

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Laval, Quebec, Canada

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Longueuil, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Georges, Quebec, Canada

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Saint-Marc-des-Carrieres, Quebec, Canada

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Sainte-Catherine, Quebec, Canada

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Sainte-Julie, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Vanier, Quebec, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Temuco, Región de la Araucanía, Chile

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Santiago, Santiago Metropolitan, Chile

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Bogotá, Colombia, Colombia

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Cartagena, Departamento de Bolívar, Colombia

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Pereira, Risaralda Department, Colombia

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Bucaramanga, Santander Department, Colombia

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Floridablanca, Santander Department, Colombia

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Cali, Valle del Cauca Department, Colombia

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Desamparados, Provincia de San José, Costa Rica

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Escazú, Provincia de San José, Costa Rica

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San Pedro, Provincia de San José, Costa Rica

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Heredia, Costa Rica

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Gentofte Municipality, Denmark

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Glostrup Municipality, Denmark

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Herlev, Denmark

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Hillerød, Denmark

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Odense C, Denmark

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El Salvador, San Salvador Department, El Salvador

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San Salvador, El Salvador

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Saku, Harju, Estonia

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Pärnu, Estonia

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Rakvere, Estonia

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Tallinn, Estonia

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Tartu, Estonia

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Viljandi County, Estonia

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Berlin, Germany

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Bochum, Germany

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Chemnitz, Germany

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Dortmund, Germany

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Dresden, Germany

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Frankfurt, Germany

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Görlitz, Germany

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Hamburg, Germany

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Künzing, Germany

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Leipzig, Germany

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Magdeburg, Germany

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Nuremberg, Germany

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Ulm, Germany

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Witten, Germany

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Kiryat Hadassah, Jerusalem, Israel

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Ashkelon Shore, Israel

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Beer Yakov, Israel

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Haifa, Israel

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Holon, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Safed, Israel

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Tel Aviv, Israel

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Tel Litwinsky, Israel

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Zrifin, Israel

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Aguascalientes, Aguascalientes, Mexico

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Mexico City, D.F, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Culiacán, Sinaloa, Mexico

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Alkmaar, Netherlands

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Amersfoort, Netherlands

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Amsterdam, Netherlands

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Breda, Netherlands

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Deventer, Netherlands

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Eindhoven, Netherlands

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Gouda, Netherlands

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Groningen, Netherlands

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Hoorn, Netherlands

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Leiden, Netherlands

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Nijmegen, Netherlands

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Rotterdam, Netherlands

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The Hague, Netherlands

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Tilburg, Netherlands

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Utrecht, Netherlands

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Velp, Netherlands

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Zoetermeer, Netherlands

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Bekkestua, Norway

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Bergen, Norway

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Bøverbru, Norway

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Elverum, Norway

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Flatåsen, Norway

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Fredrikstad, Norway

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Halden, Norway

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Heimdal, Norway

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Kristiansand, Norway

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Laksevåg, Norway

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Lena, Norway

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Lierskogen, Norway

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Lysaker, Norway

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Løvenstad, Norway

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Moelv, Norway

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Moss, Norway

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Oslo, Norway

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Paradis, Norway

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Randaberg, Norway

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Rådal, Norway

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Skedsmokorset, Norway

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Ski, Norway

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Skiptvet, Norway

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Snaroya, Norway

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Sogndal, Norway

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Spikkestad, Norway

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Stavanger, Norway

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Strømmen, Norway

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Svelvik, Norway

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Trollåsen, Norway

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Trondheim, Norway

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Østerås, Norway

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Panama City, Provincia de Panamá, Panama

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Aleksandrów Łódzki, Poland

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Bydgoszcz, Poland

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Bytom, Poland

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Chodzież, Poland

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Chorzów, Poland

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Gdansk, Poland

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Gliwice, Poland

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Jelcz Laskowice, Poland

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Karpacz, Poland

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Katowice, Poland

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Koluszki, Poland

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Krakow, Poland

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Linia, Poland

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Lodz, Poland

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Lublin, Poland

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Nowogard, Poland

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Olsztyn, Poland

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Opalenica, Poland

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Opole, Poland

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Ostrów Wielkopolski, Poland

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Oława, Poland

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Piekary Śląskie, Poland

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Poznan, Poland

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Puławy, Poland

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Radom, Poland

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Radziejów, Poland

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Rybnik, Poland

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Sieradz, Poland

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Skierniewice, Poland

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Sobótka, Poland

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Sopot, Poland

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Szczecin, Poland

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Słupca, Poland

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Tarnów, Poland

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Torun, Poland

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Trzcianka, Poland

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Turek, Poland

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Warsaw, Poland

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Wąbrzeźno, Poland

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Wejherowo, Poland

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Wroclaw, Poland

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Zabrze, Poland

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Aguas Buenas, Puerto Rico

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Caguas, Puerto Rico

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Cidra, Puerto Rico

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Levittown-toa Baja, Puerto Rico

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Ponce, Puerto Rico

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San Juan, Puerto Rico

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Cluj-Napoca, Cluj, Romania

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Timișoara, Timiș County, Romania

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Brasov, Romania

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Bucharest, Romania

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Kemerovo, Russia

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Krasnoyarsk, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Tolyatti, Russia

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Tomsk, Russia

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Tyumen, Russia

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Voronezh, Russia

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Yaroslavl, Russia

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Yekaterinburg, Russia

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Claremont, Cape Province, South Africa

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Athlone, Cape Town, South Africa

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Florida Park, Gauteng, South Africa

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Lenasia, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Witbank, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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eMkhomazi, KwaZulu-Natal, South Africa

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Morningside Manor, Morningside, South Africa

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Korsten, Port Elizabeth, South Africa

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Hillcrest, Pretoria, South Africa

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Halfway House, South Africa, South Africa

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Johannesburg, South Africa, South Africa

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Worcester, South Africa, South Africa

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Benoni, South Africa

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Lakeview, Retreat, South Africa

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Rustenburg, South Africa

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Somerset West, South Africa

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Vanderbijlpark, South Africa

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Olten, Schweiz, Switzerland

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Reading, Berkshire, United Kingdom

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Annan, Dumfries and Galloway, United Kingdom

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Blantyre, Lanarkshire, United Kingdom

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Hamilton, Lanarkshire, United Kingdom

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Strathaven, Lanarkshire, United Kingdom

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Wishaw, Lanarkshire, United Kingdom

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Paisley, Renfrewshire, United Kingdom

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Airdrie, Scotland, United Kingdom

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Glasgow, Scotland, United Kingdom

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Barrhead, United Kingdom

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Bellshill, United Kingdom

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Birmingham, United Kingdom

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Cambuslang, United Kingdom

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Cardiff, United Kingdom

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Chorley, United Kingdom

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Cumbernauld, United Kingdom

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Gourock, United Kingdom

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Greenock, United Kingdom

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Helensburgh, United Kingdom

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Kirkintilloch, United Kingdom

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Liverpool, United Kingdom

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Lockerbie, United Kingdom

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Manchester, United Kingdom

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New Stevenson, United Kingdom

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Renfrew, United Kingdom

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Stranraer, United Kingdom

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Strathblane, United Kingdom

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Thornhill, United Kingdom

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Wolverhampton, United Kingdom

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Montevideo, Uruguay

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Maracay, Municipio Girardot, Aragua, Venezuela

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Barinas, Barinas, Venezuela

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Ciudad Bolívar, Bolívar, Venezuela

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Puerto Ordaz and San Felix, Bolívar, Venezuela

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Valencia, Carabobo, Venezuela

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Barquisimeto, Lara, Venezuela

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Latrinidad Caracas, Municipio Baruta, Venezuela

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Mérida, Mérida, Venezuela

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Porlamar, Nueva Esparta, Venezuela

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Punto Fijo, Estado Falcon, Venezuela, Venezuela

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Maracaibo, Zulia, Venezuela

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Caracas, Venezuela

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Related Publications (32)

  • Hoshi RA, Alotaibi M, Liu Y, Watrous JD, Ridker PM, Glynn RJ, Serhan CN, Luttmann-Gibson H, Moorthy MV, Jain M, Demler OV, Mora S. One-Year Effects of High-Intensity Statin on Bioactive Lipids: Findings From the JUPITER Trial. Arterioscler Thromb Vasc Biol. 2024 Jul;44(7):e196-e206. doi: 10.1161/ATVBAHA.124.321058. Epub 2024 Jun 6.

  • Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

  • Ajala ON, Demler OV, Liu Y, Farukhi Z, Adelman SJ, Collins HL, Ridker PM, Rader DJ, Glynn RJ, Mora S. Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality: A Secondary Analysis of the JUPITER Randomized Clinical Trial. J Am Heart Assoc. 2020 Sep;9(17):e016507. doi: 10.1161/JAHA.119.016507. Epub 2020 Aug 15.

  • Akinkuolie AO, Lawler PR, Chu AY, Caulfield M, Mu J, Ding B, Nyberg F, Glynn RJ, Ridker PM, Hurt-Camejo E, Chasman DI, Mora S. Group IIA Secretory Phospholipase A2, Vascular Inflammation, and Incident Cardiovascular Disease. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1182-1190. doi: 10.1161/ATVBAHA.118.311894.

  • Dagenais GR, Jung H, Lonn E, Bogaty PM, Dehghan M, Held C, Avezum A, Jansky P, Keltai M, Leiter LA, Lopez-Jaramillo P, Toff WD, Bosch J, Yusuf S. Effects of Lipid-Lowering and Antihypertensive Treatments in Addition to Healthy Lifestyles in Primary Prevention: An Analysis of the HOPE-3 Trial. J Am Heart Assoc. 2018 Jul 22;7(15):e008918. doi: 10.1161/JAHA.118.008918.

  • Khera AV, Demler OV, Adelman SJ, Collins HL, Glynn RJ, Ridker PM, Rader DJ, Mora S. Cholesterol Efflux Capacity, High-Density Lipoprotein Particle Number, and Incident Cardiovascular Events: An Analysis From the JUPITER Trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin). Circulation. 2017 Jun 20;135(25):2494-2504. doi: 10.1161/CIRCULATIONAHA.116.025678. Epub 2017 Apr 27.

  • Akinkuolie AO, Glynn RJ, Padmanabhan L, Ridker PM, Mora S. Circulating N-Linked Glycoprotein Side-Chain Biomarker, Rosuvastatin Therapy, and Incident Cardiovascular Disease: An Analysis From the JUPITER Trial. J Am Heart Assoc. 2016 Jul 13;5(7):e003822. doi: 10.1161/JAHA.116.003822.

  • Dugani SB, Akinkuolie AO, Paynter N, Glynn RJ, Ridker PM, Mora S. Association of Lipoproteins, Insulin Resistance, and Rosuvastatin With Incident Type 2 Diabetes Mellitus : Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 May 1;1(2):136-45. doi: 10.1001/jamacardio.2016.0096.

  • Lawler PR, Akinkuolie AO, Chandler PD, Moorthy MV, Vandenburgh MJ, Schaumberg DA, Lee IM, Glynn RJ, Ridker PM, Buring JE, Mora S. Circulating N-Linked Glycoprotein Acetyls and Longitudinal Mortality Risk. Circ Res. 2016 Apr 1;118(7):1106-15. doi: 10.1161/CIRCRESAHA.115.308078. Epub 2016 Mar 7.

  • Mora S, Caulfield MP, Wohlgemuth J, Chen Z, Superko HR, Rowland CM, Glynn RJ, Ridker PM, Krauss RM. Atherogenic Lipoprotein Subfractions Determined by Ion Mobility and First Cardiovascular Events After Random Allocation to High-Intensity Statin or Placebo: The Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial. Circulation. 2015 Dec 8;132(23):2220-9. doi: 10.1161/CIRCULATIONAHA.115.016857. Epub 2015 Sep 25.

  • Chu AY, Giulianini F, Barratt BJ, Ding B, Nyberg F, Mora S, Ridker PM, Chasman DI. Differential Genetic Effects on Statin-Induced Changes Across Low-Density Lipoprotein-Related Measures. Circ Cardiovasc Genet. 2015 Oct;8(5):688-95. doi: 10.1161/CIRCGENETICS.114.000962. Epub 2015 Aug 13.

  • Everett BM, Zeller T, Glynn RJ, Ridker PM, Blankenberg S. High-sensitivity cardiac troponin I and B-type natriuretic Peptide as predictors of vascular events in primary prevention: impact of statin therapy. Circulation. 2015 May 26;131(21):1851-60. doi: 10.1161/CIRCULATIONAHA.114.014522. Epub 2015 Mar 30.

  • Everett BM, Mora S, Glynn RJ, MacFadyen J, Ridker PM. Safety profile of subjects treated to very low low-density lipoprotein cholesterol levels (<30 mg/dl) with rosuvastatin 20 mg daily (from JUPITER). Am J Cardiol. 2014 Dec 1;114(11):1682-9. doi: 10.1016/j.amjcard.2014.08.041. Epub 2014 Sep 16.

  • Pena JM, Aspberg S, MacFadyen J, Glynn RJ, Solomon DH, Ridker PM. Statin therapy and risk of fracture: results from the JUPITER randomized clinical trial. JAMA Intern Med. 2015 Feb;175(2):171-7. doi: 10.1001/jamainternmed.2014.6388.

  • Khera AV, Everett BM, Caulfield MP, Hantash FM, Wohlgemuth J, Ridker PM, Mora S. Lipoprotein(a) concentrations, rosuvastatin therapy, and residual vascular risk: an analysis from the JUPITER Trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). Circulation. 2014 Feb 11;129(6):635-42. doi: 10.1161/CIRCULATIONAHA.113.004406. Epub 2013 Nov 17.

  • Mora S, Glynn RJ, Ridker PM. High-density lipoprotein cholesterol, size, particle number, and residual vascular risk after potent statin therapy. Circulation. 2013 Sep 10;128(11):1189-97. doi: 10.1161/CIRCULATIONAHA.113.002671. Epub 2013 Sep 3.

  • Ridker PM, Pradhan A, MacFadyen JG, Libby P, Glynn RJ. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet. 2012 Aug 11;380(9841):565-71. doi: 10.1016/S0140-6736(12)61190-8.

  • Mora S, Glynn RJ, Boekholdt SM, Nordestgaard BG, Kastelein JJ, Ridker PM. On-treatment non-high-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and lipid ratios in relation to residual vascular risk after treatment with potent statin therapy: JUPITER (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin). J Am Coll Cardiol. 2012 Apr 24;59(17):1521-8. doi: 10.1016/j.jacc.2011.12.035.

  • Stein EA, Vidt DG, Shepherd J, Cain VA, Anzalone D, Cressman MD. Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a retrospective analysis of renal adverse events among 40,600 participants in the rosuvastatin clinical development program. Atherosclerosis. 2012 Apr;221(2):471-7. doi: 10.1016/j.atherosclerosis.2011.12.011. Epub 2012 Jan 3.

  • Dorresteijn JA, Visseren FL, Ridker PM, Wassink AM, Paynter NP, Steyerberg EW, van der Graaf Y, Cook NR. Estimating treatment effects for individual patients based on the results of randomised clinical trials. BMJ. 2011 Oct 3;343:d5888. doi: 10.1136/bmj.d5888.

  • Albert MA, Glynn RJ, Fonseca FA, Lorenzatti AJ, Ferdinand KC, MacFadyen JG, Ridker PM. Race, ethnicity, and the efficacy of rosuvastatin in primary prevention: the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial. Am Heart J. 2011 Jul;162(1):106-14.e2. doi: 10.1016/j.ahj.2011.03.032. Epub 2011 Jun 12.

  • Ridker PM, MacFadyen JG, Glynn RJ, Chasman DI. Kinesin-like protein 6 (KIF6) polymorphism and the efficacy of rosuvastatin in primary prevention. Circ Cardiovasc Genet. 2011 Jun;4(3):312-7. doi: 10.1161/CIRCGENETICS.110.959353. Epub 2011 Apr 14.

  • Koenig W, Ridker PM. Rosuvastatin for primary prevention in patients with European systematic coronary risk evaluation risk >/= 5% or Framingham risk >20%: post hoc analyses of the JUPITER trial requested by European health authorities. Eur Heart J. 2011 Jan;32(1):75-83. doi: 10.1093/eurheartj/ehq370. Epub 2010 Oct 22.

  • Ridker PM, Macfadyen JG, Nordestgaard BG, Koenig W, Kastelein JJ, Genest J, Glynn RJ. Rosuvastatin for primary prevention among individuals with elevated high-sensitivity c-reactive protein and 5% to 10% and 10% to 20% 10-year risk. Implications of the Justification for Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial for "intermediate risk". Circ Cardiovasc Qual Outcomes. 2010 Sep;3(5):447-52. doi: 10.1161/CIRCOUTCOMES.110.938118. Epub 2010 Aug 24.

  • Ridker PM, Genest J, Boekholdt SM, Libby P, Gotto AM, Nordestgaard BG, Mora S, MacFadyen JG, Glynn RJ, Kastelein JJ; JUPITER Trial Study Group. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial. Lancet. 2010 Jul 31;376(9738):333-9. doi: 10.1016/S0140-6736(10)60713-1. Epub 2010 Jul 23.

  • Ridker PM, MacFadyen J, Cressman M, Glynn RJ. Efficacy of rosuvastatin among men and women with moderate chronic kidney disease and elevated high-sensitivity C-reactive protein: a secondary analysis from the JUPITER (Justification for the Use of Statins in Prevention-an Intervention Trial Evaluating Rosuvastatin) trial. J Am Coll Cardiol. 2010 Mar 23;55(12):1266-1273. doi: 10.1016/j.jacc.2010.01.020. Epub 2010 Mar 4.

  • Mora S, Glynn RJ, Hsia J, MacFadyen JG, Genest J, Ridker PM. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation. 2010 Mar 9;121(9):1069-77. doi: 10.1161/CIRCULATIONAHA.109.906479. Epub 2010 Feb 22.

  • Ridker PM, MacFadyen JG, Fonseca FA, Genest J, Gotto AM, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Number needed to treat with rosuvastatin to prevent first cardiovascular events and death among men and women with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin (JUPITER). Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):616-23. doi: 10.1161/CIRCOUTCOMES.109.848473. Epub 2009 Sep 22.

  • Everett BM, Glynn RJ, MacFadyen JG, Ridker PM. Rosuvastatin in the prevention of stroke among men and women with elevated levels of C-reactive protein: justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER). Circulation. 2010 Jan 5;121(1):143-50. doi: 10.1161/CIRCULATIONAHA.109.874834. Epub 2009 Dec 21.

  • Glynn RJ, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Ridker PM. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N Engl J Med. 2009 Apr 30;360(18):1851-61. doi: 10.1056/NEJMoa0900241. Epub 2009 Mar 29.

  • Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Macfadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Trial Study Group. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet. 2009 Apr 4;373(9670):1175-82. doi: 10.1016/S0140-6736(09)60447-5. Epub 2009 Mar 28.

  • Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207. doi: 10.1056/NEJMoa0807646. Epub 2008 Nov 9.

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Torbjorn Lundstrom
Organization
AstraZeneca

Study Officials

  • Judith Hsia, MD

    AstraZeneca

    STUDY DIRECTOR
  • Paul Ridker, MD

    Brigham and Women's Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

February 1, 2003

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 24, 2014

Results First Posted

March 24, 2014

Record last verified: 2014-02

Locations