NCT01225562

Brief Summary

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
21,379

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2010

Typical duration for phase_3

Geographic Reach
31 countries

827 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 9, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 9, 2015

Completed
Last Updated

January 25, 2016

Status Verified

December 1, 2015

Enrollment Period

4.2 years

First QC Date

July 9, 2010

Results QC Date

November 4, 2015

Last Update Submit

December 18, 2015

Conditions

Keywords

Heart attackHeart DiseaseAcute coronary syndromeACSCardiovascular Disease

Outcome Measures

Primary Outcomes (2)

  • Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization

    Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization

    Randomization up to 47 months

  • Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients

    A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of \>= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug

    First dosing up to 48 months

Secondary Outcomes (2)

  • Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization

    Randomization up to 47 months

  • Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization

    Randomization up to 47 months

Study Arms (3)

1

EXPERIMENTAL

Oral Treatment

Drug: Ticagrelor 90 mg

2

EXPERIMENTAL

Oral Treatment

Drug: Ticagrelor 60 mg

3

PLACEBO COMPARATOR

Oral Treatment

Drug: Ticagrelor Placebo

Interventions

Oral dose twice a day

1

Oral dose twice a day

2

Oral dose twice a day

3

Eligibility Criteria

Age50 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (\>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
  • Females of child-bearing potential must have a negative pregnancy test at enrollment
  • Persons who are currently taking aspirin between 75 and 150 mg once daily

You may not qualify if:

  • Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
  • Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
  • Persons with known bleeding disorders
  • Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
  • Persons with a history of ischemic stroke
  • Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
  • Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
  • Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
  • Persons with known severe liver disease
  • Persons with kidney failure requiring dialysis
  • Persons with life expectancy \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (827)

Research Site

Alexander City, Alabama, United States

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Athens, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Sheffield, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Alhambra, California, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Fountain Valley, California, United States

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La Mesa, California, United States

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Larkspur, California, United States

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Lomita, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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Newport Beach, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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San Diego, California, United States

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San Marino, California, United States

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Santa Rosa, California, United States

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Ventura, 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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Littleton, Colorado, United States

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Loveland, Colorado, United States

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Hartford, Connecticut, United States

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Stamford, Connecticut, United States

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Newark, Delaware, United States

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

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Coral Springs, Florida, United States

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Crystal River, Florida, United States

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Davie, Florida, United States

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Daytona 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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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Naples, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Pannama City, Florida, United States

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Pensacola, Florida, United States

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Port Charlotte, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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The Villages, Florida, United States

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Wellington, 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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Cumming, Georgia, United States

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Honolulu, Hawaii, United States

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Boise, Idaho, United States

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Aurora, Illinois, United States

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Bannockburn, Illinois, United States

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Chicago, Illinois, United States

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Melrose Park, Illinois, United States

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Normal, Illinois, United States

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Rock Island, Illinois, United States

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Avon, Indiana, United States

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Elkhart, Indiana, United States

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Fort Wayne, Indiana, United States

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Franklin, Indiana, United States

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Indianapolis, Indiana, United States

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Muncie, Indiana, United States

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Munster, Indiana, United States

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Iowa City, Iowa, United States

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Hutchinson, Kansas, United States

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Crestview Hills, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Alexandria, Louisiana, United States

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Covington, Louisiana, United States

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Minden, Louisiana, United States

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New Iberia, Louisiana, United States

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Opelousas, Louisiana, United States

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Shreveport, Louisiana, United States

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Slidell, Louisiana, United States

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Auburn, Maine, United States

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Bangor, Maine, United States

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Biddeford, Maine, United States

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South Portland, Maine, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Oxon Hill, Maryland, United States

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Salisbury, 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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Haverhill, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Alpena, Michigan, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Flint, Michigan, United States

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Grand Blanc, Michigan, United States

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Grand Rapids, Michigan, United States

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Jackson, Michigan, United States

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Lapeer, Michigan, United States

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Marquette, Michigan, United States

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Petoskey, Michigan, United States

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Pontiac, Michigan, United States

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Saginaw, Michigan, United States

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Southfield, Michigan, United States

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Ypsilanti, Michigan, United States

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Baxter, Minnesota, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Biloxi, Mississippi, United States

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Tupelo, Mississippi, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Great Falls, Montana, United States

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Kalispell, Montana, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Papillion, Nebraska, United States

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Reno, Nevada, United States

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Bridgewater, New Jersey, United States

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Elizabeth, New Jersey, United States

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Elmer, New Jersey, United States

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Haddon Heights, New Jersey, United States

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Linden, New Jersey, United States

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Mine Hill, New Jersey, United States

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Newark, New Jersey, United States

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Ridgewood, New Jersey, United States

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Somerset, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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Cortlandt Manor, New York, United States

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Mineola, New York, United States

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New Windsor, New York, United States

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Poughkeepsie, New York, United States

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Saratoga Springs, New York, United States

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Southampton, New York, United States

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Stony Brook, New York, United States

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The Bronx, 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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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Morganton, North Carolina, United States

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Pinehurst, North Carolina, United States

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Raleigh, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Sanford, North Carolina, United States

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Smithfield, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Grand Forks, North Dakota, United States

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Akron, Ohio, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Fairfield, Ohio, United States

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Mansfield, Ohio, United States

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Sandusky, Ohio, United States

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Springfield, Ohio, United States

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Toledo, Ohio, United States

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Youngstown, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Bend, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Chambersburg, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Johnstown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Scranton, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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York, Pennsylvania, United States

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Providence, Rhode Island, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Florence, South Carolina, United States

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Greenville, South Carolina, United States

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Rapid City, South Dakota, United States

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Watertown, South Dakota, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Tullahoma, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Georgetown, Texas, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Kingwood, Texas, United States

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McAllen, Texas, United States

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Plano, Texas, United States

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Round Rock, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Tyler, Texas, United States

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Victoria, Texas, United States

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Provo, Utah, United States

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Burlington, Vermont, United States

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Alexandria, Virginia, United States

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Charlottesville, Virginia, United States

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Danville, Virginia, United States

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Falls Church, Virginia, United States

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Lynchburg, Virginia, United States

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Manassas, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Winchester, Virginia, United States

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Bellevue, Washington, United States

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Everett, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Green Bay, Wisconsin, United States

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Wausau, Wisconsin, United States

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Bahía Blanca, Argentina

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Buenos Aires, Argentina

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Ciudad Autonoma de BA, Argentina

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Ciudad de Buenos Aires, Argentina

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Ciudadela, Argentina

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Coronel Suárez, Argentina

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Corrientes, Argentina

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Córdoba, Argentina

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Haedo, Argentina

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La Plata, Argentina

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Mar del Plata, Argentina

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Ramos Mejía, Argentina

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Rosario, Argentina

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Rosario Santa Fe, Argentina

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San Luis, Argentina

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San Miguel de Tucumán, Argentina

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San Nicolás, Argentina

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San Salvador de Jujuy, Argentina

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Santa Fe, Argentina

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Santa Fé, Argentina

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Zárate, Argentina

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Adelaide, Australia

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Ashford, Australia

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Auchenflower, Australia

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Ballarat, Australia

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Bruce, Australia

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Chermside, Australia

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Clayton, Australia

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Concord, Australia

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East Saint Kilda, Australia

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Elizabeth Vale, Australia

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Epping, Australia

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Fremantle, Australia

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Geelong, Australia

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Gosford, Australia

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Greenslopes, Australia

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Herston, Australia

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Joondalup, Australia

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Kingswood, Australia

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Kogorah, Australia

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Launceston, Australia

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Melbourne, Australia

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Nedlands, Australia

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New Lambton Heights, Australia

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Richmond, Australia

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St Leonards, Australia

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Wollongong, Australia

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Woodville, Australia

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Woolloongabba, Australia

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Aalst, Belgium

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Antwerp, Belgium

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Bonheiden, Belgium

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Bouge, Belgium

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Brasschaat, Belgium

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Brussels, Belgium

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Brussels (Anderlecht), Belgium

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Brussels (Jette), Belgium

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Brussels (Woluwé-St-Lambert), Belgium

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Charleroi, Belgium

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Edegem, Belgium

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Genk, Belgium

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Ghent, Belgium

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Hasselt, Belgium

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Huy, Belgium

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La Louvière, Belgium

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Leuven, Belgium

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Liège, Belgium

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Mechelen, Belgium

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Mol, Belgium

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Ottignies, Belgium

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Roeselare, Belgium

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Tienen, Belgium

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Turnhout, Belgium

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Yvoir, Belgium

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Zottegem, Belgium

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Aracaju, Brazil

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Belo Horizonte, Brazil

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Blumenau, Brazil

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Brasília, Brazil

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Campina Grande do Sul, Brazil

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Campinas, Brazil

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Campo Grande, Brazil

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Curitiba, Brazil

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Goiânia, Brazil

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Maceió, Brazil

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Marília, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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Rio de Janeiro, Brazil

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S.J.Rio Preto, Brazil

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Salvador, Brazil

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São José do Rio Preto, Brazil

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São Paulo, Brazil

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Uberlândia, Brazil

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Votuporanga, Brazil

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Dimitrovgrad, Bulgaria

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Gotse Delchev, Bulgaria

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Pernik, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Razlog, Bulgaria

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Rousse, Bulgaria

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Sevlievo, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Veliko Tarnovo, Bulgaria

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Edmonton, Alberta, Canada

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Kelowna, 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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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Saint John, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, 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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Cornwall, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Newmarket, Ontario, Canada

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North York, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Sarnia, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Gatineau, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Laval, Quebec, Canada

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Lévis, Quebec, Canada

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Longueuil, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Saint-Georges, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Saint-Lambert, Quebec, Canada

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Terrebonne, Quebec, Canada

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Thetford-Mines, Quebec, Canada

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Val-d'Or, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Concepción, Chile

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Osorno, Chile

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Rancagua, Chile

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Santiago, Chile

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Santiago Centro, Chile

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Temuco, Chile

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Viña del Mar, Chile

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Beijing, China

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Changsha, China

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Chongqing, China

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Guangzhou, China

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Hangzhou, China

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Lanzhou, China

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Nanjing, China

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Shanghai, China

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Shengyang, China

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Shenyang, China

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Taiyuan, China

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Wuhan, China

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Xi'an, China

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Armenia, Colombia

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Barranquilla, Colombia

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Bogotá, Colombia

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Bogotá D.C., Colombia

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Bucaramanga, Colombia

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Cali, Colombia

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Cartagena, Colombia

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Manizales, Colombia

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Medellín, Colombia

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Medillin, Colombia

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Brno, Czechia

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Chomutov, Czechia

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Čáslav, Czechia

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Česká Lípa, Czechia

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Český Krumlov, Czechia

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Havířov, Czechia

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Kroměříž, Czechia

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Kyjov, Czechia

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Liberec, Czechia

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Mariánské Lázně, Czechia

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Ostrava, Czechia

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Ostrava-Poruba, Czechia

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Pelhřimov, Czechia

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Prague, Czechia

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Příbram, Czechia

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Slaný, Czechia

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Teplice, Czechia

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Ústí nad Labem, Czechia

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Ústí nad Orlicí, Czechia

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Zábřeh nad Odrou, Czechia

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Znojmo, Czechia

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Abbeville, France

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Albi, France

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Angers, France

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Avignon, France

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Bayonne, France

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Cannes, France

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Créteil, France

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Dijon, France

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Jossigny, France

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La Rochelle, France

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Le Chesnay, France

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Le Coudray, France

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Limoges, France

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Marseille, France

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Metz, France

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Nice, France

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Nîmes, France

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Orléans, France

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Paris, France

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Pessac, France

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Poitiers, France

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Toulouse, France

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Tourcoing, France

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Bad Krozingen, Germany

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Bad Mergentheim, Germany

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Bad Nauheim, Germany

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Berlin, Germany

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Bielefeld, Germany

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Coburg, Germany

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Deggingen, Germany

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Dortmund, Germany

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Dresden, Germany

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Essen, Germany

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Esslingen am Neckar, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Kassel, Germany

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Kiel, Germany

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Leipzig, Germany

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Limburg, Germany

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Ludwigshafen, Germany

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Lübeck, Germany

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Mainz, Germany

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Mönchengladbach, Germany

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Ulm, Germany

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Warendorf, Germany

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Witten, Germany

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Ballasagyarmat, Hungary

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Békéscsaba, Hungary

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Budapest, Hungary

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Cegléd, Hungary

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Debrecen, Hungary

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Eger, Hungary

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Gyula, Hungary

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Kalocsa, Hungary

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Kecskemét, Hungary

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Mosonmagyaróvár, Hungary

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Nyíregyháza, Hungary

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Pécs, Hungary

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Sopron, Hungary

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Szeged, Hungary

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Szekszárd, Hungary

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Székesfehérvár, Hungary

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Szolnok, Hungary

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Zalaegerszeg, Hungary

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Albano Laziale, Italy

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Bari, Italy

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Benevento, Italy

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Brescia, Italy

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Carpi, Italy

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Catania, Italy

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Genova, Italy

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Legnano, Italy

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Lucca, Italy

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Massa, Italy

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Milan, Italy

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Napoli, Italy

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Osio Sotto Frazione Di Zingoni, Italy

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Parma, Italy

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Pavia, Italy

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Perugia, Italy

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Pescara, Italy

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Pisa, Italy

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Reggio Emilia, Italy

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Roma, Italy

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Rozzano, Italy

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S Maria Capua Vetere, Italy

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Sanremo, Italy

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Sassari, Italy

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Sessa Aurunca, Italy

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Siena, Italy

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Sorrento NA, Italy

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Vimercate, Italy

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Akishima-shi, Japan

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Amagasaki-shi, Japan

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Beppu-shi, Japan

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Chūōku, Japan

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Daito-shi, Japan

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Fukui-shi, Japan

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Funabashi-shi, Japan

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Gifu, Japan

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Hamamatsu, Japan

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Himeji-shi, Japan

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Imabari, Japan

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Isehara-shi, Japan

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Kamogawa-shi, Japan

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Kanazawa, Japan

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Kawachinagano-shi, Japan

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Kisarazu-shi, Japan

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Komatsushima-shi, Japan

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Koriyama-shi, Japan

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Kumamoto, Japan

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Kure-shi, Japan

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Kusatsu-shi, Japan

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Kyoto, Japan

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Maebashi, Japan

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Matsue, Japan

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Matsumoto-shi, Japan

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Matsuyama, Japan

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Meguro-ku, Japan

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Miyazaki, Japan

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Osaka, Japan

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Saga, Japan

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Sagamihara-shi, Japan

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Saitama-shi, Japan

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Sakaide-shi, Japan

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Sakaishi, Japan

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Sapporo, Japan

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Sayama-shi, Japan

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Shimada-shi, Japan

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Shinagawa-ku, Japan

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Shizuoka, Japan

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Suwa-shi, Japan

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Takarazuka-shi, Japan

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Takasaki-shi, Japan

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Takatsuki-shi, Japan

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Tomakomai-shi, Japan

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Toyonaka-shi, Japan

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Ueda-shi, Japan

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Wakayama, Japan

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Wako-shi, Japan

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Yatsushiro-shi, Japan

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Yokohama, Japan

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Almere Stad, Netherlands

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Amersfoort, Netherlands

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Amsterdam, Netherlands

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Arnhem, Netherlands

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Beverwijk, Netherlands

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Breda, Netherlands

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Delft, Netherlands

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Den Helder, Netherlands

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Deventer, Netherlands

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Drachten, Netherlands

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Ede, Netherlands

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Eindhoven, Netherlands

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Goes, Netherlands

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Groningen, Netherlands

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Hardenberg, Netherlands

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Heerenveen, Netherlands

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Heerlen, Netherlands

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Helmond, Netherlands

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Hilversum, Netherlands

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Hoofddorp, Netherlands

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Hoogeveen, Netherlands

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Leiderdorp, Netherlands

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Maastricht, Netherlands

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Nieuwegein, Netherlands

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Nijmegen, Netherlands

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Oss, Netherlands

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Roosendaal, Netherlands

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Rotterdam, Netherlands

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Schiedam, Netherlands

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Shertogenbosch, Netherlands

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Sittardgeleen, Netherlands

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Sneek, Netherlands

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The Hague, Netherlands

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Tiel, Netherlands

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Tilburg, Netherlands

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Veldhoven, Netherlands

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Bergen, Norway

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Bodø, Norway

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Flekkefjord, Norway

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Hamar, Norway

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Levanger, Norway

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Lillehammer, Norway

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Nesttun, Norway

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Oslo, Norway

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Skien, Norway

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Tromsø, Norway

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Tynset, Norway

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Arequipa, Peru

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Callao, Peru

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Lima, Peru

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San Borja, Peru

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Trujillo, Peru

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Cebu City, Philippines

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Fuente Osmena Cebu City, Philippines

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Iloilo City, Philippines

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Las Piñas, Philippines

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Lipa City, Philippines

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Mandaluyong, Philippines

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Manila, Philippines

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Pasig, Philippines

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Quezon, Philippines

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Quezon City, Philippines

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San Juan City, Philippines

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Bialystok, Poland

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Bielsko-Biala, Poland

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Bydgoszcz, Poland

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Chorzów, Poland

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Gdansk, Poland

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Gdynia, Poland

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Giżycko, Poland

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Krakow, Poland

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Legnica, Poland

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Lodz, Poland

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Lubin, Poland

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Nowa Sól, Poland

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Olsztyn, Poland

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Opole, Poland

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Ostrów Mazowiecka, Poland

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Oława, Poland

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Piotrków, Poland

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Poznan, Poland

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Płock, Poland

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Skierniewice, Poland

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Sobótka, Poland

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Sokółka, Poland

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Szczecin, Poland

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Tarnów, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Włocławek, Poland

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Łańcut, Poland

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Łęczna, Poland

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Bacau, Romania

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Brasov, Romania

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Brăila, Romania

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Bucharest, Romania

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Buzău, Romania

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Cluj-Napoca, Romania

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Craiova, Romania

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Deva, Romania

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Focşani, Romania

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Iași, Romania

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Piteşti, Romania

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Sibiu, Romania

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Suceava, Romania

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Tg. Mures, Romania

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Timișoara, Romania

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Gatchina, Russia

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Kazan', Russia

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Krasnodar, Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Novosibirsk, Russia

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Perm, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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StPetersburg, Russia

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Vladikavkaz, Russia

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Volgograd, Russia

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Yekaterinburg, Russia

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Banská Bystrica, Slovakia

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Bardejov, Slovakia

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Bratislava, Slovakia

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Komárno, Slovakia

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Košice, Slovakia

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Liptovský Hrádok, Slovakia

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Liptovský Mikuláš, Slovakia

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Martin, Slovakia

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Nitra, Slovakia

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Partizánske, Slovakia

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Piešťany, Slovakia

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Považská Bystrica, Slovakia

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Prešov, Slovakia

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Ružomberok, Slovakia

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Trnava, Slovakia

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Žilina, Slovakia

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Alberton, South Africa

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Bloemfontein, South Africa

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Cape Town, South Africa

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Centurion, South Africa

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Durban, South Africa

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Gatesville, South Africa

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George, South Africa

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Johannesburg, South Africa

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Kempron Park, South Africa

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Panorama, South Africa

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Parow, South Africa

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Pretoria, South Africa

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Somerset West, South Africa

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Soweto, South Africa

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Worcester, South Africa

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Bucheon-si, South Korea

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Busan, South Korea

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Cheongju-si, South Korea

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Daegu, South Korea

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Daejeon, South Korea

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Gwangju, South Korea

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Jeonju, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Uijeongbu-si, South Korea

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Wŏnju, South Korea

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Almería, Spain

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Avilés, Spain

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Barcelona, Spain

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Bilbao, Spain

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Don Benito (Badajoz), Spain

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Hospitalet de Llobregat(Barcel, Spain

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Madrid, Spain

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Majadahonda, Spain

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Málaga, Spain

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Oviedo, Spain

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Palma de Mallorca, Spain

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Sabadell, Spain

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San Sebastián de los Reyes, Spain

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Santiago(A Coruña), Spain

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Seville, Spain

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Valencia, Spain

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Eksjö, Sweden

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Gothenburg, Sweden

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Jönköping, Sweden

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Linköping, Sweden

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Ljungby, Sweden

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Lund, Sweden

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Mölndal, Sweden

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Örebro, Sweden

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Östersund, Sweden

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Stockholm, Sweden

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Sundsvall, Sweden

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Umeå, Sweden

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Västerås, Sweden

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Malatya, Turkey (Türkiye)

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Mersin, Turkey (Türkiye)

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Dnipro, Ukraine

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Donetsk, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Uzhhorod, Ukraine

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Vinnitsa, Ukraine

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Zaporozye, Ukraine

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Airdrie, United Kingdom

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Antrim, United Kingdom

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Belfast, United Kingdom

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Blackpool, United Kingdom

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Bournemouth, United Kingdom

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Brighton, United Kingdom

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Bristol, United Kingdom

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Coventry, United Kingdom

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Dundee, United Kingdom

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East Kilbride, United Kingdom

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Ely, United Kingdom

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Hastings, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Middlesbrough, United Kingdom

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Northampton, United Kingdom

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Nottingham, United Kingdom

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Peterborough, United Kingdom

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Rotherham, United Kingdom

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Sheffield, United Kingdom

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Swansea, United Kingdom

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Torquay, United Kingdom

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York, United Kingdom

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Related Publications (22)

  • Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.

  • Bonaca MP, Im K, Magnani G, Bansilal S, Dellborg M, Storey RF, Bhatt DL, Steg PG, Cohen M, Johanson P, Braunwald E, Sabatine MS. Patient selection for long-term secondary prevention with ticagrelor: insights from PEGASUS-TIMI 54. Eur Heart J. 2022 Dec 21;43(48):5037-5044. doi: 10.1093/eurheartj/ehac402.

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

  • Bergmark BA, Bhatt DL, Steg PG, Budaj A, Storey RF, Gurmu Y, Kuder JF, Im K, Magnani G, Oude Ophuis T, Hamm C, Spinar J, Kiss RG, Van de Werf FJ, Montalescot G, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2021 Sep 7;10(17):e020446. doi: 10.1161/JAHA.120.020446. Epub 2021 Aug 21.

  • Magnani G, Ardissino D, Im K, Budaj A, Storey RF, Steg PG, Bhatt DL, Cohen M, Oude Ophius T, Goudev A, Parkhomenko A, Kamensky G, Angiolillo DJ, Lopez-Sendon J, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction. J Am Heart Assoc. 2021 Feb 16;10(4):e017008. doi: 10.1161/JAHA.120.017008. Epub 2021 Feb 9.

  • Furtado RHM, Venkateswaran RV, Nicolau JC, Gurmu Y, Bhatt DL, Storey RF, Steg PG, Magnani G, Goto S, Dellborg M, Kamensky G, Isaza D, Aylward P, Johanson P, Bonaca MP. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015785. doi: 10.1161/JAHA.119.015785. Epub 2020 May 15.

  • Gencer B, Li XS, Gurmu Y, Bonaca MP, Morrow DA, Cohen M, Bhatt DL, Steg PG, Storey RF, Johanson P, Wang Z, Hazen SL, Sabatine MS. Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015331. doi: 10.1161/JAHA.119.015331. Epub 2020 May 5.

  • Furtado RHM, Nicolau JC, Magnani G, Im K, Bhatt DL, Storey RF, Steg PG, Spinar J, Budaj A, Kontny F, Corbalan R, Kiss RG, Abola MT, Johanson P, Jensen EC, Braunwald E, Sabatine MS, Bonaca MP. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54. Eur Heart J. 2020 May 1;41(17):1625-1632. doi: 10.1093/eurheartj/ehz821.

  • Dellborg M, Bonaca MP, Storey RF, Steg PG, Im KA, Cohen M, Bhatt DL, Oude Ophuis T, Budaj A, Hamm C, Spinar J, Kiss RG, Lopez-Sendon J, Kamensky G, Van de Werf F, Ardissino D, Kontny F, Montalescot G, Johanson P, Bengtsson O, Himmelmann A, Braunwald E, Sabatine MS. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):200-206. doi: 10.1093/ehjcvp/pvz020.

  • Bonaca MP, Wiviott SD, Morrow DA, Steg PG, Hamm C, Bhatt DL, Storey RF, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Diaz R, Van de Werf F, Corbalan R, Goudev A, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS-TIMI 54. J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.

  • Bansilal S, Bonaca MP, Cornel JH, Storey RF, Bhatt DL, Steg PG, Im K, Murphy SA, Angiolillo DJ, Kiss RG, Parkhomenko AN, Lopez-Sendon J, Isaza D, Goudev A, Kontny F, Held P, Jensen EC, Braunwald E, Sabatine MS, Oude Ophuis AJ. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease. J Am Coll Cardiol. 2018 Feb 6;71(5):489-496. doi: 10.1016/j.jacc.2017.11.050.

  • Cavallari I, Morrow DA, Creager MA, Olin J, Bhatt DL, Steg PG, Storey RF, Cohen M, Scirica BS, Piazza G, Goodrich EL, Braunwald E, Sabatine MS, Bonaca MP. Frequency, Predictors, and Impact of Combined Antiplatelet Therapy on Venous Thromboembolism in Patients With Symptomatic Atherosclerosis. Circulation. 2018 Feb 13;137(7):684-692. doi: 10.1161/CIRCULATIONAHA.117.031062. Epub 2017 Oct 30.

  • Bonaca MP, Storey RF, Theroux P, Steg PG, Bhatt DL, Cohen MC, Im K, Murphy SA, Magnani G, Ophuis TO, Rudah M, Parkhomenko A, Isaza D, Kamensky G, Goudev A, Montalescot G, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Efficacy and Safety of Ticagrelor Over Time in Patients With Prior MI in PEGASUS-TIMI 54. J Am Coll Cardiol. 2017 Sep 12;70(11):1368-1375. doi: 10.1016/j.jacc.2017.07.768.

  • Magnuson EA, Li H, Wang K, Vilain K, Shafiq A, Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Braunwald E, Sabatine MS, Cohen DJ; PEGASUS-TIMI 54 Trial Investigators. Cost-Effectiveness of Long-Term Ticagrelor in Patients With Prior Myocardial Infarction: Results From the PEGASUS-TIMI 54 Trial. J Am Coll Cardiol. 2017 Aug 1;70(5):527-538. doi: 10.1016/j.jacc.2017.05.063.

  • Thomas MR, Angiolillo DJ, Bonaca MP, Ajjan RA, Judge HM, Rollini F, Franchi F, Ahsan AJ, Bhatt DL, Kuder JF, Steg PG, Cohen M, Muthusamy R, Sabatine MS, Storey RF. Consistent platelet inhibition with ticagrelor 60 mg twice-daily following myocardial infarction regardless of diabetes status. Thromb Haemost. 2017 May 3;117(5):940-947. doi: 10.1160/TH16-09-0703. Epub 2017 Mar 16.

  • Bonaca MP, Goto S, Bhatt DL, Steg PG, Storey RF, Cohen M, Goodrich E, Mauri L, Ophuis TO, Ruda M, Spinar J, Seung KB, Hu D, Dalby AJ, Jensen E, Held P, Morrow DA, Braunwald E, Sabatine MS. Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54). Circulation. 2016 Sep 20;134(12):861-71. doi: 10.1161/CIRCULATIONAHA.116.024637. Epub 2016 Aug 30.

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  • Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.

  • Bonaca MP, Bhatt DL, Storey RF, Steg PG, Cohen M, Kuder J, Goodrich E, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Dalby A, Spinar J, Aylward P, Corbalan R, Abola MTB, Jensen EC, Held P, Braunwald E, Sabatine MS. Ticagrelor for Prevention of Ischemic Events After Myocardial Infarction in Patients With Peripheral Artery Disease. J Am Coll Cardiol. 2016 Jun 14;67(23):2719-2728. doi: 10.1016/j.jacc.2016.03.524. Epub 2016 Apr 1.

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Related Links

MeSH Terms

Conditions

Myocardial InfarctionThrombosisStrokeHeart DiseasesAcute Coronary SyndromeCardiovascular Diseases

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisEmbolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
Anders Himmelmann, MD PhD
Organization
AstraZeneca AB

Study Officials

  • Eugene Braunwald, MD

    The TIMI Study Group

    STUDY CHAIR
  • Marc Sabatine, MD, MPh

    The TIMI Study Group

    PRINCIPAL INVESTIGATOR

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

July 9, 2010

First Posted

October 21, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 25, 2016

Results First Posted

December 9, 2015

Record last verified: 2015-12

Locations