Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

NCT ID: NCT00968708

Last Updated: 2014-05-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

Detailed Description

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Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by Takeda for use in patients with type 2 diabetes mellitus.

Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus patients who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome.

This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in adults with type 2 diabetes mellitus and acute coronary syndrome.

Conditions

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Diabetes Mellitus, Type 2 Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Alogliptin placebo matching tablets

Alogliptin

Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and \<60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR \<30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.

Group Type EXPERIMENTAL

Alogliptin

Intervention Type DRUG

Alogliptin tablets

Interventions

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Alogliptin

Alogliptin tablets

Intervention Type DRUG

Placebo

Alogliptin placebo matching tablets

Intervention Type DRUG

Other Intervention Names

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Nesina® SYR-322 SYR110322

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of type 2 diabetes mellitus
* Is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)
* Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.

Exclusion Criteria

* Signs of type 1 diabetes mellitus
* Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
* Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

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Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Mobile, Alabama, United States

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Muscle Shoals, Alabama, United States

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Cottonwood, Arizona, United States

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Goodyear, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Malvern, Arkansas, United States

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Searcy, Arkansas, United States

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White Hall, Arkansas, United States

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Alameda, California, United States

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Aliso Viejo, California, United States

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Anaheim, California, United States

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Bell Gardens, California, United States

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Beverly Hills, California, United States

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Chula Vista, California, United States

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Corona, California, United States

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Downey, California, United States

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Escondido, California, United States

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Fullerton, California, United States

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Huntington Beach, California, United States

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Huntington Park, California, United States

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Inglewood, California, United States

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La Mirada, California, United States

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Lakewood, California, United States

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Lancaster, California, United States

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Lomita, 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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Merced, California, United States

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Newport Beach, California, United States

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Northridge, California, United States

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Oakland, California, United States

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Palm Springs, California, United States

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Pomona, California, United States

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San Diego, California, United States

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San Dimas, California, United States

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Santa Ana, California, United States

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Santa Clarita, California, United States

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Stockton, California, United States

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Tarzana, California, United States

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Torrence, California, United States

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Van Nuys, California, United States

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Ventura, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Bridgeport, Connecticut, 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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Brandon, Florida, United States

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Davie, Florida, United States

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Daytona Beach, Florida, United States

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Delray Beach, Florida, United States

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Doral, Florida, United States

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Fleming Island, Florida, United States

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Fort Lauderdale, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Lake Mary, Florida, United States

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Largo, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Naples, Florida, United States

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New Smyrna Beach, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Palm Harbor, Florida, United States

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Panama City, Florida, United States

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Pembroke Pines, Florida, United States

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Pensacola, Florida, United States

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Saint Cloud, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Stuart, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Atlanta, Georgia, United States

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Cartersville, Georgia, United States

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Conyers, Georgia, United States

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Dunwoody, Georgia, United States

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Marietta, Georgia, United States

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Savannah, Georgia, United States

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Tucker, Georgia, United States

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Waycross, Georgia, United States

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Nampa, Idaho, United States

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Aurora, Illinois, United States

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Boilingbrook, Illinois, United States

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Bolingbrook, Illinois, United States

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Burr Ridge, Illinois, United States

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Chicago, Illinois, United States

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Jerseyville, Illinois, United States

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Melrose Park, Illinois, United States

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Moline, Illinois, United States

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Peoria, Illinois, United States

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Quincy, Illinois, United States

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Springfield, Illinois, United States

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Elkhart, Indiana, United States

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Evansville, 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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New Albany, Indiana, United States

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Valparaiso, Indiana, United States

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Council Bluffs, Iowa, United States

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Shawnee Mission, Kansas, United States

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Elizabethtown, Kentucky, United States

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Lexington, Kentucky, United States

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Madisonville, Kentucky, United States

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Owensboro, Kentucky, United States

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Alexandria, Louisiana, United States

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Houma, Louisiana, United States

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Lafayette, Louisiana, United States

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Natchitoches, Louisiana, United States

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New Orleans, Louisiana, United States

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Slidell, Louisiana, United States

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Biddeford, Maine, United States

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Rockport, Maine, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Oxon Hill, Maryland, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Brockton, Massachusetts, United States

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Fall River, Massachusetts, United States

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Alpena, Michigan, United States

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Bridgman, Michigan, United States

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Dearborn, Michigan, United States

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Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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Lapeer, Michigan, United States

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Livonia, Michigan, United States

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Midland, Michigan, United States

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Muskegon, Michigan, United States

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Saginaw, Michigan, United States

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Troy, Michigan, United States

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Warren, Michigan, United States

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Waterford, Michigan, United States

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Ypsilanti, Michigan, 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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Chesterfield, 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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Saint Joseph, Missouri, United States

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St Louis, Missouri, United States

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Great Falls, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Pahrump, Nevada, United States

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Brick, New Jersey, United States

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Bridgewater, New Jersey, United States

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Camden, New Jersey, United States

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Fort Lee, 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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New Brunswick, 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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Sewell, New Jersey, United States

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Sicklerville, New Jersey, United States

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South Plainfield, New Jersey, United States

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Albuquerque, New Mexico, United States

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Cortlandt Manor, New York, United States

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Freeport, New York, United States

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Huntington, New York, United States

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Johnson City, New York, United States

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Kingston, New York, United States

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New Hartford, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Saratoga Springs, New York, United States

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Springfield Gardens, New York, United States

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The Bronx, New York, United States

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Valhalla, 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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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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Forsyth, 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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Lenoir, North Carolina, United States

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Smithfield, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Minot, North Dakota, United States

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Akron, Ohio, United States

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Athens, Ohio, United States

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Berea, Ohio, United States

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Boardman, Ohio, United States

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Carlisle, Ohio, United States

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Centerville, 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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Franklin, Ohio, United States

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Lorain, Ohio, United States

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Marion, Ohio, United States

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Maumee, Ohio, United States

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Middleburg Heights, Ohio, United States

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Springfield, Ohio, United States

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Toledo, Ohio, United States

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Westlake, Ohio, United States

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Zanesville, Ohio, United States

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Bartlesville, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Yukon, Oklahoma, United States

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Bend, Oregon, United States

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Corvallis, Oregon, United States

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Hillsboro, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Clymer, Pennsylvania, United States

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Fleetwood, 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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Schwenksville, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Beaufort, South Carolina, United States

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Easley, South Carolina, United States

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Florence, South Carolina, United States

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Spartanburg, South Carolina, United States

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Taylors, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Bartlett, Tennessee, United States

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Bristol, Tennessee, United States

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Cleveland, Tennessee, United States

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Franklin, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Murfreesboro, Tennessee, United States

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Nashville, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Denton, Texas, United States

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Edinburg, Texas, United States

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Fort Worth, Texas, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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North Richland Hills, Texas, United States

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Plano, Texas, United States

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Saginaw, Texas, United States

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San Antonio, Texas, United States

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Southlake, Texas, United States

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Temple, Texas, United States

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Tomball, Texas, United States

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Bountiful, Utah, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Bennington, Vermont, United States

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South Burlington, Vermont, United States

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Burke, Virginia, United States

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Charlottesville, Virginia, United States

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Galax, Virginia, United States

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Lakeridge, 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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Roanoke, Virginia, United States

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Suffolk, Virginia, United States

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Virginia Beach, Virginia, United States

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Everett, Washington, United States

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Tacoma, Washington, 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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Manitowoc, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Waukesha, Wisconsin, United States

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Bahía Blanca, , Argentina

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Buenos Aires, , Argentina

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C0rdoba, , Argentina

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Capital Federal, Buenos Aires, , Argentina

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Capital Federal, , Argentina

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Carlos Paz, C0rdoba, , Argentina

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Ciudad Aut0noma de Buenos Aires, , Argentina

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Ciudad de C0rdoba, , Argentina

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Cordoba - Cordoba, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Derqui Pilar, Buenos Aires, , Argentina

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Formosa, , Argentina

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Haedo, Buenos Aires, , Argentina

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La Plata, , Argentina

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La Plata, Buenos Aires, , Argentina

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Mar del Plata, , Argentina

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Mar Del Plata, Provincia de Buenos Aires, , Argentina

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Mendoza, , Argentina

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Moron, Buenos Aires, , Argentina

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Olivos, , Argentina

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Quilmes, , Argentina

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Ramos Mejia, Buenos Aries, , 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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Rosario, Provincia de Santa Fe, , Argentina

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Salta, , Argentina

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San Isidro, , Argentina

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San Juan, San Juan, , Argentina

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San Justo, , Argentina

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San Luis, , Argentina

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San Miguel de Tucumán, , Argentina

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San Salvador de Jujuy, , Argentina

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Santa Fe, , Argentina

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Trelew, Chubut, , Argentina

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Villa María, , Argentina

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Broken Hill, New South Wales, Australia

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Kogarah, New South Wales, Australia

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Milton, Queensland, Australia

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Nambour, Queensland, Australia

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Hobart, Tasmania, Australia

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Fitzroy, Victoria, Australia

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Frankston, Victoria, Australia

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Heidelberg, Victoria, Australia

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Prahran, Victoria, Australia

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Adelaide, SA, , Australia

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Bruce, , Australia

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Feldkirch, , Austria

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Graz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Antwerp, , Belgium

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Bonheiden, , Belgium

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Brasschaat, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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La Louvière, , Belgium

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Curitiba, Paraná, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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São Paulo, São Paulo, Brazil

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Tatuí, São Paulo, Brazil

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Aracaju, Sergipe, , Brazil

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Belem - PA, , Brazil

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Belo Horizonte - MG, , Brazil

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Belo Horizonte, Minas Gerais, , Brazil

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Blumenau, , Brazil

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Brasilia - DF, , Brazil

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Brasilia, Distrito Federal, , Brazil

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Campina Grande do Sul, , Brazil

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Campinas, Sao Paulo, , Brazil

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Campo Grande, Mato Grosso Do Sul, , Brazil

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Curitiba, Parana, , Brazil

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Fortaleza - CE, , Brazil

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Fortaleza, Ceara, , Brazil

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Goiania, Goias, , Brazil

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Goiânia, , Brazil

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Joinville, , Brazil

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Londrina/PR, , Brazil

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Macei0, , Brazil

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Marilia, Sao Paulo, , Brazil

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Marília, , Brazil

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Mogi das Cruzes, , Brazil

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Natal, , Brazil

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Natal, RN, , Brazil

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Passo Fundo, Rio Grande Do Sul, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre - RS, , Brazil

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Porto Alegre, Rio Grande Do Sul, , Brazil

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Recife, , Brazil

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Recife, PE, , Brazil

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Recife, Pernambuco, , Brazil

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Rio de Janeiro, , Brazil

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Rio de Janeiro - RJ, , Brazil

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Salvador - BA, , Brazil

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Salvador, Bahia, , Brazil

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Santo André, , Brazil

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Sao Jose Do Rio Preto, Sao Paulo, , Brazil

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Sao Jose Do Rio Preto- SP, , Brazil

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Sao Jose, Santa Catarina, , Brazil

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Sao Paulo, Sao Paulo, , Brazil

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Sao Paulo, SP, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

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Sobral, CE, , Brazil

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Taguatinga, , Brazil

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Uberlandia, Minas Gerais, , Brazil

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Votuporanga, , Brazil

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Blagoevgrad, , Bulgaria

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Dimitrovgrad, , Bulgaria

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Kazanlak, , Bulgaria

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Lovech, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sevlievo, , Bulgaria

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Smolyan, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Abbotsford, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Grand Falls-Windsor, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Ajax, Ontario, Canada

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Cambridge, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Newmarket, Ontario, Canada

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Niagara Falls, Ontario, Canada

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Ontario, Ontario, Canada

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Oshawa, Ontario, Canada

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Pickering, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Greenfield, Quebec, Canada

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Lachine, Quebec, Canada

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Mount Royal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Terrebonne, Quebec, Canada

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Antofagasta, , Chile

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Antofagasta, Region II, , Chile

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Iquique, Region I, , Chile

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Osorno, , Chile

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Rancagua, , Chile

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Santiago, , Chile

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Talcahuano, , Chile

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Temuco, , Chile

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Temuco, Region de La Araucania, , Chile

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Viña del Mar, , Chile

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Medellín, , Colombia

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Čakovec, , Croatia

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Krapinske Toplice, , Croatia

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Osijek, , Croatia

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Rijeka, , Croatia

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Sisak, , Croatia

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Split, , Croatia

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Virovitica, , Croatia

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Zadar, , Croatia

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Zagreb, , Croatia

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Čáslav, , Czechia

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Ostrava - Vitkovice, , Czechia

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Zlín, , Czechia

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Znojmo, , Czechia

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Herlev, , Denmark

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Herning, , Denmark

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København NV, , Denmark

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Alexandria, , Egypt

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Giza, , Egypt

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Monofia, , Egypt

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Helsinki, , Finland

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Jyväskylä, , Finland

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Kokkola, , Finland

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Kuopio, , Finland

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Tampere, , Finland

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Turku, , Finland

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Bordeaux, , France

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Corbeil-Essonnes, , France

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Créteil, , France

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Dijon, , France

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La Rochelle, , France

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Lille, , France

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Montpellier, , France

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Narbonne, , France

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Paris, , France

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Pau, , France

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Pessac, , France

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Rennes, , France

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Toulouse, , France

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Bad Nauheim, , Germany

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Bensheim, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Essen, , Germany

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Halle, , Germany

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Jena, , Germany

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Kassel, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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München, , Germany

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Münster, , Germany

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Neumünster, , Germany

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Neuwied, , Germany

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Sankt Ingbert, , Germany

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Siegen, , Germany

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Wangen, , Germany

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Marousi, , Greece

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Guatemala City, , Guatemala

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Quetzaltenango, , Guatemala

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Hong Kong, , Hong Kong

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Kowloon, , Hong Kong

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Shatin, , Hong Kong

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Tsuen Wan, , Hong Kong

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Budaörs, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Dunaújváros, , Hungary

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Gyula, , Hungary

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H0dmezovasarhely, , Hungary

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Kaposvár, , Hungary

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Kecskemét, , Hungary

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Nagykanizsa, , Hungary

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Pécs, , Hungary

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Sopron, , Hungary

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Szentes, , Hungary

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Székesfehérvár, , Hungary

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Szombathely, , Hungary

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Zalaegerszeg, , Hungary

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Hyderabad, Andhra Pradesh, India

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Nellore, Andhra Pradesh, India

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Vijayawada, Andhra Pradesh, India

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Visakhapatnam, Andhra Pradesh, India

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Perumbākkam, Chennai, India

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Ahmedabad, Gujarat, India

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Anand, Gujarat, India

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Surat, Gujarat, India

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Vadodara, Gujarat, India

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Bangalore, Karnataka, India

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Belagavi, Karnataka, India

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Mangalore, Karnataka, India

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Manipal, Karnataka, India

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Mysore, Karnataka, India

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Kochi, Kerala, India

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Thiruvananthapuram, Kerala, India

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Thrissur, Kerala, India

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Trivandrum, Kerala, India

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Aurangabad, Maharashtra, India

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Mumbai, Maharashtra, India

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Nagpur, Maharashtra, India

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Nashik, Maharashtra, India

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Pune, Maharashtra, India

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Delhi, National Capital Territory of Delhi, India

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New Delhi, National Capital Territory of Delhi, India

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Jalandhar, Punjab, India

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Ludhiana, Punjab, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Coimbatore, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Kolkata, West Bengal, India

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Ashkelon, , Israel

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Beersheba, , 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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Nahariya, , Israel

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Nazareth, , Israel

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Petah Tikva, , Israel

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Rehovot, , Israel

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Rishon LeZiyyon, , Israel

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Safed, , Israel

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Tel Aviv, , Israel

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Tiberias, , Israel

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Cosenza, , Italy

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Isernia, , Italy

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Milan, , Italy

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Napoli, , Italy

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Palermo, , Italy

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Pavia, , Italy

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Ravenna, , Italy

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Roma, , Italy

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Sesto San Giovanni, , Italy

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Aichi-gun, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Seto, Aichi-ken, Japan

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Funabashi, Chiba, Japan

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Kashiwa, Chiba, Japan

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Imabari, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kasuga, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Ohkawa-city, Fukuoka, Japan

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Fukushima, Fukushima, Japan

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Gifu, Gifu, Japan

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Shibukawa, Gunma, Japan

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Takasaki, Gunma, Japan

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Higashihiroshima, Hiroshima, Japan

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Tomakomai, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Sakaidechō, Kagawa-ken, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara-shi, Kanagawa, Japan

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Nankoku, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Uji-shi, Kyoto, Japan

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Matsusaka, Mie-ken, Japan

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Nagasaki, Nagasaki, Japan

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Niigata, Niigata, Japan

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Ōita, Oita Prefecture, Japan

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Okayama, Okayama-ken, Japan

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Shimajiri-gun, Okinawa, Japan

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Tomigusuku, Okinawa, Japan

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Kishiwada, Osaka, Japan

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Matsubara, Osaka, Japan

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Yao-shi, Osaka, Japan

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Saga, Saga-ken, Japan

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Ageo, Saitama, Japan

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Wako, Saitama, Japan

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Hamada, Shimane, Japan

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Suntou-gun, Shizuoka, Japan

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Komatsushimachō, Tokushima, Japan

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Tokushima, Tokushima, Japan

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Hino, Tokyo, Japan

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Tachikawa, Tokyo, Japan

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Tokyo, Tokyo, Japan

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Iwakuni-shi, Yamaguchi, Japan

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Dasman, , Kuwait

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Daugavpils, , Latvia

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Ogre, , Latvia

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Riga, , Latvia

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Tukums, , Latvia

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Valmiera, , Latvia

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Kaunas, , Lithuania

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Kėdainiai, , Lithuania

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Klaipėda, , Lithuania

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Palanga, , Lithuania

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Panevezys, , Lithuania

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Vilnius, , Lithuania

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Alor Star, , Malaysia

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Batu Caves, , Malaysia

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George Town, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuala Selangor, , Malaysia

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Kuantan, , Malaysia

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Kubang Kerian, , Malaysia

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Pulau Pinang, , Malaysia

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Acapulco, Guerrero, , Mexico

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Aguascalientes, , Mexico

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Chihuahua City, , Mexico

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Chihuhua, Chihuhua, , Mexico

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Ciudad Obregon, Sonora, , Mexico

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Cuernavaca, , Mexico

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Cuernavaca, Morelos, , Mexico

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Culiacán, , Mexico

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Durango, , Mexico

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Guadalajara, , Mexico

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Guadalajara, Jalisco, , Mexico

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Merida, Yucatan, , Mexico

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Metepec, , Mexico

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Mexicali, Baja California, , Mexico

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Mexico City, , Mexico

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Mexico City, Mexico, , Mexico

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México, , Mexico

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Monclova, Coahuila, , Mexico

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Monterrey, , Mexico

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Monterrey, NL, , Mexico

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Monterrey, Nuevo Le0n, , Mexico

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Monterrey, Nuevo Leon, , Mexico

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Morelia, Michoacan, , Mexico

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Pachuca, , Mexico

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Saltillo, , Mexico

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Saltillo, Coahuila, , Mexico

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San Luis Potosi.SLP, , Mexico

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San Luis Potosí City, , Mexico

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Tijuana, Baja California Norte, , Mexico

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Tlalnepantla, , Mexico

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Tlalnepantla, Edo de Mexico, , Mexico

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Xalapa, Veracruz, , Mexico

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Zapopan, , Mexico

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Otahuhu, , New Zealand

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Palmerston North, , New Zealand

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Takapuna, , New Zealand

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Tauranga, , New Zealand

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Arequipa, , Peru

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Bellavista, , Peru

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Callao, , Peru

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Cusco, , Peru

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Huacho, , Peru

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Ica, , Peru

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La Victoria, Lima, , Peru

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Lima, , Peru

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Lima San Isidro, , Peru

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Los Olivos, , Peru

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Miraflores, Lima, , Peru

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Piura, , Peru

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San Isidro, Lima, , Peru

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San Miguel, Lima, , Peru

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Trujillo, , Peru

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Trujillo, La Libertad, , Peru

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Baguio City, , Philippines

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Dasmariñas, , Philippines

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Davao City, , Philippines

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Iloilo City, , Philippines

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Laoag, , Philippines

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Makati City, , Philippines

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Manila, , Philippines

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Marikina City, , Philippines

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Pasig, , Philippines

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Quezon City, , Philippines

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Częstochowa, , Poland

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Dąbrowa Górnicza, , Poland

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Elblag, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

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Grodzisk Mazowiecki, , Poland

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Inowrocław, , Poland

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Katowice, , Poland

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Kielce, , Poland

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Krakow, , Poland

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Legnica, , Poland

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Lodz, , Poland

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Lubartów, , Poland

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Lublin, , Poland

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Puławy, , Poland

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Płock, , Poland

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Radom, , Poland

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Ruda Śląska, , Poland

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Skierniewice, , Poland

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Szczecin, , Poland

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Słupsk, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Zgierz, , Poland

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Coimbra, , Portugal

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Faro, , Portugal

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Lisbon, , Portugal

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Vila Real, , Portugal

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Aibonito, PR, Puerto Rico

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Halo Rey, PR, Puerto Rico

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Ponce, PR, Puerto Rico

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Salinas, PR, Puerto Rico

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Santurce, PR, Puerto Rico

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Carolina, , Puerto Rico

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Cidra, , Puerto Rico

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Levittown, , Puerto Rico

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Manatí, , Puerto Rico

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Mayagüez, , Puerto Rico

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San Juan, , Puerto Rico

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Bacau, , Romania

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Baia Mare, , 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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Galati, , Romania

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Iași, , Romania

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Oradea, , Romania

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Ploieşti, , Romania

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Satu Mare, , Romania

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Târgu Mureş, , Romania

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Timișoara, , Romania

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Arkhangelsk, , Russia

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Barnaul, , Russia

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Ivanovo, , Russia

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Kazan', , Russia

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Kemerovo, , Russia

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Krasnodar, , Russia

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Krasnoyarsk, , Russia

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Kursk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Ufa, , Russia

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Volgograd, , Russia

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Vsevolozhsk, , Russia

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Belgrade, , Serbia

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Niš, , Serbia

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Bardejov, , Slovakia

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Bratislava, , Slovakia

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Dolný Kubín, , Slovakia

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Komárno, , Slovakia

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Kosice - Saca, , Slovakia

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Košice, , Slovakia

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Levice, , Slovakia

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Liptovský Hrádok, , Slovakia

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Nové Mesto nad Váhom, , Slovakia

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Nové Zámky, , Slovakia

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Považská Bystrica, , Slovakia

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Rimavská Sobota, , Slovakia

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Ružomberok, , Slovakia

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Svidník, , Slovakia

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Žilina, , Slovakia

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Port Elizabeth, Eastern Cape, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Paarl, Western Cape, South Africa

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Somerset West, Western Cape, South Africa

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Tygerberg, Western Cape, South Africa

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Worcester, Western Cape, South Africa

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Durban, , South Africa

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Pretoria, , South Africa

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Anyang, , South Korea

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Busan, , South Korea

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Daegu, , South Korea

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Goyang-si, , South Korea

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Guri-si, , South Korea

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Gyeonggi-do, , South Korea

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Jeonju, , South Korea

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Kangwon-do, , South Korea

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Pusan, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Yangsan, , South Korea

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Zaragoza, Arag0n, Spain

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Cuenca, Castille-La Mancha, Spain

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Barcelona, Catalonia, Spain

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Figueres, Catalonia, Spain

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A Coruña, Galicia, Spain

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Santiago de Compostela, Galicia, Spain

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Oviedo, Principality of Asturias, Spain

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Torrevieja, Valencia, Spain

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Bacarot, , Spain

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Mérida, , Spain

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Palma de Mallorca, , Spain

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Dalby, , Sweden

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Falköping, , Sweden

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Gothenburg, , Sweden

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Härnösand, , Sweden

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Kristianstad, , Sweden

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Malmo, , Sweden

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Motala, , Sweden

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Stockholm, , Sweden

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Kaohsiung City, , Taiwan

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Taipei County, , Taiwan

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Taoyuan District, , Taiwan

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Amphure Muang, , Thailand

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Bangkojk, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Chiang Rai, , Thailand

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Muang, , Thailand

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Nakhon Ratchasima, , Thailand

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Pathumwan, , Thailand

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Patumthani, , Thailand

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Phitsanulok, , Thailand

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Phrae, , Thailand

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Ankara, Balgat, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Kayseri, , Turkey (Türkiye)

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Konya, , Turkey (Türkiye)

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Donetsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Poltava, , Ukraine

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Simferopol, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhya, , Ukraine

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Abu Dhabi, , United Arab Emirates

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Barnsley, , United Kingdom

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Bath, , United Kingdom

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Birmingham, , United Kingdom

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Bournemouth, , United Kingdom

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Carshalton, , United Kingdom

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Chertsey, , United Kingdom

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Chichester, , United Kingdom

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Colchester, , United Kingdom

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Coventry, , United Kingdom

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Croydon, , United Kingdom

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Doncaster, , United Kingdom

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Glasgow, , United Kingdom

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Hull, , United Kingdom

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Inverness, , United Kingdom

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Kirkcaldy, , United Kingdom

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Liverpool, , United Kingdom

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Livingston, , United Kingdom

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London, , United Kingdom

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Nuneaton, , United Kingdom

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Stevenage, , United Kingdom

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Sunderland, , United Kingdom

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Torquay, , United Kingdom

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Wakefield, , United Kingdom

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West Midlands, , United Kingdom

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Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile Colombia Croatia Czechia Denmark Egypt Finland France Germany Greece Guatemala Hong Kong Hungary India Israel Italy Japan Kuwait Latvia Lithuania Malaysia Mexico New Zealand Peru Philippines Poland Portugal Puerto Rico Romania Russia Serbia Slovakia South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) Ukraine United Arab Emirates United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Ferreira JP, Rossignol P, Bakris G, Mehta C, White WB, Zannad F. Blood and Urine Biomarkers Predicting Worsening Kidney Function in Patients with Type 2 Diabetes Post-Acute Coronary Syndrome: An Analysis from the EXAMINE Trial. Am J Nephrol. 2021;52(12):969-976. doi: 10.1159/000519436. Epub 2021 Dec 6.

Reference Type DERIVED
PMID: 34872085 (View on PubMed)

Ferreira JP, Mehta C, Sharma A, Nissen SE, Rossignol P, Zannad F. Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial. BMC Med. 2020 Jun 4;18(1):165. doi: 10.1186/s12916-020-01616-8.

Reference Type DERIVED
PMID: 32493335 (View on PubMed)

Sharma A, Vaduganathan M, Ferreira JP, Liu Y, Bakris GL, Cannon CP, White WB, Zannad F. Clinical and Biomarker Predictors of Expanded Heart Failure Outcomes in Patients With Type 2 Diabetes Mellitus After a Recent Acute Coronary Syndrome: Insights From the EXAMINE Trial. J Am Heart Assoc. 2020 Jan 7;9(1):e012797. doi: 10.1161/JAHA.119.012797. Epub 2020 Jan 4.

Reference Type DERIVED
PMID: 31902327 (View on PubMed)

White WB, Jalil F, Cushman WC, Bakris GL, Bergenstal R, Heller SR, Liu Y, Mehta C, Zannad F, Cannon CP. Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Ischemic Heart Disease in the EXAMINE Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009114. doi: 10.1161/JAHA.118.009114.

Reference Type DERIVED
PMID: 30371278 (View on PubMed)

Jarolim P, White WB, Cannon CP, Gao Q, Morrow DA. Serial Measurement of Natriuretic Peptides and Cardiovascular Outcomes in Patients With Type 2 Diabetes in the EXAMINE Trial. Diabetes Care. 2018 Jul;41(7):1510-1515. doi: 10.2337/dc18-0109. Epub 2018 May 30.

Reference Type DERIVED
PMID: 29848776 (View on PubMed)

Sharma A, Cannon CP, White WB, Liu Y, Bakris GL, Cushman WC, Zannad F. Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial. J Am Heart Assoc. 2018 May 16;7(11):e007649. doi: 10.1161/JAHA.117.007649.

Reference Type DERIVED
PMID: 29769203 (View on PubMed)

White WB, Heller SR, Cannon CP, Howitt H, Khunti K, Bergenstal RM; EXAMINE Investigators. Alogliptin in Patients with Type 2 Diabetes Receiving Metformin and Sulfonylurea Therapies in the EXAMINE Trial. Am J Med. 2018 Jul;131(7):813-819.e5. doi: 10.1016/j.amjmed.2018.02.023. Epub 2018 Mar 23.

Reference Type DERIVED
PMID: 29581078 (View on PubMed)

Hwang YC, Morrow DA, Cannon CP, Liu Y, Bergenstal R, Heller S, Mehta C, Cushman W, Bakris GL, Zannad F, White WB. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial. Diabetes Obes Metab. 2018 Mar;20(3):654-659. doi: 10.1111/dom.13136. Epub 2017 Nov 21.

Reference Type DERIVED
PMID: 29064626 (View on PubMed)

Kay S, Strickson A, Puelles J, Selby R, Benson E, Tolley K. Comparative Effectiveness of Adding Alogliptin to Metformin Plus Sulfonylurea with Other DPP-4 Inhibitors in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis. Diabetes Ther. 2017 Apr;8(2):251-273. doi: 10.1007/s13300-017-0245-8. Epub 2017 Mar 8.

Reference Type DERIVED
PMID: 28275958 (View on PubMed)

Cavender MA, White WB, Jarolim P, Bakris GL, Cushman WC, Kupfer S, Gao Q, Mehta CR, Zannad F, Cannon CP, Morrow DA. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care). Circulation. 2017 May 16;135(20):1911-1921. doi: 10.1161/CIRCULATIONAHA.116.024632. Epub 2017 Feb 28.

Reference Type DERIVED
PMID: 28246236 (View on PubMed)

White WB, Kupfer S, Zannad F, Mehta CR, Wilson CA, Lei L, Bakris GL, Nissen SE, Cushman WC, Heller SR, Bergenstal RM, Fleck PR, Cannon CP; EXAMINE Investigators. Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndromes From the EXAMINE Trial. Diabetes Care. 2016 Jul;39(7):1267-73. doi: 10.2337/dc16-0303. Epub 2016 Jun 11.

Reference Type DERIVED
PMID: 27289121 (View on PubMed)

Zannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Lam H, White WB; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015 May 23;385(9982):2067-76. doi: 10.1016/S0140-6736(14)62225-X. Epub 2015 Mar 10.

Reference Type DERIVED
PMID: 25765696 (View on PubMed)

White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-35. doi: 10.1056/NEJMoa1305889. Epub 2013 Sep 2.

Reference Type DERIVED
PMID: 23992602 (View on PubMed)

White WB, Bakris GL, Bergenstal RM, Cannon CP, Cushman WC, Fleck P, Heller S, Mehta C, Nissen SE, Perez A, Wilson C, Zannad F. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J. 2011 Oct;162(4):620-626.e1. doi: 10.1016/j.ahj.2011.08.004. Epub 2011 Sep 14.

Reference Type DERIVED
PMID: 21982652 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1111-6825

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-011222-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-101246

Identifier Type: REGISTRY

Identifier Source: secondary_id

DOH-27-0310-3047

Identifier Type: REGISTRY

Identifier Source: secondary_id

09/H0709/63

Identifier Type: REGISTRY

Identifier Source: secondary_id

CTRI/2010/091/000046

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-011222-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-011222-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

NMRR-09-872-4471

Identifier Type: REGISTRY

Identifier Source: secondary_id

SYR-322_402

Identifier Type: -

Identifier Source: org_study_id

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