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Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

NCT ID: NCT01730534

Last Updated: 2019-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-25

Study Completion Date

2018-09-11

Brief Summary

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This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

Detailed Description

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Conditions

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Diabetes Mellitus, Non-Insulin-Dependent High Risk for Cardiovascular Event

Keywords

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Phase IIIb T2DM cardiovascular events

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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Dapagliflozin

Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Group Type EXPERIMENTAL

Dapagliflozin 10 mg

Intervention Type DRUG

Oral dose (od)

Placebo

Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

Oral dose (od)

Interventions

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Dapagliflozin 10 mg

Oral dose (od)

Intervention Type DRUG

Placebo tablet

Oral dose (od)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Female or male aged ≥40 years
* Diagnosed with Type 2 Diabetes
* High Risk for Cardiovascular events

Exclusion Criteria

* Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
* Chronic cystitis and/or recurrent urinary tract infections
* Pregnant or breast-feeding patients
Minimum Eligible Age

40 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

The TIMI Study Group

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Maria Langkilde, MD

Role: STUDY_DIRECTOR

AstraZeneca Sweden

Marc S Sabatine, MD, MPH

Role: STUDY_CHAIR

TIMI Study Group, Boston, MA, USA

Itamar Raz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Stephen D Wiviott, MD

Role: PRINCIPAL_INVESTIGATOR

TIMI Study Group, MA, USA

Locations

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Warsaw, , Poland

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Warsaw, , Poland

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Węgrów, , Poland

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Wierzchosławice, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Włocławek, , Poland

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Zabrze, , Poland

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Łęczna, , Poland

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Bacau, , Romania

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Bacau, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Cluj-Napoca, , Romania

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Constanța, , Romania

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Galati, , Romania

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Iași, , Romania

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Iași, , Romania

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Iași, , Romania

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Iași, , Romania

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Ploieşti, , Romania

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Sibiu, , Romania

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Târgu Mures, , Romania

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Târgu Mureş, , Romania

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Timișoara, , Romania

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Zalău, , Romania

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Arkhangelsk, , Russia

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Chelyabinsk, , Russia

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Chelyabinsk, , Russia

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Ivanovo, , Russia

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Izhevsk, , Russia

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Kazan', , Russia

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Kazan', , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , 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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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Tver', , Russia

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Ufa, , 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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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Dolný Kubín, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Levice, , Slovakia

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Lučenec, , Slovakia

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Námestovo, , Slovakia

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Nové Zámky, , Slovakia

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Piešťany, , Slovakia

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Poprad, , Slovakia

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Považská Bystrica, , Slovakia

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Prievidza, , Slovakia

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Rimavská Sobota, , Slovakia

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Sabinov, , Slovakia

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Šaľa, , Slovakia

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Trebišov, , Slovakia

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Trenčín, , Slovakia

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Vrútky, , Slovakia

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Žilina, , Slovakia

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Alberton, , South Africa

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Benoni, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Diepkloof, Soweto, , South Africa

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Krakow, , Poland

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Krakow, , Poland

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Legnica, , Poland

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Lublin, , Poland

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Mrągowo, , Poland

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Nakło nad Notecią, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Płock, , Poland

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Ruda Śląska, , Poland

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Skierniewice, , Poland

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Sobótka, , Poland

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Sokółka, , Poland

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Torun, , Poland

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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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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Mesa, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Alhambra, California, United States

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Bakersfield, California, United States

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Greenbrae, California, United States

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Huntington Park, California, United States

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La Mesa, California, United States

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Lomita, California, United States

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Los Alamitos, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, 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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San Ramon, California, United States

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Torrance, California, United States

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Ventura, California, United States

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Vista, California, United States

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Fort Collins, Colorado, United States

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Golden, Colorado, United States

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Bridgeport, Connecticut, United States

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Bristol, Connecticut, United States

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Norwalk, Connecticut, United States

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Stamford, Connecticut, United States

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Trumbull, Connecticut, United States

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Waterbury, Connecticut, United States

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Newark, Delaware, United States

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Seaford, Delaware, United States

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Wilmington, Delaware, United States

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

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Bradenton, Florida, United States

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Chiefland, Florida, United States

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Clearwater, Florida, United States

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Coral Springs, 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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Fort Lauderdale, Florida, United States

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Green Cove Springs, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville Beach, Florida, United States

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Lake Worth, Florida, United States

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Lakeland, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, 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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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Palm Beach Gardens, Florida, United States

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Pembroke Pines, Florida, United States

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Pembroke Pines, Florida, United States

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Pensacola, Florida, United States

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Spring Hill, Florida, United States

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St. Petersburg, 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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Trinity, Florida, United States

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Vero Beach, Florida, United States

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Wellington, Florida, United States

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Atlanta, Georgia, United States

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Calhoun, Georgia, United States

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Cumming, Georgia, United States

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Savannah, Georgia, United States

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Honolulu, Hawaii, United States

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Coeur d'Alene, Idaho, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Rock Island, Illinois, United States

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Anderson, Indiana, United States

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Avon, Indiana, United States

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Bloomington, Indiana, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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Greenfield, Indiana, United States

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Muncie, Indiana, United States

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Newburgh, Indiana, United States

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Iowa City, Iowa, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Alexandria, Louisiana, United States

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Hammond, 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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Portland, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Beltsville, Maryland, United States

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Columbia, Maryland, United States

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Boston, Massachusetts, United States

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Fall River, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Methuen, Massachusetts, United States

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Natick, Massachusetts, United States

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Alpena, Michigan, United States

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Flint, Michigan, United States

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Flint, Michigan, United States

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Grand Blanc, Michigan, United States

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Jackson, Michigan, United States

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Kalamazoo, Michigan, United States

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Petoskey, Michigan, United States

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Troy, Michigan, United States

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Duluth, Minnesota, United States

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Eagan, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Kansas City, Missouri, United States

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Lee's Summit, 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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Grand Island, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Edison, New Jersey, United States

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Newark, New Jersey, United States

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Somerset, New Jersey, United States

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Voorhees Township, 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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New Hyde Park, New York, United States

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New York, New York, United States

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Northport, New York, United States

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Poughkeepsie, 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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Westfield, 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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Hickory, North Carolina, United States

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Lenoir, North Carolina, United States

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Monroe, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Salisbury, 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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Canal Fulton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Delaware, Ohio, United States

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Elyria, Ohio, United States

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Parma Hts., 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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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Indiana, Pennsylvania, United States

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Johnstown, Pennsylvania, United States

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Kittanning, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Tyrone, Pennsylvania, United States

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York, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Arlington, Texas, United States

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Carrollton, Texas, United States

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Dallas, 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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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Irving, 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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Midland, Texas, United States

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Odessa, Texas, United States

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Plano, 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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Ogden, Utah, United States

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Salt Lake City, 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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Burke, Virginia, United States

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Danville, Virginia, United States

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Manassas, 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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Richmond, Virginia, United States

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Burien, Washington, United States

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Puyallup, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Wausau, Wisconsin, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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CABA, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Ciudad Autonoma de Buenos Aire, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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La Plata, , Argentina

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La Plata, , Argentina

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Lanús, , Argentina

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Mar del 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, , Argentina

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San Nicolás, , Argentina

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Santa Fe, , Argentina

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Adelaide - Oaklands Park, , Australia

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Ashford, , Australia

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Box Hill, , Australia

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Camperdown, , Australia

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Darlinghurst, , Australia

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Fullarton, , Australia

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Garran, , Australia

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Geelong, , Australia

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Heidelberg West, , Australia

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Herston, , Australia

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Joondalup, , Australia

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Maroubra, , Australia

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Melbourne, , Australia

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Milton, , Australia

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Murdoch, , Australia

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Wollongong, , Australia

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Aalst, , Belgium

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Antwerp, , Belgium

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Bonheiden, , Belgium

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Brasschaat, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Mechelen, , Belgium

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Merksem, , Belgium

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Roeselare, , Belgium

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Tienen, , Belgium

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Turnhout, , Belgium

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Belo Horizonte, , 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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Campinas, , Brazil

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Marília, , Brazil

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Porto Alegre, , Brazil

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São José do Rio Preto, , Brazil

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São José dos Campos, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Blagoevgrad, , Bulgaria

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Botevgrad, , Bulgaria

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Dimitrovgrad, , Bulgaria

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Dupnitsa, , Bulgaria

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Gotse Delchev, , Bulgaria

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Kozloduy, , Bulgaria

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References

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Reference Type DERIVED
PMID: 35015847 (View on PubMed)

Oyama K, Raz I, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Park KS, Goudev A, Diaz R, Spinar J, Gause-Nilsson IAM, Mosenzon O, Sabatine MS, Wiviott SD. Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE-TIMI 58 trial. Eur Heart J. 2022 Aug 14;43(31):2958-2967. doi: 10.1093/eurheartj/ehab530.

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Mosenzon O, Wiviott SD, Heerspink HJL, Dwyer JP, Cahn A, Goodrich EL, Rozenberg A, Schechter M, Yanuv I, Murphy SA, Zelniker TA, Gause-Nilsson IAM, Langkilde AM, Fredriksson M, Johansson PA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS, Raz I. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58. Diabetes Care. 2021 Aug;44(8):1805-1815. doi: 10.2337/dc21-0076. Epub 2021 Jul 7.

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Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained >/=40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.

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Zelniker TA, Raz I, Mosenzon O, Dwyer JP, Heerspink HHJL, Cahn A, Goodrich EL, Im K, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson I, Langkilde AM, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Cardiovascular Outcomes According to Baseline Kidney Function and Albuminuria Status in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):801-810. doi: 10.1001/jamacardio.2021.0660.

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Cahn A, Raz I, Leiter LA, Mosenzon O, Murphy SA, Goodrich EL, Yanuv I, Rozenberg A, Bhatt DL, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Langkilde AM, Sabatine MS, Wiviott SD. Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58. Diabetes Care. 2021 May;44(5):1159-1167. doi: 10.2337/dc20-2492. Epub 2021 Mar 2.

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O'Donoghue ML, Kato ET, Mosenzon O, Murphy SA, Cahn A, Herrera M, Tankova T, Smahelova A, Merlini P, Gause-Nilsson I, Langkilde AM, McGuire DK, Wilding JPH, Leiter LA, Bhatt DL, Raz I, Sabatine MS, Wiviott SD. The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus. Diabetologia. 2021 Jun;64(6):1226-1234. doi: 10.1007/s00125-021-05399-2. Epub 2021 Feb 20.

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Bonaca MP, Wiviott SD, Zelniker TA, Mosenzon O, Bhatt DL, Leiter LA, McGuire DK, Goodrich EL, De Mendonca Furtado RH, Wilding JPH, Cahn A, Gause-Nilsson IAM, Johanson P, Fredriksson M, Johansson PA, Langkilde AM, Raz I, Sabatine MS. Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58. Circulation. 2020 Aug 25;142(8):734-747. doi: 10.1161/CIRCULATIONAHA.119.044775. Epub 2020 Aug 3.

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Zelniker TA, Bonaca MP, Furtado RHM, Mosenzon O, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Budaj A, Kiss RG, Padilla F, Gause-Nilsson I, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus: Insights From the DECLARE-TIMI 58 Trial. Circulation. 2020 Apr 14;141(15):1227-1234. doi: 10.1161/CIRCULATIONAHA.119.044183. Epub 2020 Jan 27.

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Cahn A, Mosenzon O, Wiviott SD, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study. Diabetes Care. 2020 Feb;43(2):468-475. doi: 10.2337/dc19-1476. Epub 2019 Dec 16.

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PMID: 31843945 (View on PubMed)

Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.

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Mosenzon O, Wiviott SD, Cahn A, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Heerspink HJL, Zelniker TA, Dwyer JP, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Kato ET, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):606-617. doi: 10.1016/S2213-8587(19)30180-9. Epub 2019 Jun 10.

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Furtado RHM, Bonaca MP, Raz I, Zelniker TA, Mosenzon O, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Nicolau JC, Gause-Nilsson IAM, Fredriksson M, Langkilde AM, Sabatine MS, Wiviott SD. Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction. Circulation. 2019 May 28;139(22):2516-2527. doi: 10.1161/CIRCULATIONAHA.119.039996. Epub 2019 Mar 18.

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Kato ET, Silverman MG, Mosenzon O, Zelniker TA, Cahn A, Furtado RHM, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Bonaca MP, Ruff CT, Desai AS, Goto S, Johansson PA, Gause-Nilsson I, Johanson P, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536. doi: 10.1161/CIRCULATIONAHA.119.040130. Epub 2019 Mar 18.

Reference Type DERIVED
PMID: 30882238 (View on PubMed)

Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.

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PMID: 30415602 (View on PubMed)

Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Bansilal S, Bhatt DL, Leiter LA, McGuire DK, Wilding JP, Gause-Nilsson IA, Langkilde AM, Johansson PA, Sabatine MS. The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial. Am Heart J. 2018 Jun;200:83-89. doi: 10.1016/j.ahj.2018.01.012. Epub 2018 Feb 7.

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Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

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Bloch MJ. Blood pressure effects of SGLT2 inhibitors make them an attractive option in diabetic patients with hypertension. J Am Soc Hypertens. 2016 Mar;10(3):186-7. doi: 10.1016/j.jash.2016.01.001. No abstract available.

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PMID: 27408945 (View on PubMed)

Leiter LA, Cefalu WT, de Bruin TW, Xu J, Parikh S, Johnsson E, Gause-Nilsson I. Long-term maintenance of efficacy of dapagliflozin in patients with type 2 diabetes mellitus and cardiovascular disease. Diabetes Obes Metab. 2016 Aug;18(8):766-74. doi: 10.1111/dom.12666. Epub 2016 May 12.

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PMID: 27009868 (View on PubMed)

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