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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00781391
Registration number
NCT00781391
Ethics application status
Date submitted
28/10/2008
Date registered
29/10/2008
Titles & IDs
Public title
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
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Scientific title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
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Secondary ID [1]
0
0
DU176b-C-U301
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Universal Trial Number (UTN)
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Trial acronym
EngageAFTIMI48
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
0
0
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Atrial Fibrillation
0
0
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Embolism
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
0
0
0
0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - warfarin tablets
Treatment: Drugs - Edoxaban tablets (high dose regimen-60mg)
Treatment: Drugs - Edoxaban tablets (low dose regimen-30mg)
Treatment: Drugs - placebo warfarin
Treatment: Drugs - placebo edoxaban
Active comparator: Warfarin/placebo edoxaban - Warfarin tablets plus placebo Edoxaban tablets
Experimental: high dose edoxaban/placebo warfarin - Edoxaban tablets (60mg) plus warfarin placebo tablets
Experimental: low dose edoxaban/placebo warfarin - Edoxaban tablets (30mg) plus warfarin placebo tablets
Treatment: Drugs: warfarin tablets
Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
Treatment: Drugs: Edoxaban tablets (high dose regimen-60mg)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
Treatment: Drugs: Edoxaban tablets (low dose regimen-30mg)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
Treatment: Drugs: placebo warfarin
placebo warfarin
Treatment: Drugs: placebo edoxaban
placebo edoxaban
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
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Assessment method [1]
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0
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.
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Timepoint [1]
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0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Primary outcome [2]
0
0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
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Assessment method [2]
0
0
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.
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Timepoint [2]
0
0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Primary outcome [3]
0
0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
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Assessment method [3]
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0
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.
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Timepoint [3]
0
0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Primary outcome [4]
0
0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
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Assessment method [4]
0
0
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.
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Timepoint [4]
0
0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Primary outcome [5]
0
0
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
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Assessment method [5]
0
0
Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.
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Timepoint [5]
0
0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Secondary outcome [1]
0
0
Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality
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Assessment method [1]
0
0
Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.
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Timepoint [1]
0
0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Secondary outcome [2]
0
0
Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding
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Assessment method [2]
0
0
Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.
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Timepoint [2]
0
0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Secondary outcome [3]
0
0
Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality
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Assessment method [3]
0
0
Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.
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Timepoint [3]
0
0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Secondary outcome [4]
0
0
Adjudicated Bleeding Events
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Assessment method [4]
0
0
Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.
Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements.
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Timepoint [4]
0
0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
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Eligibility
Key inclusion criteria
* 21 years of age or older; male or female.
* Able to provide written informed consent.
* History of documented AF within the prior 12 months
* A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Transient atrial fibrillation secondary to other reversible disorders
* Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
* Subjects with any contraindication for anticoagulant agents;
* Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
* Females of childbearing potential including the following:
* Females with a history of tubal-ligation
* Females less than 2 years post-menopausal
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2013
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Sample size
Target
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Accrual to date
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Final
21105
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
0
0
- Broken Hill
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Recruitment hospital [2]
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0
- East Gosford
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Recruitment hospital [3]
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- Carina Heights
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Recruitment hospital [4]
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- Milton
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Recruitment hospital [5]
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- Adelaide
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Recruitment hospital [6]
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0
- Frankston
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Recruitment hospital [7]
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- Ashford
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Recruitment hospital [8]
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- Camperdown
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Recruitment hospital [9]
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- Elizabeth Vale
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Recruitment hospital [10]
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- Joondalup
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Recruitment hospital [11]
0
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- Melbourne
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Recruitment hospital [12]
0
0
- Parkville
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Recruitment hospital [13]
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- Perth
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Recruitment postcode(s) [1]
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- Broken Hill
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Recruitment postcode(s) [2]
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0
- East Gosford
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Recruitment postcode(s) [3]
0
0
- Carina Heights
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Recruitment postcode(s) [4]
0
0
- Milton
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Recruitment postcode(s) [5]
0
0
- Adelaide
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Recruitment postcode(s) [6]
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0
- Frankston
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Recruitment postcode(s) [7]
0
0
- Ashford
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Recruitment postcode(s) [8]
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0
- Camperdown
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Recruitment postcode(s) [9]
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0
- Elizabeth Vale
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Recruitment postcode(s) [10]
0
0
- Joondalup
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Recruitment postcode(s) [11]
0
0
- Melbourne
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Recruitment postcode(s) [12]
0
0
- Parkville
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Recruitment postcode(s) [13]
0
0
- Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
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California
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Country [5]
0
0
United States of America
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State/province [5]
0
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Colorado
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Country [6]
0
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United States of America
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State/province [6]
0
0
Connecticut
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Country [7]
0
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United States of America
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State/province [7]
0
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Delaware
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Country [8]
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United States of America
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State/province [8]
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District of Columbia
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Country [9]
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United States of America
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State/province [9]
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Florida
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Country [10]
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United States of America
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State/province [10]
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Georgia
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Country [11]
0
0
United States of America
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State/province [11]
0
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Hawaii
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Country [12]
0
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United States of America
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State/province [12]
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Idaho
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Country [13]
0
0
United States of America
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State/province [13]
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Illinois
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Country [14]
0
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United States of America
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State/province [14]
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Indiana
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Country [15]
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United States of America
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State/province [15]
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Iowa
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Country [16]
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United States of America
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Kansas
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Country [17]
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United States of America
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Kentucky
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Louisiana
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United States of America
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Maine
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United States of America
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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West Virginia
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United States of America
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State/province [47]
0
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Wisconsin
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Country [48]
0
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Argentina
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State/province [48]
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Bahia Blanca
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Country [49]
0
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Argentina
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State/province [49]
0
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Buenos Aires
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Country [50]
0
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Argentina
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State/province [50]
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Cordoba
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Argentina
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Corrientes
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Argentina
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Formosa
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Argentina
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Godoy Cruz
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0
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Argentina
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Jujuy
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0
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Argentina
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Mar del Plata
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0
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Argentina
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State/province [56]
0
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Mendoza
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0
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Argentina
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State/province [57]
0
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Paraguay
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0
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Argentina
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Provincia De Chaco
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0
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Argentina
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Provincia De Rio Negro
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Argentina
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State/province [60]
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Provincia De Salta
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0
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Argentina
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San Luis
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Argentina
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Santa Fe
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Argentina
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State/province [63]
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Sante Fe
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0
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Argentina
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State/province [64]
0
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Tucuman
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Country [65]
0
0
Belgium
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State/province [65]
0
0
Antwerpen
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Country [66]
0
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Belgium
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State/province [66]
0
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Arlon
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Country [67]
0
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Belgium
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State/province [67]
0
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Brugge
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Country [68]
0
0
Belgium
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State/province [68]
0
0
Bruxelles
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Country [69]
0
0
Belgium
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State/province [69]
0
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Genk
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0
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Belgium
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Hasselt
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0
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Belgium
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Leuven
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0
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Belgium
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Liege
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Belgium
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Mechelen
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Belgium
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Merksem
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Belgium
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Moerkerke
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Belgium
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Montegnee
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Belgium
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Mousron
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Belgium
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Torhout
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Belgium
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Veurne
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Belgium
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0
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Wetteren
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0
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Brazil
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Belo Horizonte
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0
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Brazil
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Blumenau
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0
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Brazil
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Brasilia
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0
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Brazil
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Campina Grande do Sul
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Brazil
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Campinas
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Brazil
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Caxias do Sul
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Brazil
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Curitiba
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Brazil
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Goiania
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0
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Brazil
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0
Lajeados
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0
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Brazil
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State/province [90]
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Maceio
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0
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Brazil
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State/province [91]
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Marilia
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0
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Ribeirao Preto
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Santo Andre
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Brazil
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Sao Jose
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Brazil
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Sao Paulo
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Brazil
Query!
State/province [101]
0
0
Uberlandia
Query!
Country [102]
0
0
Bulgaria
Query!
State/province [102]
0
0
Burgas
Query!
Country [103]
0
0
Bulgaria
Query!
State/province [103]
0
0
Dimitrovgrad
Query!
Country [104]
0
0
Bulgaria
Query!
State/province [104]
0
0
Haskovo
Query!
Country [105]
0
0
Bulgaria
Query!
State/province [105]
0
0
Pleven
Query!
Country [106]
0
0
Bulgaria
Query!
State/province [106]
0
0
Plovdiv
Query!
Country [107]
0
0
Bulgaria
Query!
State/province [107]
0
0
Ruse
Query!
Country [108]
0
0
Bulgaria
Query!
State/province [108]
0
0
Sofia
Query!
Country [109]
0
0
Bulgaria
Query!
State/province [109]
0
0
Varna
Query!
Country [110]
0
0
Canada
Query!
State/province [110]
0
0
Alberta
Query!
Country [111]
0
0
Canada
Query!
State/province [111]
0
0
British Columbia
Query!
Country [112]
0
0
Canada
Query!
State/province [112]
0
0
New Brunswick
Query!
Country [113]
0
0
Canada
Query!
State/province [113]
0
0
Nova Scotia
Query!
Country [114]
0
0
Canada
Query!
State/province [114]
0
0
Ontario
Query!
Country [115]
0
0
Canada
Query!
State/province [115]
0
0
Quebec
Query!
Country [116]
0
0
Canada
Query!
State/province [116]
0
0
Saskatchewan
Query!
Country [117]
0
0
Canada
Query!
State/province [117]
0
0
Mount Pearl
Query!
Country [118]
0
0
Canada
Query!
State/province [118]
0
0
St. John's
Query!
Country [119]
0
0
Chile
Query!
State/province [119]
0
0
Iquique
Query!
Country [120]
0
0
Chile
Query!
State/province [120]
0
0
La Serena
Query!
Country [121]
0
0
Chile
Query!
State/province [121]
0
0
Osorno
Query!
Country [122]
0
0
Chile
Query!
State/province [122]
0
0
Puerto Montt
Query!
Country [123]
0
0
Chile
Query!
State/province [123]
0
0
Rancagua
Query!
Country [124]
0
0
Chile
Query!
State/province [124]
0
0
Santiago
Query!
Country [125]
0
0
Chile
Query!
State/province [125]
0
0
Talcahuano
Query!
Country [126]
0
0
Chile
Query!
State/province [126]
0
0
Temuco
Query!
Country [127]
0
0
Chile
Query!
State/province [127]
0
0
Victoria
Query!
Country [128]
0
0
Chile
Query!
State/province [128]
0
0
Vina del Mar
Query!
Country [129]
0
0
China
Query!
State/province [129]
0
0
Baotou
Query!
Country [130]
0
0
China
Query!
State/province [130]
0
0
Beijing
Query!
Country [131]
0
0
China
Query!
State/province [131]
0
0
Changchun
Query!
Country [132]
0
0
China
Query!
State/province [132]
0
0
Changsha
Query!
Country [133]
0
0
China
Query!
State/province [133]
0
0
Chendu City
Query!
Country [134]
0
0
China
Query!
State/province [134]
0
0
Chongqing
Query!
Country [135]
0
0
China
Query!
State/province [135]
0
0
Guangxi
Query!
Country [136]
0
0
China
Query!
State/province [136]
0
0
Guangzhou
Query!
Country [137]
0
0
China
Query!
State/province [137]
0
0
Hainan Province
Query!
Country [138]
0
0
China
Query!
State/province [138]
0
0
Hangzhou
Query!
Country [139]
0
0
China
Query!
State/province [139]
0
0
Harbin
Query!
Country [140]
0
0
China
Query!
State/province [140]
0
0
Jinzhou
Query!
Country [141]
0
0
China
Query!
State/province [141]
0
0
Lanzhou
Query!
Country [142]
0
0
China
Query!
State/province [142]
0
0
Liaoning Province
Query!
Country [143]
0
0
China
Query!
State/province [143]
0
0
Nanchang
Query!
Country [144]
0
0
China
Query!
State/province [144]
0
0
Shaanxi Province
Query!
Country [145]
0
0
China
Query!
State/province [145]
0
0
Shanghai
Query!
Country [146]
0
0
China
Query!
State/province [146]
0
0
Shenyang
Query!
Country [147]
0
0
China
Query!
State/province [147]
0
0
Shijiazhuang City
Query!
Country [148]
0
0
China
Query!
State/province [148]
0
0
Tianjin
Query!
Country [149]
0
0
China
Query!
State/province [149]
0
0
Wenzhou
Query!
Country [150]
0
0
China
Query!
State/province [150]
0
0
Wuhan
Query!
Country [151]
0
0
Colombia
Query!
State/province [151]
0
0
Antioquia
Query!
Country [152]
0
0
Colombia
Query!
State/province [152]
0
0
Armenia
Query!
Country [153]
0
0
Colombia
Query!
State/province [153]
0
0
Barranquilla
Query!
Country [154]
0
0
Colombia
Query!
State/province [154]
0
0
Bogota
Query!
Country [155]
0
0
Colombia
Query!
State/province [155]
0
0
Bucaramanga
Query!
Country [156]
0
0
Colombia
Query!
State/province [156]
0
0
Cartagena
Query!
Country [157]
0
0
Colombia
Query!
State/province [157]
0
0
Envigado
Query!
Country [158]
0
0
Colombia
Query!
State/province [158]
0
0
Manizales
Query!
Country [159]
0
0
Colombia
Query!
State/province [159]
0
0
Medellin
Query!
Country [160]
0
0
Croatia
Query!
State/province [160]
0
0
Dubrovnik
Query!
Country [161]
0
0
Croatia
Query!
State/province [161]
0
0
Karlovac
Query!
Country [162]
0
0
Croatia
Query!
State/province [162]
0
0
Koprivnica
Query!
Country [163]
0
0
Croatia
Query!
State/province [163]
0
0
Krapinski Toplice
Query!
Country [164]
0
0
Croatia
Query!
State/province [164]
0
0
Osijek
Query!
Country [165]
0
0
Croatia
Query!
State/province [165]
0
0
Rijeka
Query!
Country [166]
0
0
Croatia
Query!
State/province [166]
0
0
Slavonski Brod
Query!
Country [167]
0
0
Croatia
Query!
State/province [167]
0
0
Split
Query!
Country [168]
0
0
Croatia
Query!
State/province [168]
0
0
Varazdin
Query!
Country [169]
0
0
Croatia
Query!
State/province [169]
0
0
Zadar
Query!
Country [170]
0
0
Croatia
Query!
State/province [170]
0
0
Zagreb
Query!
Country [171]
0
0
Czechia
Query!
State/province [171]
0
0
Benatky nad Jizerou
Query!
Country [172]
0
0
Czechia
Query!
State/province [172]
0
0
Benesov
Query!
Country [173]
0
0
Czechia
Query!
State/province [173]
0
0
Bilovec
Query!
Country [174]
0
0
Czechia
Query!
State/province [174]
0
0
Brno-Lesna
Query!
Country [175]
0
0
Czechia
Query!
State/province [175]
0
0
Brno
Query!
Country [176]
0
0
Czechia
Query!
State/province [176]
0
0
Cesky Krumlov
Query!
Country [177]
0
0
Czechia
Query!
State/province [177]
0
0
Chrudim
Query!
Country [178]
0
0
Czechia
Query!
State/province [178]
0
0
Havlickux Brod
Query!
Country [179]
0
0
Czechia
Query!
State/province [179]
0
0
Hradec Kralove
Query!
Country [180]
0
0
Czechia
Query!
State/province [180]
0
0
Hranice
Query!
Country [181]
0
0
Czechia
Query!
State/province [181]
0
0
Jindrichuv Hradec
Query!
Country [182]
0
0
Czechia
Query!
State/province [182]
0
0
Kolin
Query!
Country [183]
0
0
Czechia
Query!
State/province [183]
0
0
Kromeriz
Query!
Country [184]
0
0
Czechia
Query!
State/province [184]
0
0
Marianske Lazne
Query!
Country [185]
0
0
Czechia
Query!
State/province [185]
0
0
Mlada Boleslav
Query!
Country [186]
0
0
Czechia
Query!
State/province [186]
0
0
Nachod
Query!
Country [187]
0
0
Czechia
Query!
State/province [187]
0
0
Ostrava-Trebovice
Query!
Country [188]
0
0
Czechia
Query!
State/province [188]
0
0
Ostrava
Query!
Country [189]
0
0
Czechia
Query!
State/province [189]
0
0
Pardubice
Query!
Country [190]
0
0
Czechia
Query!
State/province [190]
0
0
Plzen
Query!
Country [191]
0
0
Czechia
Query!
State/province [191]
0
0
Praha
Query!
Country [192]
0
0
Czechia
Query!
State/province [192]
0
0
Pribram
Query!
Country [193]
0
0
Czechia
Query!
State/province [193]
0
0
Revnice
Query!
Country [194]
0
0
Czechia
Query!
State/province [194]
0
0
Semily
Query!
Country [195]
0
0
Czechia
Query!
State/province [195]
0
0
Slany
Query!
Country [196]
0
0
Czechia
Query!
State/province [196]
0
0
Teplice
Query!
Country [197]
0
0
Czechia
Query!
State/province [197]
0
0
Trutnov
Query!
Country [198]
0
0
Czechia
Query!
State/province [198]
0
0
Usti nad Labem
Query!
Country [199]
0
0
Denmark
Query!
State/province [199]
0
0
Aarhus N
Query!
Country [200]
0
0
Denmark
Query!
State/province [200]
0
0
Esbjerg
Query!
Country [201]
0
0
Denmark
Query!
State/province [201]
0
0
Frederiksberg
Query!
Country [202]
0
0
Denmark
Query!
State/province [202]
0
0
Glostrup
Query!
Country [203]
0
0
Denmark
Query!
State/province [203]
0
0
Hellerup
Query!
Country [204]
0
0
Denmark
Query!
State/province [204]
0
0
Holbaek
Query!
Country [205]
0
0
Denmark
Query!
State/province [205]
0
0
Horsens
Query!
Country [206]
0
0
Denmark
Query!
State/province [206]
0
0
Kobenhaven
Query!
Country [207]
0
0
Denmark
Query!
State/province [207]
0
0
Kobenhavn
Query!
Country [208]
0
0
Estonia
Query!
State/province [208]
0
0
Harjumaa
Query!
Country [209]
0
0
Estonia
Query!
State/province [209]
0
0
Tartu
Query!
Country [210]
0
0
Estonia
Query!
State/province [210]
0
0
Parnu
Query!
Country [211]
0
0
Estonia
Query!
State/province [211]
0
0
Tallinn
Query!
Country [212]
0
0
Estonia
Query!
State/province [212]
0
0
Tallin
Query!
Country [213]
0
0
Finland
Query!
State/province [213]
0
0
Jyvaskyla
Query!
Country [214]
0
0
Finland
Query!
State/province [214]
0
0
Kuopio
Query!
Country [215]
0
0
Finland
Query!
State/province [215]
0
0
Lappeenranta
Query!
Country [216]
0
0
Finland
Query!
State/province [216]
0
0
Oulu
Query!
Country [217]
0
0
Finland
Query!
State/province [217]
0
0
Seinajoki
Query!
Country [218]
0
0
Finland
Query!
State/province [218]
0
0
Tampere
Query!
Country [219]
0
0
France
Query!
State/province [219]
0
0
Abbeville
Query!
Country [220]
0
0
France
Query!
State/province [220]
0
0
Amiens Cedex
Query!
Country [221]
0
0
France
Query!
State/province [221]
0
0
Brest
Query!
Country [222]
0
0
France
Query!
State/province [222]
0
0
Cambrai
Query!
Country [223]
0
0
France
Query!
State/province [223]
0
0
Clamart
Query!
Country [224]
0
0
France
Query!
State/province [224]
0
0
La Roche sur Yon
Query!
Country [225]
0
0
France
Query!
State/province [225]
0
0
Lille
Query!
Country [226]
0
0
France
Query!
State/province [226]
0
0
Lyon Cedex
Query!
Country [227]
0
0
France
Query!
State/province [227]
0
0
Massy
Query!
Country [228]
0
0
France
Query!
State/province [228]
0
0
Nantes
Query!
Country [229]
0
0
France
Query!
State/province [229]
0
0
Paris
Query!
Country [230]
0
0
France
Query!
State/province [230]
0
0
Pau
Query!
Country [231]
0
0
France
Query!
State/province [231]
0
0
Pessac
Query!
Country [232]
0
0
France
Query!
State/province [232]
0
0
Poitiers
Query!
Country [233]
0
0
France
Query!
State/province [233]
0
0
Tours Cedex
Query!
Country [234]
0
0
France
Query!
State/province [234]
0
0
Valenciennes
Query!
Country [235]
0
0
Germany
Query!
State/province [235]
0
0
Altenburg
Query!
Country [236]
0
0
Germany
Query!
State/province [236]
0
0
Aschaffenburg
Query!
Country [237]
0
0
Germany
Query!
State/province [237]
0
0
Augsburg
Query!
Country [238]
0
0
Germany
Query!
State/province [238]
0
0
Bad Nauheim
Query!
Country [239]
0
0
Germany
Query!
State/province [239]
0
0
Berlin
Query!
Country [240]
0
0
Germany
Query!
State/province [240]
0
0
Bochum
Query!
Country [241]
0
0
Germany
Query!
State/province [241]
0
0
Cloppenburg
Query!
Country [242]
0
0
Germany
Query!
State/province [242]
0
0
Dortmund
Query!
Country [243]
0
0
Germany
Query!
State/province [243]
0
0
Dresden
Query!
Country [244]
0
0
Germany
Query!
State/province [244]
0
0
Essen
Query!
Country [245]
0
0
Germany
Query!
State/province [245]
0
0
Frankfurt
Query!
Country [246]
0
0
Germany
Query!
State/province [246]
0
0
Giengen
Query!
Country [247]
0
0
Germany
Query!
State/province [247]
0
0
Goerlitz
Query!
Country [248]
0
0
Germany
Query!
State/province [248]
0
0
Grossheirath
Query!
Country [249]
0
0
Germany
Query!
State/province [249]
0
0
Hamburg
Query!
Country [250]
0
0
Germany
Query!
State/province [250]
0
0
Heidelberg
Query!
Country [251]
0
0
Germany
Query!
State/province [251]
0
0
Heilbronn
Query!
Country [252]
0
0
Germany
Query!
State/province [252]
0
0
Homburg
Query!
Country [253]
0
0
Germany
Query!
State/province [253]
0
0
Ingelheim
Query!
Country [254]
0
0
Germany
Query!
State/province [254]
0
0
Kallstadt
Query!
Country [255]
0
0
Germany
Query!
State/province [255]
0
0
Kassel
Query!
Country [256]
0
0
Germany
Query!
State/province [256]
0
0
Kiel-Kronshagen
Query!
Country [257]
0
0
Germany
Query!
State/province [257]
0
0
Koeln
Query!
Country [258]
0
0
Germany
Query!
State/province [258]
0
0
Leipzig
Query!
Country [259]
0
0
Germany
Query!
State/province [259]
0
0
Ludwigshafen
Query!
Country [260]
0
0
Germany
Query!
State/province [260]
0
0
Luebeck
Query!
Country [261]
0
0
Germany
Query!
State/province [261]
0
0
Magdeburg
Query!
Country [262]
0
0
Germany
Query!
State/province [262]
0
0
Mainz
Query!
Country [263]
0
0
Germany
Query!
State/province [263]
0
0
Mannheim
Query!
Country [264]
0
0
Germany
Query!
State/province [264]
0
0
Markkleeberg
Query!
Country [265]
0
0
Germany
Query!
State/province [265]
0
0
Muenchen
Query!
Country [266]
0
0
Germany
Query!
State/province [266]
0
0
Nienburg
Query!
Country [267]
0
0
Germany
Query!
State/province [267]
0
0
Northeinm
Query!
Country [268]
0
0
Germany
Query!
State/province [268]
0
0
Offenbach-beiber
Query!
Country [269]
0
0
Germany
Query!
State/province [269]
0
0
Potsdam
Query!
Country [270]
0
0
Germany
Query!
State/province [270]
0
0
Ruedersdorf
Query!
Country [271]
0
0
Germany
Query!
State/province [271]
0
0
Siegen
Query!
Country [272]
0
0
Germany
Query!
State/province [272]
0
0
Stuhr
Query!
Country [273]
0
0
Germany
Query!
State/province [273]
0
0
Ulm
Query!
Country [274]
0
0
Germany
Query!
State/province [274]
0
0
Unterschneidheim
Query!
Country [275]
0
0
Germany
Query!
State/province [275]
0
0
Wardenburg
Query!
Country [276]
0
0
Germany
Query!
State/province [276]
0
0
Wermsdorf
Query!
Country [277]
0
0
Germany
Query!
State/province [277]
0
0
Weyhe
Query!
Country [278]
0
0
Germany
Query!
State/province [278]
0
0
Witten
Query!
Country [279]
0
0
Germany
Query!
State/province [279]
0
0
Woerishofen
Query!
Country [280]
0
0
Germany
Query!
State/province [280]
0
0
Wuppertal
Query!
Country [281]
0
0
Greece
Query!
State/province [281]
0
0
Athens
Query!
Country [282]
0
0
Greece
Query!
State/province [282]
0
0
Larissa
Query!
Country [283]
0
0
Greece
Query!
State/province [283]
0
0
Rhodes
Query!
Country [284]
0
0
Greece
Query!
State/province [284]
0
0
Rio-Patras
Query!
Country [285]
0
0
Greece
Query!
State/province [285]
0
0
Thessaloniki
Query!
Country [286]
0
0
Greece
Query!
State/province [286]
0
0
Trikala
Query!
Country [287]
0
0
Greece
Query!
State/province [287]
0
0
Voula
Query!
Country [288]
0
0
Guatemala
Query!
State/province [288]
0
0
Ciudad
Query!
Country [289]
0
0
Guatemala
Query!
State/province [289]
0
0
Clinica
Query!
Country [290]
0
0
Guatemala
Query!
State/province [290]
0
0
Edificio Multimedica
Query!
Country [291]
0
0
Guatemala
Query!
State/province [291]
0
0
Nivel
Query!
Country [292]
0
0
Guatemala
Query!
State/province [292]
0
0
Oficina
Query!
Country [293]
0
0
Guatemala
Query!
State/province [293]
0
0
Quetzaltenango
Query!
Country [294]
0
0
Guatemala
Query!
State/province [294]
0
0
Zacapa
Query!
Country [295]
0
0
Hungary
Query!
State/province [295]
0
0
Ajka
Query!
Country [296]
0
0
Hungary
Query!
State/province [296]
0
0
Baja
Query!
Country [297]
0
0
Hungary
Query!
State/province [297]
0
0
Bekescsaba
Query!
Country [298]
0
0
Hungary
Query!
State/province [298]
0
0
Budapest
Query!
Country [299]
0
0
Hungary
Query!
State/province [299]
0
0
Debrecen
Query!
Country [300]
0
0
Hungary
Query!
State/province [300]
0
0
Hodmezovasarhely
Query!
Country [301]
0
0
Hungary
Query!
State/province [301]
0
0
Kecskemet
Query!
Country [302]
0
0
Hungary
Query!
State/province [302]
0
0
Keeskemet
Query!
Country [303]
0
0
Hungary
Query!
State/province [303]
0
0
Kistarcsa
Query!
Country [304]
0
0
Hungary
Query!
State/province [304]
0
0
Komarom
Query!
Country [305]
0
0
Hungary
Query!
State/province [305]
0
0
Mako
Query!
Country [306]
0
0
Hungary
Query!
State/province [306]
0
0
Nagykanizsa
Query!
Country [307]
0
0
Hungary
Query!
State/province [307]
0
0
Nyiregyhaza
Query!
Country [308]
0
0
Hungary
Query!
State/province [308]
0
0
Pecs
Query!
Country [309]
0
0
Hungary
Query!
State/province [309]
0
0
Sopron
Query!
Country [310]
0
0
Hungary
Query!
State/province [310]
0
0
Szekszard
Query!
Country [311]
0
0
Hungary
Query!
State/province [311]
0
0
Szombathely
Query!
Country [312]
0
0
Hungary
Query!
State/province [312]
0
0
Zalaegerszeg
Query!
Country [313]
0
0
India
Query!
State/province [313]
0
0
AP
Query!
Country [314]
0
0
India
Query!
State/province [314]
0
0
Kerala
Query!
Country [315]
0
0
India
Query!
State/province [315]
0
0
Ahmedabad
Query!
Country [316]
0
0
India
Query!
State/province [316]
0
0
Anddhra Pradesh
Query!
Country [317]
0
0
India
Query!
State/province [317]
0
0
Andhra Pradesh
Query!
Country [318]
0
0
India
Query!
State/province [318]
0
0
Aurangabad
Query!
Country [319]
0
0
India
Query!
State/province [319]
0
0
Bangalore
Query!
Country [320]
0
0
India
Query!
State/province [320]
0
0
Bikaner
Query!
Country [321]
0
0
India
Query!
State/province [321]
0
0
Chennai
Query!
Country [322]
0
0
India
Query!
State/province [322]
0
0
Coimbatore
Query!
Country [323]
0
0
India
Query!
State/province [323]
0
0
Delhi
Query!
Country [324]
0
0
India
Query!
State/province [324]
0
0
Gujrat
Query!
Country [325]
0
0
India
Query!
State/province [325]
0
0
Indore
Query!
Country [326]
0
0
India
Query!
State/province [326]
0
0
Jaipur
Query!
Country [327]
0
0
India
Query!
State/province [327]
0
0
Karnataka
Query!
Country [328]
0
0
India
Query!
State/province [328]
0
0
Kolkata
Query!
Country [329]
0
0
India
Query!
State/province [329]
0
0
Ludhiana
Query!
Country [330]
0
0
India
Query!
State/province [330]
0
0
Madhya Pradesh
Query!
Country [331]
0
0
India
Query!
State/province [331]
0
0
Maharashtra
Query!
Country [332]
0
0
India
Query!
State/province [332]
0
0
Mangalore
Query!
Country [333]
0
0
India
Query!
State/province [333]
0
0
Mumbai
Query!
Country [334]
0
0
India
Query!
State/province [334]
0
0
Nagpur
Query!
Country [335]
0
0
India
Query!
State/province [335]
0
0
Nashik
Query!
Country [336]
0
0
India
Query!
State/province [336]
0
0
New Delhi
Query!
Country [337]
0
0
India
Query!
State/province [337]
0
0
Pune
Query!
Country [338]
0
0
India
Query!
State/province [338]
0
0
Puni
Query!
Country [339]
0
0
India
Query!
State/province [339]
0
0
Punjab
Query!
Country [340]
0
0
India
Query!
State/province [340]
0
0
Rajasthan
Query!
Country [341]
0
0
India
Query!
State/province [341]
0
0
Ramnagar
Query!
Country [342]
0
0
India
Query!
State/province [342]
0
0
Shimoga
Query!
Country [343]
0
0
India
Query!
State/province [343]
0
0
Surat
Query!
Country [344]
0
0
India
Query!
State/province [344]
0
0
Trivandrum
Query!
Country [345]
0
0
India
Query!
State/province [345]
0
0
Vadodara
Query!
Country [346]
0
0
Israel
Query!
State/province [346]
0
0
Afula
Query!
Country [347]
0
0
Israel
Query!
State/province [347]
0
0
Beer-Sheva
Query!
Country [348]
0
0
Israel
Query!
State/province [348]
0
0
Dimona
Query!
Country [349]
0
0
Israel
Query!
State/province [349]
0
0
Givatayim
Query!
Country [350]
0
0
Israel
Query!
State/province [350]
0
0
Hadera
Query!
Country [351]
0
0
Israel
Query!
State/province [351]
0
0
Haifa
Query!
Country [352]
0
0
Israel
Query!
State/province [352]
0
0
Holon
Query!
Country [353]
0
0
Israel
Query!
State/province [353]
0
0
Jerusalem
Query!
Country [354]
0
0
Israel
Query!
State/province [354]
0
0
Kfar Saba
Query!
Country [355]
0
0
Israel
Query!
State/province [355]
0
0
Nahariya
Query!
Country [356]
0
0
Israel
Query!
State/province [356]
0
0
Nazareth
Query!
Country [357]
0
0
Israel
Query!
State/province [357]
0
0
Petach Tikva
Query!
Country [358]
0
0
Israel
Query!
State/province [358]
0
0
Petah-Tikva
Query!
Country [359]
0
0
Israel
Query!
State/province [359]
0
0
Poriya
Query!
Country [360]
0
0
Israel
Query!
State/province [360]
0
0
Raanana
Query!
Country [361]
0
0
Israel
Query!
State/province [361]
0
0
Rehovot
Query!
Country [362]
0
0
Israel
Query!
State/province [362]
0
0
Tel Aviv
Query!
Country [363]
0
0
Israel
Query!
State/province [363]
0
0
Tel Hashomer
Query!
Country [364]
0
0
Israel
Query!
State/province [364]
0
0
Zerifin
Query!
Country [365]
0
0
Italy
Query!
State/province [365]
0
0
Bologna
Query!
Country [366]
0
0
Italy
Query!
State/province [366]
0
0
Brescia
Query!
Country [367]
0
0
Italy
Query!
State/province [367]
0
0
Cantania
Query!
Country [368]
0
0
Italy
Query!
State/province [368]
0
0
Casarano
Query!
Country [369]
0
0
Italy
Query!
State/province [369]
0
0
Caserta
Query!
Country [370]
0
0
Italy
Query!
State/province [370]
0
0
Chieti
Query!
Country [371]
0
0
Italy
Query!
State/province [371]
0
0
Cremona
Query!
Country [372]
0
0
Italy
Query!
State/province [372]
0
0
Genova
Query!
Country [373]
0
0
Italy
Query!
State/province [373]
0
0
Grosseto
Query!
Country [374]
0
0
Italy
Query!
State/province [374]
0
0
Legnano
Query!
Country [375]
0
0
Italy
Query!
State/province [375]
0
0
Manerbio
Query!
Country [376]
0
0
Italy
Query!
State/province [376]
0
0
Milano
Query!
Country [377]
0
0
Italy
Query!
State/province [377]
0
0
Monserrato
Query!
Country [378]
0
0
Italy
Query!
State/province [378]
0
0
Napoli
Query!
Country [379]
0
0
Italy
Query!
State/province [379]
0
0
Novara
Query!
Country [380]
0
0
Italy
Query!
State/province [380]
0
0
Ostia
Query!
Country [381]
0
0
Italy
Query!
State/province [381]
0
0
Pavia
Query!
Country [382]
0
0
Italy
Query!
State/province [382]
0
0
Pisa
Query!
Country [383]
0
0
Italy
Query!
State/province [383]
0
0
Pozzuoli
Query!
Country [384]
0
0
Italy
Query!
State/province [384]
0
0
Roma
Query!
Country [385]
0
0
Italy
Query!
State/province [385]
0
0
Santa Maria Capua Vetere
Query!
Country [386]
0
0
Italy
Query!
State/province [386]
0
0
Sassari
Query!
Country [387]
0
0
Italy
Query!
State/province [387]
0
0
Seriate
Query!
Country [388]
0
0
Italy
Query!
State/province [388]
0
0
Siena
Query!
Country [389]
0
0
Italy
Query!
State/province [389]
0
0
Trieste
Query!
Country [390]
0
0
Italy
Query!
State/province [390]
0
0
Venezia Mestre
Query!
Country [391]
0
0
Japan
Query!
State/province [391]
0
0
Kyoto
Query!
Country [392]
0
0
Japan
Query!
State/province [392]
0
0
Nagano
Query!
Country [393]
0
0
Japan
Query!
State/province [393]
0
0
Tokyo
Query!
Country [394]
0
0
Japan
Query!
State/province [394]
0
0
Aichi
Query!
Country [395]
0
0
Japan
Query!
State/province [395]
0
0
Aomori
Query!
Country [396]
0
0
Japan
Query!
State/province [396]
0
0
Chiaki
Query!
Country [397]
0
0
Japan
Query!
State/province [397]
0
0
Chiba
Query!
Country [398]
0
0
Japan
Query!
State/province [398]
0
0
Ehime
Query!
Country [399]
0
0
Japan
Query!
State/province [399]
0
0
Fukuoka
Query!
Country [400]
0
0
Japan
Query!
State/province [400]
0
0
Fukushima
Query!
Country [401]
0
0
Japan
Query!
State/province [401]
0
0
Gifu
Query!
Country [402]
0
0
Japan
Query!
State/province [402]
0
0
Gunma
Query!
Country [403]
0
0
Japan
Query!
State/province [403]
0
0
Hiroshima
Query!
Country [404]
0
0
Japan
Query!
State/province [404]
0
0
Hokkai-do
Query!
Country [405]
0
0
Japan
Query!
State/province [405]
0
0
Hokkaido
Query!
Country [406]
0
0
Japan
Query!
State/province [406]
0
0
Hyogo
Query!
Country [407]
0
0
Japan
Query!
State/province [407]
0
0
Ibaraki
Query!
Country [408]
0
0
Japan
Query!
State/province [408]
0
0
Isesaki-shi
Query!
Country [409]
0
0
Japan
Query!
State/province [409]
0
0
Ishikawa
Query!
Country [410]
0
0
Japan
Query!
State/province [410]
0
0
Iwate
Query!
Country [411]
0
0
Japan
Query!
State/province [411]
0
0
Kagawa
Query!
Country [412]
0
0
Japan
Query!
State/province [412]
0
0
Kanagawa
Query!
Country [413]
0
0
Japan
Query!
State/province [413]
0
0
Kumamoto
Query!
Country [414]
0
0
Japan
Query!
State/province [414]
0
0
Kyota
Query!
Country [415]
0
0
Japan
Query!
State/province [415]
0
0
Mie
Query!
Country [416]
0
0
Japan
Query!
State/province [416]
0
0
Miyagi
Query!
Country [417]
0
0
Japan
Query!
State/province [417]
0
0
Nagaoka-shi
Query!
Country [418]
0
0
Japan
Query!
State/province [418]
0
0
Nagasaki
Query!
Country [419]
0
0
Japan
Query!
State/province [419]
0
0
Niigata
Query!
Country [420]
0
0
Japan
Query!
State/province [420]
0
0
Okayama
Query!
Country [421]
0
0
Japan
Query!
State/province [421]
0
0
Osaka
Query!
Country [422]
0
0
Japan
Query!
State/province [422]
0
0
Saitama
Query!
Country [423]
0
0
Japan
Query!
State/province [423]
0
0
Shimane
Query!
Country [424]
0
0
Japan
Query!
State/province [424]
0
0
Shizuoka
Query!
Country [425]
0
0
Japan
Query!
State/province [425]
0
0
Tokushima
Query!
Country [426]
0
0
Japan
Query!
State/province [426]
0
0
Yamaguchi
Query!
Country [427]
0
0
Japan
Query!
State/province [427]
0
0
Yokohama-shi
Query!
Country [428]
0
0
Korea, Republic of
Query!
State/province [428]
0
0
Busan
Query!
Country [429]
0
0
Korea, Republic of
Query!
State/province [429]
0
0
Daegu
Query!
Country [430]
0
0
Korea, Republic of
Query!
State/province [430]
0
0
Daejeon
Query!
Country [431]
0
0
Korea, Republic of
Query!
State/province [431]
0
0
Gangwon-do
Query!
Country [432]
0
0
Korea, Republic of
Query!
State/province [432]
0
0
Gwangju-si
Query!
Country [433]
0
0
Korea, Republic of
Query!
State/province [433]
0
0
Gyeonggi-do
Query!
Country [434]
0
0
Korea, Republic of
Query!
State/province [434]
0
0
Incheon
Query!
Country [435]
0
0
Korea, Republic of
Query!
State/province [435]
0
0
Pusan
Query!
Country [436]
0
0
Korea, Republic of
Query!
State/province [436]
0
0
Seoul
Query!
Country [437]
0
0
Mexico
Query!
State/province [437]
0
0
Jalisco
Query!
Country [438]
0
0
Mexico
Query!
State/province [438]
0
0
Veracruz
Query!
Country [439]
0
0
Mexico
Query!
State/province [439]
0
0
Aguascalientes
Query!
Country [440]
0
0
Mexico
Query!
State/province [440]
0
0
Chihuahua
Query!
Country [441]
0
0
Mexico
Query!
State/province [441]
0
0
Distrito Federal
Query!
Country [442]
0
0
Mexico
Query!
State/province [442]
0
0
Durango
Query!
Country [443]
0
0
Mexico
Query!
State/province [443]
0
0
Monterrey
Query!
Country [444]
0
0
Mexico
Query!
State/province [444]
0
0
San Luis Potosi
Query!
Country [445]
0
0
Mexico
Query!
State/province [445]
0
0
Yucatan
Query!
Country [446]
0
0
Netherlands
Query!
State/province [446]
0
0
Almere
Query!
Country [447]
0
0
Netherlands
Query!
State/province [447]
0
0
Amstelveen
Query!
Country [448]
0
0
Netherlands
Query!
State/province [448]
0
0
Amsterdam
Query!
Country [449]
0
0
Netherlands
Query!
State/province [449]
0
0
Dordrecht
Query!
Country [450]
0
0
Netherlands
Query!
State/province [450]
0
0
Eindhoven
Query!
Country [451]
0
0
Netherlands
Query!
State/province [451]
0
0
Ewijk
Query!
Country [452]
0
0
Netherlands
Query!
State/province [452]
0
0
Leiderdorp
Query!
Country [453]
0
0
Netherlands
Query!
State/province [453]
0
0
Maastricht
Query!
Country [454]
0
0
Netherlands
Query!
State/province [454]
0
0
Rotterdam
Query!
Country [455]
0
0
Netherlands
Query!
State/province [455]
0
0
Venlo
Query!
Country [456]
0
0
Netherlands
Query!
State/province [456]
0
0
Wildervlank
Query!
Country [457]
0
0
New Zealand
Query!
State/province [457]
0
0
Wellington
Query!
Country [458]
0
0
New Zealand
Query!
State/province [458]
0
0
Auckland
Query!
Country [459]
0
0
New Zealand
Query!
State/province [459]
0
0
Christchurch
Query!
Country [460]
0
0
New Zealand
Query!
State/province [460]
0
0
Dunedin
Query!
Country [461]
0
0
New Zealand
Query!
State/province [461]
0
0
Hamilton
Query!
Country [462]
0
0
New Zealand
Query!
State/province [462]
0
0
Nelson
Query!
Country [463]
0
0
New Zealand
Query!
State/province [463]
0
0
Tauranga
Query!
Country [464]
0
0
Norway
Query!
State/province [464]
0
0
Bodo
Query!
Country [465]
0
0
Norway
Query!
State/province [465]
0
0
Harstad
Query!
Country [466]
0
0
Norway
Query!
State/province [466]
0
0
Haugesund
Query!
Country [467]
0
0
Norway
Query!
State/province [467]
0
0
Oslo
Query!
Country [468]
0
0
Norway
Query!
State/province [468]
0
0
Rud
Query!
Country [469]
0
0
Peru
Query!
State/province [469]
0
0
Arequipa
Query!
Country [470]
0
0
Peru
Query!
State/province [470]
0
0
Callao
Query!
Country [471]
0
0
Peru
Query!
State/province [471]
0
0
Lima
Query!
Country [472]
0
0
Philippines
Query!
State/province [472]
0
0
Cebu City
Query!
Country [473]
0
0
Philippines
Query!
State/province [473]
0
0
Cebu
Query!
Country [474]
0
0
Philippines
Query!
State/province [474]
0
0
Davao City
Query!
Country [475]
0
0
Philippines
Query!
State/province [475]
0
0
Pasig City
Query!
Country [476]
0
0
Philippines
Query!
State/province [476]
0
0
Quezon City
Query!
Country [477]
0
0
Poland
Query!
State/province [477]
0
0
Mazowiecka
Query!
Country [478]
0
0
Poland
Query!
State/province [478]
0
0
Bydgoszcz
Query!
Country [479]
0
0
Poland
Query!
State/province [479]
0
0
Chojnice
Query!
Country [480]
0
0
Poland
Query!
State/province [480]
0
0
Elblag
Query!
Country [481]
0
0
Poland
Query!
State/province [481]
0
0
Elk
Query!
Country [482]
0
0
Poland
Query!
State/province [482]
0
0
Gdansk
Query!
Country [483]
0
0
Poland
Query!
State/province [483]
0
0
Inowroclaw
Query!
Country [484]
0
0
Poland
Query!
State/province [484]
0
0
Jaroslaw
Query!
Country [485]
0
0
Poland
Query!
State/province [485]
0
0
Katowice
Query!
Country [486]
0
0
Poland
Query!
State/province [486]
0
0
Kolobrzeg
Query!
Country [487]
0
0
Poland
Query!
State/province [487]
0
0
Komenskiego
Query!
Country [488]
0
0
Poland
Query!
State/province [488]
0
0
Krakow
Query!
Country [489]
0
0
Poland
Query!
State/province [489]
0
0
Kutno
Query!
Country [490]
0
0
Poland
Query!
State/province [490]
0
0
Libiaz
Query!
Country [491]
0
0
Poland
Query!
State/province [491]
0
0
Lodz
Query!
Country [492]
0
0
Poland
Query!
State/province [492]
0
0
Lubartow
Query!
Country [493]
0
0
Poland
Query!
State/province [493]
0
0
Lublin
Query!
Country [494]
0
0
Poland
Query!
State/province [494]
0
0
Plock
Query!
Country [495]
0
0
Poland
Query!
State/province [495]
0
0
Pomorskie
Query!
Country [496]
0
0
Poland
Query!
State/province [496]
0
0
Pulawy
Query!
Country [497]
0
0
Poland
Query!
State/province [497]
0
0
Ruda Slaska
Query!
Country [498]
0
0
Poland
Query!
State/province [498]
0
0
Rzeszow
Query!
Country [499]
0
0
Poland
Query!
State/province [499]
0
0
Skierniewice
Query!
Country [500]
0
0
Poland
Query!
State/province [500]
0
0
Sopot
Query!
Country [501]
0
0
Poland
Query!
State/province [501]
0
0
Sucharskiego
Query!
Country [502]
0
0
Poland
Query!
State/province [502]
0
0
Szczecin
Query!
Country [503]
0
0
Poland
Query!
State/province [503]
0
0
Tarnow
Query!
Country [504]
0
0
Poland
Query!
State/province [504]
0
0
Torun
Query!
Country [505]
0
0
Poland
Query!
State/province [505]
0
0
Warszawa
Query!
Country [506]
0
0
Poland
Query!
State/province [506]
0
0
Warzawa
Query!
Country [507]
0
0
Poland
Query!
State/province [507]
0
0
Wroclaw
Query!
Country [508]
0
0
Portugal
Query!
State/province [508]
0
0
Amadora
Query!
Country [509]
0
0
Portugal
Query!
State/province [509]
0
0
Aveiro
Query!
Country [510]
0
0
Portugal
Query!
State/province [510]
0
0
Braga
Query!
Country [511]
0
0
Portugal
Query!
State/province [511]
0
0
Coimbra
Query!
Country [512]
0
0
Portugal
Query!
State/province [512]
0
0
Leiria
Query!
Country [513]
0
0
Portugal
Query!
State/province [513]
0
0
Lisboa
Query!
Country [514]
0
0
Portugal
Query!
State/province [514]
0
0
Lisbon
Query!
Country [515]
0
0
Portugal
Query!
State/province [515]
0
0
Ponta Delgada
Query!
Country [516]
0
0
Portugal
Query!
State/province [516]
0
0
Setubal
Query!
Country [517]
0
0
Portugal
Query!
State/province [517]
0
0
Viseu
Query!
Country [518]
0
0
Romania
Query!
State/province [518]
0
0
Bacau
Query!
Country [519]
0
0
Romania
Query!
State/province [519]
0
0
Braila
Query!
Country [520]
0
0
Romania
Query!
State/province [520]
0
0
Brasov
Query!
Country [521]
0
0
Romania
Query!
State/province [521]
0
0
Buccuresti
Query!
Country [522]
0
0
Romania
Query!
State/province [522]
0
0
Bucuresti
Query!
Country [523]
0
0
Romania
Query!
State/province [523]
0
0
Buzau
Query!
Country [524]
0
0
Romania
Query!
State/province [524]
0
0
Covasna
Query!
Country [525]
0
0
Romania
Query!
State/province [525]
0
0
Dambovita
Query!
Country [526]
0
0
Romania
Query!
State/province [526]
0
0
Iasi
Query!
Country [527]
0
0
Romania
Query!
State/province [527]
0
0
Judetul Maramures
Query!
Country [528]
0
0
Romania
Query!
State/province [528]
0
0
Judetul Mures
Query!
Country [529]
0
0
Romania
Query!
State/province [529]
0
0
Judetul Suceava
Query!
Country [530]
0
0
Romania
Query!
State/province [530]
0
0
Judetul Vrancea
Query!
Country [531]
0
0
Romania
Query!
State/province [531]
0
0
Oradea
Query!
Country [532]
0
0
Romania
Query!
State/province [532]
0
0
Timisoara
Query!
Country [533]
0
0
Russian Federation
Query!
State/province [533]
0
0
Barnaul
Query!
Country [534]
0
0
Russian Federation
Query!
State/province [534]
0
0
Chelyabinsk
Query!
Country [535]
0
0
Russian Federation
Query!
State/province [535]
0
0
Kemerovo
Query!
Country [536]
0
0
Russian Federation
Query!
State/province [536]
0
0
Krasnoyarsk
Query!
Country [537]
0
0
Russian Federation
Query!
State/province [537]
0
0
Moscow
Query!
Country [538]
0
0
Russian Federation
Query!
State/province [538]
0
0
Nizhny Novgorod
Query!
Country [539]
0
0
Russian Federation
Query!
State/province [539]
0
0
Novosibirsk
Query!
Country [540]
0
0
Russian Federation
Query!
State/province [540]
0
0
Omsk
Query!
Country [541]
0
0
Russian Federation
Query!
State/province [541]
0
0
Orenburg
Query!
Country [542]
0
0
Russian Federation
Query!
State/province [542]
0
0
Perm
Query!
Country [543]
0
0
Russian Federation
Query!
State/province [543]
0
0
Ryazan
Query!
Country [544]
0
0
Russian Federation
Query!
State/province [544]
0
0
Saratov
Query!
Country [545]
0
0
Russian Federation
Query!
State/province [545]
0
0
Smolensk
Query!
Country [546]
0
0
Russian Federation
Query!
State/province [546]
0
0
St-Petersburg
Query!
Country [547]
0
0
Russian Federation
Query!
State/province [547]
0
0
St. Petersburg
Query!
Country [548]
0
0
Russian Federation
Query!
State/province [548]
0
0
Tula
Query!
Country [549]
0
0
Russian Federation
Query!
State/province [549]
0
0
Tyumen
Query!
Country [550]
0
0
Russian Federation
Query!
State/province [550]
0
0
Volgograd
Query!
Country [551]
0
0
Russian Federation
Query!
State/province [551]
0
0
Voronezh
Query!
Country [552]
0
0
Russian Federation
Query!
State/province [552]
0
0
Yaroslavl
Query!
Country [553]
0
0
Serbia
Query!
State/province [553]
0
0
Belgrade
Query!
Country [554]
0
0
Serbia
Query!
State/province [554]
0
0
Niska Banja
Query!
Country [555]
0
0
Serbia
Query!
State/province [555]
0
0
Nis
Query!
Country [556]
0
0
Serbia
Query!
State/province [556]
0
0
Sremska Kamenica
Query!
Country [557]
0
0
Serbia
Query!
State/province [557]
0
0
Zemun
Query!
Country [558]
0
0
Serbia
Query!
State/province [558]
0
0
Zmaj Jovina
Query!
Country [559]
0
0
Slovakia
Query!
State/province [559]
0
0
Bardejov
Query!
Country [560]
0
0
Slovakia
Query!
State/province [560]
0
0
Bratislava
Query!
Country [561]
0
0
Slovakia
Query!
State/province [561]
0
0
Dolny Kubin
Query!
Country [562]
0
0
Slovakia
Query!
State/province [562]
0
0
Galanta
Query!
Country [563]
0
0
Slovakia
Query!
State/province [563]
0
0
Kosice
Query!
Country [564]
0
0
Slovakia
Query!
State/province [564]
0
0
Levice
Query!
Country [565]
0
0
Slovakia
Query!
State/province [565]
0
0
Lucenec
Query!
Country [566]
0
0
Slovakia
Query!
State/province [566]
0
0
Nitra
Query!
Country [567]
0
0
Slovakia
Query!
State/province [567]
0
0
Nove Zamky
Query!
Country [568]
0
0
Slovakia
Query!
State/province [568]
0
0
Presov
Query!
Country [569]
0
0
Slovakia
Query!
State/province [569]
0
0
Rimavska Sobota
Query!
Country [570]
0
0
South Africa
Query!
State/province [570]
0
0
Alberton
Query!
Country [571]
0
0
South Africa
Query!
State/province [571]
0
0
Benoni
Query!
Country [572]
0
0
South Africa
Query!
State/province [572]
0
0
Bloemfontein
Query!
Country [573]
0
0
South Africa
Query!
State/province [573]
0
0
Cape Town
Query!
Country [574]
0
0
South Africa
Query!
State/province [574]
0
0
Diepkloof
Query!
Country [575]
0
0
South Africa
Query!
State/province [575]
0
0
Durban
Query!
Country [576]
0
0
South Africa
Query!
State/province [576]
0
0
Lyttelton
Query!
Country [577]
0
0
South Africa
Query!
State/province [577]
0
0
Parktown West
Query!
Country [578]
0
0
South Africa
Query!
State/province [578]
0
0
Port Elizabeth
Query!
Country [579]
0
0
South Africa
Query!
State/province [579]
0
0
Potchefstroom
Query!
Country [580]
0
0
South Africa
Query!
State/province [580]
0
0
Pretoria
Query!
Country [581]
0
0
South Africa
Query!
State/province [581]
0
0
Somerset West
Query!
Country [582]
0
0
South Africa
Query!
State/province [582]
0
0
Worcester
Query!
Country [583]
0
0
Spain
Query!
State/province [583]
0
0
Alcoy
Query!
Country [584]
0
0
Spain
Query!
State/province [584]
0
0
Almeria
Query!
Country [585]
0
0
Spain
Query!
State/province [585]
0
0
Barcelona
Query!
Country [586]
0
0
Spain
Query!
State/province [586]
0
0
Bilbao
Query!
Country [587]
0
0
Spain
Query!
State/province [587]
0
0
De La Castellana
Query!
Country [588]
0
0
Spain
Query!
State/province [588]
0
0
Donostia-San Sebastian
Query!
Country [589]
0
0
Spain
Query!
State/province [589]
0
0
Figueras
Query!
Country [590]
0
0
Spain
Query!
State/province [590]
0
0
Jaen
Query!
Country [591]
0
0
Spain
Query!
State/province [591]
0
0
La Coruna
Query!
Country [592]
0
0
Spain
Query!
State/province [592]
0
0
Lleida
Query!
Country [593]
0
0
Spain
Query!
State/province [593]
0
0
Madrid
Query!
Country [594]
0
0
Spain
Query!
State/province [594]
0
0
Murcia
Query!
Country [595]
0
0
Spain
Query!
State/province [595]
0
0
Santiago De Compostela
Query!
Country [596]
0
0
Spain
Query!
State/province [596]
0
0
Sevilla
Query!
Country [597]
0
0
Spain
Query!
State/province [597]
0
0
Vigo
Query!
Country [598]
0
0
Spain
Query!
State/province [598]
0
0
Vitoria
Query!
Country [599]
0
0
Sweden
Query!
State/province [599]
0
0
Alingsas
Query!
Country [600]
0
0
Sweden
Query!
State/province [600]
0
0
Enkoping
Query!
Country [601]
0
0
Sweden
Query!
State/province [601]
0
0
Goteborg
Query!
Country [602]
0
0
Sweden
Query!
State/province [602]
0
0
Halmstad
Query!
Country [603]
0
0
Sweden
Query!
State/province [603]
0
0
Karlshamn
Query!
Country [604]
0
0
Sweden
Query!
State/province [604]
0
0
Koping
Query!
Country [605]
0
0
Sweden
Query!
State/province [605]
0
0
Lindesberg
Query!
Country [606]
0
0
Sweden
Query!
State/province [606]
0
0
Lulea
Query!
Country [607]
0
0
Sweden
Query!
State/province [607]
0
0
Lund
Query!
Country [608]
0
0
Sweden
Query!
State/province [608]
0
0
Malmo
Query!
Country [609]
0
0
Sweden
Query!
State/province [609]
0
0
Molndal
Query!
Country [610]
0
0
Sweden
Query!
State/province [610]
0
0
Mora
Query!
Country [611]
0
0
Sweden
Query!
State/province [611]
0
0
Orebro
Query!
Country [612]
0
0
Sweden
Query!
State/province [612]
0
0
Skene
Query!
Country [613]
0
0
Sweden
Query!
State/province [613]
0
0
Umea
Query!
Country [614]
0
0
Sweden
Query!
State/province [614]
0
0
Uppsala
Query!
Country [615]
0
0
Sweden
Query!
State/province [615]
0
0
Varberg
Query!
Country [616]
0
0
Switzerland
Query!
State/province [616]
0
0
Lausanne
Query!
Country [617]
0
0
Switzerland
Query!
State/province [617]
0
0
Lugano
Query!
Country [618]
0
0
Taiwan
Query!
State/province [618]
0
0
Changhua City
Query!
Country [619]
0
0
Taiwan
Query!
State/province [619]
0
0
Hualien City
Query!
Country [620]
0
0
Taiwan
Query!
State/province [620]
0
0
Kaohsiung City
Query!
Country [621]
0
0
Taiwan
Query!
State/province [621]
0
0
Taichung City
Query!
Country [622]
0
0
Taiwan
Query!
State/province [622]
0
0
Taipei City
Query!
Country [623]
0
0
Taiwan
Query!
State/province [623]
0
0
Taipei
Query!
Country [624]
0
0
Taiwan
Query!
State/province [624]
0
0
Taoyuan County
Query!
Country [625]
0
0
Taiwan
Query!
State/province [625]
0
0
Yongkang City
Query!
Country [626]
0
0
Thailand
Query!
State/province [626]
0
0
Bangkok
Query!
Country [627]
0
0
Thailand
Query!
State/province [627]
0
0
Chang Mai
Query!
Country [628]
0
0
Thailand
Query!
State/province [628]
0
0
Khon Kaen
Query!
Country [629]
0
0
Thailand
Query!
State/province [629]
0
0
Nakhon Ratchasima
Query!
Country [630]
0
0
Thailand
Query!
State/province [630]
0
0
Pathumthani
Query!
Country [631]
0
0
Thailand
Query!
State/province [631]
0
0
Sai Mai
Query!
Country [632]
0
0
Thailand
Query!
State/province [632]
0
0
Songkhla
Query!
Country [633]
0
0
Turkey
Query!
State/province [633]
0
0
Adana
Query!
Country [634]
0
0
Turkey
Query!
State/province [634]
0
0
Ankara
Query!
Country [635]
0
0
Turkey
Query!
State/province [635]
0
0
Antalya
Query!
Country [636]
0
0
Turkey
Query!
State/province [636]
0
0
Aydin
Query!
Country [637]
0
0
Turkey
Query!
State/province [637]
0
0
Erzurum
Query!
Country [638]
0
0
Turkey
Query!
State/province [638]
0
0
Eskisehir
Query!
Country [639]
0
0
Turkey
Query!
State/province [639]
0
0
Isparta
Query!
Country [640]
0
0
Turkey
Query!
State/province [640]
0
0
Istanbul
Query!
Country [641]
0
0
Turkey
Query!
State/province [641]
0
0
Izmir
Query!
Country [642]
0
0
Turkey
Query!
State/province [642]
0
0
Konya
Query!
Country [643]
0
0
Turkey
Query!
State/province [643]
0
0
Sivas
Query!
Country [644]
0
0
Ukraine
Query!
State/province [644]
0
0
Cherkasy
Query!
Country [645]
0
0
Ukraine
Query!
State/province [645]
0
0
Chernigiv
Query!
Country [646]
0
0
Ukraine
Query!
State/province [646]
0
0
Dnipropetrovsk
Query!
Country [647]
0
0
Ukraine
Query!
State/province [647]
0
0
Donetsk
Query!
Country [648]
0
0
Ukraine
Query!
State/province [648]
0
0
Ivano-Frankivsh
Query!
Country [649]
0
0
Ukraine
Query!
State/province [649]
0
0
Ivano-Frankivsk
Query!
Country [650]
0
0
Ukraine
Query!
State/province [650]
0
0
Kharkiv
Query!
Country [651]
0
0
Ukraine
Query!
State/province [651]
0
0
Kherson
Query!
Country [652]
0
0
Ukraine
Query!
State/province [652]
0
0
Kyiv
Query!
Country [653]
0
0
Ukraine
Query!
State/province [653]
0
0
Lugansk
Query!
Country [654]
0
0
Ukraine
Query!
State/province [654]
0
0
Lutsk
Query!
Country [655]
0
0
Ukraine
Query!
State/province [655]
0
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Daiichi Sankyo
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The TIMI Study Group
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Summary
Brief summary
This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, \& Warfarin. The expected duration of the study is 24 months.
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Trial website
https://clinicaltrials.gov/study/NCT00781391
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Trial related presentations / publications
Bonaca MP, Antman EM, Cunningham JW, Wiviott SD, Murphy SA, Halperin JL, Weitz JI, Grosso MA, Lanz HJ, Braunwald E, Giugliano RP, Ruff CT. Ischaemic and bleeding risk in atrial fibrillation with and without peripheral artery disease and efficacy and safety of full- and half-dose edoxaban vs. warfarin: insights from ENGAGE AF-TIMI 48. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 29;8(7):695-706. doi: 10.1093/ehjcvp/pvab089. Oyama K, Giugliano RP, Berg DD, Ruff CT, Jarolim P, Tang M, Murphy SA, Lanz HJ, Grosso MA, Antman EM, Braunwald E, Morrow DA. Serial assessment of biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2021 May 1;42(17):1698-1706. doi: 10.1093/eurheartj/ehab141. Steffel J, Ruff CT, Yin O, Braunwald E, Park JG, Murphy SA, Connolly S, Antman EM, Giugliano RP. Randomized, Double-Blind Comparison of Half-Dose Versus Full-Dose Edoxaban in 14,014 Patients With Atrial Fibrillation. J Am Coll Cardiol. 2021 Mar 9;77(9):1197-1207. doi: 10.1016/j.jacc.2020.12.053. Wilkinson C, Wu J, Searle SD, Todd O, Hall M, Kunadian V, Clegg A, Rockwood K, Gale CP. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med. 2020 Dec 24;18(1):401. doi: 10.1186/s12916-020-01870-w. Vilain K, Li H, Kwong WJ, Antman EM, Ruff CT, Braunwald E, Cohen DJ, Giugliano RP, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006511. doi: 10.1161/CIRCOUTCOMES.120.006511. Epub 2020 Nov 5. Inciardi RM, Giugliano RP, Claggett B, Gupta DK, Chandra A, Ruff CT, Antman EM, Mercuri MF, Grosso MA, Braunwald E, Solomon SD; ENGAGE AF-TIMI 48 Investigators. Left atrial structure and function and the risk of death or heart failure in atrial fibrillation. Eur J Heart Fail. 2019 Dec;21(12):1571-1579. doi: 10.1002/ejhf.1606. Epub 2019 Nov 27. Bergmark BA, Kamphuisen PW, Wiviott SD, Ruff CT, Antman EM, Nordio F, Kuder JF, Mercuri MF, Lanz HJ, Braunwald E, Giugliano RP. Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial. Circulation. 2019 Nov 26;140(22):1792-1801. doi: 10.1161/CIRCULATIONAHA.119.041346. Epub 2019 Oct 10. Berg DD, Ruff CT, Jarolim P, Giugliano RP, Nordio F, Lanz HJ, Mercuri MF, Antman EM, Braunwald E, Morrow DA. Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48. Circulation. 2019 Feb 5;139(6):760-771. doi: 10.1161/CIRCULATIONAHA.118.038312. Corbalan R, Nicolau JC, Lopez-Sendon J, Garcia-Castillo A, Botero R, Sotomora G, Horna M, Ruff CT, Hamershock RA, Grip LT, Antman EM, Braunwald E, Giugliano RP. Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2018 Sep 25;72(13):1466-1475. doi: 10.1016/j.jacc.2018.07.037. Yin OQP, Antman EM, Braunwald E, Mercuri MF, Miller R, Morrow D, Ruff CT, Truitt K, Weitz JI, Giugliano RP. Linking Endogenous Factor Xa Activity, a Biologically Relevant Pharmacodynamic Marker, to Edoxaban Plasma Concentrations and Clinical Outcomes in the ENGAGE AF-TIMI 48 Trial. Circulation. 2018 Oct 30;138(18):1963-1973. doi: 10.1161/CIRCULATIONAHA.118.033933. Aisenberg J, Chatterjee-Murphy P, Friedman Flack K, Weitz JI, Ruff CT, Nordio F, Mercuri MF, Choi Y, Antman EM, Braunwald E, Giugliano RP. Gastrointestinal Bleeding With Edoxaban Versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction). Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003998. doi: 10.1161/CIRCOUTCOMES.117.003998. Wang K, Li H, Kwong WJ, Antman EM, Ruff CT, Giugliano RP, Cohen DJ, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Aug 11;6(8):e006703. doi: 10.1161/JAHA.117.006703. Eisen A, Ruff CT, Braunwald E, Hamershock RA, Lewis BS, Hassager C, Chao TF, Le Heuzey JY, Mercuri M, Rutman H, Antman EM, Giugliano RP. Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Jun 30;6(7):e006035. doi: 10.1161/JAHA.117.006035. De Caterina R, Renda G, Carnicelli AP, Nordio F, Trevisan M, Mercuri MF, Ruff CT, Antman EM, Braunwald E, Giugliano RP. Valvular Heart Disease Patients on Edoxaban or Warfarin in the ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2017 Mar 21;69(11):1372-1382. doi: 10.1016/j.jacc.2016.12.031. Erratum In: J Am Coll Cardiol. 2019 Feb 12;73(5):627. doi: 10.1016/j.jacc.2019.01.002. Link MS, Giugliano RP, Ruff CT, Scirica BM, Huikuri H, Oto A, Crompton AE, Murphy SA, Lanz H, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Stroke and Mortality Risk in Patients With Various Patterns of Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Circ Arrhythm Electrophysiol. 2017 Jan;10(1):e004267. doi: 10.1161/CIRCEP.116.004267. Ruff CT, Giugliano RP, Braunwald E, Murphy SA, Brown K, Jarolim P, Mercuri M, Antman EM, Morrow DA. Cardiovascular Biomarker Score and Clinical Outcomes in Patients With Atrial Fibrillation: A Subanalysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):999-1006. doi: 10.1001/jamacardio.2016.3311. Steffel J, Giugliano RP, Braunwald E, Murphy SA, Mercuri M, Choi Y, Aylward P, White H, Zamorano JL, Antman EM, Ruff CT. Edoxaban Versus Warfarin in Atrial Fibrillation Patients at Risk of Falling: ENGAGE AF-TIMI 48 Analysis. J Am Coll Cardiol. 2016 Sep 13;68(11):1169-1178. doi: 10.1016/j.jacc.2016.06.034. Erratum In: J Am Coll Cardiol. 2017 Jul 25;70(4):512-513. doi: 10.1016/j.jacc.2017.06.021. Eisen A, Ruff CT, Braunwald E, Nordio F, Corbalan R, Dalby A, Dorobantu M, Mercuri M, Lanz H, Rutman H, Wiviott SD, Antman EM, Giugliano RP. Sudden Cardiac Death in Patients With Atrial Fibrillation: Insights From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 Jul 8;5(7):e003735. doi: 10.1161/JAHA.116.003735. Rost NS, Giugliano RP, Ruff CT, Murphy SA, Crompton AE, Norden AD, Silverman S, Singhal AB, Nicolau JC, SomaRaju B, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Stroke. 2016 Aug;47(8):2075-82. doi: 10.1161/STROKEAHA.116.013540. Epub 2016 Jul 7. Bohula EA, Giugliano RP, Ruff CT, Kuder JF, Murphy SA, Antman EM, Braunwald E. Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial. Circulation. 2016 Jul 5;134(1):24-36. doi: 10.1161/CIRCULATIONAHA.116.022361. Kato ET, Giugliano RP, Ruff CT, Koretsune Y, Yamashita T, Kiss RG, Nordio F, Murphy SA, Kimura T, Jin J, Lanz H, Mercuri M, Braunwald E, Antman EM. Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 May 20;5(5):e003432. doi: 10.1161/JAHA.116.003432. Xu H, Ruff CT, Giugliano RP, Murphy SA, Nordio F, Patel I, Shi M, Mercuri M, Antman EM, Braunwald E. Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF-TIMI48 Trial. J Am Heart Assoc. 2016 Feb 23;5(2):e002587. doi: 10.1161/JAHA.115.002587. Ruff CT, Giugliano RP, Braunwald E, Morrow DA, Murphy SA, Kuder JF, Deenadayalu N, Jarolim P, Betcher J, Shi M, Brown K, Patel I, Mercuri M, Antman EM. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2288-95. doi: 10.1016/S0140-6736(14)61943-7. Epub 2015 Mar 11. Mega JL, Walker JR, Ruff CT, Vandell AG, Nordio F, Deenadayalu N, Murphy SA, Lee J, Mercuri MF, Giugliano RP, Antman EM, Braunwald E, Sabatine MS. Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2280-7. doi: 10.1016/S0140-6736(14)61994-2. Epub 2015 Mar 11. Ruff CT, Giugliano RP, Braunwald E, Mercuri M, Curt V, Betcher J, Grip L, Cange AL, Crompton AE, Murphy SA, Deenadayalu N, Antman EM. Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial. J Am Coll Cardiol. 2014 Aug 12;64(6):576-84. doi: 10.1016/j.jacc.2014.05.028. Giugliano RP, Ruff CT, Rost NS, Silverman S, Wiviott SD, Lowe C, Deenadayalu N, Murphy SA, Grip LT, Betcher JM, Duggal A, Dave J, Shi M, Mercuri M, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48. Stroke. 2014 Aug;45(8):2372-8. doi: 10.1161/STROKEAHA.114.006025. Epub 2014 Jun 19. Gupta DK, Shah AM, Giugliano RP, Ruff CT, Antman EM, Grip LT, Deenadayalu N, Hoffman E, Patel I, Shi M, Mercuri M, Mitrovic V, Braunwald E, Solomon SD; Effective aNticoaGulation with factor xA next GEneration in AF-Thrombolysis In Myocardial Infarction 48 Echocardiographic Study Investigators. Left atrial structure and function in atrial fibrillation: ENGAGE AF-TIMI 48. Eur Heart J. 2014 Jun 7;35(22):1457-65. doi: 10.1093/eurheartj/eht500. Epub 2013 Dec 2. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19. Salazar DE, Mendell J, Kastrissios H, Green M, Carrothers TJ, Song S, Patel I, Bocanegra TS, Antman EM, Giugliano RP, Kunitada S, Dornseif B, Shi M, Tachibana M, Zhou S, Rohatagi S. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012 May;107(5):925-36. doi: 10.1160/TH11-08-0566. Epub 2012 Mar 8. Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010 Oct;160(4):635-41. doi: 10.1016/j.ahj.2010.06.042.
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Public notes
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Contacts
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
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Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00781391