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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01147250
Registration number
NCT01147250
Ethics application status
Date submitted
17/06/2010
Date registered
22/06/2010
Date last updated
20/12/2016
Titles & IDs
Public title
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome
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Secondary ID [1]
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2009-012852-26
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Secondary ID [2]
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EFC11319
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Universal Trial Number (UTN)
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Trial acronym
ELIXA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lixisenatide (AVE0010)
Treatment: Drugs - Placebo
Placebo comparator: Placebo - Placebo matched to lixisenatide once daily (QD) up to end of treatment.
Experimental: Lixisenatide - Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.
Treatment: Drugs: Lixisenatide (AVE0010)
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.
Treatment: Drugs: Placebo
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina
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Assessment method [1]
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Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.
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Timepoint [1]
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From randomization up to the end of study (median follow-up of 25 months)
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Secondary outcome [1]
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Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure
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Assessment method [1]
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All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.
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Timepoint [1]
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From randomization up to the end of study (median follow-up of 25 months)
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Secondary outcome [2]
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Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure
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Assessment method [2]
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All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.
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Timepoint [2]
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From randomization up to the end of study (median follow-up of 25 months)
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Secondary outcome [3]
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Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108
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Assessment method [3]
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Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.
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Timepoint [3]
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Baseline to Week 108 (LOCF)
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable angina) with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an ACS which lead to admission to an acute care facility, within 180 days following the ACS event and prior to screening.
* Participants with a history of type 2 diabetes (for participants newly diagnosed, diagnosis was based on the World Health Organization (WHO) criteria: i.e., either a fasting venous plasma glucose concentration = 7.0 mmol/L [126 mg/dL] or 2-hour post glucose load venous plasma glucose = 11.1 mmol/L [200 mg/dL], confirmed on 2 occasions) prior to the screening visit.
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Minimum age
30
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
Exclusion criteria:
* Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.
* Glycosylated hemoglobin (HbA1c) <5.5 % or >11% measured at screening visit.
* Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the double-blind treatment period.
* Participants who had undergone coronary artery bypass graft (CABG) surgery following the qualifying ACS event.
* Participants who had undergone percutaneous coronary intervention (PCI) within 15 days prior to screening.
* Participants with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit.
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).
* Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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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 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
1/06/2010
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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
1/02/2015
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Sample size
Target
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Accrual to date
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Final
6068
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036015 - Epping
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Investigational Site Number 036001 - Fremantle
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Investigational Site Number 036009 - Geelong
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Investigational Site Number 036005 - St Leonards
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Investigational Site Number 036016 - Townsville
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3076 - Epping
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6160 - Fremantle
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3220 - Geelong
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6000 - Perth
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2065 - St Leonards
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4810 - Townsville
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Chile
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State/province [119]
0
0
Valdivia
Query!
Country [120]
0
0
Chile
Query!
State/province [120]
0
0
Valparaíso
Query!
Country [121]
0
0
Chile
Query!
State/province [121]
0
0
Vina Del Mar
Query!
Country [122]
0
0
Chile
Query!
State/province [122]
0
0
Viña Del Mar
Query!
Country [123]
0
0
China
Query!
State/province [123]
0
0
Beijing
Query!
Country [124]
0
0
China
Query!
State/province [124]
0
0
Dalian
Query!
Country [125]
0
0
China
Query!
State/province [125]
0
0
Guangzhou
Query!
Country [126]
0
0
China
Query!
State/province [126]
0
0
Jinan
Query!
Country [127]
0
0
China
Query!
State/province [127]
0
0
Nanjing
Query!
Country [128]
0
0
China
Query!
State/province [128]
0
0
Shanghai
Query!
Country [129]
0
0
China
Query!
State/province [129]
0
0
Shenyang
Query!
Country [130]
0
0
China
Query!
State/province [130]
0
0
Suzhou
Query!
Country [131]
0
0
China
Query!
State/province [131]
0
0
Urumchi
Query!
Country [132]
0
0
Colombia
Query!
State/province [132]
0
0
Armenia
Query!
Country [133]
0
0
Colombia
Query!
State/province [133]
0
0
Barranquilla
Query!
Country [134]
0
0
Colombia
Query!
State/province [134]
0
0
Bogota
Query!
Country [135]
0
0
Colombia
Query!
State/province [135]
0
0
Bucaramanga
Query!
Country [136]
0
0
Colombia
Query!
State/province [136]
0
0
Cali
Query!
Country [137]
0
0
Colombia
Query!
State/province [137]
0
0
Cartagena
Query!
Country [138]
0
0
Colombia
Query!
State/province [138]
0
0
Espinal - Tolima
Query!
Country [139]
0
0
Colombia
Query!
State/province [139]
0
0
Floridablanca
Query!
Country [140]
0
0
Colombia
Query!
State/province [140]
0
0
Manizales
Query!
Country [141]
0
0
Colombia
Query!
State/province [141]
0
0
Medellin
Query!
Country [142]
0
0
Colombia
Query!
State/province [142]
0
0
Pereira
Query!
Country [143]
0
0
Denmark
Query!
State/province [143]
0
0
Aarhus C
Query!
Country [144]
0
0
Denmark
Query!
State/province [144]
0
0
Aarhus
Query!
Country [145]
0
0
Denmark
Query!
State/province [145]
0
0
Esbjerg
Query!
Country [146]
0
0
Denmark
Query!
State/province [146]
0
0
Farsø
Query!
Country [147]
0
0
Denmark
Query!
State/province [147]
0
0
Hellerup
Query!
Country [148]
0
0
Denmark
Query!
State/province [148]
0
0
Herlev
Query!
Country [149]
0
0
Denmark
Query!
State/province [149]
0
0
Hillerød
Query!
Country [150]
0
0
Denmark
Query!
State/province [150]
0
0
Hvidovre
Query!
Country [151]
0
0
Denmark
Query!
State/province [151]
0
0
København Nv
Query!
Country [152]
0
0
Denmark
Query!
State/province [152]
0
0
København S
Query!
Country [153]
0
0
Denmark
Query!
State/province [153]
0
0
København Ø
Query!
Country [154]
0
0
Ecuador
Query!
State/province [154]
0
0
Guayaquil
Query!
Country [155]
0
0
Ecuador
Query!
State/province [155]
0
0
Quito
Query!
Country [156]
0
0
Egypt
Query!
State/province [156]
0
0
Alexandria
Query!
Country [157]
0
0
Egypt
Query!
State/province [157]
0
0
Cairo
Query!
Country [158]
0
0
Estonia
Query!
State/province [158]
0
0
Tallinn
Query!
Country [159]
0
0
Estonia
Query!
State/province [159]
0
0
Tartu
Query!
Country [160]
0
0
Estonia
Query!
State/province [160]
0
0
Viljandimaa
Query!
Country [161]
0
0
Finland
Query!
State/province [161]
0
0
Jyväskylä
Query!
Country [162]
0
0
Finland
Query!
State/province [162]
0
0
Rauma
Query!
Country [163]
0
0
Finland
Query!
State/province [163]
0
0
Tampere
Query!
Country [164]
0
0
Finland
Query!
State/province [164]
0
0
Turku
Query!
Country [165]
0
0
Finland
Query!
State/province [165]
0
0
Valkeakoski
Query!
Country [166]
0
0
Finland
Query!
State/province [166]
0
0
Vantaa
Query!
Country [167]
0
0
France
Query!
State/province [167]
0
0
Brest Cedex
Query!
Country [168]
0
0
France
Query!
State/province [168]
0
0
Corbeil Essonnes
Query!
Country [169]
0
0
France
Query!
State/province [169]
0
0
Nantes
Query!
Country [170]
0
0
France
Query!
State/province [170]
0
0
Nimes
Query!
Country [171]
0
0
France
Query!
State/province [171]
0
0
Paris Cedex 15
Query!
Country [172]
0
0
France
Query!
State/province [172]
0
0
Pessac
Query!
Country [173]
0
0
France
Query!
State/province [173]
0
0
Poitiers Cedex
Query!
Country [174]
0
0
France
Query!
State/province [174]
0
0
Rennes
Query!
Country [175]
0
0
France
Query!
State/province [175]
0
0
Toulouse Cedex 4
Query!
Country [176]
0
0
Georgia
Query!
State/province [176]
0
0
Batumi
Query!
Country [177]
0
0
Georgia
Query!
State/province [177]
0
0
Kutaisi
Query!
Country [178]
0
0
Georgia
Query!
State/province [178]
0
0
Tbilisi
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Berlin
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Bochum
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Chemnitz
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Dresden
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Elsterwerda
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Frankfurt A.M.
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Frankfurt Am Main
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Görlitz
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Haßloch
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Heidelberg
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Leipzig
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Magdeburg
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Mühldorf Am Inn
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Pirna
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Pohlheim
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Rotenburg An Der Fulda
Query!
Country [195]
0
0
Guatemala
Query!
State/province [195]
0
0
Guatemala
Query!
Country [196]
0
0
Guatemala
Query!
State/province [196]
0
0
Quetzaltenango
Query!
Country [197]
0
0
India
Query!
State/province [197]
0
0
Ahmedabad
Query!
Country [198]
0
0
India
Query!
State/province [198]
0
0
Bangalore
Query!
Country [199]
0
0
India
Query!
State/province [199]
0
0
Belgaum
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Chandigarh
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Cochin
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Gurgaon
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Hubli
Query!
Country [204]
0
0
India
Query!
State/province [204]
0
0
Hyderabad
Query!
Country [205]
0
0
India
Query!
State/province [205]
0
0
Jaipur
Query!
Country [206]
0
0
India
Query!
State/province [206]
0
0
Kolkata
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Lucknow
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
Ludhiana
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
Madurai
Query!
Country [210]
0
0
India
Query!
State/province [210]
0
0
Mangalore
Query!
Country [211]
0
0
India
Query!
State/province [211]
0
0
Manipal
Query!
Country [212]
0
0
India
Query!
State/province [212]
0
0
Mysore
Query!
Country [213]
0
0
India
Query!
State/province [213]
0
0
Nagpur
Query!
Country [214]
0
0
India
Query!
State/province [214]
0
0
Nashik
Query!
Country [215]
0
0
India
Query!
State/province [215]
0
0
Nasik
Query!
Country [216]
0
0
India
Query!
State/province [216]
0
0
New Delhi
Query!
Country [217]
0
0
India
Query!
State/province [217]
0
0
Pune
Query!
Country [218]
0
0
Israel
Query!
State/province [218]
0
0
Afula
Query!
Country [219]
0
0
Israel
Query!
State/province [219]
0
0
Givatayim
Query!
Country [220]
0
0
Israel
Query!
State/province [220]
0
0
Haifa
Query!
Country [221]
0
0
Israel
Query!
State/province [221]
0
0
Holon
Query!
Country [222]
0
0
Israel
Query!
State/province [222]
0
0
Jerusalem
Query!
Country [223]
0
0
Israel
Query!
State/province [223]
0
0
Nahariya
Query!
Country [224]
0
0
Israel
Query!
State/province [224]
0
0
Safed
Query!
Country [225]
0
0
Israel
Query!
State/province [225]
0
0
Tel Aviv
Query!
Country [226]
0
0
Israel
Query!
State/province [226]
0
0
Tel Hashomer
Query!
Country [227]
0
0
Israel
Query!
State/province [227]
0
0
Tzrifin
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Carpi
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
Chieri
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Chieti
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Fermo
Query!
Country [232]
0
0
Italy
Query!
State/province [232]
0
0
Firenze
Query!
Country [233]
0
0
Italy
Query!
State/province [233]
0
0
Genova
Query!
Country [234]
0
0
Italy
Query!
State/province [234]
0
0
Messina
Query!
Country [235]
0
0
Italy
Query!
State/province [235]
0
0
Milano
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Napoli
Query!
Country [237]
0
0
Italy
Query!
State/province [237]
0
0
Novara
Query!
Country [238]
0
0
Italy
Query!
State/province [238]
0
0
Palermo
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
Pisa
Query!
Country [240]
0
0
Italy
Query!
State/province [240]
0
0
Roma
Query!
Country [241]
0
0
Italy
Query!
State/province [241]
0
0
Rozzano
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Chuo-Ku
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Fuchu-Shi
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Fujisawa-Shi
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Hachioji-Shi
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Hakusan-Shi
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Hamamatsu-Shi
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Hitachi-Shi
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Itabashi-Ku
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Kawanishi-Shi
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Kobe-Shi
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Matsuyama-Shi
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Nagasaki-Shi
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Noda-Shi
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Osaka-Shi
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Sapporo-Shi
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Setagaya-Ku
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Shinagawa-Ku
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Shirakawa-Shi
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Suita-Shi
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Tachikawa-Shi
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Takasaki-Shi
Query!
Country [263]
0
0
Korea, Republic of
Query!
State/province [263]
0
0
Bucheon
Query!
Country [264]
0
0
Korea, Republic of
Query!
State/province [264]
0
0
Daegu
Query!
Country [265]
0
0
Korea, Republic of
Query!
State/province [265]
0
0
Gwangju
Query!
Country [266]
0
0
Korea, Republic of
Query!
State/province [266]
0
0
Incheon
Query!
Country [267]
0
0
Korea, Republic of
Query!
State/province [267]
0
0
Seongnam
Query!
Country [268]
0
0
Korea, Republic of
Query!
State/province [268]
0
0
Seoul
Query!
Country [269]
0
0
Korea, Republic of
Query!
State/province [269]
0
0
Wonju
Query!
Country [270]
0
0
Latvia
Query!
State/province [270]
0
0
Cesis
Query!
Country [271]
0
0
Latvia
Query!
State/province [271]
0
0
Daugavpils
Query!
Country [272]
0
0
Latvia
Query!
State/province [272]
0
0
Liepaja
Query!
Country [273]
0
0
Latvia
Query!
State/province [273]
0
0
Riga
Query!
Country [274]
0
0
Latvia
Query!
State/province [274]
0
0
Sigulda
Query!
Country [275]
0
0
Lithuania
Query!
State/province [275]
0
0
Kaunas
Query!
Country [276]
0
0
Lithuania
Query!
State/province [276]
0
0
Klaipeda
Query!
Country [277]
0
0
Lithuania
Query!
State/province [277]
0
0
Panevezys
Query!
Country [278]
0
0
Lithuania
Query!
State/province [278]
0
0
Vilnius
Query!
Country [279]
0
0
Mexico
Query!
State/province [279]
0
0
Acapulco
Query!
Country [280]
0
0
Mexico
Query!
State/province [280]
0
0
Aguascalientes
Query!
Country [281]
0
0
Mexico
Query!
State/province [281]
0
0
Chihuahua
Query!
Country [282]
0
0
Mexico
Query!
State/province [282]
0
0
Ciudad Madero
Query!
Country [283]
0
0
Mexico
Query!
State/province [283]
0
0
Durango
Query!
Country [284]
0
0
Mexico
Query!
State/province [284]
0
0
Guadalajara
Query!
Country [285]
0
0
Mexico
Query!
State/province [285]
0
0
Leon
Query!
Country [286]
0
0
Mexico
Query!
State/province [286]
0
0
Mexico City
Query!
Country [287]
0
0
Mexico
Query!
State/province [287]
0
0
Monterrey
Query!
Country [288]
0
0
Mexico
Query!
State/province [288]
0
0
Morelia
Query!
Country [289]
0
0
Mexico
Query!
State/province [289]
0
0
San Luis Potosi
Query!
Country [290]
0
0
Mexico
Query!
State/province [290]
0
0
Tlalnepantla
Query!
Country [291]
0
0
Mexico
Query!
State/province [291]
0
0
Xalapa
Query!
Country [292]
0
0
Netherlands
Query!
State/province [292]
0
0
Alkmaar
Query!
Country [293]
0
0
Netherlands
Query!
State/province [293]
0
0
Den Haag
Query!
Country [294]
0
0
Netherlands
Query!
State/province [294]
0
0
Deventer
Query!
Country [295]
0
0
Netherlands
Query!
State/province [295]
0
0
Hoorn
Query!
Country [296]
0
0
Netherlands
Query!
State/province [296]
0
0
Rotterdam
Query!
Country [297]
0
0
Netherlands
Query!
State/province [297]
0
0
Tilburg
Query!
Country [298]
0
0
Netherlands
Query!
State/province [298]
0
0
Venlo
Query!
Country [299]
0
0
Norway
Query!
State/province [299]
0
0
Bodø
Query!
Country [300]
0
0
Norway
Query!
State/province [300]
0
0
Haugesund
Query!
Country [301]
0
0
Norway
Query!
State/province [301]
0
0
Stavanger
Query!
Country [302]
0
0
Panama
Query!
State/province [302]
0
0
Cuidad De Panama
Query!
Country [303]
0
0
Panama
Query!
State/province [303]
0
0
La Chorrera
Query!
Country [304]
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0
Panama
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State/province [304]
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0
Penonome
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0
Peru
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0
Arequipa
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Country [306]
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0
Peru
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State/province [306]
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Callao
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Country [307]
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0
Peru
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0
Lima
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0
Philippines
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State/province [308]
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0
Cavite
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Country [309]
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0
Philippines
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State/province [309]
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0
Iligan City, Lanao Del Norte
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Country [310]
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0
Philippines
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State/province [310]
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0
Makati City
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Country [311]
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0
Philippines
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0
Manila
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0
Philippines
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State/province [312]
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0
Marikina City
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Country [313]
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0
Philippines
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State/province [313]
0
0
Pasay City
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Country [314]
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0
Philippines
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State/province [314]
0
0
Quezon City
Query!
Country [315]
0
0
Poland
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State/province [315]
0
0
?ód?
Query!
Country [316]
0
0
Poland
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State/province [316]
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0
Bialystok
Query!
Country [317]
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0
Poland
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0
Bydgoszcz
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Country [318]
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0
Poland
Query!
State/province [318]
0
0
Czeladz
Query!
Country [319]
0
0
Poland
Query!
State/province [319]
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0
Czestochowa
Query!
Country [320]
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0
Poland
Query!
State/province [320]
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0
Gdynia
Query!
Country [321]
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0
Poland
Query!
State/province [321]
0
0
Gliwice
Query!
Country [322]
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0
Poland
Query!
State/province [322]
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0
Grodzisk Mazowiecki
Query!
Country [323]
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0
Poland
Query!
State/province [323]
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0
Katowice
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Country [324]
0
0
Poland
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State/province [324]
0
0
Krakow
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Country [325]
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0
Poland
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State/province [325]
0
0
Leczyca
Query!
Country [326]
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0
Poland
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State/province [326]
0
0
Poland
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Country [327]
0
0
Poland
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State/province [327]
0
0
Pulawy
Query!
Country [328]
0
0
Poland
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State/province [328]
0
0
Ruda Slaska
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Country [329]
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0
Poland
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State/province [329]
0
0
Szczecin
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Country [330]
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0
Poland
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0
0
Warszawa
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0
Poland
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Wroclaw
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Country [332]
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0
Poland
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State/province [332]
0
0
Zgierz
Query!
Country [333]
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0
Portugal
Query!
State/province [333]
0
0
Amadora
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Country [334]
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0
Portugal
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0
Coimbra
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Country [335]
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0
Portugal
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0
Lisboa
Query!
Country [336]
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0
Portugal
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0
Penafiel
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0
Portugal
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State/province [337]
0
0
Porto
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Country [338]
0
0
Romania
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State/province [338]
0
0
Arad
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Country [339]
0
0
Romania
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0
Baia Mare
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Country [340]
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0
Romania
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0
Braila
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Country [341]
0
0
Romania
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State/province [341]
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0
Brasov
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Country [342]
0
0
Romania
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State/province [342]
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0
Bucharest
Query!
Country [343]
0
0
Romania
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State/province [343]
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0
Bucuresti
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Country [344]
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0
Romania
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State/province [344]
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0
Cluj Napoca
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0
Romania
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State/province [345]
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0
Craiova
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Country [346]
0
0
Romania
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0
0
Deva
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Country [347]
0
0
Romania
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State/province [347]
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0
Iasi
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Country [348]
0
0
Romania
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State/province [348]
0
0
Oradea
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Country [349]
0
0
Romania
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State/province [349]
0
0
Pitesti
Query!
Country [350]
0
0
Romania
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State/province [350]
0
0
Ploiesti
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Country [351]
0
0
Romania
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State/province [351]
0
0
Suceava
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Country [352]
0
0
Romania
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State/province [352]
0
0
Targu Mures
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Country [353]
0
0
Romania
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State/province [353]
0
0
Timisoara
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Country [354]
0
0
Russian Federation
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0
0
Barnaul
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Country [355]
0
0
Russian Federation
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State/province [355]
0
0
Kazan
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Country [356]
0
0
Russian Federation
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State/province [356]
0
0
Kemerovo
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Country [357]
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0
Russian Federation
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State/province [357]
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0
Krasnodar
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Country [358]
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0
Russian Federation
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0
Moscow
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Country [359]
0
0
Russian Federation
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State/province [359]
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Nizhny Novgorod
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Country [360]
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Russian Federation
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State/province [360]
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0
Novosibirsk
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Country [361]
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0
Russian Federation
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State/province [361]
0
0
Omsk
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Country [362]
0
0
Russian Federation
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State/province [362]
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0
Penza
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Country [363]
0
0
Russian Federation
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State/province [363]
0
0
Perm
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Country [364]
0
0
Russian Federation
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State/province [364]
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0
Rostov-Na-Donu
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0
Russian Federation
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State/province [365]
0
0
Ryazan
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Country [366]
0
0
Russian Federation
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State/province [366]
0
0
Saint-Petersburg
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Country [367]
0
0
Russian Federation
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State/province [367]
0
0
Saratov
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Country [368]
0
0
Russian Federation
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State/province [368]
0
0
Smolensk
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Country [369]
0
0
Russian Federation
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State/province [369]
0
0
St-Petersburg
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Country [370]
0
0
Russian Federation
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State/province [370]
0
0
Tomsk
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Country [371]
0
0
Russian Federation
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State/province [371]
0
0
Tver
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Country [372]
0
0
Russian Federation
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State/province [372]
0
0
Tyumen
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Country [373]
0
0
Russian Federation
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State/province [373]
0
0
Vladimir
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Country [374]
0
0
Russian Federation
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State/province [374]
0
0
Voronezh
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Country [375]
0
0
Russian Federation
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State/province [375]
0
0
Yaroslavl
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Country [376]
0
0
Serbia
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State/province [376]
0
0
Belgrade
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Country [377]
0
0
Serbia
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State/province [377]
0
0
Nis
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Country [378]
0
0
South Africa
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State/province [378]
0
0
Alberton
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Country [379]
0
0
South Africa
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State/province [379]
0
0
Cape Town
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Country [380]
0
0
South Africa
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State/province [380]
0
0
Chatsworth
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Country [381]
0
0
South Africa
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State/province [381]
0
0
Durban
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Country [382]
0
0
South Africa
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0
George
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Country [383]
0
0
South Africa
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State/province [383]
0
0
Kempton Park
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Country [384]
0
0
South Africa
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State/province [384]
0
0
Paarl
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Country [385]
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0
South Africa
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State/province [385]
0
0
Parow
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Country [386]
0
0
South Africa
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State/province [386]
0
0
Pretoria
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Country [387]
0
0
South Africa
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State/province [387]
0
0
Richards Bay
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Country [388]
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0
South Africa
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State/province [388]
0
0
Somerset West
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Country [389]
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0
South Africa
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State/province [389]
0
0
Worcester
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Country [390]
0
0
Spain
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State/province [390]
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0
Alcalá De Henares
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Country [391]
0
0
Spain
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State/province [391]
0
0
Almería
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Country [392]
0
0
Spain
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State/province [392]
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0
Barakaldo
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Country [393]
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0
Spain
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State/province [393]
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0
Barcelona
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Country [394]
0
0
Spain
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State/province [394]
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0
Bilbao
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Country [395]
0
0
Spain
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State/province [395]
0
0
Cáceres
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Country [396]
0
0
Spain
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State/province [396]
0
0
La Coruña
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Country [397]
0
0
Spain
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State/province [397]
0
0
Lérida
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Country [398]
0
0
Spain
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State/province [398]
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0
Madrid
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Country [399]
0
0
Spain
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State/province [399]
0
0
Murcia
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Country [400]
0
0
Spain
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State/province [400]
0
0
Oviedo
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Country [401]
0
0
Spain
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State/province [401]
0
0
Pontevedra
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Country [402]
0
0
Spain
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State/province [402]
0
0
Sevilla
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Country [403]
0
0
Spain
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State/province [403]
0
0
Valencia
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Country [404]
0
0
Spain
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State/province [404]
0
0
Vigo
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Country [405]
0
0
Sweden
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State/province [405]
0
0
Karlstad
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Country [406]
0
0
Sweden
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State/province [406]
0
0
Kristianstad
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Country [407]
0
0
Sweden
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State/province [407]
0
0
Ljungby
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Country [408]
0
0
Sweden
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State/province [408]
0
0
Oskarshamn
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Country [409]
0
0
Sweden
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State/province [409]
0
0
Stockholm
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Country [410]
0
0
Sweden
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State/province [410]
0
0
Växjö
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Country [411]
0
0
Switzerland
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0
Lugano
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Country [412]
0
0
Taiwan
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0
Chia-Yi
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0
Taiwan
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Taichung
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0
0
Taiwan
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0
Tainan Hsien
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0
Taiwan
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State/province [415]
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0
Taipei 111
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0
Taiwan
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State/province [416]
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0
Taipei Hsien
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0
Taiwan
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0
Taipei
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Country [418]
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0
Tunisia
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Sfax
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0
Tunisia
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0
Tunis
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Country [420]
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0
Turkey
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State/province [420]
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0
Ankara
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Country [421]
0
0
Turkey
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State/province [421]
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0
Capa / Istanbul
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Country [422]
0
0
Turkey
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Istanbul
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Country [423]
0
0
Turkey
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0
Izmir
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0
Turkey
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0
Mersin
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Country [425]
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0
Turkey
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0
Samsun
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Country [426]
0
0
Ukraine
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0
Chernivtsi
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Country [427]
0
0
Ukraine
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State/province [427]
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0
Dnepropetrovsk
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Country [428]
0
0
Ukraine
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State/province [428]
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0
Dnipropetrovsk
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Country [429]
0
0
Ukraine
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State/province [429]
0
0
Kharkiv
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Country [430]
0
0
Ukraine
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0
Kharkov
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Country [431]
0
0
Ukraine
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State/province [431]
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0
Kiev
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Country [432]
0
0
Ukraine
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State/province [432]
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0
Kyiv
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Country [433]
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Ukraine
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Lviv
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Country [434]
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0
Ukraine
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Odessa
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Country [435]
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0
United Arab Emirates
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Abu Dhabi
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United Arab Emirates
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Dubai
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Country [437]
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United Kingdom
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Antrim
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United Kingdom
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Ashton-Under-Lyne
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United Kingdom
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Barnstaple
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United Kingdom
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Bath
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Country [441]
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United Kingdom
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Birmingham
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United Kingdom
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Bolton
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Country [443]
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United Kingdom
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Bradford
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United Kingdom
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Carmarthen
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United Kingdom
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Chester
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United Kingdom
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Dumfries
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United Kingdom
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East Kilbride
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Harrogate
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United Kingdom
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Ipswich
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Country [452]
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United Kingdom
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Larbert
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Country [453]
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United Kingdom
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Liverpool
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Country [454]
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United Kingdom
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Londonderry
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Country [455]
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United Kingdom
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Manchester
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Country [456]
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United Kingdom
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Norwich
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Country [457]
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United Kingdom
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Nuneaton
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Country [458]
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0
United Kingdom
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Oldham
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Country [459]
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United Kingdom
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Salford
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Country [460]
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United Kingdom
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Stoke-On-Trent
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United Kingdom
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Swansea
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Country [462]
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United Kingdom
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Taunton
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Country [463]
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United Kingdom
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Truro
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Country [464]
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United Kingdom
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State/province [464]
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Wolverhampton
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Country [465]
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0
United Kingdom
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State/province [465]
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0
Yeovil
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objective: - To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event. Secondary Objectives: To demonstrate that when compared to placebo, lixisenatide can reduce: * composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure. * composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. * urinary albumin excretion (based on the urinary albumin/creatinine ratio). To assess the safety and tolerability of lixisenatide.
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Trial website
https://clinicaltrials.gov/study/NCT01147250
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Trial related presentations / publications
Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Kober LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12. Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225. Gerstein HC, Hess S, Claggett B, Dickstein K, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study. Diabetes Care. 2022 Sep 1;45(9):2152-2155. doi: 10.2337/dc22-0453. Wijkman MO, Claggett B, Diaz R, Gerstein HC, Kober L, Lewis E, Maggioni AP, Wolsk E, Aguilar D, Bentley-Lewis R, McMurray JJ, Probstfield J, Riddle M, Tardif JC, Solomon SD, Pfeffer MA. Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Cardiovasc Diabetol. 2020 Oct 12;19(1):175. doi: 10.1186/s12933-020-01150-0. Shin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25. Seferovic JP, Bentley-Lewis R, Claggett B, Diaz R, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Pfeffer MA. Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018. Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3. Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155. Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Kober L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6):e004743. doi: 10.1161/JAHA.116.004743. Wohlfart P, Linz W, Hubschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.
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Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerst...
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Results are available at
https://clinicaltrials.gov/study/NCT01147250
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