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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07000357
Registration number
NCT07000357
Ethics application status
Date submitted
30/05/2025
Date registered
2/06/2025
Date last updated
29/06/2025
Titles & IDs
Public title
A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event
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Scientific title
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event
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Secondary ID [1]
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2025-520519-14
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Secondary ID [2]
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D7960C00015
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Universal Trial Number (UTN)
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Trial acronym
AZURE-Outcomes
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD0780
Treatment: Drugs - Placebo
Experimental: AZD0780 - Participants will receive oral AZD0780 once daily
Placebo comparator: Placebo - Participants will receive oral placebo once daily
Treatment: Drugs: AZD0780
Participants will receive oral AZD0780 once daily
Treatment: Drugs: Placebo
Participants will receive oral placebo once daily
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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 event of any component of MACE-PLUS
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Assessment method [1]
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To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS (the composite of CV death, myocardial infarction \[MI\], ischaemic stroke, acute lower limb ischemia, major amputation of a vascular aetiology, and urgent arterial revascularisation)
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Timepoint [1]
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Up to approximately 54 months
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Secondary outcome [1]
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Time to first event of any component of 3P MACE
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Assessment method [1]
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To compare the effect of treatment with AZD0780 to placebo in reducing the risk of 3-point (3P)-MACE (the composite of CV death, MI, and ischaemic stroke)
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Timepoint [1]
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Up to approximately 54 months
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Secondary outcome [2]
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Time to first event of any component of MACE PLUS
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Assessment method [2]
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To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS in patients with a history of ASCVD
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Timepoint [2]
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Up to approximately 54 months
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Secondary outcome [3]
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Time to first event of MI
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Assessment method [3]
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To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MI
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Timepoint [3]
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Up to approximately 54 months
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Secondary outcome [4]
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Time to first event of urgent coronary revascularisation
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Assessment method [4]
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To compare the effect of treatment with AZD0780 to placebo in reducing the risk of urgent coronary revascularisation
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Timepoint [4]
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Up to approximately 54 months
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Secondary outcome [5]
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Time to CV death
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Assessment method [5]
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To compare the effect of treatment with AZD0780 to placebo in reducing the risk of CV death
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Timepoint [5]
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Up to approximately 54 months
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Secondary outcome [6]
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Time to first event of MALE
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Assessment method [6]
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To compare the effect of treatment with AZD0780 to placebo in reducing the risk of major adverse limb event (MALE) (the composite of acute lower limb ischemia, major amputation of vascular aetiology, and urgent lower extremity revascularisation)
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Timepoint [6]
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Up to approximately 54 months
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Secondary outcome [7]
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Time to all-cause mortality
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Assessment method [7]
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To compare the effect of treatment with AZD0780 to placebo in reducing the risk of all-cause mortality
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Timepoint [7]
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Up to approximately 54 months
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Eligibility
Key inclusion criteria
* Meets one of the following:
1. Participants with history of an ASCVD event: Participants = 18 years of age at the time of signing the ICF with a history of ASCVD defined as ACS within 1 to 12 months prior to randomisation, or large artery ischaemic stroke suspected to be due to atherosclerotic vascular disease within 1 to 12 months prior to randomisation, or revascularisation for symptomatic lower limb PAD, and LDL-C = 60 mg/dL (= 1.55 mmol/L).
Additional risk factors based on the level of the screening LDL-C:
o Participants with an LDL-C = 75 mg/dL (= 1.9 mmol/L) need to have at least one of the other additional risk factors below.
* T2DM requiring ongoing medical therapy
* Age = 65 years
* Previous above ankle amputation due to PAD
* Previous diagnosis of non-end stage CKD
2. Participants at increased risk of a first ASCVD event: Male participant = 50 years of age or female participant = 55 years of age at the time of signing the ICF with LDL-C = 100 mg/dL (= 2.6 mmol/L) and diagnostic evidence of at least one of the following disease categories (i, ii, or iii):
i) Significant atherosclerotic artery disease
ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of end-organ disease (diabetic nephropathy, retinopathy, neuropathy or an ABI outside the normal range [0.9 to 1.4])
iii) Documented atherosclerosis of less significance
For ii) and iii), participants need to have at least one of the additional risk factors below:
1. CKD with eGFR = xx mL/min/1.73 m2
2. Current tobacco use
3. Age = 65
4. T2DM (if included on the less significant atherosclerosis criterion iii)
* Participant should be receiving a maximally tolerated lipid-lowering regimen including a maximally tolerated dose of a statin.
1. Participants who are judged by the treating physician not to tolerate high-intensity statins (according to guidelines, typically, atorvastatin = 40 mg once daily or rosuvastatin = 20 mg once daily) may be included if treated with a low or moderate intensity statin dose.
2. Participants not receiving any statins must have documented intolerable side effects to at least 2 different statins, including one at the lowest standard dose or on a chronic medication that would prohibit the use of a statin (according to the prescribing information for the statin in question).
3. Participants must achieve a stable dose (> 28 days) of lipid-lowering therapies before screening.
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Minimum age
18
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:
* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.
* Any revascularisation procedure planned within the next 3 months.
* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.
* Calculated eGFR < 15 mL /min/1.73 m2
* Any laboratory values with the following deviations at screening:
* AST or ALT > 3 × ULN
* TBL > 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN)
* Fasting triglycerides = 400 mg/dL (= 4.52 mmol/L).
* Creatine kinase > 5 × ULN
* Urine albumin/creatinine ratio = 500 mg/g
* Uncontrolled T2DM defined as HbA1c = 9.5% at screening.
* Inadequately treated hypothyroidism defined as TSH > 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.
* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.
* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.
* Use of PCSK9 inhibitors: evolocumab/alirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.
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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 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
Recruiting
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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
4/06/2025
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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
24/10/2029
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Actual
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Sample size
Target
15100
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Accrual to date
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Final
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0
0
Herlev
Query!
Country [116]
0
0
Denmark
Query!
State/province [116]
0
0
Herning
Query!
Country [117]
0
0
Denmark
Query!
State/province [117]
0
0
Hillerød
Query!
Country [118]
0
0
Denmark
Query!
State/province [118]
0
0
Hvidovre
Query!
Country [119]
0
0
Denmark
Query!
State/province [119]
0
0
København
Query!
Country [120]
0
0
Denmark
Query!
State/province [120]
0
0
Roskilde
Query!
Country [121]
0
0
Denmark
Query!
State/province [121]
0
0
Slagelse
Query!
Country [122]
0
0
Denmark
Query!
State/province [122]
0
0
Svendborg
Query!
Country [123]
0
0
Denmark
Query!
State/province [123]
0
0
Vejle
Query!
Country [124]
0
0
Denmark
Query!
State/province [124]
0
0
Viborg
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Bordeaux
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Brest Cedex
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Bron
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Corbeil-Essonnes
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Dijon Cedex
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Dijon
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
La Tronche
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Lille
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Limoges
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Lyon
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Marseille
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Montpellier
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Narbonne CEDEX
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Paris 14
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
PARIS Cedex 15
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Paris
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Rennes Cedex 9
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Rouen
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Strasbourg Cedex
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Toulouse
Query!
Country [145]
0
0
France
Query!
State/province [145]
0
0
TOURS Cedex 9
Query!
Country [146]
0
0
France
Query!
State/province [146]
0
0
Valenciennes
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Bad Friedrichshall
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Bad Homburg
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Bad Oeynhausen
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Berlin-Lichtenberg
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Berlin
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Bielefeld
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Bonn
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Bremen
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Bruchsal
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Chemnitz
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Dresden
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Duesseldorf
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Erlangen
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Essen
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Frankfurt
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Freiburg
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Fulda
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Greifswald
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Göttingen
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Hamburg
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Hannover
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Haßloch
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Heidelberg
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Heilbronn
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Herne
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Hohenmölsen
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Jena
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Jerichow
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Kaiserslautern
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Kamp Lintfort
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Karlsbad
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Karlsruhe
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Kiel
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Leipzig
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Ludwigshafen
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Luebeck
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Magdeburg
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Mainz
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Mannheim
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Markkleeberg
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Muenster
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Munich
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
München
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Münster
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Nuernberg
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Obertshausen
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Offenbach am Main
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Osnabrück
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Potsdam
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Regensburg
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Rotenburg A.d. Fulda
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Rüsselsheim am Main
Query!
Country [199]
0
0
Germany
Query!
State/province [199]
0
0
Schwerin
Query!
Country [200]
0
0
Germany
Query!
State/province [200]
0
0
Speyer
Query!
Country [201]
0
0
Germany
Query!
State/province [201]
0
0
Stuhr
Query!
Country [202]
0
0
Germany
Query!
State/province [202]
0
0
Stuttgart
Query!
Country [203]
0
0
Germany
Query!
State/province [203]
0
0
Trier
Query!
Country [204]
0
0
Germany
Query!
State/province [204]
0
0
Weinheim
Query!
Country [205]
0
0
Germany
Query!
State/province [205]
0
0
Wermsdorf
Query!
Country [206]
0
0
Germany
Query!
State/province [206]
0
0
Wiesbaden
Query!
Country [207]
0
0
Germany
Query!
State/province [207]
0
0
Witten
Query!
Country [208]
0
0
Greece
Query!
State/province [208]
0
0
Alexandroupolis
Query!
Country [209]
0
0
Greece
Query!
State/province [209]
0
0
Athens
Query!
Country [210]
0
0
Greece
Query!
State/province [210]
0
0
Chios
Query!
Country [211]
0
0
Greece
Query!
State/province [211]
0
0
Heraklion
Query!
Country [212]
0
0
Greece
Query!
State/province [212]
0
0
Ioannina
Query!
Country [213]
0
0
Greece
Query!
State/province [213]
0
0
Larissa
Query!
Country [214]
0
0
Greece
Query!
State/province [214]
0
0
Piraeus
Query!
Country [215]
0
0
Greece
Query!
State/province [215]
0
0
Thessaloniki
Query!
Country [216]
0
0
Hungary
Query!
State/province [216]
0
0
Balatonfüred
Query!
Country [217]
0
0
Hungary
Query!
State/province [217]
0
0
Budapest
Query!
Country [218]
0
0
Hungary
Query!
State/province [218]
0
0
Békéscsaba
Query!
Country [219]
0
0
Hungary
Query!
State/province [219]
0
0
Debrecen
Query!
Country [220]
0
0
Hungary
Query!
State/province [220]
0
0
Encs
Query!
Country [221]
0
0
Hungary
Query!
State/province [221]
0
0
Kalocsa
Query!
Country [222]
0
0
Hungary
Query!
State/province [222]
0
0
Kaposvár
Query!
Country [223]
0
0
Hungary
Query!
State/province [223]
0
0
Nyíregyháza-Sóstóhegy
Query!
Country [224]
0
0
Hungary
Query!
State/province [224]
0
0
Nyíregyháza
Query!
Country [225]
0
0
Hungary
Query!
State/province [225]
0
0
Pécs
Query!
Country [226]
0
0
Hungary
Query!
State/province [226]
0
0
Szeged
Query!
Country [227]
0
0
Hungary
Query!
State/province [227]
0
0
Szekszárd
Query!
Country [228]
0
0
Hungary
Query!
State/province [228]
0
0
Szolnok
Query!
Country [229]
0
0
Hungary
Query!
State/province [229]
0
0
Székesfehérvár
Query!
Country [230]
0
0
Hungary
Query!
State/province [230]
0
0
Veszprém
Query!
Country [231]
0
0
Hungary
Query!
State/province [231]
0
0
Zalaegerszeg
Query!
Country [232]
0
0
India
Query!
State/province [232]
0
0
Ahamadabad
Query!
Country [233]
0
0
India
Query!
State/province [233]
0
0
Bangalore
Query!
Country [234]
0
0
India
Query!
State/province [234]
0
0
Belagavi
Query!
Country [235]
0
0
India
Query!
State/province [235]
0
0
Dehradun
Query!
Country [236]
0
0
India
Query!
State/province [236]
0
0
Delhi
Query!
Country [237]
0
0
India
Query!
State/province [237]
0
0
Dwarka
Query!
Country [238]
0
0
India
Query!
State/province [238]
0
0
Gurgaon
Query!
Country [239]
0
0
India
Query!
State/province [239]
0
0
Hydarabad
Query!
Country [240]
0
0
India
Query!
State/province [240]
0
0
Hyderabad
Query!
Country [241]
0
0
India
Query!
State/province [241]
0
0
Kanpur
Query!
Country [242]
0
0
India
Query!
State/province [242]
0
0
Kochi
Query!
Country [243]
0
0
India
Query!
State/province [243]
0
0
Kolkata
Query!
Country [244]
0
0
India
Query!
State/province [244]
0
0
Ludhiana
Query!
Country [245]
0
0
India
Query!
State/province [245]
0
0
Manipal
Query!
Country [246]
0
0
India
Query!
State/province [246]
0
0
Mumbai
Query!
Country [247]
0
0
India
Query!
State/province [247]
0
0
Nagpur
Query!
Country [248]
0
0
India
Query!
State/province [248]
0
0
New Dehli
Query!
Country [249]
0
0
India
Query!
State/province [249]
0
0
New Delhi
Query!
Country [250]
0
0
India
Query!
State/province [250]
0
0
Vadodara
Query!
Country [251]
0
0
India
Query!
State/province [251]
0
0
Vijayawada
Query!
Country [252]
0
0
Italy
Query!
State/province [252]
0
0
Arzignano
Query!
Country [253]
0
0
Italy
Query!
State/province [253]
0
0
Bergamo
Query!
Country [254]
0
0
Italy
Query!
State/province [254]
0
0
Bologna
Query!
Country [255]
0
0
Italy
Query!
State/province [255]
0
0
Brescia
Query!
Country [256]
0
0
Italy
Query!
State/province [256]
0
0
Caserta
Query!
Country [257]
0
0
Italy
Query!
State/province [257]
0
0
Catania
Query!
Country [258]
0
0
Italy
Query!
State/province [258]
0
0
Cona
Query!
Country [259]
0
0
Italy
Query!
State/province [259]
0
0
Foggia
Query!
Country [260]
0
0
Italy
Query!
State/province [260]
0
0
Genoa
Query!
Country [261]
0
0
Italy
Query!
State/province [261]
0
0
Lecco
Query!
Country [262]
0
0
Italy
Query!
State/province [262]
0
0
Milano
Query!
Country [263]
0
0
Italy
Query!
State/province [263]
0
0
Napoli
Query!
Country [264]
0
0
Italy
Query!
State/province [264]
0
0
Novara
Query!
Country [265]
0
0
Italy
Query!
State/province [265]
0
0
Parma
Query!
Country [266]
0
0
Italy
Query!
State/province [266]
0
0
Pavia
Query!
Country [267]
0
0
Italy
Query!
State/province [267]
0
0
Perugia
Query!
Country [268]
0
0
Italy
Query!
State/province [268]
0
0
Pordenone
Query!
Country [269]
0
0
Italy
Query!
State/province [269]
0
0
Rivoli
Query!
Country [270]
0
0
Italy
Query!
State/province [270]
0
0
Roma
Query!
Country [271]
0
0
Italy
Query!
State/province [271]
0
0
Rozzano
Query!
Country [272]
0
0
Italy
Query!
State/province [272]
0
0
Torino
Query!
Country [273]
0
0
Japan
Query!
State/province [273]
0
0
Ami-machi
Query!
Country [274]
0
0
Japan
Query!
State/province [274]
0
0
Asahi-shi
Query!
Country [275]
0
0
Japan
Query!
State/province [275]
0
0
Chuo-ku
Query!
Country [276]
0
0
Japan
Query!
State/province [276]
0
0
Fujisawa-shi
Query!
Country [277]
0
0
Japan
Query!
State/province [277]
0
0
Hamamatsu-shi
Query!
Country [278]
0
0
Japan
Query!
State/province [278]
0
0
Higashiyamato-shi
Query!
Country [279]
0
0
Japan
Query!
State/province [279]
0
0
Hiroshima-shi
Query!
Country [280]
0
0
Japan
Query!
State/province [280]
0
0
Ichikawa-shi
Query!
Country [281]
0
0
Japan
Query!
State/province [281]
0
0
Kamakura
Query!
Country [282]
0
0
Japan
Query!
State/province [282]
0
0
Kanazawa-shi
Query!
Country [283]
0
0
Japan
Query!
State/province [283]
0
0
Kanoya-shi
Query!
Country [284]
0
0
Japan
Query!
State/province [284]
0
0
Kashiwara-shi
Query!
Country [285]
0
0
Japan
Query!
State/province [285]
0
0
Kasuya-gun
Query!
Country [286]
0
0
Japan
Query!
State/province [286]
0
0
Kishiwada-shi
Query!
Country [287]
0
0
Japan
Query!
State/province [287]
0
0
Kitakyushu
Query!
Country [288]
0
0
Japan
Query!
State/province [288]
0
0
Kobe-shi
Query!
Country [289]
0
0
Japan
Query!
State/province [289]
0
0
Kobe
Query!
Country [290]
0
0
Japan
Query!
State/province [290]
0
0
Koga-shi
Query!
Country [291]
0
0
Japan
Query!
State/province [291]
0
0
Komatsu-shi
Query!
Country [292]
0
0
Japan
Query!
State/province [292]
0
0
Kumamoto-shi
Query!
Country [293]
0
0
Japan
Query!
State/province [293]
0
0
Kure-shi
Query!
Country [294]
0
0
Japan
Query!
State/province [294]
0
0
Kyoto-shi
Query!
Country [295]
0
0
Japan
Query!
State/province [295]
0
0
Matsuyama-city
Query!
Country [296]
0
0
Japan
Query!
State/province [296]
0
0
Minato-ku
Query!
Country [297]
0
0
Japan
Query!
State/province [297]
0
0
Miyakonojo-shi
Query!
Country [298]
0
0
Japan
Query!
State/province [298]
0
0
Miyazaki
Query!
Country [299]
0
0
Japan
Query!
State/province [299]
0
0
Nagasaki-shi
Query!
Country [300]
0
0
Japan
Query!
State/province [300]
0
0
Nakagami-gun
Query!
Country [301]
0
0
Japan
Query!
State/province [301]
0
0
Niigata-shi
Query!
Country [302]
0
0
Japan
Query!
State/province [302]
0
0
Obu
Query!
Country [303]
0
0
Japan
Query!
State/province [303]
0
0
Oita-shi
Query!
Country [304]
0
0
Japan
Query!
State/province [304]
0
0
Okayama-shi
Query!
Country [305]
0
0
Japan
Query!
State/province [305]
0
0
Omura-shi
Query!
Country [306]
0
0
Japan
Query!
State/province [306]
0
0
Osaka-shi
Query!
Country [307]
0
0
Japan
Query!
State/province [307]
0
0
Sapporo-shi
Query!
Country [308]
0
0
Japan
Query!
State/province [308]
0
0
Shinjuku-ku
Query!
Country [309]
0
0
Japan
Query!
State/province [309]
0
0
Suita-shi
Query!
Country [310]
0
0
Japan
Query!
State/province [310]
0
0
Suwa-shi
Query!
Country [311]
0
0
Japan
Query!
State/province [311]
0
0
Tamana-shi
Query!
Country [312]
0
0
Japan
Query!
State/province [312]
0
0
Tanabe-shi
Query!
Country [313]
0
0
Japan
Query!
State/province [313]
0
0
Tokushima-shi
Query!
Country [314]
0
0
Japan
Query!
State/province [314]
0
0
Toride-shi
Query!
Country [315]
0
0
Japan
Query!
State/province [315]
0
0
Tsukuba-shi
Query!
Country [316]
0
0
Japan
Query!
State/province [316]
0
0
Urasoe-Shi
Query!
Country [317]
0
0
Japan
Query!
State/province [317]
0
0
Urayasu-shi
Query!
Country [318]
0
0
Japan
Query!
State/province [318]
0
0
Ushiku-shi
Query!
Country [319]
0
0
Japan
Query!
State/province [319]
0
0
Utsunomiya-shi
Query!
Country [320]
0
0
Japan
Query!
State/province [320]
0
0
Yokohama City
Query!
Country [321]
0
0
Japan
Query!
State/province [321]
0
0
Yokohama-shi
Query!
Country [322]
0
0
Korea, Republic of
Query!
State/province [322]
0
0
Bucheon-si
Query!
Country [323]
0
0
Korea, Republic of
Query!
State/province [323]
0
0
Busan
Query!
Country [324]
0
0
Korea, Republic of
Query!
State/province [324]
0
0
Changwon-si
Query!
Country [325]
0
0
Korea, Republic of
Query!
State/province [325]
0
0
Daegu
Query!
Country [326]
0
0
Korea, Republic of
Query!
State/province [326]
0
0
Daejeon
Query!
Country [327]
0
0
Korea, Republic of
Query!
State/province [327]
0
0
Goyang-si
Query!
Country [328]
0
0
Korea, Republic of
Query!
State/province [328]
0
0
Gwangju
Query!
Country [329]
0
0
Korea, Republic of
Query!
State/province [329]
0
0
Gwangmyeong-si
Query!
Country [330]
0
0
Korea, Republic of
Query!
State/province [330]
0
0
Jung-gu
Query!
Country [331]
0
0
Korea, Republic of
Query!
State/province [331]
0
0
Seoul
Query!
Country [332]
0
0
Korea, Republic of
Query!
State/province [332]
0
0
Suncheon
Query!
Country [333]
0
0
Korea, Republic of
Query!
State/province [333]
0
0
Yongin-si
Query!
Country [334]
0
0
Malaysia
Query!
State/province [334]
0
0
Alor Setar
Query!
Country [335]
0
0
Malaysia
Query!
State/province [335]
0
0
George Town
Query!
Country [336]
0
0
Malaysia
Query!
State/province [336]
0
0
Kajang
Query!
Country [337]
0
0
Malaysia
Query!
State/province [337]
0
0
Kota Kinabalu
Query!
Country [338]
0
0
Malaysia
Query!
State/province [338]
0
0
Kota Samarahan
Query!
Country [339]
0
0
Malaysia
Query!
State/province [339]
0
0
Kuala Lumpur
Query!
Country [340]
0
0
Malaysia
Query!
State/province [340]
0
0
Kuala Terengganu
Query!
Country [341]
0
0
Malaysia
Query!
State/province [341]
0
0
Kuantan
Query!
Country [342]
0
0
Malaysia
Query!
State/province [342]
0
0
Kuching
Query!
Country [343]
0
0
Malaysia
Query!
State/province [343]
0
0
Sarawak Miri
Query!
Country [344]
0
0
Malaysia
Query!
State/province [344]
0
0
Seri Manjung
Query!
Country [345]
0
0
Mexico
Query!
State/province [345]
0
0
Acapulco
Query!
Country [346]
0
0
Mexico
Query!
State/province [346]
0
0
Aguascalientes
Query!
Country [347]
0
0
Mexico
Query!
State/province [347]
0
0
Chihuahua
Query!
Country [348]
0
0
Mexico
Query!
State/province [348]
0
0
Ciudad de México
Query!
Country [349]
0
0
Mexico
Query!
State/province [349]
0
0
Cuauhtemoc
Query!
Country [350]
0
0
Mexico
Query!
State/province [350]
0
0
Cuernavaca
Query!
Country [351]
0
0
Mexico
Query!
State/province [351]
0
0
Culiacan
Query!
Country [352]
0
0
Mexico
Query!
State/province [352]
0
0
Guadalajara
Query!
Country [353]
0
0
Mexico
Query!
State/province [353]
0
0
Mexico City
Query!
Country [354]
0
0
Mexico
Query!
State/province [354]
0
0
Mexico
Query!
Country [355]
0
0
Mexico
Query!
State/province [355]
0
0
Monterey
Query!
Country [356]
0
0
Mexico
Query!
State/province [356]
0
0
Monterrey
Query!
Country [357]
0
0
Mexico
Query!
State/province [357]
0
0
México
Query!
Country [358]
0
0
Mexico
Query!
State/province [358]
0
0
Querétaro
Query!
Country [359]
0
0
Mexico
Query!
State/province [359]
0
0
San Juan del Rio
Query!
Country [360]
0
0
Mexico
Query!
State/province [360]
0
0
Veracruz
Query!
Country [361]
0
0
Mexico
Query!
State/province [361]
0
0
Zapopan
Query!
Country [362]
0
0
New Zealand
Query!
State/province [362]
0
0
Auckland
Query!
Country [363]
0
0
New Zealand
Query!
State/province [363]
0
0
Christchurch
Query!
Country [364]
0
0
New Zealand
Query!
State/province [364]
0
0
Ebdentown
Query!
Country [365]
0
0
New Zealand
Query!
State/province [365]
0
0
Grafton
Query!
Country [366]
0
0
New Zealand
Query!
State/province [366]
0
0
Hamilton
Query!
Country [367]
0
0
New Zealand
Query!
State/province [367]
0
0
Hastings
Query!
Country [368]
0
0
New Zealand
Query!
State/province [368]
0
0
Hutt Central
Query!
Country [369]
0
0
New Zealand
Query!
State/province [369]
0
0
New Lynn
Query!
Country [370]
0
0
New Zealand
Query!
State/province [370]
0
0
Palmerston North Central
Query!
Country [371]
0
0
New Zealand
Query!
State/province [371]
0
0
Papatoetoe
Query!
Country [372]
0
0
New Zealand
Query!
State/province [372]
0
0
Pukekohe
Query!
Country [373]
0
0
New Zealand
Query!
State/province [373]
0
0
Rotorua
Query!
Country [374]
0
0
New Zealand
Query!
State/province [374]
0
0
Woodhill
Query!
Country [375]
0
0
Peru
Query!
State/province [375]
0
0
Bellavista
Query!
Country [376]
0
0
Peru
Query!
State/province [376]
0
0
Chorrillos
Query!
Country [377]
0
0
Peru
Query!
State/province [377]
0
0
Lima
Query!
Country [378]
0
0
Peru
Query!
State/province [378]
0
0
Miraflores
Query!
Country [379]
0
0
Peru
Query!
State/province [379]
0
0
Piura
Query!
Country [380]
0
0
Peru
Query!
State/province [380]
0
0
San Isidro
Query!
Country [381]
0
0
Peru
Query!
State/province [381]
0
0
Wanchac
Query!
Country [382]
0
0
Philippines
Query!
State/province [382]
0
0
Angeles City
Query!
Country [383]
0
0
Philippines
Query!
State/province [383]
0
0
Baguio City
Query!
Country [384]
0
0
Philippines
Query!
State/province [384]
0
0
Cebu
Query!
Country [385]
0
0
Philippines
Query!
State/province [385]
0
0
Davao City
Query!
Country [386]
0
0
Philippines
Query!
State/province [386]
0
0
Davao
Query!
Country [387]
0
0
Philippines
Query!
State/province [387]
0
0
Iloilo City
Query!
Country [388]
0
0
Philippines
Query!
State/province [388]
0
0
Laguna
Query!
Country [389]
0
0
Philippines
Query!
State/province [389]
0
0
Manadaluyong City
Query!
Country [390]
0
0
Philippines
Query!
State/province [390]
0
0
Manila
Query!
Country [391]
0
0
Philippines
Query!
State/province [391]
0
0
Marikina
Query!
Country [392]
0
0
Philippines
Query!
State/province [392]
0
0
Pasig City
Query!
Country [393]
0
0
Philippines
Query!
State/province [393]
0
0
Quezon City
Query!
Country [394]
0
0
Philippines
Query!
State/province [394]
0
0
San Juan
Query!
Country [395]
0
0
Philippines
Query!
State/province [395]
0
0
Tacloban City
Query!
Country [396]
0
0
Poland
Query!
State/province [396]
0
0
Bialystok
Query!
Country [397]
0
0
Poland
Query!
State/province [397]
0
0
Bydgoszcz
Query!
Country [398]
0
0
Poland
Query!
State/province [398]
0
0
Gdansk
Query!
Country [399]
0
0
Poland
Query!
State/province [399]
0
0
Gdynia
Query!
Country [400]
0
0
Poland
Query!
State/province [400]
0
0
Jelenia Góra
Query!
Country [401]
0
0
Poland
Query!
State/province [401]
0
0
Katowice
Query!
Country [402]
0
0
Poland
Query!
State/province [402]
0
0
Kraków
Query!
Country [403]
0
0
Poland
Query!
State/province [403]
0
0
Kedzierzyn-Kozle
Query!
Country [404]
0
0
Poland
Query!
State/province [404]
0
0
Lublin
Query!
Country [405]
0
0
Poland
Query!
State/province [405]
0
0
Ostrów Mazowiecka
Query!
Country [406]
0
0
Poland
Query!
State/province [406]
0
0
Poznan
Query!
Country [407]
0
0
Poland
Query!
State/province [407]
0
0
Plock
Query!
Country [408]
0
0
Poland
Query!
State/province [408]
0
0
Ruda Slaska
Query!
Country [409]
0
0
Poland
Query!
State/province [409]
0
0
Rzeszów
Query!
Country [410]
0
0
Poland
Query!
State/province [410]
0
0
Szczecin
Query!
Country [411]
0
0
Poland
Query!
State/province [411]
0
0
Tarnów
Query!
Country [412]
0
0
Poland
Query!
State/province [412]
0
0
Torun
Query!
Country [413]
0
0
Poland
Query!
State/province [413]
0
0
Warszawa
Query!
Country [414]
0
0
Poland
Query!
State/province [414]
0
0
Wroclaw
Query!
Country [415]
0
0
Poland
Query!
State/province [415]
0
0
Lódz
Query!
Country [416]
0
0
Romania
Query!
State/province [416]
0
0
Arad
Query!
Country [417]
0
0
Romania
Query!
State/province [417]
0
0
Bacau
Query!
Country [418]
0
0
Romania
Query!
State/province [418]
0
0
Bucharest
Query!
Country [419]
0
0
Romania
Query!
State/province [419]
0
0
Bucuresti
Query!
Country [420]
0
0
Romania
Query!
State/province [420]
0
0
Craiova
Query!
Country [421]
0
0
Romania
Query!
State/province [421]
0
0
Iasi
Query!
Country [422]
0
0
Romania
Query!
State/province [422]
0
0
Oradea
Query!
Country [423]
0
0
Romania
Query!
State/province [423]
0
0
Satu Mare
Query!
Country [424]
0
0
Romania
Query!
State/province [424]
0
0
Targu Mures
Query!
Country [425]
0
0
Romania
Query!
State/province [425]
0
0
Timisoara
Query!
Country [426]
0
0
Romania
Query!
State/province [426]
0
0
Tirgu-Mures
Query!
Country [427]
0
0
Slovakia
Query!
State/province [427]
0
0
Bratislava
Query!
Country [428]
0
0
Slovakia
Query!
State/province [428]
0
0
Brezno
Query!
Country [429]
0
0
Slovakia
Query!
State/province [429]
0
0
Dolný Kubín
Query!
Country [430]
0
0
Slovakia
Query!
State/province [430]
0
0
Kosice
Query!
Country [431]
0
0
Slovakia
Query!
State/province [431]
0
0
Košice
Query!
Country [432]
0
0
Slovakia
Query!
State/province [432]
0
0
Levice
Query!
Country [433]
0
0
Slovakia
Query!
State/province [433]
0
0
Malacky
Query!
Country [434]
0
0
Slovakia
Query!
State/province [434]
0
0
Nitra
Query!
Country [435]
0
0
Slovakia
Query!
State/province [435]
0
0
Presov
Query!
Country [436]
0
0
Slovakia
Query!
State/province [436]
0
0
Prešov
Query!
Country [437]
0
0
Slovakia
Query!
State/province [437]
0
0
Trnava
Query!
Country [438]
0
0
Slovakia
Query!
State/province [438]
0
0
Vinica
Query!
Country [439]
0
0
Slovakia
Query!
State/province [439]
0
0
Zilina
Query!
Country [440]
0
0
Slovakia
Query!
State/province [440]
0
0
Šamorín
Query!
Country [441]
0
0
South Africa
Query!
State/province [441]
0
0
Bellville
Query!
Country [442]
0
0
South Africa
Query!
State/province [442]
0
0
Benoni
Query!
Country [443]
0
0
South Africa
Query!
State/province [443]
0
0
Bloemfontein
Query!
Country [444]
0
0
South Africa
Query!
State/province [444]
0
0
Brackenfell
Query!
Country [445]
0
0
South Africa
Query!
State/province [445]
0
0
Cape Town
Query!
Country [446]
0
0
South Africa
Query!
State/province [446]
0
0
Centurion
Query!
Country [447]
0
0
South Africa
Query!
State/province [447]
0
0
Durban
Query!
Country [448]
0
0
South Africa
Query!
State/province [448]
0
0
George
Query!
Country [449]
0
0
South Africa
Query!
State/province [449]
0
0
Johannesburg
Query!
Country [450]
0
0
South Africa
Query!
State/province [450]
0
0
Kimberley
Query!
Country [451]
0
0
South Africa
Query!
State/province [451]
0
0
Middelbrug
Query!
Country [452]
0
0
South Africa
Query!
State/province [452]
0
0
Midrand
Query!
Country [453]
0
0
South Africa
Query!
State/province [453]
0
0
Paarl
Query!
Country [454]
0
0
South Africa
Query!
State/province [454]
0
0
Panorama
Query!
Country [455]
0
0
South Africa
Query!
State/province [455]
0
0
Pretoria
Query!
Country [456]
0
0
South Africa
Query!
State/province [456]
0
0
Somerset West
Query!
Country [457]
0
0
South Africa
Query!
State/province [457]
0
0
Umhlanga Rocks
Query!
Country [458]
0
0
South Africa
Query!
State/province [458]
0
0
Umkomaas
Query!
Country [459]
0
0
Spain
Query!
State/province [459]
0
0
A Coruna
Query!
Country [460]
0
0
Spain
Query!
State/province [460]
0
0
Alicante
Query!
Country [461]
0
0
Spain
Query!
State/province [461]
0
0
Barcelona
Query!
Country [462]
0
0
Spain
Query!
State/province [462]
0
0
Madrid
Query!
Country [463]
0
0
Spain
Query!
State/province [463]
0
0
Murcia
Query!
Country [464]
0
0
Spain
Query!
State/province [464]
0
0
Málaga
Query!
Country [465]
0
0
Spain
Query!
State/province [465]
0
0
Palma de Mallorca
Query!
Country [466]
0
0
Spain
Query!
State/province [466]
0
0
Sanlúcar De Barrameda (Cádiz)
Query!
Country [467]
0
0
Spain
Query!
State/province [467]
0
0
Santiago(A Coruña)
Query!
Country [468]
0
0
Spain
Query!
State/province [468]
0
0
Sevilla
Query!
Country [469]
0
0
Spain
Query!
State/province [469]
0
0
Tarragona
Query!
Country [470]
0
0
Spain
Query!
State/province [470]
0
0
Valencia
Query!
Country [471]
0
0
Spain
Query!
State/province [471]
0
0
Vigo
Query!
Country [472]
0
0
Spain
Query!
State/province [472]
0
0
Villamartín (Cádiz)
Query!
Country [473]
0
0
Sweden
Query!
State/province [473]
0
0
Alingsås
Query!
Country [474]
0
0
Sweden
Query!
State/province [474]
0
0
Falun
Query!
Country [475]
0
0
Sweden
Query!
State/province [475]
0
0
Huddinge
Query!
Country [476]
0
0
Sweden
Query!
State/province [476]
0
0
Lund
Query!
Country [477]
0
0
Sweden
Query!
State/province [477]
0
0
Stockholm
Query!
Country [478]
0
0
Sweden
Query!
State/province [478]
0
0
Umeå
Query!
Country [479]
0
0
Sweden
Query!
State/province [479]
0
0
Uppsala
Query!
Country [480]
0
0
Sweden
Query!
State/province [480]
0
0
Vasteras
Query!
Country [481]
0
0
Taiwan
Query!
State/province [481]
0
0
Changhua
Query!
Country [482]
0
0
Taiwan
Query!
State/province [482]
0
0
Hsinchu
Query!
Country [483]
0
0
Taiwan
Query!
State/province [483]
0
0
Hualien City
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Country [484]
0
0
Taiwan
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State/province [484]
0
0
Kaohsiung City
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Country [485]
0
0
Taiwan
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State/province [485]
0
0
Kaohsiung
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Country [486]
0
0
Taiwan
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State/province [486]
0
0
New Taipei
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Country [487]
0
0
Taiwan
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State/province [487]
0
0
Taichung City
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Country [488]
0
0
Taiwan
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State/province [488]
0
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Taichung
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Country [489]
0
0
Taiwan
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State/province [489]
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0
Tainan
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Country [490]
0
0
Taiwan
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State/province [490]
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0
Taipei City
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Country [491]
0
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Taiwan
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State/province [491]
0
0
Taipei
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Country [492]
0
0
Taiwan
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State/province [492]
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0
Taoyuan
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Country [493]
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0
Taiwan
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State/province [493]
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Yilan
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Country [494]
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Thailand
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State/province [494]
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Bangkok
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Country [495]
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Thailand
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State/province [495]
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0
Banphaeo
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Country [496]
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Thailand
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State/province [496]
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Chiang Mai
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Country [497]
0
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Thailand
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State/province [497]
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0
Hat Yai
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Country [498]
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Thailand
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State/province [498]
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Khon-Kaen
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Country [499]
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Thailand
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State/province [499]
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0
Klong Luang
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Country [500]
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Thailand
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State/province [500]
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Mueang
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Country [501]
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Thailand
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State/province [501]
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Nakhon Ratchasima
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Country [502]
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Turkey
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State/province [502]
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Afyonkarahisar
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Country [503]
0
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Turkey
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State/province [503]
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Ankara
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Country [504]
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Turkey
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State/province [504]
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Antalya
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Country [505]
0
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Turkey
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State/province [505]
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Canakkale
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Country [506]
0
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Turkey
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State/province [506]
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Edirne
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Country [507]
0
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Turkey
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Istanbul
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Country [508]
0
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Turkey
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State/province [508]
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Izmir
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Country [509]
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Turkey
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State/province [509]
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0
Kayseri
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Country [510]
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Turkey
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State/province [510]
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0
Kazimkarabekir
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Country [511]
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Turkey
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State/province [511]
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0
Kütahya
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Country [512]
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Turkey
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State/province [512]
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Mugla
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Country [513]
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0
Turkey
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State/province [513]
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0
Odunpazari
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Country [514]
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Turkey
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State/province [514]
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Tokat
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Country [515]
0
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Turkey
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State/province [515]
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0
Yenimahalle
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Country [516]
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Ukraine
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State/province [516]
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0
Chernivtsi
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Country [517]
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Ukraine
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State/province [517]
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Ivano-Frankivsk
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Country [518]
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Ukraine
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State/province [518]
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Kyiv
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Country [519]
0
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Ukraine
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State/province [519]
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Lutsk
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Country [520]
0
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Ukraine
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State/province [520]
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Uzhhorod
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Country [521]
0
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Ukraine
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State/province [521]
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0
Vinnytsia
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Country [522]
0
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Ukraine
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State/province [522]
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Vinnytsya
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Country [523]
0
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Ukraine
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State/province [523]
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Zhytomyr
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Country [524]
0
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United Kingdom
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State/province [524]
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Birmingham
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Country [525]
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United Kingdom
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State/province [525]
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Bristol
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Country [526]
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United Kingdom
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State/province [526]
0
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Calow
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Country [527]
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United Kingdom
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State/province [527]
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Congleton
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Country [528]
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United Kingdom
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State/province [528]
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Dundee
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Country [529]
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United Kingdom
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State/province [529]
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Gateshead
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Country [530]
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United Kingdom
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Glasgow
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Country [531]
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United Kingdom
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State/province [531]
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Harefield
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Country [532]
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United Kingdom
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State/province [532]
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King's Lynn
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Country [533]
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United Kingdom
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London
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Country [534]
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United Kingdom
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Middlesex
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Country [535]
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United Kingdom
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State/province [535]
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Milton Keynes
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Country [536]
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United Kingdom
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State/province [536]
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Newcastle Upon Tyne
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Country [537]
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United Kingdom
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State/province [537]
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Poole
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Country [538]
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United Kingdom
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Sheffield
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Country [539]
0
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United Kingdom
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Wakefield
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Country [540]
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United Kingdom
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State/province [540]
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West Bromwich
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Country [541]
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United Kingdom
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State/province [541]
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Wirral
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Country [542]
0
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Vietnam
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Can Tho
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Country [543]
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Vietnam
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Danang
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Country [544]
0
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Vietnam
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0
Hai Phong
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Country [545]
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Vietnam
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State/province [545]
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0
Ho Chi Minh City
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Country [546]
0
0
Vietnam
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State/province [546]
0
0
Ho Chi Minh
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Country [547]
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0
Vietnam
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State/province [547]
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Hue
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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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
The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.
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Trial website
https://clinicaltrials.gov/study/NCT07000357
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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0
1-877-240-9479
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Fax
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Email
0
0
information.center@astrazeneca.com
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Contact person for scientific queries
Data sharing statement
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 not provided in
https://clinicaltrials.gov/study/NCT07000357
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