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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02065791
Registration number
NCT02065791
Ethics application status
Date submitted
17/02/2014
Date registered
19/02/2014
Date last updated
5/12/2019
Titles & IDs
Public title
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
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Scientific title
A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy
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Secondary ID [1]
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2013-004494-28
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Secondary ID [2]
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CR103517
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Universal Trial Number (UTN)
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Trial acronym
CREDENCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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0
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Diabetic Nephropathy
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Canagliflozin
Treatment: Drugs - Placebo
Experimental: Canagliflozin 100 mg - Each participant will receive 100 mg of canagliflozin once daily
Placebo Comparator: Placebo - Each participant will receive matching placebo once daily
Treatment: Drugs: Canagliflozin
One 100 mg over-encapsulated tablet orally once daily
Treatment: Drugs: Placebo
One matching placebo capsule orally (by mouth) 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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Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death
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Assessment method [1]
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Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented.
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Timepoint [1]
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Up to 4.6 years
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Secondary outcome [1]
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Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)
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Assessment method [1]
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The composite endpoint included CV death and HHF. CV death included death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented.
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Timepoint [1]
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Up to 4.6 years
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Secondary outcome [2]
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Major Adverse Cardiac Event (MACE)
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Assessment method [2]
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The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.
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Timepoint [2]
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Up to 4.6 years
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Secondary outcome [3]
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Hospitalized Heart Failure (HHF)
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Assessment method [3]
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Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of hospitalized heart failure are presented.
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Timepoint [3]
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Up to 4.6 years
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Secondary outcome [4]
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Renal Composite Endpoint
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Assessment method [4]
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The renal composite endpoint included composite of DoSC, ESKD and Renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 mL/min/1.73 m^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented.
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Timepoint [4]
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Up to 4.6 years
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Secondary outcome [5]
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Cardiovascular (CV) Death
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Assessment method [5]
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CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented.
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Timepoint [5]
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Up to 4.6 years
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Secondary outcome [6]
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All-cause Mortality
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Assessment method [6]
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Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented.
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Timepoint [6]
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Up to 4.6 years
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Secondary outcome [7]
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CV Composite Endpoint
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Assessment method [7]
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The CV composite endpoint included the CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented.
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Timepoint [7]
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Up to 4.6 years
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Eligibility
Key inclusion criteria
- Type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) greater than or equal to (>=)
6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular
filtration rate (eGFR) of >= 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less
than (<) 90 mL/min/1.73 m^2
- Participants need to be on a stable maximum tolerated labeled daily dose of an
angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
for at least 4 weeks prior to randomization
- Must have a urine albumin to creatinine ratio (UACR) of greater than (>) 300 milligram
(mg)/gram (g) and <= 5000 mg/g
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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
- History of diabetic ketoacidosis or type 1 diabetes mellitus
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Renal disease that required treatment with immunosuppressive therapy
- Known significant liver disease
- Current or history of New York Heart Association (NYHA) Class IV heart failure
- Blood potassium level >5.5 millimole (mmol)/liter (L) during Screening
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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 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
17/02/2014
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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
30/10/2018
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Sample size
Target
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Accrual to date
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Final
4401
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Recruitment in Australia
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- Cairns
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- Concord
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- Darlinghurst
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- Elizabeth Vale
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Recruitment postcode(s) [16]
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Recruitment outside Australia
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Plovdiv
Query!
Country [98]
0
0
Bulgaria
Query!
State/province [98]
0
0
Sofia
Query!
Country [99]
0
0
Bulgaria
Query!
State/province [99]
0
0
Varna
Query!
Country [100]
0
0
Canada
Query!
State/province [100]
0
0
Alberta
Query!
Country [101]
0
0
Canada
Query!
State/province [101]
0
0
British Columbia
Query!
Country [102]
0
0
Canada
Query!
State/province [102]
0
0
Manitoba
Query!
Country [103]
0
0
Canada
Query!
State/province [103]
0
0
Ontario
Query!
Country [104]
0
0
Canada
Query!
State/province [104]
0
0
Quebec
Query!
Country [105]
0
0
Canada
Query!
State/province [105]
0
0
Québec
Query!
Country [106]
0
0
Canada
Query!
State/province [106]
0
0
Toronto
Query!
Country [107]
0
0
Canada
Query!
State/province [107]
0
0
Vancouver
Query!
Country [108]
0
0
Chile
Query!
State/province [108]
0
0
Concepcion
Query!
Country [109]
0
0
Chile
Query!
State/province [109]
0
0
Santiago
Query!
Country [110]
0
0
Chile
Query!
State/province [110]
0
0
Temuco
Query!
Country [111]
0
0
China
Query!
State/province [111]
0
0
Beijing
Query!
Country [112]
0
0
China
Query!
State/province [112]
0
0
Changchun
Query!
Country [113]
0
0
China
Query!
State/province [113]
0
0
Changde
Query!
Country [114]
0
0
China
Query!
State/province [114]
0
0
Changsha
Query!
Country [115]
0
0
China
Query!
State/province [115]
0
0
Chengdu
Query!
Country [116]
0
0
China
Query!
State/province [116]
0
0
Chenzhou
Query!
Country [117]
0
0
China
Query!
State/province [117]
0
0
Dalian
Query!
Country [118]
0
0
China
Query!
State/province [118]
0
0
Foshan
Query!
Country [119]
0
0
China
Query!
State/province [119]
0
0
Guangzhou
Query!
Country [120]
0
0
China
Query!
State/province [120]
0
0
Huai'an
Query!
Country [121]
0
0
China
Query!
State/province [121]
0
0
Nanchang
Query!
Country [122]
0
0
China
Query!
State/province [122]
0
0
Nanjing
Query!
Country [123]
0
0
China
Query!
State/province [123]
0
0
Shanghai
Query!
Country [124]
0
0
China
Query!
State/province [124]
0
0
Shenyang
Query!
Country [125]
0
0
China
Query!
State/province [125]
0
0
Wuhan
Query!
Country [126]
0
0
China
Query!
State/province [126]
0
0
Wulumuqi
Query!
Country [127]
0
0
China
Query!
State/province [127]
0
0
Xian
Query!
Country [128]
0
0
Colombia
Query!
State/province [128]
0
0
Barranquilla
Query!
Country [129]
0
0
Colombia
Query!
State/province [129]
0
0
Bogota
Query!
Country [130]
0
0
Colombia
Query!
State/province [130]
0
0
Bucaramanga
Query!
Country [131]
0
0
Colombia
Query!
State/province [131]
0
0
Cali
Query!
Country [132]
0
0
Colombia
Query!
State/province [132]
0
0
Floridablanca
Query!
Country [133]
0
0
Colombia
Query!
State/province [133]
0
0
Manizales
Query!
Country [134]
0
0
Colombia
Query!
State/province [134]
0
0
Medellin
Query!
Country [135]
0
0
Colombia
Query!
State/province [135]
0
0
Pasto
Query!
Country [136]
0
0
Colombia
Query!
State/province [136]
0
0
Pereira
Query!
Country [137]
0
0
Czechia
Query!
State/province [137]
0
0
Ceske Budejovice
Query!
Country [138]
0
0
Czechia
Query!
State/province [138]
0
0
Cesky Krumlov
Query!
Country [139]
0
0
Czechia
Query!
State/province [139]
0
0
Chocen
Query!
Country [140]
0
0
Czechia
Query!
State/province [140]
0
0
Havlickuv Brod
Query!
Country [141]
0
0
Czechia
Query!
State/province [141]
0
0
Hradec Kralove-Vekose
Query!
Country [142]
0
0
Czechia
Query!
State/province [142]
0
0
Hradec Nad Svitavou
Query!
Country [143]
0
0
Czechia
Query!
State/province [143]
0
0
Jindrichuv Hradec
Query!
Country [144]
0
0
Czechia
Query!
State/province [144]
0
0
Olomouc
Query!
Country [145]
0
0
Czechia
Query!
State/province [145]
0
0
Praha 10
Query!
Country [146]
0
0
Czechia
Query!
State/province [146]
0
0
Praha 2
Query!
Country [147]
0
0
Czechia
Query!
State/province [147]
0
0
Praha 4
Query!
Country [148]
0
0
Czechia
Query!
State/province [148]
0
0
Praha 5
Query!
Country [149]
0
0
Czechia
Query!
State/province [149]
0
0
Praha
Query!
Country [150]
0
0
Czechia
Query!
State/province [150]
0
0
Slany
Query!
Country [151]
0
0
Czechia
Query!
State/province [151]
0
0
Trutnov
Query!
Country [152]
0
0
Czechia
Query!
State/province [152]
0
0
Uherske Hradiste
Query!
Country [153]
0
0
Czechia
Query!
State/province [153]
0
0
Usti Nad Labem
Query!
Country [154]
0
0
France
Query!
State/province [154]
0
0
Besancon Cedex
Query!
Country [155]
0
0
France
Query!
State/province [155]
0
0
Brest cedex
Query!
Country [156]
0
0
France
Query!
State/province [156]
0
0
Colmar N/a
Query!
Country [157]
0
0
France
Query!
State/province [157]
0
0
Corbeil Essonnes Cedex
Query!
Country [158]
0
0
France
Query!
State/province [158]
0
0
Créteil Cedex
Query!
Country [159]
0
0
France
Query!
State/province [159]
0
0
Grenoble
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
Lyon cedex 03
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
Marseille Cedex 05
Query!
Country [162]
0
0
France
Query!
State/province [162]
0
0
Metz cedex 03
Query!
Country [163]
0
0
France
Query!
State/province [163]
0
0
Nantes Cedex 01
Query!
Country [164]
0
0
France
Query!
State/province [164]
0
0
Paris Cedex 15
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Paris Cedex 18
Query!
Country [166]
0
0
France
Query!
State/province [166]
0
0
Paris
Query!
Country [167]
0
0
France
Query!
State/province [167]
0
0
Pierre-Bénit
Query!
Country [168]
0
0
France
Query!
State/province [168]
0
0
Poitiers
Query!
Country [169]
0
0
France
Query!
State/province [169]
0
0
St Priest-en-Jarez
Query!
Country [170]
0
0
France
Query!
State/province [170]
0
0
Strasbourg
Query!
Country [171]
0
0
France
Query!
State/province [171]
0
0
Toulouse Cedex 9
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Bad Kreuznach - Bosenheim
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Dietzenbach
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Dresden
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Essen
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Hamburg
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Hannover
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Köln
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Muenster
Query!
Country [180]
0
0
Guatemala
Query!
State/province [180]
0
0
Guatemala City
Query!
Country [181]
0
0
Guatemala
Query!
State/province [181]
0
0
Guatemala
Query!
Country [182]
0
0
Hungary
Query!
State/province [182]
0
0
Baja
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Balatonfured
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Budapest
Query!
Country [185]
0
0
Hungary
Query!
State/province [185]
0
0
Debrecen
Query!
Country [186]
0
0
Hungary
Query!
State/province [186]
0
0
Eger
Query!
Country [187]
0
0
Hungary
Query!
State/province [187]
0
0
Esztergom
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Godollo
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Gyula
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Hu-4012 Debrecen N/a
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Kaposvar
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Kecskemet N/a
Query!
Country [193]
0
0
Hungary
Query!
State/province [193]
0
0
Komarom
Query!
Country [194]
0
0
Hungary
Query!
State/province [194]
0
0
Nyiregyhaza
Query!
Country [195]
0
0
Hungary
Query!
State/province [195]
0
0
Pecs
Query!
Country [196]
0
0
Hungary
Query!
State/province [196]
0
0
Szeged N/a
Query!
Country [197]
0
0
Hungary
Query!
State/province [197]
0
0
Szigetvar
Query!
Country [198]
0
0
Hungary
Query!
State/province [198]
0
0
Veszprem
Query!
Country [199]
0
0
Hungary
Query!
State/province [199]
0
0
Zalaegerszeg
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Calicut
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Chennai
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Delhi
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Hyderabad
Query!
Country [204]
0
0
India
Query!
State/province [204]
0
0
Kozhikode
Query!
Country [205]
0
0
India
Query!
State/province [205]
0
0
Lucknow
Query!
Country [206]
0
0
India
Query!
State/province [206]
0
0
Ludhiyana
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Mangalore
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
Mumbai
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
Mysore
Query!
Country [210]
0
0
India
Query!
State/province [210]
0
0
Secunderabad
Query!
Country [211]
0
0
India
Query!
State/province [211]
0
0
Trivandrum
Query!
Country [212]
0
0
India
Query!
State/province [212]
0
0
Vijayawada
Query!
Country [213]
0
0
India
Query!
State/province [213]
0
0
Vishakhapatnam
Query!
Country [214]
0
0
Japan
Query!
State/province [214]
0
0
Ageo-shi
Query!
Country [215]
0
0
Japan
Query!
State/province [215]
0
0
Chiyoda-ku
Query!
Country [216]
0
0
Japan
Query!
State/province [216]
0
0
Fukuoka
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Hamamatsu-shi
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Hamura-shi
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Ina-shi
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Izumisano
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Kamakura-shi
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Kanazawa
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Kawanishi-shi
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Koriyama-shi
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Kuki-shi
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Kyoto
Query!
Country [227]
0
0
Japan
Query!
State/province [227]
0
0
Matsuyama-shi
Query!
Country [228]
0
0
Japan
Query!
State/province [228]
0
0
Midori-shi
Query!
Country [229]
0
0
Japan
Query!
State/province [229]
0
0
Minato-ku
Query!
Country [230]
0
0
Japan
Query!
State/province [230]
0
0
Nagoya-shi
Query!
Country [231]
0
0
Japan
Query!
State/province [231]
0
0
Osaka-shi
Query!
Country [232]
0
0
Japan
Query!
State/province [232]
0
0
Ota-shi
Query!
Country [233]
0
0
Japan
Query!
State/province [233]
0
0
Saiki-shi
Query!
Country [234]
0
0
Japan
Query!
State/province [234]
0
0
Sashima-gun
Query!
Country [235]
0
0
Japan
Query!
State/province [235]
0
0
Shinjuku-ku
Query!
Country [236]
0
0
Japan
Query!
State/province [236]
0
0
Toyama-shi
Query!
Country [237]
0
0
Japan
Query!
State/province [237]
0
0
Uwajima-shi
Query!
Country [238]
0
0
Japan
Query!
State/province [238]
0
0
Yamanashi
Query!
Country [239]
0
0
Japan
Query!
State/province [239]
0
0
Yokohama-City
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Yokohama-shi
Query!
Country [241]
0
0
Korea, Republic of
Query!
State/province [241]
0
0
Busan
Query!
Country [242]
0
0
Korea, Republic of
Query!
State/province [242]
0
0
Daegu
Query!
Country [243]
0
0
Korea, Republic of
Query!
State/province [243]
0
0
Incheon
Query!
Country [244]
0
0
Korea, Republic of
Query!
State/province [244]
0
0
Seongnam
Query!
Country [245]
0
0
Korea, Republic of
Query!
State/province [245]
0
0
Seoul
Query!
Country [246]
0
0
Lithuania
Query!
State/province [246]
0
0
Kaunas
Query!
Country [247]
0
0
Lithuania
Query!
State/province [247]
0
0
Klaipeda
Query!
Country [248]
0
0
Lithuania
Query!
State/province [248]
0
0
Siauliai
Query!
Country [249]
0
0
Malaysia
Query!
State/province [249]
0
0
Batu Caves
Query!
Country [250]
0
0
Malaysia
Query!
State/province [250]
0
0
Ipoh
Query!
Country [251]
0
0
Malaysia
Query!
State/province [251]
0
0
Johor
Query!
Country [252]
0
0
Malaysia
Query!
State/province [252]
0
0
Kuala Lumpur N/a
Query!
Country [253]
0
0
Malaysia
Query!
State/province [253]
0
0
Kuala Lumpur
Query!
Country [254]
0
0
Malaysia
Query!
State/province [254]
0
0
Kuantan
Query!
Country [255]
0
0
Malaysia
Query!
State/province [255]
0
0
Melaka
Query!
Country [256]
0
0
Malaysia
Query!
State/province [256]
0
0
Perai
Query!
Country [257]
0
0
Malaysia
Query!
State/province [257]
0
0
Petaling Jaya
Query!
Country [258]
0
0
Malaysia
Query!
State/province [258]
0
0
Seremban
Query!
Country [259]
0
0
Malaysia
Query!
State/province [259]
0
0
Seri Manjung
Query!
Country [260]
0
0
Malaysia
Query!
State/province [260]
0
0
Sungai Petani, Kedah
Query!
Country [261]
0
0
Malaysia
Query!
State/province [261]
0
0
Tampin
Query!
Country [262]
0
0
Malaysia
Query!
State/province [262]
0
0
Temerloh
Query!
Country [263]
0
0
Mexico
Query!
State/province [263]
0
0
Aguascalientes
Query!
Country [264]
0
0
Mexico
Query!
State/province [264]
0
0
Celaya
Query!
Country [265]
0
0
Mexico
Query!
State/province [265]
0
0
Chihuahua
Query!
Country [266]
0
0
Mexico
Query!
State/province [266]
0
0
Ciudad De Mexico
Query!
Country [267]
0
0
Mexico
Query!
State/province [267]
0
0
Ciudad De Mexic
Query!
Country [268]
0
0
Mexico
Query!
State/province [268]
0
0
Cuautitlan Izcalli
Query!
Country [269]
0
0
Mexico
Query!
State/province [269]
0
0
Culiacan
Query!
Country [270]
0
0
Mexico
Query!
State/province [270]
0
0
Culiacán
Query!
Country [271]
0
0
Mexico
Query!
State/province [271]
0
0
Durango
Query!
Country [272]
0
0
Mexico
Query!
State/province [272]
0
0
El Salto
Query!
Country [273]
0
0
Mexico
Query!
State/province [273]
0
0
Guadalajara
Query!
Country [274]
0
0
Mexico
Query!
State/province [274]
0
0
Leon
Query!
Country [275]
0
0
Mexico
Query!
State/province [275]
0
0
Merida
Query!
Country [276]
0
0
Mexico
Query!
State/province [276]
0
0
Mexico City
Query!
Country [277]
0
0
Mexico
Query!
State/province [277]
0
0
Mexico
Query!
Country [278]
0
0
Mexico
Query!
State/province [278]
0
0
Monterrey
Query!
Country [279]
0
0
Mexico
Query!
State/province [279]
0
0
Morelia
Query!
Country [280]
0
0
Mexico
Query!
State/province [280]
0
0
Orizaba
Query!
Country [281]
0
0
Mexico
Query!
State/province [281]
0
0
Pachuca de Soto
Query!
Country [282]
0
0
Mexico
Query!
State/province [282]
0
0
Pachuca
Query!
Country [283]
0
0
Mexico
Query!
State/province [283]
0
0
Queretaro
Query!
Country [284]
0
0
Mexico
Query!
State/province [284]
0
0
San Luis Potosi
Query!
Country [285]
0
0
Mexico
Query!
State/province [285]
0
0
Tlalnepantla de Baz
Query!
Country [286]
0
0
Mexico
Query!
State/province [286]
0
0
Veracruz
Query!
Country [287]
0
0
Mexico
Query!
State/province [287]
0
0
Zapopan
Query!
Country [288]
0
0
New Zealand
Query!
State/province [288]
0
0
Auckland
Query!
Country [289]
0
0
New Zealand
Query!
State/province [289]
0
0
Christchurch
Query!
Country [290]
0
0
New Zealand
Query!
State/province [290]
0
0
Dunedin
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Country [291]
0
0
New Zealand
Query!
State/province [291]
0
0
Palmerston North
Query!
Country [292]
0
0
New Zealand
Query!
State/province [292]
0
0
Rotorua
Query!
Country [293]
0
0
New Zealand
Query!
State/province [293]
0
0
Takapuna Auckland
Query!
Country [294]
0
0
New Zealand
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State/province [294]
0
0
Tauranga
Query!
Country [295]
0
0
New Zealand
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State/province [295]
0
0
Wellington
Query!
Country [296]
0
0
Philippines
Query!
State/province [296]
0
0
Cagayan De Oro City
Query!
Country [297]
0
0
Philippines
Query!
State/province [297]
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0
Cebuu City
Query!
Country [298]
0
0
Philippines
Query!
State/province [298]
0
0
Cebu
Query!
Country [299]
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0
Philippines
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State/province [299]
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0
Davao City
Query!
Country [300]
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0
Philippines
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State/province [300]
0
0
Iloilo City
Query!
Country [301]
0
0
Philippines
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State/province [301]
0
0
Lipa City
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Country [302]
0
0
Philippines
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State/province [302]
0
0
Marikina City
Query!
Country [303]
0
0
Philippines
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State/province [303]
0
0
Pasay City
Query!
Country [304]
0
0
Philippines
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State/province [304]
0
0
Pasig
Query!
Country [305]
0
0
Philippines
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State/province [305]
0
0
Quezon City
Query!
Country [306]
0
0
Philippines
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State/province [306]
0
0
San Fernando
Query!
Country [307]
0
0
Philippines
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State/province [307]
0
0
Tagbilaran City
Query!
Country [308]
0
0
Philippines
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State/province [308]
0
0
Taytay
Query!
Country [309]
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0
Poland
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State/province [309]
0
0
Bydgoszcz
Query!
Country [310]
0
0
Poland
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State/province [310]
0
0
Chorzow
Query!
Country [311]
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0
Poland
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State/province [311]
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0
Katowice
Query!
Country [312]
0
0
Poland
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State/province [312]
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0
Krakow
Query!
Country [313]
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0
Poland
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State/province [313]
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Lodz
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Country [314]
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0
Poland
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State/province [314]
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0
Lublin
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Country [315]
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0
Poland
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State/province [315]
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0
Parczew
Query!
Country [316]
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0
Poland
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State/province [316]
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0
Poznan
Query!
Country [317]
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0
Poland
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State/province [317]
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0
Radom
Query!
Country [318]
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0
Poland
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State/province [318]
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0
Rzeszow
Query!
Country [319]
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0
Poland
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State/province [319]
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Torun
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Country [320]
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0
Poland
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State/province [320]
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0
Warswa
Query!
Country [321]
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0
Poland
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State/province [321]
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0
Wroclaw
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Country [322]
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0
Poland
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State/province [322]
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0
Zgierz
Query!
Country [323]
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0
Poland
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State/province [323]
0
0
Znin
Query!
Country [324]
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0
Puerto Rico
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State/province [324]
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0
Caguas
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Country [325]
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0
Puerto Rico
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State/province [325]
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Ponce
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Country [326]
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0
Puerto Rico
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State/province [326]
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0
San Juan
Query!
Country [327]
0
0
Romania
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State/province [327]
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0
Brasov
Query!
Country [328]
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0
Romania
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0
Bucuresti
Query!
Country [329]
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0
Romania
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State/province [329]
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0
Cluj Napoca
Query!
Country [330]
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0
Romania
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Deva
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Country [331]
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0
Romania
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State/province [331]
0
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Iasi
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Country [332]
0
0
Romania
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State/province [332]
0
0
Oradea
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Country [333]
0
0
Romania
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State/province [333]
0
0
Ploiesti
Query!
Country [334]
0
0
Romania
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State/province [334]
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0
Targu Mures
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Country [335]
0
0
Romania
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0
0
Timisoara
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Country [336]
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0
Russian Federation
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0
Arkhangelsk
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Country [337]
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0
Russian Federation
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0
Barnaul
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Country [338]
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0
Russian Federation
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0
Ivanovo
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Country [339]
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0
Russian Federation
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0
Kemerovo
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Country [340]
0
0
Russian Federation
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State/province [340]
0
0
Moscow
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Country [341]
0
0
Russian Federation
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State/province [341]
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0
Novosibirsk
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0
0
Russian Federation
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0
0
Petrozavodsk
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0
0
Russian Federation
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0
Rostov-on-Don
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0
0
Russian Federation
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0
Ryazan
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0
0
Russian Federation
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0
0
Saint Petersburg
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0
Russian Federation
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0
Saint-Petersburg
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0
Russian Federation
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0
0
Saratov
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Country [348]
0
0
Russian Federation
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State/province [348]
0
0
Sestroretsk, Saint-Petersburg
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Country [349]
0
0
Russian Federation
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State/province [349]
0
0
St. Petersburg
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Country [350]
0
0
Russian Federation
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0
0
Tomsk
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Country [351]
0
0
Russian Federation
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State/province [351]
0
0
Ufa
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Country [352]
0
0
Russian Federation
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State/province [352]
0
0
Volgograd
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Country [353]
0
0
Russian Federation
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State/province [353]
0
0
Yaroslavl
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Country [354]
0
0
Serbia
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State/province [354]
0
0
Belgrade
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Country [355]
0
0
Serbia
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State/province [355]
0
0
Nis
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Country [356]
0
0
Serbia
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State/province [356]
0
0
Zajecar
Query!
Country [357]
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0
Slovakia
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State/province [357]
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0
Bardejov
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Country [358]
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0
Slovakia
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State/province [358]
0
0
Bratislava
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Country [359]
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0
Slovakia
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State/province [359]
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0
Kosice
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Country [360]
0
0
Slovakia
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State/province [360]
0
0
Lubochna
Query!
Country [361]
0
0
Slovakia
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State/province [361]
0
0
Nitra
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Country [362]
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0
Slovakia
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State/province [362]
0
0
Prievidza
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Country [363]
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0
Slovakia
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State/province [363]
0
0
Puchov
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Country [364]
0
0
Slovakia
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State/province [364]
0
0
Rimavska Sobota
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Country [365]
0
0
Slovakia
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State/province [365]
0
0
Sturovo
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Country [366]
0
0
Slovakia
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State/province [366]
0
0
Svidnik
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Country [367]
0
0
Slovakia
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State/province [367]
0
0
Zilina
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Country [368]
0
0
South Africa
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State/province [368]
0
0
Cape Town
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Country [369]
0
0
South Africa
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State/province [369]
0
0
Durban
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Country [370]
0
0
South Africa
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State/province [370]
0
0
Isipingo Rail
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Country [371]
0
0
South Africa
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State/province [371]
0
0
Johannesburg
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Country [372]
0
0
South Africa
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State/province [372]
0
0
Krugersdorp
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Country [373]
0
0
South Africa
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State/province [373]
0
0
Port Elizabeth
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Country [374]
0
0
South Africa
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State/province [374]
0
0
Pretoria Gauteng
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Country [375]
0
0
South Africa
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State/province [375]
0
0
Pretoria
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Country [376]
0
0
South Africa
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State/province [376]
0
0
Soweto
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Country [377]
0
0
Spain
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State/province [377]
0
0
A Coruna
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Country [378]
0
0
Spain
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State/province [378]
0
0
Almeria
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Country [379]
0
0
Spain
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State/province [379]
0
0
Barcelona
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Country [380]
0
0
Spain
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State/province [380]
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0
Burela
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Country [381]
0
0
Spain
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State/province [381]
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0
Ciudad Real
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Country [382]
0
0
Spain
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State/province [382]
0
0
Getafe
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Country [383]
0
0
Spain
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State/province [383]
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0
Girona
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Country [384]
0
0
Spain
Query!
State/province [384]
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0
Granada
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Country [385]
0
0
Spain
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State/province [385]
0
0
La Roca del Vallès
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Country [386]
0
0
Spain
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State/province [386]
0
0
Madrid
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Country [387]
0
0
Spain
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State/province [387]
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0
Majadahonda
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Country [388]
0
0
Spain
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State/province [388]
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0
Málaga
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Country [389]
0
0
Spain
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State/province [389]
0
0
Palma de Mallorca
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Country [390]
0
0
Spain
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State/province [390]
0
0
Pozuelo de Alarcón
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Country [391]
0
0
Spain
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State/province [391]
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0
Sagunto
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Country [392]
0
0
Spain
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State/province [392]
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0
Santander
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Country [393]
0
0
Spain
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State/province [393]
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0
Sevilla
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Country [394]
0
0
Spain
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State/province [394]
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0
Valencia
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Country [395]
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0
Spain
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State/province [395]
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0
Vic
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Country [396]
0
0
Spain
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State/province [396]
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0
Viladecans
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Country [397]
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0
Taiwan
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State/province [397]
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0
Kaohsiung
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Country [398]
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0
Taiwan
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State/province [398]
0
0
New Taipei City
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Country [399]
0
0
Taiwan
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State/province [399]
0
0
Taichung
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Country [400]
0
0
Taiwan
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State/province [400]
0
0
Taipei
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Country [401]
0
0
Ukraine
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State/province [401]
0
0
Chernivtsi
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Country [402]
0
0
Ukraine
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State/province [402]
0
0
Dnipropetrovsk
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Country [403]
0
0
Ukraine
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State/province [403]
0
0
Ivano-Frankivsk
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Country [404]
0
0
Ukraine
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State/province [404]
0
0
Kharkiv
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Country [405]
0
0
Ukraine
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State/province [405]
0
0
Kiev
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Country [406]
0
0
Ukraine
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State/province [406]
0
0
Kyiv
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Country [407]
0
0
Ukraine
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State/province [407]
0
0
Ternopil
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Country [408]
0
0
Ukraine
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State/province [408]
0
0
Vinnitsya
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Country [409]
0
0
Ukraine
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State/province [409]
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0
Vinnytsia
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Country [410]
0
0
Ukraine
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State/province [410]
0
0
Zaporizhzhia
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Country [411]
0
0
United Arab Emirates
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State/province [411]
0
0
Ajman
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Country [412]
0
0
United Arab Emirates
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State/province [412]
0
0
Dubai
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Country [413]
0
0
United Arab Emirates
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State/province [413]
0
0
Sharjah
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Country [414]
0
0
United Kingdom
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State/province [414]
0
0
Aberdeen
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Country [415]
0
0
United Kingdom
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Antrim
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Country [416]
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0
United Kingdom
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Barry
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Country [417]
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0
United Kingdom
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0
Birmingham
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Country [418]
0
0
United Kingdom
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State/province [418]
0
0
Blackburn
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Country [419]
0
0
United Kingdom
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State/province [419]
0
0
Bolton
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Country [420]
0
0
United Kingdom
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State/province [420]
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0
Bournemouth
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0
United Kingdom
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State/province [421]
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0
Bradford
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Country [422]
0
0
United Kingdom
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0
Bristol
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Country [423]
0
0
United Kingdom
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0
Burbage
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0
United Kingdom
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Cardff
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0
United Kingdom
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0
Cardiff
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0
United Kingdom
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0
Carlshalton
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Country [427]
0
0
United Kingdom
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0
Carmarthen
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Country [428]
0
0
United Kingdom
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State/province [428]
0
0
Chester
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Country [429]
0
0
United Kingdom
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0
0
Darlington
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Country [430]
0
0
United Kingdom
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State/province [430]
0
0
Doncaster
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Country [431]
0
0
United Kingdom
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State/province [431]
0
0
Durham
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Country [432]
0
0
United Kingdom
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State/province [432]
0
0
Ely
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Country [433]
0
0
United Kingdom
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0
Hampstead
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Country [434]
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0
United Kingdom
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0
Harlow
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Country [435]
0
0
United Kingdom
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0
Huntingdon
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Country [436]
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0
United Kingdom
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0
Leamington Spa
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Country [437]
0
0
United Kingdom
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State/province [437]
0
0
Liskeard
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Country [438]
0
0
United Kingdom
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State/province [438]
0
0
London
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Country [439]
0
0
United Kingdom
Query!
State/province [439]
0
0
Middlesbrough
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Country [440]
0
0
United Kingdom
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State/province [440]
0
0
Plymouth
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Country [441]
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0
United Kingdom
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State/province [441]
0
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Rhyl
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Country [442]
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0
United Kingdom
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State/province [442]
0
0
Rugby
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Country [443]
0
0
United Kingdom
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State/province [443]
0
0
Salford
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Country [444]
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0
United Kingdom
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State/province [444]
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0
Stoke On Trent
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Country [445]
0
0
United Kingdom
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0
0
Swansea
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Country [446]
0
0
United Kingdom
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State/province [446]
0
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Torpoint
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Country [447]
0
0
United Kingdom
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State/province [447]
0
0
Watford
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Country [448]
0
0
United Kingdom
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State/province [448]
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0
Welwyn Garden City
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Country [449]
0
0
United Kingdom
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State/province [449]
0
0
Westcliff on Sea
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Country [450]
0
0
United Kingdom
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State/province [450]
0
0
Wokingham
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Country [451]
0
0
United Kingdom
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State/province [451]
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0
Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Janssen Research & Development, LLC
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
The George Institute for Global Health, Australia
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The goal of this study is to assess whether canagliflozin has a renal and vascular protective
effect in reducing the progression of renal impairment relative to placebo in participants
with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and
macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled
daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor
blocker (ARB).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02065791
Query!
Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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0
0
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Phone
0
0
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0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02065791
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