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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00403767




Registration number
NCT00403767
Ethics application status
Date submitted
23/11/2006
Date registered
27/11/2006
Date last updated
29/04/2014

Titles & IDs
Public title
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Scientific title
A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
Secondary ID [1] 0 0
39039039AFL3001
Secondary ID [2] 0 0
CR012157
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Embolism 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban
Treatment: Drugs - Warfarin
Treatment: Drugs - Matching placebo for Rivaroxaban arm (Warfarin placebo)
Treatment: Drugs - Matching placebo for Warfarin arm (Rivaroxaban placebo)

Experimental: Rivaroxaban -

Active comparator: Warfarin -


Treatment: Drugs: Rivaroxaban
Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)

Treatment: Drugs: Warfarin
Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years

Treatment: Drugs: Matching placebo for Rivaroxaban arm (Warfarin placebo)
Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years

Treatment: Drugs: Matching placebo for Warfarin arm (Rivaroxaban placebo)
Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
Timepoint [1] 0 0
Up to 4 years
Primary outcome [2] 0 0
The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
Timepoint [2] 0 0
Up to 4 years
Primary outcome [3] 0 0
The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [1] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
All-cause Mortality
Timepoint [7] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
* Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
* History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant mitral stenosis
* Transient atrial fibrillation caused by a reversible disorder
* Active internal bleeding
* Severe disabling stroke
* History of intracranial bleeding
* Hemorrhagic disorders

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
14269
Recruitment in Australia
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- Adelaide
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- Auchenflower
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- Bedford Park
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- Box Hill
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- Caboolture
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- Cairns
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- Camperdown
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- Chermside
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- Clayton
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- Coffs Harbour
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- Footscray
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- Garran
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- Geelong
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- Gosford
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- Heidelberg Heights
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- Herston
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- Hobart
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- Joondalup
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- Lismore
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- Liverpool
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- Miranda
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- Nedlands
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- New Lambton Heights
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- Parkville
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- Penrith
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- Prahran
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- Reservoir
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- Southport
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- Windsor
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- Wolloongabba
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- Adelaide
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- Auchenflower
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- Bedford Park
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- Box Hill
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- Caboolture
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- Cairns
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- Camperdown
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- Chermside
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- Clayton
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- Coffs Harbour
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- Footscray
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- Garran
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- Geelong
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- Gosford
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- Heidelberg Heights
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- Herston
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- Hobart
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- Joondalup
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- Lismore
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- Liverpool
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- Miranda
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- Nedlands
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- New Lambton Heights
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- Parkville
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- Penrith
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- Prahran
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- Reservoir
Recruitment postcode(s) [28] 0 0
- Southport
Recruitment postcode(s) [29] 0 0
- Windsor
Recruitment postcode(s) [30] 0 0
- Wolloongabba
Recruitment outside Australia
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Praha 5
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Czech Republic
State/province [182] 0 0
Praha 8
Country [183] 0 0
Czech Republic
State/province [183] 0 0
Praha
Country [184] 0 0
Czech Republic
State/province [184] 0 0
Slany
Country [185] 0 0
Czech Republic
State/province [185] 0 0
Svitavy 2
Country [186] 0 0
Czech Republic
State/province [186] 0 0
Svitavy
Country [187] 0 0
Czech Republic
State/province [187] 0 0
Trutnov
Country [188] 0 0
Czech Republic
State/province [188] 0 0
Uherské Hradistì 6
Country [189] 0 0
Czech Republic
State/province [189] 0 0
Zlín 1
Country [190] 0 0
Denmark
State/province [190] 0 0
Esbjerg
Country [191] 0 0
Denmark
State/province [191] 0 0
Frederiksberg
Country [192] 0 0
Denmark
State/province [192] 0 0
Gentofte
Country [193] 0 0
Denmark
State/province [193] 0 0
Hellerup
Country [194] 0 0
Denmark
State/province [194] 0 0
Helsingør
Country [195] 0 0
Denmark
State/province [195] 0 0
Hvidovre
Country [196] 0 0
Denmark
State/province [196] 0 0
Koege
Country [197] 0 0
Denmark
State/province [197] 0 0
København
Country [198] 0 0
Denmark
State/province [198] 0 0
Næstved
Country [199] 0 0
Denmark
State/province [199] 0 0
Roskilde
Country [200] 0 0
Denmark
State/province [200] 0 0
Slagelse
Country [201] 0 0
Denmark
State/province [201] 0 0
Viborg
Country [202] 0 0
Finland
State/province [202] 0 0
Helsinki
Country [203] 0 0
Finland
State/province [203] 0 0
Jyväskylä N/A
Country [204] 0 0
Finland
State/province [204] 0 0
Kuopio
Country [205] 0 0
Finland
State/province [205] 0 0
Mikkeli
Country [206] 0 0
Finland
State/province [206] 0 0
Oulu
Country [207] 0 0
Finland
State/province [207] 0 0
Turku
Country [208] 0 0
France
State/province [208] 0 0
Albi
Country [209] 0 0
France
State/province [209] 0 0
Arras
Country [210] 0 0
France
State/province [210] 0 0
Bayonne
Country [211] 0 0
France
State/province [211] 0 0
Belfort
Country [212] 0 0
France
State/province [212] 0 0
Besancon N/A
Country [213] 0 0
France
State/province [213] 0 0
Bourg En Bresse
Country [214] 0 0
France
State/province [214] 0 0
Brest
Country [215] 0 0
France
State/province [215] 0 0
Béziers Languedoc-Roussillon
Country [216] 0 0
France
State/province [216] 0 0
Carcassonne
Country [217] 0 0
France
State/province [217] 0 0
Clermont Ferrand
Country [218] 0 0
France
State/province [218] 0 0
Corbeil Essonnes
Country [219] 0 0
France
State/province [219] 0 0
Lille
Country [220] 0 0
France
State/province [220] 0 0
Marseille
Country [221] 0 0
France
State/province [221] 0 0
Montbeliard
Country [222] 0 0
France
State/province [222] 0 0
Montpellier
Country [223] 0 0
France
State/province [223] 0 0
Paris Cedex 14
Country [224] 0 0
France
State/province [224] 0 0
Paris
Country [225] 0 0
France
State/province [225] 0 0
Perpignan
Country [226] 0 0
France
State/province [226] 0 0
Poitiers
Country [227] 0 0
France
State/province [227] 0 0
Saint-Brieuc
Country [228] 0 0
France
State/province [228] 0 0
St Jean De Verges
Country [229] 0 0
France
State/province [229] 0 0
Strasbourg
Country [230] 0 0
France
State/province [230] 0 0
Thionville
Country [231] 0 0
France
State/province [231] 0 0
Toulouse
Country [232] 0 0
France
State/province [232] 0 0
Trelivan
Country [233] 0 0
Germany
State/province [233] 0 0
Aalen
Country [234] 0 0
Germany
State/province [234] 0 0
Berlin/Spandau
Country [235] 0 0
Germany
State/province [235] 0 0
Berlin
Country [236] 0 0
Germany
State/province [236] 0 0
Biberach
Country [237] 0 0
Germany
State/province [237] 0 0
Bochum
Country [238] 0 0
Germany
State/province [238] 0 0
Bonn
Country [239] 0 0
Germany
State/province [239] 0 0
Chemnitz
Country [240] 0 0
Germany
State/province [240] 0 0
Coburg
Country [241] 0 0
Germany
State/province [241] 0 0
Dachau
Country [242] 0 0
Germany
State/province [242] 0 0
Dortmund
Country [243] 0 0
Germany
State/province [243] 0 0
Dresden
Country [244] 0 0
Germany
State/province [244] 0 0
Duisburg
Country [245] 0 0
Germany
State/province [245] 0 0
Ebersbach
Country [246] 0 0
Germany
State/province [246] 0 0
Eilenburg
Country [247] 0 0
Germany
State/province [247] 0 0
Erfurt
Country [248] 0 0
Germany
State/province [248] 0 0
Essen
Country [249] 0 0
Germany
State/province [249] 0 0
Frankfurt
Country [250] 0 0
Germany
State/province [250] 0 0
Freiburg
Country [251] 0 0
Germany
State/province [251] 0 0
Greifswald
Country [252] 0 0
Germany
State/province [252] 0 0
Halle
Country [253] 0 0
Germany
State/province [253] 0 0
Hamburg
Country [254] 0 0
Germany
State/province [254] 0 0
Hartmannsdorf
Country [255] 0 0
Germany
State/province [255] 0 0
Heidelberg
Country [256] 0 0
Germany
State/province [256] 0 0
Henstedt-Rhen
Country [257] 0 0
Germany
State/province [257] 0 0
Herford
Country [258] 0 0
Germany
State/province [258] 0 0
Homburg/Saar
Country [259] 0 0
Germany
State/province [259] 0 0
Jena
Country [260] 0 0
Germany
State/province [260] 0 0
Julich
Country [261] 0 0
Germany
State/province [261] 0 0
Kamen
Country [262] 0 0
Germany
State/province [262] 0 0
Karlsbad
Country [263] 0 0
Germany
State/province [263] 0 0
Kassel
Country [264] 0 0
Germany
State/province [264] 0 0
Kirchzarten
Country [265] 0 0
Germany
State/province [265] 0 0
Krefeld
Country [266] 0 0
Germany
State/province [266] 0 0
Leipzig
Country [267] 0 0
Germany
State/province [267] 0 0
Ludwigsburg
Country [268] 0 0
Germany
State/province [268] 0 0
Ludwigshafen
Country [269] 0 0
Germany
State/province [269] 0 0
Lüneburg
Country [270] 0 0
Germany
State/province [270] 0 0
Magdeburg
Country [271] 0 0
Germany
State/province [271] 0 0
Mainz
Country [272] 0 0
Germany
State/province [272] 0 0
Mannheim
Country [273] 0 0
Germany
State/province [273] 0 0
Markkleeberg
Country [274] 0 0
Germany
State/province [274] 0 0
Meißen
Country [275] 0 0
Germany
State/province [275] 0 0
Melsungen
Country [276] 0 0
Germany
State/province [276] 0 0
Monchengladbach
Country [277] 0 0
Germany
State/province [277] 0 0
Munchen
Country [278] 0 0
Germany
State/province [278] 0 0
Mühldorf
Country [279] 0 0
Germany
State/province [279] 0 0
Mülheim
Country [280] 0 0
Germany
State/province [280] 0 0
Münster
Country [281] 0 0
Germany
State/province [281] 0 0
Neuwied
Country [282] 0 0
Germany
State/province [282] 0 0
Nienburg
Country [283] 0 0
Germany
State/province [283] 0 0
Nuernberg
Country [284] 0 0
Germany
State/province [284] 0 0
Paderborn
Country [285] 0 0
Germany
State/province [285] 0 0
Potsdam
Country [286] 0 0
Germany
State/province [286] 0 0
Riesa
Country [287] 0 0
Germany
State/province [287] 0 0
Rottweil
Country [288] 0 0
Germany
State/province [288] 0 0
Sachsen
Country [289] 0 0
Germany
State/province [289] 0 0
Siegen
Country [290] 0 0
Germany
State/province [290] 0 0
Ulm
Country [291] 0 0
Germany
State/province [291] 0 0
Wermsdorf
Country [292] 0 0
Germany
State/province [292] 0 0
Witten
Country [293] 0 0
Germany
State/province [293] 0 0
Wolmirstedt
Country [294] 0 0
Germany
State/province [294] 0 0
Wuppertal
Country [295] 0 0
Greece
State/province [295] 0 0
Athens Attica
Country [296] 0 0
Greece
State/province [296] 0 0
Ioannina
Country [297] 0 0
Greece
State/province [297] 0 0
Maroussi Athens
Country [298] 0 0
Greece
State/province [298] 0 0
Patra
Country [299] 0 0
Greece
State/province [299] 0 0
Piraeus Attica
Country [300] 0 0
Greece
State/province [300] 0 0
Tripoli
Country [301] 0 0
Greece
State/province [301] 0 0
Voula Attica
Country [302] 0 0
Hong Kong
State/province [302] 0 0
Aberdeen
Country [303] 0 0
Hong Kong
State/province [303] 0 0
Hk
Country [304] 0 0
Hong Kong
State/province [304] 0 0
Kln
Country [305] 0 0
Hong Kong
State/province [305] 0 0
Sha Tin
Country [306] 0 0
Hungary
State/province [306] 0 0
Budapest N/A
Country [307] 0 0
Hungary
State/province [307] 0 0
Budapest Nap
Country [308] 0 0
Hungary
State/province [308] 0 0
Budapest
Country [309] 0 0
Hungary
State/province [309] 0 0
Debrecen County
Country [310] 0 0
Hungary
State/province [310] 0 0
Eger
Country [311] 0 0
Hungary
State/province [311] 0 0
Gyongyos
Country [312] 0 0
Hungary
State/province [312] 0 0
Gyõr
Country [313] 0 0
Hungary
State/province [313] 0 0
Kesckemet
Country [314] 0 0
Hungary
State/province [314] 0 0
Miskolc
Country [315] 0 0
Hungary
State/province [315] 0 0
Nyiregyhaza
Country [316] 0 0
Hungary
State/province [316] 0 0
Pecs
Country [317] 0 0
Hungary
State/province [317] 0 0
Szeged
Country [318] 0 0
Hungary
State/province [318] 0 0
Szekszard
Country [319] 0 0
Hungary
State/province [319] 0 0
Szombathely
Country [320] 0 0
Hungary
State/province [320] 0 0
Veszprem
Country [321] 0 0
Hungary
State/province [321] 0 0
Zalaegerszeg
Country [322] 0 0
India
State/province [322] 0 0
Ahmedabad
Country [323] 0 0
India
State/province [323] 0 0
Bangalore
Country [324] 0 0
India
State/province [324] 0 0
Bikaner
Country [325] 0 0
India
State/province [325] 0 0
Chennai
Country [326] 0 0
India
State/province [326] 0 0
Coimbatore
Country [327] 0 0
India
State/province [327] 0 0
Gandhinagar Guiarat
Country [328] 0 0
India
State/province [328] 0 0
Hyderabad Andra Pradesh
Country [329] 0 0
India
State/province [329] 0 0
Hyderabad
Country [330] 0 0
India
State/province [330] 0 0
Jalandhar
Country [331] 0 0
India
State/province [331] 0 0
Madurai
Country [332] 0 0
India
State/province [332] 0 0
Mangalore
Country [333] 0 0
India
State/province [333] 0 0
Mumbai
Country [334] 0 0
India
State/province [334] 0 0
Mysore
Country [335] 0 0
India
State/province [335] 0 0
New Delhi
Country [336] 0 0
India
State/province [336] 0 0
Pune
Country [337] 0 0
India
State/province [337] 0 0
Suraj
Country [338] 0 0
India
State/province [338] 0 0
Vadodara
Country [339] 0 0
India
State/province [339] 0 0
Vishakapatnam
Country [340] 0 0
Israel
State/province [340] 0 0
Afula
Country [341] 0 0
Israel
State/province [341] 0 0
Ashkelon
Country [342] 0 0
Israel
State/province [342] 0 0
Hadera
Country [343] 0 0
Israel
State/province [343] 0 0
Haifa
Country [344] 0 0
Israel
State/province [344] 0 0
Holon
Country [345] 0 0
Israel
State/province [345] 0 0
Jerusalem
Country [346] 0 0
Israel
State/province [346] 0 0
Nazareth
Country [347] 0 0
Israel
State/province [347] 0 0
Netanya
Country [348] 0 0
Israel
State/province [348] 0 0
Petach-Tikva
Country [349] 0 0
Israel
State/province [349] 0 0
Petah-Tikva
Country [350] 0 0
Israel
State/province [350] 0 0
Poriya
Country [351] 0 0
Israel
State/province [351] 0 0
Rehovot
Country [352] 0 0
Israel
State/province [352] 0 0
Safed
Country [353] 0 0
Israel
State/province [353] 0 0
Tel Aviv
Country [354] 0 0
Israel
State/province [354] 0 0
Tel Hashomer
Country [355] 0 0
Israel
State/province [355] 0 0
Zerifin
Country [356] 0 0
Korea, Republic of
State/province [356] 0 0
Anyang
Country [357] 0 0
Korea, Republic of
State/province [357] 0 0
Daegu
Country [358] 0 0
Korea, Republic of
State/province [358] 0 0
Daejeon
Country [359] 0 0
Korea, Republic of
State/province [359] 0 0
Goyang
Country [360] 0 0
Korea, Republic of
State/province [360] 0 0
Kyonggi-Do
Country [361] 0 0
Korea, Republic of
State/province [361] 0 0
Pusan
Country [362] 0 0
Korea, Republic of
State/province [362] 0 0
Seoul
Country [363] 0 0
Korea, Republic of
State/province [363] 0 0
Sungnam
Country [364] 0 0
Korea, Republic of