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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00781391




Registration number
NCT00781391
Ethics application status
Date submitted
28/10/2008
Date registered
29/10/2008
Date last updated
5/03/2019

Titles & IDs
Public title
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Scientific title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
Secondary ID [1] 0 0
DU176b-C-U301
Universal Trial Number (UTN)
Trial acronym
EngageAFTIMI48
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Atrial Fibrillation 0 0
Embolism 0 0
Condition category
Condition code
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 - warfarin tablets
Treatment: Drugs - Edoxaban tablets (high dose regimen-60mg)
Treatment: Drugs - Edoxaban tablets (low dose regimen-30mg)
Treatment: Drugs - placebo warfarin
Treatment: Drugs - placebo edoxaban

Active Comparator: Warfarin/placebo edoxaban - Warfarin tablets plus placebo Edoxaban tablets

Experimental: high dose edoxaban/placebo warfarin - Edoxaban tablets (60mg) plus warfarin placebo tablets

Experimental: low dose edoxaban/placebo warfarin - Edoxaban tablets (30mg) plus warfarin placebo tablets


Treatment: Drugs: warfarin tablets
Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months

Treatment: Drugs: Edoxaban tablets (high dose regimen-60mg)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

Treatment: Drugs: Edoxaban tablets (low dose regimen-30mg)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

Treatment: Drugs: placebo warfarin
placebo warfarin

Treatment: Drugs: placebo edoxaban
placebo edoxaban

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). - The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.
Timepoint [1] 0 0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Primary outcome [2] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). - The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.
Timepoint [2] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Primary outcome [3] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). - The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.
Timepoint [3] 0 0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Primary outcome [4] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). - The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.
Timepoint [4] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Primary outcome [5] 0 0
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). - Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.
Timepoint [5] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcome [1] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality - Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.
Timepoint [1] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcome [2] 0 0
Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding - Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.
Timepoint [2] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcome [3] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality - Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.
Timepoint [3] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcome [4] 0 0
Adjudicated Bleeding Events - Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.
Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements.
Timepoint [4] 0 0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Eligibility
Key inclusion criteria
- 21 years of age or older; male or female.

- Able to provide written informed consent.

- History of documented AF within the prior 12 months

- A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Transient atrial fibrillation secondary to other reversible disorders

- Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a
mechanical heart valve

- Subjects with any contraindication for anticoagulant agents;

- Subjects with conditions associated with high risk of bleeding or have known or
suspected hereditary or acquired bleeding disorders

- Females of childbearing potential including the following:

- Females with a history of tubal-ligation

- Females less than 2 years post-menopausal

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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- Broken Hill
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- East Gosford
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- Carina Heights
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- Milton
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- Adelaide
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- Frankston
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- Ashford
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- Camperdown
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- Elizabeth Vale
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- Joondalup
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- Melbourne
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- Parkville
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- Perth
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- Broken Hill
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- East Gosford
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- Carina Heights
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- Milton
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- Adelaide
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- Frankston
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- Ashford
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- Camperdown
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- Elizabeth Vale
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- Joondalup
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- Melbourne
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- Parkville
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- Perth
Recruitment outside Australia
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Ostrava
Country [189] 0 0
Czechia
State/province [189] 0 0
Pardubice
Country [190] 0 0
Czechia
State/province [190] 0 0
Plzen
Country [191] 0 0
Czechia
State/province [191] 0 0
Praha
Country [192] 0 0
Czechia
State/province [192] 0 0
Pribram
Country [193] 0 0
Czechia
State/province [193] 0 0
Revnice
Country [194] 0 0
Czechia
State/province [194] 0 0
Semily
Country [195] 0 0
Czechia
State/province [195] 0 0
Slany
Country [196] 0 0
Czechia
State/province [196] 0 0
Teplice
Country [197] 0 0
Czechia
State/province [197] 0 0
Trutnov
Country [198] 0 0
Czechia
State/province [198] 0 0
Usti nad Labem
Country [199] 0 0
Denmark
State/province [199] 0 0
Aarhus N
Country [200] 0 0
Denmark
State/province [200] 0 0
Esbjerg
Country [201] 0 0
Denmark
State/province [201] 0 0
Frederiksberg
Country [202] 0 0
Denmark
State/province [202] 0 0
Glostrup
Country [203] 0 0
Denmark
State/province [203] 0 0
Hellerup
Country [204] 0 0
Denmark
State/province [204] 0 0
Holbaek
Country [205] 0 0
Denmark
State/province [205] 0 0
Horsens
Country [206] 0 0
Denmark
State/province [206] 0 0
Kobenhaven
Country [207] 0 0
Denmark
State/province [207] 0 0
Kobenhavn
Country [208] 0 0
Estonia
State/province [208] 0 0
Harjumaa
Country [209] 0 0
Estonia
State/province [209] 0 0
Tartu
Country [210] 0 0
Estonia
State/province [210] 0 0
Parnu
Country [211] 0 0
Estonia
State/province [211] 0 0
Tallinn
Country [212] 0 0
Estonia
State/province [212] 0 0
Tallin
Country [213] 0 0
Finland
State/province [213] 0 0
Jyvaskyla
Country [214] 0 0
Finland
State/province [214] 0 0
Kuopio
Country [215] 0 0
Finland
State/province [215] 0 0
Lappeenranta
Country [216] 0 0
Finland
State/province [216] 0 0
Oulu
Country [217] 0 0
Finland
State/province [217] 0 0
Seinajoki
Country [218] 0 0
Finland
State/province [218] 0 0
Tampere
Country [219] 0 0
France
State/province [219] 0 0
Abbeville
Country [220] 0 0
France
State/province [220] 0 0
Amiens Cedex
Country [221] 0 0
France
State/province [221] 0 0
Brest
Country [222] 0 0
France
State/province [222] 0 0
Cambrai
Country [223] 0 0
France
State/province [223] 0 0
Clamart
Country [224] 0 0
France
State/province [224] 0 0
La Roche sur Yon
Country [225] 0 0
France
State/province [225] 0 0
Lille
Country [226] 0 0
France
State/province [226] 0 0
Lyon Cedex
Country [227] 0 0
France
State/province [227] 0 0
Massy
Country [228] 0 0
France
State/province [228] 0 0
Nantes
Country [229] 0 0
France
State/province [229] 0 0
Paris
Country [230] 0 0
France
State/province [230] 0 0
Pau
Country [231] 0 0
France
State/province [231] 0 0
Pessac
Country [232] 0 0
France
State/province [232] 0 0
Poitiers
Country [233] 0 0
France
State/province [233] 0 0
Tours Cedex
Country [234] 0 0
France
State/province [234] 0 0
Valenciennes
Country [235] 0 0
Germany
State/province [235] 0 0
Altenburg
Country [236] 0 0
Germany
State/province [236] 0 0
Aschaffenburg
Country [237] 0 0
Germany
State/province [237] 0 0
Augsburg
Country [238] 0 0
Germany
State/province [238] 0 0
Bad Nauheim
Country [239] 0 0
Germany
State/province [239] 0 0
Berlin
Country [240] 0 0
Germany
State/province [240] 0 0
Bochum
Country [241] 0 0
Germany
State/province [241] 0 0
Cloppenburg
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
Essen
Country [245] 0 0
Germany
State/province [245] 0 0
Frankfurt
Country [246] 0 0
Germany
State/province [246] 0 0
Giengen
Country [247] 0 0
Germany
State/province [247] 0 0
Goerlitz
Country [248] 0 0
Germany
State/province [248] 0 0
Grossheirath
Country [249] 0 0
Germany
State/province [249] 0 0
Hamburg
Country [250] 0 0
Germany
State/province [250] 0 0
Heidelberg
Country [251] 0 0
Germany
State/province [251] 0 0
Heilbronn
Country [252] 0 0
Germany
State/province [252] 0 0
Homburg
Country [253] 0 0
Germany
State/province [253] 0 0
Ingelheim
Country [254] 0 0
Germany
State/province [254] 0 0
Kallstadt
Country [255] 0 0
Germany
State/province [255] 0 0
Kassel
Country [256] 0 0
Germany
State/province [256] 0 0
Kiel-Kronshagen
Country [257] 0 0
Germany
State/province [257] 0 0
Koeln
Country [258] 0 0
Germany
State/province [258] 0 0
Leipzig
Country [259] 0 0
Germany
State/province [259] 0 0
Ludwigshafen
Country [260] 0 0
Germany
State/province [260] 0 0
Luebeck
Country [261] 0 0
Germany
State/province [261] 0 0
Magdeburg
Country [262] 0 0
Germany
State/province [262] 0 0
Mainz
Country [263] 0 0
Germany
State/province [263] 0 0
Mannheim
Country [264] 0 0
Germany
State/province [264] 0 0
Markkleeberg
Country [265] 0 0
Germany
State/province [265] 0 0
Muenchen
Country [266] 0 0
Germany
State/province [266] 0 0
Nienburg
Country [267] 0 0
Germany
State/province [267] 0 0
Northeinm
Country [268] 0 0
Germany
State/province [268] 0 0
Offenbach-beiber
Country [269] 0 0
Germany
State/province [269] 0 0
Potsdam
Country [270] 0 0
Germany
State/province [270] 0 0
Ruedersdorf
Country [271] 0 0
Germany
State/province [271] 0 0
Siegen
Country [272] 0 0
Germany
State/province [272] 0 0
Stuhr
Country [273] 0 0
Germany
State/province [273] 0 0
Ulm
Country [274] 0 0
Germany
State/province [274] 0 0
Unterschneidheim
Country [275] 0 0
Germany
State/province [275] 0 0
Wardenburg
Country [276] 0 0
Germany
State/province [276] 0 0
Wermsdorf
Country [277] 0 0
Germany
State/province [277] 0 0
Weyhe
Country [278] 0 0
Germany
State/province [278] 0 0
Witten
Country [279] 0 0
Germany
State/province [279] 0 0
Woerishofen
Country [280] 0 0
Germany
State/province [280] 0 0
Wuppertal
Country [281] 0 0
Greece
State/province [281] 0 0
Athens
Country [282] 0 0
Greece
State/province [282] 0 0
Larissa
Country [283] 0 0
Greece
State/province [283] 0 0
Rhodes
Country [284] 0 0
Greece
State/province [284] 0 0
Rio-Patras
Country [285] 0 0
Greece
State/province [285] 0 0
Thessaloniki
Country [286] 0 0
Greece
State/province [286] 0 0
Trikala
Country [287] 0 0
Greece
State/province [287] 0 0
Voula
Country [288] 0 0
Guatemala
State/province [288] 0 0
Ciudad
Country [289] 0 0
Guatemala
State/province [289] 0 0
Clinica
Country [290] 0 0
Guatemala
State/province [290] 0 0
Edificio Multimedica
Country [291] 0 0
Guatemala
State/province [291] 0 0
Nivel
Country [292] 0 0
Guatemala
State/province [292] 0 0
Oficina
Country [293] 0 0
Guatemala
State/province [293] 0 0
Quetzaltenango
Country [294] 0 0
Guatemala
State/province [294] 0 0
Zacapa
Country [295] 0 0
Hungary
State/province [295] 0 0
Ajka
Country [296] 0 0
Hungary
State/province [296] 0 0
Baja
Country [297] 0 0
Hungary
State/province [297] 0 0
Bekescsaba
Country [298] 0 0
Hungary
State/province [298] 0 0
Budapest
Country [299] 0 0
Hungary
State/province [299] 0 0
Debrecen
Country [300] 0 0
Hungary
State/province [300] 0 0
Hodmezovasarhely
Country [301] 0 0
Hungary
State/province [301] 0 0
Kecskemet
Country [302] 0 0
Hungary
State/province [302] 0 0
Keeskemet
Country [303] 0 0
Hungary
State/province [303] 0 0
Kistarcsa
Country [304] 0 0
Hungary
State/province [304] 0 0
Komarom
Country [305] 0 0
Hungary
State/province [305] 0 0
Mako
Country [306] 0 0
Hungary
State/province [306] 0 0
Nagykanizsa
Country [307] 0 0
Hungary
State/province [307] 0 0
Nyiregyhaza
Country [308] 0 0
Hungary
State/province [308] 0 0
Pecs
Country [309] 0 0
Hungary
State/province [309] 0 0
Sopron
Country [310] 0 0
Hungary
State/province [310] 0 0
Szekszard
Country [311] 0 0
Hungary
State/province [311] 0 0
Szombathely
Country [312] 0 0
Hungary
State/province [312] 0 0
Zalaegerszeg
Country [313] 0 0
India
State/province [313] 0 0
AP
Country [314] 0 0
India
State/province [314] 0 0
Kerala
Country [315] 0 0
India
State/province [315] 0 0
Ahmedabad
Country [316] 0 0
India
State/province [316] 0 0
Anddhra Pradesh
Country [317] 0 0
India
State/province [317] 0 0
Andhra Pradesh
Country [318] 0 0
India
State/province [318] 0 0
Aurangabad
Country [319] 0 0
India
State/province [319] 0 0
Bangalore
Country [320] 0 0
India
State/province [320] 0 0
Bikaner
Country [321] 0 0
India
State/province [321] 0 0
Chennai
Country [322] 0 0
India
State/province [322] 0 0
Coimbatore
Country [323] 0 0
India
State/province [323] 0 0
Delhi
Country [324] 0 0
India
State/province [324] 0 0
Gujrat
Country [325] 0 0
India
State/province [325] 0 0
Indore
Country [326] 0 0
India
State/province [326] 0 0
Jaipur
Country [327] 0 0
India
State/province [327] 0 0
Karnataka
Country [328] 0 0
India
State/province [328] 0 0
Kolkata
Country [329] 0 0
India
State/province [329] 0 0
Ludhiana
Country [330] 0 0
India
State/province [330] 0 0
Madhya Pradesh
Country [331] 0 0
India
State/province [331] 0 0
Maharashtra
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
Nagpur
Country [335] 0 0
India
State/province [335] 0 0
Nashik
Country [336] 0 0
India
State/province [336] 0 0
New Delhi
Country [337] 0 0
India
State/province [337] 0 0
Pune
Country [338] 0 0
India
State/province [338] 0 0
Puni
Country [339] 0 0
India
State/province [339] 0 0
Punjab
Country [340] 0 0
India
State/province [340] 0 0
Rajasthan
Country [341] 0 0
India
State/province [341] 0 0
Ramnagar
Country [342] 0 0
India
State/province [342] 0 0
Shimoga
Country [343] 0 0
India
State/province [343] 0 0
Surat
Country [344] 0 0
India
State/province [344] 0 0
Trivandrum
Country [345] 0 0
India
State/province [345] 0 0
Vadodara
Country [346] 0 0
Israel
State/province [346] 0 0
Afula
Country [347] 0 0
Israel
State/province [347] 0 0
Beer-Sheva
Country [348] 0 0
Israel
State/province [348] 0 0
Dimona
Country [349] 0 0
Israel
State/province [349] 0 0
Givatayim
Country [350] 0 0
Israel
State/province [350] 0 0
Hadera
Country [351] 0 0
Israel
State/province [351] 0 0
Haifa
Country [352] 0 0
Israel
State/province [352] 0 0
Holon
Country [353] 0 0
Israel
State/province [353] 0 0
Jerusalem
Country [354] 0 0
Israel
State/province [354] 0 0
Kfar Saba
Country [355] 0 0
Israel
State/province [355] 0 0
Nahariya
Country [356] 0 0
Israel
State/province [356] 0 0
Nazareth
Country [357] 0 0
Israel
State/province [357] 0 0
Petach Tikva
Country [358] 0 0
Israel
State/province [358] 0 0
Petah-Tikva
Country [359] 0 0
Israel
State/province [359] 0 0
Poriya
Country [360] 0 0
Israel
State/province [360] 0 0
Raanana
Country [361] 0 0
Israel
State/province [361] 0 0
Rehovot
Country [362] 0 0
Israel
State/province [362] 0 0
Tel Aviv
Country [363] 0 0
Israel
State/province [363] 0 0
Tel Hashomer
Country [364] 0 0
Israel
State/province [364] 0 0
Zerifin
Country [365] 0 0
Italy
State/province [365] 0 0
Bologna
Country [366] 0 0
Italy
State/province [366] 0 0
Brescia
Country [367] 0 0
Italy
State/province [367] 0 0
Cantania
Country [368] 0 0
Italy
State/province [368] 0 0
Casarano
Country [369] 0 0
Italy
State/province [369] 0 0
Caserta
Country [370] 0 0
Italy
State/province [370] 0 0
Chieti
Country [371] 0 0
Italy
State/province [371] 0 0
Cremona
Country [372] 0 0
Italy
State/province [372] 0 0
Genova
Country [373] 0 0
Italy
State/province [373] 0 0
Grosseto
Country [374] 0 0
Italy
State/province [374] 0 0
Legnano
Country [375] 0 0
Italy
State/province [375] 0 0
Manerbio
Country [376] 0 0
Italy
State/province [376] 0 0
Milano
Country [377] 0 0
Italy
State/province [377] 0 0
Monserrato
Country [378] 0 0
Italy
State/province [378] 0 0
Napoli
Country [379] 0 0
Italy
State/province [379] 0 0
Novara
Country [380] 0 0
Italy
State/province [380] 0 0
Ostia
Country [381] 0 0
Italy
State/province [381] 0 0
Pavia
Country [382] 0 0
Italy
State/province [382] 0 0
Pisa
Country [383] 0 0
Italy
State/province [383] 0 0
Pozzuoli
Country [384] 0 0
Italy
State/province [384] 0 0
Roma
Country [385] 0 0
Italy
State/province [385] 0 0
Santa Maria Capua Vetere
Country [386] 0 0
Italy
State/province [386] 0 0
Sassari
Country [387] 0 0
Italy
State/province [387] 0 0
Seriate
Country [388] 0 0
Italy
State/province [388] 0 0
Siena
Country [389] 0 0
Italy
State/province [389] 0 0
Trieste
Country [390] 0 0
Italy
State/province [390] 0 0
Venezia Mestre
Country [391] 0 0
Japan
State/province [391] 0 0
Kyoto
Country [392] 0 0
Japan
State/province [392] 0 0
Nagano
Country [393] 0 0
Japan
State/province [393] 0 0
Tokyo
Country [394] 0 0
Japan
State/province [394] 0 0
Aichi
Country [395] 0 0
Japan
State/province [395] 0 0
Aomori
Country [396] 0 0
Japan
State/province [396] 0 0
Chiaki
Country [397] 0 0
Japan
State/province [397] 0 0
Chiba
Country [398] 0 0
Japan
State/province [398] 0 0
Ehime
Country [399] 0 0
Japan
State/province [399] 0 0
Fukuoka
Country [400] 0 0
Japan
State/province [400] 0 0
Fukushima
Country [401] 0 0
Japan
State/province [401] 0 0
Gifu
Country [402] 0 0
Japan
State/province [402] 0 0
Gunma
Country [403] 0 0
Japan
State/province [403] 0 0
Hiroshima
Country [404] 0 0
Japan
State/province [404] 0 0
Hokkai-do
Country [405] 0 0
Japan
State/province [405] 0 0
Hokkaido
Country [406] 0 0
Japan
State/province [406] 0 0
Hyogo
Country [407] 0 0
Japan
State/province [407] 0 0
Ibaraki
Country [408] 0 0
Japan
State/province [408] 0 0
Isesaki-shi
Country [409] 0 0
Japan
State/province [409] 0 0
Ishikawa
Country [410] 0 0
Japan
State/province [410] 0 0
Iwate
Country [411] 0 0
Japan
State/province [411] 0 0
Kagawa
Country [412] 0 0
Japan
State/province [412] 0 0
Kanagawa
Country [413] 0 0
Japan
State/province [413] 0 0
Kumamoto
Country [414] 0 0
Japan
State/province [414] 0 0
Kyota
Country [415] 0 0
Japan
State/province [415] 0 0
Mie
Country [416] 0 0
Japan
State/province [416] 0 0
Miyagi
Country [417] 0 0
Japan
State/province [417] 0 0
Nagaoka-shi
Country [418] 0 0
Japan
State/province [418] 0 0
Nagasaki
Country [419] 0 0
Japan
State/province [419] 0 0
Niigata
Country [420] 0 0
Japan
State/province [420] 0 0
Okayama
Country [421] 0 0
Japan
State/province [421] 0 0
Osaka
Country [422] 0 0
Japan
State/province [422] 0 0
Saitama
Country [423] 0 0
Japan
State/province [423] 0 0
Shimane
Country [424] 0 0
Japan
State/province [424] 0 0
Shizuoka
Country [425] 0 0
Japan
State/province [425] 0 0
Tokushima
Country [426] 0 0
Japan
State/province [426] 0 0
Yamaguchi
Country [427] 0 0
Japan
State/province [427] 0 0
Yokohama-shi
Country [428] 0 0
Korea, Republic of
State/province [428] 0 0
Busan