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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00391872




Registration number
NCT00391872
Ethics application status
Date submitted
23/10/2006
Date registered
25/10/2006
Date last updated
13/03/2012

Titles & IDs
Public title
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
Scientific title
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
Secondary ID [1] 0 0
PLATO
Secondary ID [2] 0 0
D5130C05262
Universal Trial Number (UTN)
Trial acronym
PLATO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Clopidogrel

Active comparator: Clopidogrel - Oral treatment

Experimental: Ticagrelor - Oral treatment


Treatment: Drugs: Ticagrelor
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)

Treatment: Drugs: Clopidogrel
Clopidogrel 75 mg once daily dose (ODD)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
Timepoint [1] 0 0
Randomization up to 12 months
Primary outcome [2] 0 0
Participants With Any Major Bleeding Event
Timepoint [2] 0 0
First dosing up to 12 months
Secondary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
Timepoint [1] 0 0
Randomization up to 12 months
Secondary outcome [2] 0 0
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
Timepoint [2] 0 0
Randomization up to 12 months
Secondary outcome [3] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
Timepoint [3] 0 0
Randomization up to 12 months
Secondary outcome [4] 0 0
Participants With MI Event
Timepoint [4] 0 0
Randomization up to 12 months
Secondary outcome [5] 0 0
Participants With Death From Vascular Causes
Timepoint [5] 0 0
Randomization up to 12 months
Secondary outcome [6] 0 0
Participants With Stroke
Timepoint [6] 0 0
Randomization up to 12 months
Secondary outcome [7] 0 0
Participants With Death From Any Cause
Timepoint [7] 0 0
Randomization up to 12 months
Secondary outcome [8] 0 0
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
Timepoint [8] 0 0
First dosing up to 12 months
Secondary outcome [9] 0 0
Participants With Major or Minor Bleeding
Timepoint [9] 0 0
First dosing up to 12 months
Secondary outcome [10] 0 0
Participants With Non-procedural Major Bleeding
Timepoint [10] 0 0
First dosing up to 12 months
Secondary outcome [11] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
Timepoint [11] 0 0
First dosing up to 12 months
Secondary outcome [12] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
Timepoint [12] 0 0
First dosing up to 12 months
Secondary outcome [13] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
Timepoint [13] 0 0
1-week period following randomization
Secondary outcome [14] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
Timepoint [14] 0 0
1-week period following randomization

Eligibility
Key inclusion criteria
* Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
* Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Persons with moderate or severe liver disease
* Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
* Persons who are being treated with blood clotting agents that cannot be stopped

Study design
Purpose of the study
Treatment
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
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
18624
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Bruce
Recruitment hospital [2] 0 0
Research Site - Chermside
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Research Site - Herston
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Research Site - Woolloongabba
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Research Site - Bedford Park
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Research Site - Melbourne
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Research Site - Perth
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- Dandenong
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- Geelong
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- Melbourne
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- Perth
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Germany
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Germany
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Germany
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Germany
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Germany
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Muhlheim An Der Ruhr
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Germany
State/province [223] 0 0
Munster
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Germany
State/province [224] 0 0
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Germany
State/province [225] 0 0
Rostock
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Germany
State/province [226] 0 0
ULM
Country [227] 0 0
Germany
State/province [227] 0 0
Warendorf
Country [228] 0 0
Germany
State/province [228] 0 0
Witten
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Germany
State/province [229] 0 0
Wuppertal
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Germany
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Greece
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Crete
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Greece
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Greece
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Larissa
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Greece
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Patra
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Greece
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Piraeus
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Greece
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Cegled
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Hungary
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Debrecen
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Hungary
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Hungary
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Hodmez-vasarhely
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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India
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Country [250] 0 0
India
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Delhi
Country [251] 0 0
India
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Country [252] 0 0
India
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India
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Kerala
Country [254] 0 0
India
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Madhya Pradesh
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India
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India
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India
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Rajasthan
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India
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Tamilnadu
Country [259] 0 0
India
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West Bengal
Country [260] 0 0
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Bali
Country [261] 0 0
Indonesia
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Jawa Barat
Country [262] 0 0
Indonesia
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Jawa Timur
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Indonesia
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Jakarta
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Indonesia
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Makassar
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Indonesia
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Semarang
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Israel
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Afula
Country [267] 0 0
Israel
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Ashkelon
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Israel
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Israel
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Hadera
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Israel
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Israel
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Israel
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Jerusalem
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Israel
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Poriya M.p. Lower Galilee
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Israel
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Israel
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Tel Aviv
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Israel
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AN
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CE
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CT
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SS
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VE
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VR
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Massa Carrara
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Italy
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Napoli
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Malaysia
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Wilayah Persekutuan
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Mexico
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Mexico
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Mexico
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Mexico
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Netherlands
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Netherlands
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Netherlands
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Amersfoort
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Capelle Aan Den Ijssel
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Netherlands
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EDE
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Maastricht
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Tiel
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Netherlands
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Country [348] 0 0
Netherlands
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Veldhoven
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Netherlands
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Arendal
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Norway
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Bergen
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Norway
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Bodo
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Norway
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Drammen
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Norway
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Flekkefjord
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Norway
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Gjovik
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Norway
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Hamar
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Norway
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Kongsberg
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Norway
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Kristiansand
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Norway
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Lillehammer
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Norway
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Nordbyhagen
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Norway
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Norway
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Oslo
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Norway
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RUD
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Norway
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Tromso
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Norway
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Country [366] 0 0
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Cebu
Country [367] 0 0
Philippines
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Davao City
Country [368] 0 0
Philippines
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Manila
Country [369] 0 0
Philippines
State/province [369] 0 0
Pasig City
Country [370] 0 0
Philippines
State/province [370] 0 0
Quezon City
Country [371] 0 0
Poland
State/province [371] 0 0
Bialystok
Country [372] 0 0
Poland
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Bielsko-biala
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Poland
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Bydgoszcz
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Poland
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Bytom
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Poland
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Czestochowa
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Poland
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Elblag
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Poland
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Gda?sk
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Poland
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Gdynia
Country [379] 0 0
Poland
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Grodzisk Mazowiecki
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Poland
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Inowroclaw
Country [381] 0 0
Poland
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Katowice
Country [382] 0 0
Poland
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Krakow
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Poland
State/province [383] 0 0
Lodz
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Poland
State/province [384] 0 0
Lublin
Country [385] 0 0
Poland