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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
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)
ACT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Bruce
Recruitment hospital [2] 0 0
Research Site - Chermside
Recruitment hospital [3] 0 0
Research Site - Herston
Recruitment hospital [4] 0 0
Research Site - Woolloongabba
Recruitment hospital [5] 0 0
Research Site - Bedford Park
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Research Site - Dandenong
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Research Site - Geelong
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Research Site - Melbourne
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Research Site - Perth
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- Herston
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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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Germany
State/province [223] 0 0
Munster
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Germany
State/province [224] 0 0
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Germany
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Germany
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ULM
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Germany
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Warendorf
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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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Greece
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Greece
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Greece
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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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Hungary
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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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India
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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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India
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India
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West Bengal
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Bali
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Indonesia
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Jawa Barat
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Indonesia
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Jawa Timur
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Indonesia
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Indonesia
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Indonesia
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Israel
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Afula
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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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Israel
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Poriya M.p. Lower Galilee
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Israel
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Israel
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Israel
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VE
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Massa Carrara
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Italy
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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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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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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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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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Netherlands
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Netherlands
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Tiel
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Netherlands
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Netherlands
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Netherlands
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Norway
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Norway
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Norway
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Drammen
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Norway
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Norway
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Norway
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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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Norway
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Norway
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Norway
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RUD
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Norway
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Norway
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Country [366] 0 0
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Country [367] 0 0
Philippines
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Country [368] 0 0
Philippines
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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