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For full trial details, please see the original record athttps://clinicaltrials.gov/ct2/show/NCT01042769
Registration number
NCT01042769
Ethics application status
Date submitted
5/01/2010
Date registered
6/01/2010
Date last updated
2/11/2016
Titles & IDs
Public title
A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
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Scientific title
A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
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Secondary ID [1]00
2009-012269-71
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Secondary ID [2]00
BC22140
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 200
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Condition category
Condition code
Cardiovascular 0000
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Coronary heart disease
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Metabolic and Endocrine0000
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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 - Aleglitazar Experimental: Aleglitazar - Placebo Comparator: Placebo - Treatment: Drugs: Aleglitazar Treatment: Drugs: Placebo
Treatment: Drugs - Placebo
aleglitazar 150 micrograms po daily
placebo control po daily
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Intervention code [1]00
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]00
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
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Timepoint [1]00
Throughout study, approximately 4.5 years
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Secondary outcome [1]00
Effects on other cardiovascular endpoints
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Timepoint [1]00
Throughout study, approximately 4.5 years
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Secondary outcome [2]00
Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk
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Timepoint [2]00
Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter
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Secondary outcome [3]00
Tolerability and long-term safety profile
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Timepoint [3]00
Throughout study, approximately 4.5 years
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Eligibility
Key inclusion criteria
- Adults >18 years of age - Type 2 diabetes mellitus - Hospitalization for ACS event and randomization between hospital discharge and 8 weeks
after the ACS index event (day of hospitalization)
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Minimum age
18Years
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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
- Estimated glomerular filtration rate <45 mL/min/1.73m2 - Concomitant treatment with a thiazolidinedione and/or fibrate - Triglycerides >400 mg/dL - Anaemia - Symptomatic congestive heart failure classified as New York Heart Association (NYHA)
class II-IV (France and Germany: Symptomatic congestive heart failure classified as
NYHA class I-IV)
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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 concealmentprocedures)
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Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)
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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
1/02/2010
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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
1/11/2013
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Sample size
Target
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Accrual to date
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Final
7226
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]00
- Garran
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Recruitment hospital [2]00
- Bankstown
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Recruitment hospital [3]00
- Concord
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Recruitment hospital [4]00
- Darlinghurst
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Recruitment hospital [5]00
- Liverpool BC
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Recruitment hospital [6]00
- New Lambton
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Recruitment hospital [7]00
- Penrith
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Recruitment hospital [8]00
- St. Leonards
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Recruitment hospital [9]00
- Sydney
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Recruitment hospital [10]00
- Wollongong
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Recruitment hospital [11]00
- Douglas
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Recruitment hospital [12]00
- Milton
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Recruitment hospital [13]00
- Redcliffe
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- Southport
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- Woolloongabba
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- Adelaide
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- Elizabeth Vale
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- Woodville
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- Ballarat
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- Geelong
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- Richmond
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- Shepparton
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Recruitment postcode(s) [1]00
2605 - Garran
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2200 - Bankstown
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2139 - Concord
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2010 - Darlinghurst
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1871 - Liverpool BC
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Recruitment postcode(s) [6]00
2305 - New Lambton
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2751 - Penrith
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2065 - St. Leonards
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2217 - Sydney
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2500 - Wollongong
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4184 - Douglas
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4064 - Milton
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4020 - Redcliffe
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4215 - Southport
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4102 - Woolloongabba
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5000 - Adelaide
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5112 - Elizabeth Vale
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5011 - Woodville
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3353 - Ballarat
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3220 - Geelong
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3121 - Richmond
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3630 - Shepparton
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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United States of America
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Louisiana
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Maine
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Hungary
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Pécs
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Hungary
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Szolnok
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Hungary
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Szombathely
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Hungary
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Hungary
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Kerala
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India
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Maharashtra
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India
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Ahmedabad
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India
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Bangalore
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India
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Banglore
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India
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Belgaum
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India
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Chennai
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India
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Cochin
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India
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Gurgaon
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India
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Hyderabad
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India
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Indore
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India
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Jaipur
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India
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Kolkata
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India
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Lucknow
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India
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Madhurai
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India
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Mangalore
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India
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Mumbai
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India
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Mysore
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India
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Nagpur
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India
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New Delhi
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India
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Palakkad
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India
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Pune
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India
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Secunderabad
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India
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Trivandeum
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Ballinasloe
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Ireland
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Dublin
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Ireland
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Galway
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Ireland
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Tallaght Dublin
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Umbria
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Italy
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Veneto
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Gyeonggi-do
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Incheon
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Jeollabuk-do
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Kyonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Korea, Republic of
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Uijongbu
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Ulsan
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Wonju
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Kelantan
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Malaysia
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Kota Bharu
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuantan
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Malaysia
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Malaysia
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Malaysia
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Serdang
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Pachuca
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Mexico
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Puebla
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Mexico
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Mexico
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Queretaro
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Mexico
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San Luis Potosi S.L.P.
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Mexico
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Tampico
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Mexico
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Mexico
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Mexico
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Veracruz
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Mexico
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Xalapa
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Mexico
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Zapopan
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Netherlands
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AC Amsterdam
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Netherlands
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Amstelveen
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Netherlands
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Amsterdam
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Netherlands
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Hoorn
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Leiden
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Netherlands
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Maastricht
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Netherlands
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Netherlands
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Nijmegen
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Netherlands
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Purmerend
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Netherlands
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Tilburg
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Netherlands
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Weert
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Netherlands
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Zaandam
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Netherlands
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Zwolle
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Auckland
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Christchurch
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New Zealand
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Hamiton
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New Zealand
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Lower Hutt
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New Zealand
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Nelson
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New Zealand
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Palmerston North
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New Zealand
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Tauranga
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Bytom
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Poland
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Bêdzin
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Poland
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Cracow
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Gorlice
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Poland
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Grodzisk Mazowiecki
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Poland
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Katowice
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Poland
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Kedzierzyn-Kozle
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Kutno
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Poland
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Libiaz
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Nowa Sol
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Poland
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Nysa
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Poland
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Olawa
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Poland
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Olesnica, Spalice
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Poland
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Olsztyn
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Poznan
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Poland
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Pulawy
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Poland
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Radom
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Poland
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Rzeszow
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Poland
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Swidnica
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Poland
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Tarnow
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Poland
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Tarnów
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Poland
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Torun
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Poland
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Ustron
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Poland
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Ustroñ
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Poland
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Warsaw
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Poland
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Warszawa
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Poland
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Wola
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Poland
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Wroclaw
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Poland
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Zamosc
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Poland
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Zarow
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Poland
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Zgorzelec
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Poland
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£ódx
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Buzau
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Galati
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Romania
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Oradea
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Romania
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Ploiesti
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Romania
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Targu-Mures
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Spain
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Alava
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Spain
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Alicante
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Cadiz
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Spain
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Girona
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Spain
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La Coruña
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Tarragona
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Spain
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Vizcaya
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Spain
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Almeria
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Spain
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Guadalajara
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Spain
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Lugo
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Spain
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Malaga
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Spain
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Murcia
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Danderyd Stockholm
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Sweden
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Goteborg
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Sweden
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Halmstad
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Sweden
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Kalmar
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Sweden
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Karlstad
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Sweden
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Kristianstad
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Sweden
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Malmö
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Sweden
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Ostersund
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Sweden
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Skellefteå
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Sweden
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Skovde
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Sweden
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Stockholm
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Thailand
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Amphur Mae-Rim
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Thailand
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Amphur Muang
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Thailand
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Bangkok
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Thailand
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ChiangMai
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Thailand
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Chonburi
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Thailand
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Khon Kaen
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Thailand
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Khonkaen
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Thailand
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Klong Luang
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Thailand
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Phitsanulok
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Thailand
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Saraburi
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Country [369]00
United Kingdom
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Abano Terme
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United Kingdom
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Antrim
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United Kingdom
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AYR
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United Kingdom
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Basildon
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United Kingdom
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Bath
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United Kingdom
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Belfast
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United Kingdom
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Brighton
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United Kingdom
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Cambridge
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United Kingdom
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Craigavon
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United Kingdom
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Derby
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United Kingdom
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Glasgow
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United Kingdom
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Harrow
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United Kingdom
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Inverness
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United Kingdom
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Isle of Wight
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Country [383]00
United Kingdom
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Isleworth
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Country [384]00
United Kingdom
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Leeds
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Country [385]00
United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesex
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Northampton
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United Kingdom
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Paddington
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United Kingdom
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Plymouth
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United Kingdom
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Poole
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United Kingdom
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Romford
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United Kingdom
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Stoker on Trent
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United Kingdom
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State/province [395]00
West Bromwich
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Country [396]00
United Kingdom
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Wrexham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This double-blind, parallel, two-arm study will evaluate the potential to reduce
cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to
placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and
type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or
placebo once daily as oral doses. The study will last until at least 950 events occur, but
time on study treatment will be for at least 2.5 years.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01042769
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name00
Clinical Trials
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Address00
Hoffmann-La Roche
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Phone00
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Email00
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Contact person for public queries
Name00
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Phone00
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Email00
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Contact person for scientific queries
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
