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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00153101




Registration number
NCT00153101
Ethics application status
Date submitted
9/09/2005
Date registered
12/09/2005
Date last updated
20/05/2014

Titles & IDs
Public title
Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo.
Scientific title
ONTARGET ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial A Large, Simple Randomized Trial of an Angiotensin II Receptor Antagonist (Telmisartan) and an ACE-Inhibitor (Ramipril) in Patients at High Risk for Cardiovascular Events and TRANSCEND Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects With Cardiovascular Disease. A Parallel Study Comparing the Effects of Telmisartan With Placebo and Outcomes in Patients at High Risk for Cardiovascular Events and Intolerant to ACE-I.
Secondary ID [1] 0 0
502.373
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Timepoint [1] 0 0
56 months
Primary outcome [2] 0 0
ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients
Timepoint [2] 0 0
56 months
Primary outcome [3] 0 0
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Timepoint [3] 0 0
56 months
Secondary outcome [1] 0 0
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Timepoint [1] 0 0
56 months
Secondary outcome [2] 0 0
ONTARGET. Cardiovascular Death
Timepoint [2] 0 0
56 months
Secondary outcome [3] 0 0
ONTARGET. Non-fatal Myocardial Infarction
Timepoint [3] 0 0
56 months
Secondary outcome [4] 0 0
ONTARGET. Non-fatal Stroke
Timepoint [4] 0 0
56 months
Secondary outcome [5] 0 0
ONTARGET. Hospitalization for Congestive Heart Failure
Timepoint [5] 0 0
56 months
Secondary outcome [6] 0 0
ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients
Timepoint [6] 0 0
56 months
Secondary outcome [7] 0 0
ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients
Timepoint [7] 0 0
56 months
Secondary outcome [8] 0 0
ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients
Timepoint [8] 0 0
56 months
Secondary outcome [9] 0 0
ONTARGET. Doubling of Serum Creatinine
Timepoint [9] 0 0
56 months
Secondary outcome [10] 0 0
ONTARGET. Progression to ESRD
Timepoint [10] 0 0
56 months
Secondary outcome [11] 0 0
ONTARGET. New Microalbuminuria
Timepoint [11] 0 0
56 months
Secondary outcome [12] 0 0
ONTARGET. New Macroalbuminuria
Timepoint [12] 0 0
56 months
Secondary outcome [13] 0 0
ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria
Timepoint [13] 0 0
56 months
Secondary outcome [14] 0 0
ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria
Timepoint [14] 0 0
56 months
Secondary outcome [15] 0 0
ONTARGET. Newly Diagnosed Congestive Heart Failure
Timepoint [15] 0 0
56 months
Secondary outcome [16] 0 0
ONTARGET. Cardiovascular Revascularization Procedure
Timepoint [16] 0 0
56 months
Secondary outcome [17] 0 0
ONTARGET. Newly Diagnosed Diabetes
Timepoint [17] 0 0
56 months
Secondary outcome [18] 0 0
ONTARGET. Cognitive Decline
Timepoint [18] 0 0
56 months
Secondary outcome [19] 0 0
ONTARGET. New Onset of Atrial Fibrillation
Timepoint [19] 0 0
56 months
Secondary outcome [20] 0 0
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Timepoint [20] 0 0
56 months
Secondary outcome [21] 0 0
TRANSCEND. Cardiovascular Death
Timepoint [21] 0 0
56 months
Secondary outcome [22] 0 0
TRANSCEND. Non-fatal Myocardial Infarction
Timepoint [22] 0 0
56 months
Secondary outcome [23] 0 0
TRANSCEND. Non-fatal Stroke
Timepoint [23] 0 0
56 months
Secondary outcome [24] 0 0
TRANSCEND. Hospitalization for Congestive Heart Failure
Timepoint [24] 0 0
56 months
Secondary outcome [25] 0 0
TRANSCEND. Doubling of Serum Creatinine
Timepoint [25] 0 0
56 months
Secondary outcome [26] 0 0
TRANSCEND. Progression to ESRD
Timepoint [26] 0 0
56 months
Secondary outcome [27] 0 0
TRANSCEND. New Microalbuminuria
Timepoint [27] 0 0
56 months
Secondary outcome [28] 0 0
TRANSCEND. New Macroalbuminuria
Timepoint [28] 0 0
56 months
Secondary outcome [29] 0 0
TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria
Timepoint [29] 0 0
56 months
Secondary outcome [30] 0 0
TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria
Timepoint [30] 0 0
56 months
Secondary outcome [31] 0 0
TRANSCEND. New Onset of Atrial Fibrillation
Timepoint [31] 0 0
56 months
Secondary outcome [32] 0 0
TRANSCEND. Cognitive Decline
Timepoint [32] 0 0
56 months
Secondary outcome [33] 0 0
TRANSCEND. Newly Diagnosed Diabetes
Timepoint [33] 0 0
56 months
Secondary outcome [34] 0 0
TRANSCEND. Cardiovascular Revascularization Procedure
Timepoint [34] 0 0
56 months
Secondary outcome [35] 0 0
TRANSCEND. Newly Diagnosed Congestive Heart Failure
Timepoint [35] 0 0
56 months

Eligibility
Key inclusion criteria
Coronary Artery Disease: Previous Myocardial infarction(> 2 days prior to informed consent), or stable or previous unstable angina (> 30 days prior to informed consent) with documented multivessel coronary artery disease or a positive stress test, or multivessel Percutaneous Transluminal Coronary Angioplasty (> 30 days prior to informed consent), or previous multivessel Coronary Artery Bypass Grafting without angina (if surgery performed > 4 years prior to informed consent) or with recurrent angina after surgery.

Other High Risk:

1. Peripheral Arterial Disease: Previous limb bypass surgery or angioplasty or amputation, intermittent claudication on history with ankle/arm Blood Pressure ratio < 0.8 on at least one side, or significant stenosis by angiography or non-invasive testing
2. Previous stroke
3. Transient ischemic Attack > 7 days and < 1 year prior to informed consent
4. Diabetes Mellitus (types I or II): with evidence of end-organ damage (retinopathy, Left ventricular hypertrophy, micro or macro albuminuria), or any evidence of previous cardiac or vascular disease.

No definite and specific indication or contraindication for any of the study treatments. Written informed consent.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A. Medication use:

1. Inability to discontinue Angiotension Converting Enzyme (ACE) inhibitors or Angiotension 2 receptor antagonists (AIIAs).
2. Patients with known hypersensitivity or intolerance to Angiotension 2 receptor antagonists (AIIAs) or Angiotension Converting Enzyme (ACE)inhibitors.

NOTE: Patients with known intolerance to Angiotension Converting Enzyme inhibitor intolerance ( ACE-I) can be enrolled in the TRANSCEND study.

B. Cardiovascular disease:

1. Symptomatic congestive heart failure.
2. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
3. Constrictive pericarditis.
4. Complex congenital heart disease.
5. Syncopal episodes of unknown etiology < 3 months before informed consent.
6. Planned cardiac surgery or angioplasty within three months.
7. Uncontrolled hypertension on treatment (i.e.Blood pressure ( BP) > 160/100).
8. Heart transplant recipient.
9. Strokes due to subarachnoid hemorrhage

C. Other conditions:

1. Significant renal disease defined as:

1. Renal artery stenosis;
2. Creatinine clearance < 0.6 ml/min or serum creatinine > 265 umol/L (> 3.0 mg/dL);
3. Hyperkalemia: potassium > 5.5 mmol/L.
4. Proteinuria* (for TRANSCEND only).
2. Hepatic dysfunction as defined by the following laboratory parameters: Serum Glutamate Pyruvate Transaminase( SGPT) Alaninaminotransferase (ALT) or Serum Glutamic Oxaloacetic Transaminase (SGOT) Aspartate aminotransferase (AST) > than 4 times upper limit of normal or additional criteria for hepatic impairment the upper limit of normal range, total Bilirubin > 20 umol/L, biliary obstructive disorders.
3. Uncorrected volume depletion or sodium depletion.
4. Primary aldosteronism.
5. Hereditary fructose intolerance.
6. Any other major non-cardiac illness expected to reduce life expectancy or interfere with study participation.
7. Patient is simultaneously taking another experimental drug.
8. Patient with significant disability that precludes regular attendance at clinic for follow-up.
9. Patient has sufficient disability or other incapacity that precludes regular attendance at clinic for follow-up.
10. Unable or unwilling to provide written informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
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?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/11/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
31546
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
502.373.0534 The Canberra Hospital - Woden
Recruitment hospital [2] 0 0
502.373.0536 Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
502.373.0544 Coffs Harbour Cardiovascular Clinic - Coffs Harbour
Recruitment hospital [4] 0 0
502.373.0538 Concord Repatriation General Hospital - Concord
Recruitment hospital [5] 0 0
502.373.0539 Central Coast Neuroscience Research - Gosford
Recruitment hospital [6] 0 0
502.373.0556 Gosford Hospital - Gosford
Recruitment hospital [7] 0 0
502.373.0542 St. George Hospital - Kogarah
Recruitment hospital [8] 0 0
502.373.0552 St George Private Hospital - Kogarah
Recruitment hospital [9] 0 0
502.373.0559 St George Hospital - Dept of Clinical Pharmacology - Kogarah
Recruitment hospital [10] 0 0
502.373.0528 John Hunter Hospital - Newcastle
Recruitment hospital [11] 0 0
502.373.0535 The Prince of Wales Hospital - Randwick
Recruitment hospital [12] 0 0
502.373.0533 Royal North Shore Hospital - St Leonards
Recruitment hospital [13] 0 0
502.373.0549 Illawarra Regional Hospital - Wollongong
Recruitment hospital [14] 0 0
502.373.0523 The Prince Charles Hospital - Chermside
Recruitment hospital [15] 0 0
502.373.0524 Royal Brisbane Hospital - Herston
Recruitment hospital [16] 0 0
502.373.0526 Peninsula Clinical Research Centre - Kippa-Ring
Recruitment hospital [17] 0 0
502.373.0540 Gold Coast Hospital - Southport
Recruitment hospital [18] 0 0
502.373.0521 Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [19] 0 0
502.373.0546 Flinders Medical Centre - Bedford Park
Recruitment hospital [20] 0 0
502.373.0550 Repatriation General Hospital - Daw Park
Recruitment hospital [21] 0 0
502.373.0551 Port Lincoln "The Investigator" Clinic - Port Lincoln
Recruitment hospital [22] 0 0
502.373.0529 Launceston General Hospital - Launceston
Recruitment hospital [23] 0 0
502.373.0531 Box Hill Hospital - Box Hill
Recruitment hospital [24] 0 0
502.373.0548 The Northern Hospital - Epping
Recruitment hospital [25] 0 0
502.373.0522 The Geelong Hospital - Geelong
Recruitment hospital [26] 0 0
502.373.0520 Royal Melbourne Hospital - Parkville
Recruitment hospital [27] 0 0
502.373.0525 The Alfred Hospital - Prahran
Recruitment hospital [28] 0 0
502.373.0532 Baker Medical Research Centre - Prahran
Recruitment hospital [29] 0 0
502.373.0557 Maroondah Hospital - Ringwood East
Recruitment hospital [30] 0 0
502.373.0537 Austin & Repatriation Medical Centre - West Heidelberg
Recruitment hospital [31] 0 0
502.373.0547 Fremantle Hospital - Fremantle
Recruitment hospital [32] 0 0
502.373.0530 Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [33] 0 0
502.373.0545 Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Woden
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Coffs Harbour
Recruitment postcode(s) [4] 0 0
- Concord
Recruitment postcode(s) [5] 0 0
- Gosford
Recruitment postcode(s) [6] 0 0
- Kogarah
Recruitment postcode(s) [7] 0 0
- Newcastle
Recruitment postcode(s) [8] 0 0
- Randwick
Recruitment postcode(s) [9] 0 0
- St Leonards
Recruitment postcode(s) [10] 0 0
- Wollongong
Recruitment postcode(s) [11] 0 0
- Chermside
Recruitment postcode(s) [12] 0 0
- Herston
Recruitment postcode(s) [13] 0 0
- Kippa-Ring
Recruitment postcode(s) [14] 0 0
- Southport
Recruitment postcode(s) [15] 0 0
- Woolloongabba
Recruitment postcode(s) [16] 0 0
- Bedford Park
Recruitment postcode(s) [17] 0 0
- Daw Park
Recruitment postcode(s) [18] 0 0
- Port Lincoln
Recruitment postcode(s) [19] 0 0
- Launceston
Recruitment postcode(s) [20] 0 0
- Box Hill
Recruitment postcode(s) [21] 0 0
- Epping
Recruitment postcode(s) [22] 0 0
- Geelong
Recruitment postcode(s) [23] 0 0
- Parkville
Recruitment postcode(s) [24] 0 0
- Prahran
Recruitment postcode(s) [25] 0 0
- Ringwood East
Recruitment postcode(s) [26] 0 0
- West Heidelberg
Recruitment postcode(s) [27] 0 0
- Fremantle
Recruitment postcode(s) [28] 0 0
- Nedlands
Recruitment postcode(s) [29] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
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Connecticut
Country [6] 0 0
United States of America
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District of Columbia
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United States of America
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Florida
Country [8] 0 0
United States of America
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Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
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Massachusetts
Country [15] 0 0
United States of America
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Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
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Nevada
Country [21] 0 0
United States of America
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New Jersey
Country [22] 0 0
United States of America
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New York
Country [23] 0 0
United States of America
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North Carolina
Country [24] 0 0
United States of America
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North Dakota
Country [25] 0 0
United States of America
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Ohio
Country [26] 0 0
United States of America
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Oklahoma
Country [27] 0 0
United States of America
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Oregon
Country [28] 0 0
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Pennsylvania
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United States of America
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South Carolina
Country [30] 0 0
United States of America
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Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
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Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Argentina
State/province [34] 0 0
Capital Federal
Country [35] 0 0
Argentina
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Corones Suárez
Country [36] 0 0
Argentina
State/province [36] 0 0
Córdoba
Country [37] 0 0
Argentina
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La Plata
Country [38] 0 0
Argentina
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Mar del Plata
Country [39] 0 0
Argentina
State/province [39] 0 0
Mendoza
Country [40] 0 0
Argentina
State/province [40] 0 0
Rosario
Country [41] 0 0
Argentina
State/province [41] 0 0
Salta
Country [42] 0 0
Argentina
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Santa Fe
Country [43] 0 0
Argentina
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Tucumán
Country [44] 0 0
Argentina
State/province [44] 0 0
Zárate
Country [45] 0 0
Austria
State/province [45] 0 0
Graz
Country [46] 0 0
Austria
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Wels
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Austria
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Wien
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Belgium
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Aalst
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Belgium
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Anderlecht
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Belgium
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Antwerpen
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Belgium
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Bornem
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Belgium
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Brasschaat
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Belgium
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Brugge
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Belgium
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Charleroi
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Belgium
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Genk
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Belgium
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Godinne
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Belgium
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Haine-Saint-Paul
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Belgium
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Hasselt
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Belgium
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Leuven
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Belgium
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Mechelen
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Belgium
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Mol
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Belgium
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Roeselare
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Belgium
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Seraing
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Belgium
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Turnhout
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Belgium
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Woluwé-Saint-Lambert
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Brazil
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Belo Horizonte
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Brazil
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Botucatu -
Country [68] 0 0
Brazil
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Campinas
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Brazil
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Cerqueira César - São Paulo
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Brazil
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Curitiba
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Brazil
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Goiania
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Brazil
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Marília
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Brazil
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Pelotas
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Brazil
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Porto Alegre - Rs
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Brazil
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Porto Alegre
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Brazil
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Ribeirao Preto
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Brazil
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Rio de Janeiro - Rj
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Santa Catalina
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Brazil
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Sao Jose do Rio Preto
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Brazil
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Vila Clementino, São Paulo
Country [85] 0 0
Canada
State/province [85] 0 0
Alberta
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Canada
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British Columbia
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Canada
State/province [87] 0 0
Manitoba
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Canada
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Newfoundland and Labrador
Country [89] 0 0
Canada
State/province [89] 0 0
Nova Scotia
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Canada
State/province [90] 0 0
Ontario
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Canada
State/province [91] 0 0
Quebec
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Canada
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Saskatchewan
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China
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Beijing
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China
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Changsha
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China
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Chengdu
Country [96] 0 0
China
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Guangzhou
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China
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Harbin
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China
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HeBei Province
Country [99] 0 0
China
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Henan Province
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China
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Hubei Province
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China
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Nanjing
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China
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QingDao
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China
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ShanDong Province
Country [104] 0 0
China
State/province [104] 0 0
Shanghai
Country [105] 0 0
China
State/province [105] 0 0
Shen Yang
Country [106] 0 0
China
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Shijiazhuang
Country [107] 0 0
China
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Tianjin
Country [108] 0 0
China
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Weizikeng
Country [109] 0 0
China
State/province [109] 0 0
Wuhan
Country [110] 0 0
China
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Zhenzhou
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Czech Republic
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Brno
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Czech Republic
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Havirov
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Czech Republic
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Kladno
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Czech Republic
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Mlada Boleslav
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Czech Republic
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Plzen
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Czech Republic
State/province [116] 0 0
Prague 5
Country [117] 0 0
Czech Republic
State/province [117] 0 0
Prague
Country [118] 0 0
Czech Republic
State/province [118] 0 0
Praha 2
Country [119] 0 0
Czech Republic
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Pribram 1
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Czech Republic
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Usti nad Orlici
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Denmark
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Aalborg
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Denmark
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Aarhus C
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Denmark
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Frederiksberg C
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Denmark
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Frederiksberg
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Denmark
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Helsingoer
Country [126] 0 0
Denmark
State/province [126] 0 0
Hilleroed
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Denmark
State/province [127] 0 0
Holbaek
Country [128] 0 0
Denmark
State/province [128] 0 0
Hvidovre
Country [129] 0 0
Denmark
State/province [129] 0 0
Kjellerup
Country [130] 0 0
Denmark
State/province [130] 0 0
Randers
Country [131] 0 0
Denmark
State/province [131] 0 0
Slagelse
Country [132] 0 0
Denmark
State/province [132] 0 0
Svendborg
Country [133] 0 0
Finland
State/province [133] 0 0
Helsinki
Country [134] 0 0
Finland
State/province [134] 0 0
Hämeenlinna
Country [135] 0 0
Finland
State/province [135] 0 0
Jyväskylä
Country [136] 0 0
Finland
State/province [136] 0 0
Kuopio
Country [137] 0 0
Finland
State/province [137] 0 0
Kuusankoski
Country [138] 0 0
Finland
State/province [138] 0 0
Liperi
Country [139] 0 0
Finland
State/province [139] 0 0
Oulun kaupunki
Country [140] 0 0
Finland
State/province [140] 0 0
Turku
Country [141] 0 0
Finland
State/province [141] 0 0
Vantaa
Country [142] 0 0
France
State/province [142] 0 0
Albens
Country [143] 0 0
France
State/province [143] 0 0
Beziers
Country [144] 0 0
France
State/province [144] 0 0
Bourges
Country [145] 0 0
France
State/province [145] 0 0
Broglie
Country [146] 0 0
France
State/province [146] 0 0
Castelnaudary
Country [147] 0 0
France
State/province [147] 0 0
Gemenos
Country [148] 0 0
France
State/province [148] 0 0
Husseren Wesserlin
Country [149] 0 0
France
State/province [149] 0 0
Hyeres
Country [150] 0 0
France
State/province [150] 0 0
L'Aigle
Country [151] 0 0
France
State/province [151] 0 0
La Rochelle
Country [152] 0 0
France
State/province [152] 0 0
Le Pradet
Country [153] 0 0
France
State/province [153] 0 0
Murs Erigne
Country [154] 0 0
France
State/province [154] 0 0
Nantes
Country [155] 0 0
France
State/province [155] 0 0
Niort
Country [156] 0 0
France
State/province [156] 0 0
Ortez
Country [157] 0 0
France
State/province [157] 0 0
Paris
Country [158] 0 0
France
State/province [158] 0 0
Rennes
Country [159] 0 0
France
State/province [159] 0 0
Rosiers d'Egletons
Country [160] 0 0
France
State/province [160] 0 0
Saint Julien des Landes
Country [161] 0 0
France
State/province [161] 0 0
Saint Martin dHyeres
Country [162] 0 0
France
State/province [162] 0 0
Saint Pierre de Chandieu
Country [163] 0 0
France
State/province [163] 0 0
Saint Romain sur Cher
Country [164] 0 0
France
State/province [164] 0 0
Strasbourg
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France
State/province [165] 0 0
Tours
Country [166] 0 0
Germany
State/province [166] 0 0
Bad Lausick
Country [167] 0 0
Germany
State/province [167] 0 0
Bad Lauterberg
Country [168] 0 0
Germany
State/province [168] 0 0
Bad Mergentheim
Country [169] 0 0
Germany
State/province [169] 0 0
Berlin
Country [170] 0 0
Germany
State/province [170] 0 0
Bielefeld
Country [171] 0 0
Germany
State/province [171] 0 0
Dessau
Country [172] 0 0
Germany
State/province [172] 0 0
Dortmund
Country [173] 0 0
Germany
State/province [173] 0 0
Dresden
Country [174] 0 0
Germany
State/province [174] 0 0
Eberswalde
Country [175] 0 0
Germany
State/province [175] 0 0
Erlangen
Country [176] 0 0
Germany
State/province [176] 0 0
Essen
Country [177] 0 0
Germany
State/province [177] 0 0
Haag
Country [178] 0 0
Germany
State/province [178] 0 0
Hamburg
Country [179] 0 0
Germany
State/province [179] 0 0
Heidelberg
Country [180] 0 0
Germany
State/province [180] 0 0
Homburg/Saar
Country [181] 0 0
Germany
State/province [181] 0 0
Karlsburg
Country [182] 0 0
Germany
State/province [182] 0 0
Kelkheim
Country [183] 0 0
Germany
State/province [183] 0 0
Köln
Country [184] 0 0
Germany
State/province [184] 0 0
Künzing
Country [185] 0 0
Germany
State/province [185] 0 0
Lübeck
Country [186] 0 0
Germany
State/province [186] 0 0
Mainz
Country [187] 0 0
Germany
State/province [187] 0 0
Melsungen
Country [188] 0 0
Germany
State/province [188] 0 0
München
Country [189] 0 0
Germany
State/province [189] 0 0
Offenbach am Main
Country [190] 0 0
Germany
State/province [190] 0 0
Riesa
Country [191] 0 0
Germany
State/province [191] 0 0
Rostock
Country [192] 0 0
Germany
State/province [192] 0 0
Sindelfingen
Country [193] 0 0
Germany
State/province [193] 0 0
Starnberg
Country [194] 0 0
Germany
State/province [194] 0 0
Stuttgart
Country [195] 0 0
Germany
State/province [195] 0 0
Timmendorfer Strand
Country [196] 0 0
Germany
State/province [196] 0 0
Wiesbaden
Country [197] 0 0
Germany
State/province [197] 0 0
Witten
Country [198] 0 0
Greece
State/province [198] 0 0
Athens
Country [199] 0 0
Greece
State/province [199] 0 0
Elefsina
Country [200] 0 0
Greece
State/province [200] 0 0
Goudi/ Athens
Country [201] 0 0
Greece
State/province [201] 0 0
Ioannina
Country [202] 0 0
Greece
State/province [202] 0 0
Kavala,greece
Country [203] 0 0
Greece
State/province [203] 0 0
Korinthos
Country [204] 0 0
Greece
State/province [204] 0 0
Melissia, Athens
Country [205] 0 0
Greece
State/province [205] 0 0
Thessaloniki
Country [206] 0 0
Greece
State/province [206] 0 0
Veria
Country [207] 0 0
Hong Kong
State/province [207] 0 0
Hong Kong
Country [208] 0 0
Hungary
State/province [208] 0 0
Budapest
Country [209] 0 0
Hungary
State/province [209] 0 0
Debrecen
Country [210] 0 0
Hungary
State/province [210] 0 0
Kecskemet
Country [211] 0 0
Hungary
State/province [211] 0 0
Nyiregyhaza
Country [212] 0 0
Hungary
State/province [212] 0 0
Pecs
Country [213] 0 0
Hungary
State/province [213] 0 0
Siofok
Country [214] 0 0
Hungary
State/province [214] 0 0
Szeged
Country [215] 0 0
Hungary
State/province [215] 0 0
Szekesfehervar
Country [216] 0 0
Hungary
State/province [216] 0 0
Tatabanya
Country [217] 0 0
Hungary
State/province [217] 0 0
Veszprem
Country [218] 0 0
Ireland
State/province [218] 0 0
Dublin 24
Country [219] 0 0
Ireland
State/province [219] 0 0
Dublin 8
Country [220] 0 0
Ireland
State/province [220] 0 0
Dublin 9
Country [221] 0 0
Ireland
State/province [221] 0 0
Mallow
Country [222] 0 0
Italy
State/province [222] 0 0
Ascoli Piceno
Country [223] 0 0
Italy
State/province [223] 0 0
Bentivoglio (BO)
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Italy
State/province [224] 0 0
Bologna
Country [225] 0 0
Italy
State/province [225] 0 0
Brescia
Country [226] 0 0
Italy
State/province [226] 0 0
Casarano (LE)
Country [227] 0 0
Italy
State/province [227] 0 0
Caserta
Country [228] 0 0
Italy
State/province [228] 0 0
Città della Pieve (PG)
Country [229] 0 0
Italy
State/province [229] 0 0
Ferrara
Country [230] 0 0
Italy
State/province [230] 0 0
Monfalcone (go)
Country [231] 0 0
Italy
State/province [231] 0 0
Napoli
Country [232] 0 0
Italy
State/province [232] 0 0
Palermo
Country [233] 0 0
Italy
State/province [233] 0 0
Pavia
Country [234] 0 0
Italy
State/province [234] 0 0
Perugia
Country [235] 0 0
Italy
State/province [235] 0 0
Pozzilli (IS)
Country [236] 0 0
Italy
State/province [236] 0 0
Roma
Country [237] 0 0
Italy
State/province [237] 0 0
S. Pietro Vernotico (BR)
Country [238] 0 0
Italy
State/province [238] 0 0
Sassari
Country [239] 0 0
Italy
State/province [239] 0 0
Torino
Country [240] 0 0
Italy
State/province [240] 0 0
Varese
Country [241] 0 0
Italy
State/province [241] 0 0
Venezia
Country [242] 0 0
Italy
State/province [242] 0 0
Viterbo
Country [243] 0 0
Korea, Republic of
State/province [243] 0 0
Incheon
Country [244] 0 0
Korea, Republic of
State/province [244] 0 0
Kwang-ju
Country [245] 0 0
Korea, Republic of
State/province [245] 0 0
Pusan
Country [246] 0 0
Korea, Republic of
State/province [246] 0 0
Seoul
Country [247] 0 0
Korea, Republic of
State/province [247] 0 0
Taegu
Country [248] 0 0
Malaysia
State/province [248] 0 0
Johor Baharu
Country [249] 0 0
Malaysia
State/province [249] 0 0
Kelantan Darul Naim
Country [250] 0 0
Malaysia
State/province [250] 0 0
Kelantan
Country [251] 0 0
Malaysia
State/province [251] 0 0
Kuala Lumpur
Country [252] 0 0
Malaysia
State/province [252] 0 0
Penang
Country [253] 0 0
Malaysia
State/province [253] 0 0
Putrajaya
Country [254] 0 0
Malaysia
State/province [254] 0 0
Selangor
Country [255] 0 0
Mexico
State/province [255] 0 0
Guadalajara
Country [256] 0 0
Mexico
State/province [256] 0 0
Mexico
Country [257] 0 0
Mexico
State/province [257] 0 0
Monterrey
Country [258] 0 0
Mexico
State/province [258] 0 0
Zapopan
Country [259] 0 0
Netherlands
State/province [259] 0 0
Amsterdam
Country [260] 0 0
Netherlands
State/province [260] 0 0
Beverwijk
Country [261] 0 0
Netherlands
State/province [261] 0 0
Den Bosch
Country [262] 0 0
Netherlands
State/province [262] 0 0
Den Haag
Country [263] 0 0
Netherlands
State/province [263] 0 0
Doetinchem
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Netherlands
State/province [264] 0 0
Drachten
Country [265] 0 0
Netherlands
State/province [265] 0 0
Eindhoven
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Netherlands
State/province [266] 0 0
Ermelo
Country [267] 0 0
Netherlands
State/province [267] 0 0
Ewijk
Country [268] 0 0
Netherlands
State/province [268] 0 0
Hengelo
Country [269] 0 0
Netherlands
State/province [269] 0 0
Hoorn
Country [270] 0 0
Netherlands
State/province [270] 0 0
Huizen
Country [271] 0 0
Netherlands
State/province [271] 0 0
Lichtenvoorde
Country [272] 0 0
Netherlands
State/province [272] 0 0
Losser
Country [273] 0 0
Netherlands
State/province [273] 0 0
Nieuwegein
Country [274] 0 0
Netherlands
State/province [274] 0 0
Rijswijk
Country [275] 0 0
Netherlands
State/province [275] 0 0
Roelofarendsveen
Country [276] 0 0
Netherlands
State/province [276] 0 0
Rotterdam
Country [277] 0 0
Netherlands
State/province [277] 0 0
Spijkenisse
Country [278] 0 0
Netherlands
State/province [278] 0 0
Stadskanaal
Country [279] 0 0
Netherlands
State/province [279] 0 0
Tilburg
Country [280] 0 0
Netherlands
State/province [280] 0 0
Utrecht
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Netherlands
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Velp
Country [282] 0 0
New Zealand
State/province [282] 0 0
Auckland 3
Country [283] 0 0
New Zealand
State/province [283] 0 0
Auckland
Country [284] 0 0
New Zealand
State/province [284] 0 0
Christchurch
Country [285] 0 0
New Zealand
State/province [285] 0 0
Hamiton
Country [286] 0 0
New Zealand
State/province [286] 0 0
Hasting
Country [287] 0 0
New Zealand
State/province [287] 0 0
Otahuhu Auckland
Country [288] 0 0
New Zealand
State/province [288] 0 0
Takapuna Auckland
Country [289] 0 0
New Zealand
State/province [289] 0 0
Tauranga
Country [290] 0 0
Norway
State/province [290] 0 0
Fevik
Country [291] 0 0
Norway
State/province [291] 0 0
Nesttun
Country [292] 0 0
Norway
State/province [292] 0 0
Stavanger
Country [293] 0 0
Norway
State/province [293] 0 0
Tvedestrand
Country [294] 0 0
Norway
State/province [294] 0 0
Tønsberg
Country [295] 0 0
Philippines
State/province [295] 0 0
Cavite
Country [296] 0 0
Philippines
State/province [296] 0 0
Manila
Country [297] 0 0
Philippines
State/province [297] 0 0
Pasig City
Country [298] 0 0
Philippines
State/province [298] 0 0
Quezon City
Country [299] 0 0
Poland
State/province [299] 0 0
Bydgoszcz
Country [300] 0 0
Poland
State/province [300] 0 0
Czestochowa
Country [301] 0 0
Poland
State/province [301] 0 0
Gdynia Redlowo
Country [302] 0 0
Poland
State/province [302] 0 0
Gdynia
Country [303] 0 0
Poland
State/province [303] 0 0
Grojec
Country [304] 0 0
Poland
State/province [304] 0 0
Grudziadz
Country [305] 0 0
Poland
State/province [305] 0 0
Inowroclaw
Country [306] 0 0
Poland
State/province [306] 0 0
Jaroslawiec
Country [307] 0 0
Poland
State/province [307] 0 0
Katowice
Country [308] 0 0
Poland
State/province [308] 0 0
Kielce
Country [309] 0 0
Poland
State/province [309] 0 0
Lodz
Country [310] 0 0
Poland
State/province [310] 0 0
Lubartow
Country [311] 0 0
Poland
State/province [311] 0 0
Lubin
Country [312] 0 0
Poland
State/province [312] 0 0
Nowy Sacz
Country [313] 0 0
Poland
State/province [313] 0 0
Piotrkow Trybunalski
Country [314] 0 0
Poland
State/province [314] 0 0
Poznan
Country [315] 0 0
Poland
State/province [315] 0 0
Ruda Slaska
Country [316] 0 0
Poland
State/province [316] 0 0
Skierniewice
Country [317] 0 0
Poland
State/province [317] 0 0
Tarnow
Country [318] 0 0
Poland
State/province [318] 0 0
Tomaszow Mazowiecki
Country [319] 0 0
Poland
State/province [319] 0 0
Torun
Country [320] 0 0
Poland
State/province [320] 0 0
Warsaw
Country [321] 0 0
Poland
State/province [321] 0 0
Wegrow
Country [322] 0 0
Portugal
State/province [322] 0 0
Almada
Country [323] 0 0
Portugal
State/province [323] 0 0
Amadora
Country [324] 0 0
Portugal
State/province [324] 0 0
Carnaxide
Country [325] 0 0
Portugal
State/province [325] 0 0
Coimbra
Country [326] 0 0
Portugal
State/province [326] 0 0
Faro
Country [327] 0 0
Portugal
State/province [327] 0 0
Lisboa
Country [328] 0 0
Portugal
State/province [328] 0 0
Matosinhos
Country [329] 0 0
Portugal
State/province [329] 0 0
Porto
Country [330] 0 0
Portugal
State/province [330] 0 0
Vila Nova de Gaia
Country [331] 0 0
Puerto Rico
State/province [331] 0 0
Caguas
Country [332] 0 0
Puerto Rico
State/province [332] 0 0
Las Lomas
Country [333] 0 0
Puerto Rico
State/province [333] 0 0
Manati
Country [334] 0 0
Puerto Rico
State/province [334] 0 0
Orocovis
Country [335] 0 0
Puerto Rico
State/province [335] 0 0
Rio Piedras
Country [336] 0 0
Russian Federation
State/province [336] 0 0
Moscow
Country [337] 0 0
Russian Federation
State/province [337] 0 0
St. Petersburg
Country [338] 0 0
Singapore
State/province [338] 0 0
Kuala Lumpur
Country [339] 0 0
Singapore
State/province [339] 0 0
Singapore
Country [340] 0 0
Slovakia
State/province [340] 0 0
Bratislava
Country [341] 0 0
Slovakia
State/province [341] 0 0
Kosice
Country [342] 0 0
Slovakia
State/province [342] 0 0
Nitra
Country [343] 0 0
Slovakia
State/province [343] 0 0
Rimavska Sobota
Country [344] 0 0
South Africa
State/province [344] 0 0
Bellville
Country [345] 0 0
South Africa
State/province [345] 0 0
Bloemfontein
Country [346] 0 0
South Africa
State/province [346] 0 0
Cape Town
Country [347] 0 0
South Africa
State/province [347] 0 0
Congella
Country [348] 0 0
South Africa
State/province [348] 0 0
Durban
Country [349] 0 0
South Africa
State/province [349] 0 0
Fiachrdtpark, Bloemfontein
Country [350] 0 0
South Africa
State/province [350] 0 0
George East
Country [351] 0 0
South Africa
State/province [351] 0 0
Park Town West
Country [352] 0 0
South Africa
State/province [352] 0 0
Port Elizabeth
Country [353] 0 0
South Africa
State/province [353] 0 0
Soweto
Country [354] 0 0
South Africa
State/province [354] 0 0
Sunninghill
Country [355] 0 0
South Africa
State/province [355] 0 0
Vanderbijlpark
Country [356] 0 0
Spain
State/province [356] 0 0
Alcorcón (Madrid)
Country [357] 0 0
Spain
State/province [357] 0 0
Alicante
Country [358] 0 0
Spain
State/province [358] 0 0
Barcelona
Country [359] 0 0
Spain
State/province [359] 0 0
Burjasot (Valencia)
Country [360] 0 0
Spain
State/province [360] 0 0
Granada
Country [361] 0 0
Spain
State/province [361] 0 0
Madrid
Country [362] 0 0
Spain
State/province [362] 0 0
Murcia
Country [363] 0 0
Spain
State/province [363] 0 0
Málaga
Country [364] 0 0
Spain
State/province [364] 0 0
Santiago de Compostela
Country [365] 0 0
Spain
State/province [365] 0 0
Sevilla
Country [366] 0 0
Spain
State/province [366] 0 0
Valencia
Country [367] 0 0
Sweden
State/province [367] 0 0
Göteborg
Country [368] 0 0
Sweden
State/province [368] 0 0
Helsingborg
Country [369] 0 0
Sweden
State/province [369] 0 0
Järfälla
Country [370] 0 0
Sweden
State/province [370] 0 0
Malmoe
Country [371] 0 0
Sweden
State/province [371] 0 0
Malmö
Country [372] 0 0
Sweden
State/province [372] 0 0
Sjuntorp
Country [373] 0 0
Sweden
State/province [373] 0 0
Trollhättan
Country [374] 0 0
Sweden
State/province [374] 0 0
Vännäs
Country [375] 0 0
Switzerland
State/province [375] 0 0
Basel
Country [376] 0 0
Switzerland
State/province [376] 0 0
Bellinzona
Country [377] 0 0
Switzerland
State/province [377] 0 0
Bern
Country [378] 0 0
Switzerland
State/province [378] 0 0
Biel/Bienne
Country [379] 0 0
Switzerland
State/province [379] 0 0
Chur
Country [380] 0 0
Switzerland
State/province [380] 0 0
Kreuzlingen
Country [381] 0 0
Switzerland
State/province [381] 0 0
Lausanne
Country [382] 0 0
Switzerland
State/province [382] 0 0
Lugano
Country [383] 0 0
Switzerland
State/province [383] 0 0
St. Gallen
Country [384] 0 0
Switzerland
State/province [384] 0 0
Zürich
Country [385] 0 0
Taiwan
State/province [385] 0 0
Changhua
Country [386] 0 0
Taiwan
State/province [386] 0 0
Chia-Yi
Country [387] 0 0
Taiwan
State/province [387] 0 0
Hualien
Country [388] 0 0
Taiwan
State/province [388] 0 0
Kaohsiung
Country [389] 0 0
Taiwan
State/province [389] 0 0
Tainan
Country [390] 0 0
Taiwan
State/province [390] 0 0
Taipei
Country [391] 0 0
Thailand
State/province [391] 0 0
Bangkok
Country [392] 0 0
Thailand
State/province [392] 0 0
Khon Kaen
Country [393] 0 0
Thailand
State/province [393] 0 0
Nonthaburi
Country [394] 0 0
Turkey
State/province [394] 0 0
Adana
Country [395] 0 0
Turkey
State/province [395] 0 0
Ankara
Country [396] 0 0
Turkey
State/province [396] 0 0
Istanbul
Country [397] 0 0
Turkey
State/province [397] 0 0
Izmir
Country [398] 0 0
Turkey
State/province [398] 0 0
Kayseri
Country [399] 0 0
Ukraine
State/province [399] 0 0
Dnyepropetrovsk
Country [400] 0 0
Ukraine
State/province [400] 0 0
Kharkov
Country [401] 0 0
Ukraine
State/province [401] 0 0
Kiev
Country [402] 0 0
United Arab Emirates
State/province [402] 0 0
Abu Dhabi
Country [403] 0 0
United Arab Emirates
State/province [403] 0 0
Dubai
Country [404] 0 0
United Arab Emirates
State/province [404] 0 0
Sharjah
Country [405] 0 0
United Kingdom
State/province [405] 0 0
Aberdeen
Country [406] 0 0
United Kingdom
State/province [406] 0 0
Bathampton
Country [407] 0 0
United Kingdom
State/province [407] 0 0
Belfast
Country [408] 0 0
United Kingdom
State/province [408] 0 0
Birmingham
Country [409] 0 0
United Kingdom
State/province [409] 0 0
Brighton
Country [410] 0 0
United Kingdom
State/province [410] 0 0
Cardiff
Country [411] 0 0
United Kingdom
State/province [411] 0 0
Chichester
Country [412] 0 0
United Kingdom
State/province [412] 0 0
Derby
Country [413] 0 0
United Kingdom
State/province [413] 0 0
Gateshead
Country [414] 0 0
United Kingdom
State/province [414] 0 0
Glasgow
Country [415] 0 0
United Kingdom
State/province [415] 0 0
Kirkcaldy, Fife
Country [416] 0 0
United Kingdom
State/province [416] 0 0
Leeds
Country [417] 0 0
United Kingdom
State/province [417] 0 0
Leicester
Country [418] 0 0
United Kingdom
State/province [418] 0 0
Lincoln
Country [419] 0 0
United Kingdom
State/province [419] 0 0
Liverpool
Country [420] 0 0
United Kingdom
State/province [420] 0 0
London
Country [421] 0 0
United Kingdom
State/province [421] 0 0
Manchester
Country [422] 0 0
United Kingdom
State/province [422] 0 0
Portadown, County Atrim
Country [423] 0 0
United Kingdom
State/province [423] 0 0
Rugby
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Sheffield
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Stirling

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00153101