A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects (TRILOGY ACS)

This study has been completed.
Sponsor:
Collaborators:
Daiichi Sankyo Co., Ltd.
Duke Clinical Research Institute
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00699998
First received: June 16, 2008
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Clopidogrel
Drug: Prasugrel
Drug: Commercially-available Aspirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke [ Time Frame: Randomization through end of study (30-month visit) ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.


Secondary Outcome Measures:
  • Percentage of Participants With a Composite Endpoint of CV Death and MI [ Time Frame: Randomization through end of study (30-month visit) ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.

  • Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) [ Time Frame: Randomization through end of study (30-month visit) ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.

  • Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke [ Time Frame: Randomization through end of study (30-month visit) ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.

  • Platelet Aggregation Measures [ Time Frame: Day 30 and 12 Months ] [ Designated as safety issue: No ]
    Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.

  • Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) [ Time Frame: Day 30 and 6 Months ] [ Designated as safety issue: No ]
    Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.

  • Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) [ Time Frame: Day 30 and Month 6 ] [ Designated as safety issue: No ]
    C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.

  • Genotyping Related to Drug Metabolism [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.

  • Economic and Quality of Life Outcomes [ Time Frame: Baseline and follow-up (24 months) ] [ Designated as safety issue: No ]
    Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.

  • Summary of All Deaths [ Time Frame: Randomization through end of study (30-month visit) ] [ Designated as safety issue: Yes ]
    All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.


Enrollment: 9326
Study Start Date: June 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel
Prasugrel and Low-dose Commercially-available Aspirin
Drug: Prasugrel
30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study
Other Names:
  • LY640315
  • Effient
  • Efient
  • CS-747
Drug: Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study
Active Comparator: Clopidogrel
Clopidogrel and Low-Dose Commercially-available Aspirin
Drug: Clopidogrel
300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study
Drug: Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study

Detailed Description:

Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) Study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
  • Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
  • Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Key Exclusion Criteria:

  • Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
  • Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
  • Previous or planned PCI or CABG as treatment for the index event
  • PCI/CABG within previous 30 days
  • ST-segment elevation myocardial infarction (STEMI) as the index event
  • Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
  • History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
  • Hemodialysis or peritoneal dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699998

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United States, Alabama
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Natchitoches, Louisiana, United States, 71457
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New Orleans, Louisiana, United States, 70112
United States, Maryland
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Baltimore, Maryland, United States, 21287
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Salisbury, Maryland, United States, 21804
United States, Massachusetts
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Boston, Massachusetts, United States, 02135
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Fall River, Massachusetts, United States, 02720
United States, Michigan
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Bay City, Michigan, United States, 48706
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Flint, Michigan, United States, 48532
United States, Minnesota
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Minneapolis, Minnesota, United States, 55417
United States, Mississippi
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Picayune, Mississippi, United States, 39466
United States, Missouri
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Columbia, Missouri, United States, 65201
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Kansas City, Missouri, United States, 64111
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St Louis, Missouri, United States, 63128
United States, Montana
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Kalispell, Montana, United States, 59901
United States, Nebraska
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Omaha, Nebraska, United States, 68198
United States, Nevada
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Las Vegas, Nevada, United States, 89148
United States, New Hampshire
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Nashua, New Hampshire, United States, 03060
United States, New Jersey
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Bridgewater, New Jersey, United States, 08807
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Cherry Hill, New Jersey, United States, 08002
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Flemington, New Jersey, United States, 08822
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Ridgewood, New Jersey, United States, 07652
United States, New York
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Bronx, New York, United States, 10461
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Brooklyn, New York, United States, 11220
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Buffalo, New York, United States, 14215
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Flushing, New York, United States, 11355
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New Hartford, New York, United States, 13413
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New York, New York, United States, 10016
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Syracuse, New York, United States, 13210
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599
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Charlotte, North Carolina, United States, 28204
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Elizabeth City, North Carolina, United States, 27909
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Gastonia, North Carolina, United States, 28054
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Hickory, North Carolina, United States, 28601
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Lenoir, North Carolina, United States, 28645
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Matthews, North Carolina, United States, 28105
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Pinehurst, North Carolina, United States, 28374
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Salisbury, North Carolina, United States, 28144
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Sanford, North Carolina, United States, 27330
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Statesville, North Carolina, United States, 28677
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Wilmington, North Carolina, United States, 28403
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Winston Salem, North Carolina, United States, 27157
United States, Ohio
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Cincinnati, Ohio, United States, 45220
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Cleveland, Ohio, United States, 44106
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Mansfield, Ohio, United States, 44906
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Toledo, Ohio, United States, 43608
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Zanesville, Ohio, United States, 43701
United States, Oklahoma
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Muskogee, Oklahoma, United States, 74401
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Oklahoma City, Oklahoma, United States, 73104
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Tulsa, Oklahoma, United States, 74104
United States, Oregon
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Hillsboro, Oregon, United States, 97123
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Portland, Oregon, United States, 97220
United States, Pennsylvania
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Abington, Pennsylvania, United States, 19001
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Bethlehem, Pennsylvania, United States, 18015
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Chambersburg, Pennsylvania, United States, 17201
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Clarks Summit, Pennsylvania, United States, 18411
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Doylestown, Pennsylvania, United States, 18901
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Erie, Pennsylvania, United States, 16502
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Greensburg, Pennsylvania, United States, 15601
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Harrisburg, Pennsylvania, United States, 17110
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Pittsburgh, Pennsylvania, United States, 15240
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Pottstown, Pennsylvania, United States, 19464
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Sayre, Pennsylvania, United States, 18840
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Sellersville, Pennsylvania, United States, 18960
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West Chester, Pennsylvania, United States, 19380
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Wormleysburg, Pennsylvania, United States, 17043
United States, South Carolina
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Charleston, South Carolina, United States, 29425
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Rock Hill, South Carolina, United States, 29732
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
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Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
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Germantown, Tennessee, United States, 38138
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Hendersonville, Tennessee, United States, 37075
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Jackson, Tennessee, United States, 38301
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Johnson City, Tennessee, United States, 37601
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Knoxville, Tennessee, United States, 37917
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Lexington, Tennessee, United States, 38351
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Memphis, Tennessee, United States, 38120
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Oak Ridge, Tennessee, United States, 37830
United States, Texas
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Amarillo, Texas, United States, 79106
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Austin, Texas, United States, 78745
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Corpus Christi, Texas, United States, 78404
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Edinburg, Texas, United States, 78539
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Fort Sam Houston, Texas, United States, 78234
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Houston, Texas, United States, 77089
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Lackland Afb, Texas, United States, 78236
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San Antonio, Texas, United States, 78201
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Victoria, Texas, United States, 77901
United States, Utah
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American Fork, Utah, United States, 84003
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Salt Lake City, Utah, United States, 84124
United States, Virginia
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Charlottesville, Virginia, United States, 22908
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Danville, Virginia, United States, 24541
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Hopewell, Virginia, United States, 23860
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Lake Ridge, Virginia, United States, 22192
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Manassas, Virginia, United States, 20109
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Newport News, Virginia, United States, 23601
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Richmond, Virginia, United States, 23298
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Roanoke, Virginia, United States, 24014
United States, Washington
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Seattle, Washington, United States, 98122
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Spokane, Washington, United States, 99204
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Tacoma, Washington, United States, 98405
United States, Wisconsin
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Burlington, Wisconsin, United States, 53105
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Milwaukee, Wisconsin, United States, 53215
Argentina
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Bahia Blanca, Argentina, B8001DDU
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Buenos Aires, Argentina, 1094
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Caba, Argentina, C1180AAX
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Concordia, Argentina, E3202BQF
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Corrientes, Argentina, 3400
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Córdoba, Argentina, X5000JHQ
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Formosa, Argentina, 3606
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Godoy Cruz, Argentina, 5501
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La Plata, Argentina, B1900AVS
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Mar Del Plata, Argentina, B7600FZD
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Moron, Argentina, B1708KCH
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Rosario, Argentina, S2002KDS
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Salta, Argentina, A4402DTC
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San Luis, Argentina, D5702JRS
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San Miguel De Tucuman, Argentina, T4000NIL
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Santa Fe, Argentina, S3000FUJ
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Villa Cabrera, Argentina, S5009BSN
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Villa Maria, Argentina, X5900JKA
Australia, New South Wales
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Coffs Harbour, New South Wales, Australia, 2450
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Lismore, New South Wales, Australia, 2480
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Newcastle, New South Wales, Australia, 2305
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Wollongong, New South Wales, Australia, 2500
Australia, Queensland
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Herston, Queensland, Australia, 4029
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Nambour, Queensland, Australia, 4560
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Redcliffe, Queensland, Australia, 4020
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Southport, Queensland, Australia, 4215
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
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Elizabeth Vale, South Australia, Australia, 5112
Australia, Tasmania
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Hobart, Tasmania, Australia, 7000
Austria
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Feldkirch, Austria, 6807
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Vienna, Austria, 1100
Belgium
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Brussels, Belgium, 1200
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Huy, Belgium, 4500
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Liège, Belgium, 4000
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Mol, Belgium, 2400
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Overpelt, Belgium, 3900
Brazil
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Aracaju, Brazil, 49015-400
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Belo Horizonte, Brazil, 30380-090
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Blumenau, Brazil, 89010-500
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Brasilia, Brazil, 70658-700
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Campina Grande Do Sul, Brazil, 83430-000
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Campinas, Brazil, 13010-001
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Campo Grande, Brazil, 79080-190
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Caxias Do Sul, Brazil, 95070560
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Curitiba, Brazil, 80010-030
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Dois Lajeados, Brazil, 95900-000
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Goiania, Brazil, 74223-130
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Maceio, Brazil, 57021-500
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Maringa, Brazil, 87015-290
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Passo Fundo, Brazil, 99010-080
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Piracicaba, Brazil, 13405-126
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Porto Alegre, Brazil, 91350-200
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Recife, Brazil, 52051-380
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Ribeirao Preto, Brazil, 14048-900
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Rio De Janeiro, Brazil, 21041-030
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Salvador, Brazil, 41144900
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Santo Andre, Brazil, 09190-610
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Sao Caetano Do Sul, Brazil, 09540-400
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Sao Jose, Brazil, 88103-460
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Sao Jose Rio Preto, Brazil, 15090-000
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São Paulo, Brazil, 05017000
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Uberlandia, Brazil, 38400-368
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Votuporanga, Brazil, 15500-003
Bulgaria
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Dimitrovgrad, Bulgaria, 6400
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Haskovo, Bulgaria, 6300
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Kazanlak, Bulgaria, 6100
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Kjustendil, Bulgaria, 2500
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Pazardzhik, Bulgaria, 4400
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Rousse, Bulgaria, 7002
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Sofia, Bulgaria, 1606
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Varna, Bulgaria, 9010
Canada, Alberta
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Edmonton, Alberta, Canada, T6K 4C1
Canada, British Columbia
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Campbell River, British Columbia, Canada, V9W 5Y4
Canada, Newfoundland and Labrador
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St Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
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Ajax, Ontario, Canada, L1S 2J5
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Burlington, Ontario, Canada, L7M 4Y1
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Cambridge, Ontario, Canada, N1R 7R1
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London, Ontario, Canada, N6A 5A5
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Oshawa, Ontario, Canada, L1H 1B9
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Sarnia, Ontario, Canada, N7T 4R9
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Scarborough, Ontario, Canada, M1E 5E9
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Sudbury, Ontario, Canada, P3E 2N8
Canada, Quebec
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Montreal, Quebec, Canada, H3G 1A4
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Sainte-Foy, Quebec, Canada, G1V 4G5
Chile
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La Serena, Chile
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Osorno, Chile, 5290000
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Puente Alto, Chile, 8207257
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Rancagua, Chile
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Santiago, Chile, 8900085
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Temuco, Chile, 478-1151
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Vina Del Mar, Chile
China
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Beijing, China, 100730
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Bejing, China, 100032
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Changsha, China, 410013
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Fuzhou, China, 350001
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Guang Zhou, China, 510120
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Hangzhou, China, 310013
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Harbin, China, 150001
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Jiangsu, China, 210009
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Nanchang, China
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Nanjing, China, 210008
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Shanghai, China, 200032
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Shaoguan, China, 512026
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Shengyang, China, 110004
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Shenyang, China, 110001
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Shijiazhuang, China, 050050
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Suzhou City, China, 215004
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Wenzhou, China, 325027
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Wu Han, China, 430060
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Wuhan City, China, 430030
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Xian, China, 710061
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Xuzhou, China, 221006
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Zhengzhou, China, 450003
Colombia
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Armenia-Quindio, Colombia
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Barranquilla, Colombia
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Bogota, Colombia
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Cali, Colombia
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Floridablanca, Colombia
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Medellin, Colombia
Costa Rica
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San Jose, Costa Rica
Croatia
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Dubrovnik, Croatia, 20000
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Karlovac, Croatia, 47000
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Koprivnica, Croatia, 48000
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Krapinske Toplice, Croatia, 49217
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Rijeka, Croatia, 51 000
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Slavonski Brod, Croatia, 35 000
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Split, Croatia, 21000
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Varazdin, Croatia, 42 000
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Zadar, Croatia, 23000
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Zagreb, Croatia, 10000
Czech Republic
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Decin, Czech Republic, 405 99
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Frydek-Mistek, Czech Republic, 738 18
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Hradec Kralove, Czech Republic, 500 05
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Karlovy Vary, Czech Republic, 360 66
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Kromeriz, Czech Republic, 767 55
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Liberec, Czech Republic, 460 03
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Novy Jicin, Czech Republic, 74101
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Pardubice, Czech Republic, 532 03
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Prague, Czech Republic, 140 21
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Zlin, Czech Republic, 76275
Denmark
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Copenhagen, Denmark, 2300
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Hellerup, Denmark, 2900
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Kobenhavn, Denmark, 2400
Egypt
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Alexandria, Egypt, 21131
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Beni Sweif, Egypt
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Cairo, Egypt
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Ismailia, Egypt
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Menoufiya, Egypt
Finland
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Jyvaskyla, Finland, 40620
France
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Angers, France, 49933
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Arras, France, 62000
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Besancon, France, 25030
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Cambrai, France, 59407
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Chartres Cedex, France, 28018
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Dijon, France, 21079
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Douai, France, 59507
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La Roche Sur Yon, France, 85025
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Lagny Sur Marne, France, 77405
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Nantes, France, 44277
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Nice, France, 06002
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Paris, France, 75015
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Pessac, France, 33604
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Poitiers, France, 86021
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Strasbourg, France, 67091
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Toulouse, France, 31059
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Valenciennes, France, 59322
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Vandoeuvre Les Nancy, France, 54511
Germany
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Bad Nauheim, Germany, 61231
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Darmstadt, Germany, 64283
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Dortmund, Germany, 44137
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Frankfurt, Germany, 65929
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Halle, Germany, 06120
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Idar-Oberstein, Germany, 55743
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Köln, Germany, 50968
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Leipzig, Germany, 04289
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Mainz, Germany, 55131
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Mannheim, Germany, 68167
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Stuttgart, Germany, 70376
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Tuebingen, Germany, 72076
Greece
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Athens, Greece, 16673
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Haidari/Athens, Greece, 12462
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Kallithea, Greece, 17674
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Magoula, Greece, 19600
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Patras, Greece, 26504
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Rhodos, Greece, 85100
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Trikala, Greece, 42100
Hungary
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Baja, Hungary, 6500
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Bekescsaba, Hungary, 5601
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Budapest, Hungary, 1125
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Kalocsa, Hungary, 6300
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Kecskemet, Hungary, 6000
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Komarom, Hungary, 2921
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Miskolc, Hungary, H-3529
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Satoraljaujhely, Hungary, H-3980
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Sopron, Hungary, 9400
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Szekszard, Hungary, 7100
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Zalaegerszeg, Hungary, 8900
India
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Ahmedabad, India, 382 428
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Anand, India, 388325
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Aurangabad, India, 431001
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Bangalore, India, 560034
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Baramati, India, 413102
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Bikaner, India, 334003
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Calicut, India, 673004
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Chidambaram, India, 608002
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Cochin, India, 683572
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Coimbatore, India, 641004
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Ernakulam, India, 683577
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Guntur, India, 522001
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Gurgaon, India, 122001
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Hyderabaad, India, 500001
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Indore, India, 452018
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Jaipur, India, 302017
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Jalandhar, India, 144008
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Kolkata, India, 700091
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Kottayam, India, 686016
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Lucknow, India, 226003
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Madurai, India, 625020
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Mumbai, India, 400012
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Mysore, India, 570004
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Nagpur, India, 440033
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Nashik, India, 422005
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New Delhi, India, 110015
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Patiala, India, 147001
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Pune, India, 411033
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Saket, India, 110017
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Secunderabad, India, 500 003
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Shivamogga, India, 577201
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Solapur, India, 413003
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Surat, India, 395007
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Thrissur, India, 680002
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Tirupati, India, 517 507
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Trivandrum, India, 695002
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Vadodara, India, 390015
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Vijayawada, India, 520008
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Visakhapatnam, India, 530 003
Ireland
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Dublin, Ireland
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Galway, Ireland
Israel
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Afula, Israel, 18101
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Ashkelon, Israel, 78278
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Beer Sheva, Israel, 84101
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Eilat, Israel, 88104
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Haifa, Israel, 31096
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Jerusalem, Israel, 91240
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Kfar Saba, Israel, 44281
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Nahariya, Israel, 22100
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Nazareth, Israel, 16100
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Rehovot, Israel, 76100
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Tel Aviv, Israel, 64239
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Tel Hashomer, Israel, 52621
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Tiberias, Israel, 15208
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Tzfat, Israel, 13100
Italy
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Albano Laziale, Italy, 00041
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Ascoli Piceno, Italy, 63100
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Bari, Italy, 70124
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Bergamo, Italy, 24128
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Brescia, Italy, 25127
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Caserta, Italy, 81100
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Forli, Italy, 47100
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Lecco, Italy, 23900
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Legnago, Italy, 37045
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Legnano, Italy, 20025
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Milano, Italy, 20162
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Novara, Italy, 28100
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Parma, Italy, 43100
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Perugia, Italy, 06156
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Pescara, Italy, 65124
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Reggio Emilia, Italy, 42100
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Rimini, Italy, 47900
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Rome, Italy, 00161
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San Daniele Del Friuli, Italy, 33038
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Santa Maria Capua Vetere, Italy, 81055
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Saronno, Italy, 21047
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Sorrento, Italy, 80067
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Terni, Italy, 5100
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Trieste, Italy, 34142
Korea, Republic of
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Busan, Korea, Republic of, 614-735
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Daegu, Korea, Republic of, 705-718
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Daejeon, Korea, Republic of, 302-718
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Gangwon-Do, Korea, Republic of, 220-701
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Gwangju, Korea, Republic of, 501-757
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Incheon, Korea, Republic of, 405-760
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Jeon Ju-City, Korea, Republic of, 561-712
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Jin-Ju-Si, Korea, Republic of, 660-702
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Seoul, Korea, Republic of, 120-752
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Ulsan-Si, Korea, Republic of, 682-714
Lithuania
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Kaunas, Lithuania, LT-50009
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Klaipeda, Lithuania, 92288
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Siauliai, Lithuania, 73231
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Vilnius, Lithuania, LT-08661
Malaysia
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Cheras, Kuala Lumpur, Malaysia, 56000
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Johor Bahru, Malaysia, 80100
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Kelantan, Malaysia, 16150
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Kuala Lumpur, Malaysia, 59100
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Kuantan Pahang, Malaysia, 25100
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Perak, Malaysia, 30990
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Sarawak, Malaysia, 93586
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Selangor, Malaysia, 43300
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Taiping Perak, Malaysia, 34000
Malta
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Gozo, Malta, VCT102
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Msida, Malta, 2090
Mexico
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Aguascalientes, Mexico, 20230
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Culiacan, Mexico, 80270
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Durango, Mexico, 340000
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Jalisco, Mexico, 44210
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Leon, Mexico, 37660
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Monterrey, Mexico, 64020
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Puebla, Mexico, 72490
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Queretaro, Mexico, 76180
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San Luis Potosi, Mexico, 78240
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Tijuana, Mexico, 22500
Netherlands
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Alkmaar, Netherlands, 1815 JD
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Almelo, Netherlands, 7609 PP
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Amsterdam, Netherlands, 1091AC
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Apeldoorn, Netherlands, 7334 DZ
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Beverwijk, Netherlands, 1942 LE
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Blaricum, Netherlands, 1261 AN
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Delft, Netherlands, 2625AD
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Ede, Netherlands, 6716 RP
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Eindhoven, Netherlands, 5623 EJ
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Gouda, Netherlands, 2803 HH
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Hoorn, Netherlands, 1625 HV
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Leeuwarden, Netherlands, 8934 AD
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Leiden, Netherlands, 2334 CK
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Leiderdorp, Netherlands, 2353 GA
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Meppel, Netherlands, 7943 KA
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Oss, Netherlands, 5342 BT
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Roosendaal, Netherlands, 4708 AE
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Venlo, Netherlands, 5912 BL
New Zealand
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Auckland, New Zealand, 0622
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Christchurch, New Zealand, 8011
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Nelson, New Zealand, 7010
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Wellington, New Zealand, 6022
Panama
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Cocle, Panama
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David, Panama
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Panama, Panama
Peru
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Arequipa, Peru
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Callao, Peru
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Cuzco, Peru
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Lima, Peru, Lima 29
Philippines
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Cagayan De De Oro, Philippines, 9000
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Cavite City, Philippines, 4114
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Davao City, Philippines, 8000
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Iloilo City, Philippines, 5000
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Manila, Philippines, 1000
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Marikina City, Philippines
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Metro Manila, Philippines, 1503
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Pasig City, Philippines, 1605
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Quezon City, Philippines, 1102
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Quezon City, Philippines, 1110
Poland
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Bydgoszcz, Poland, 85-826
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Elblag, Poland, 02-300
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Gdansk, Poland, 80-345
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Katowice, Poland, 40-635
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Koszalin, Poland, 75-581
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Krakow, Poland, 31-501
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Kutno, Poland, 99-300
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Lodz, Poland, 94-255
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Lubin, Poland, 59-301
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Lublin, Poland, 20-954
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Myslenice, Poland, 32-400
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Nowy Sacz, Poland, 33-300
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Olawa, Poland, 55-200
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Piotrkow Trybunalski, Poland, 97-300
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Pulawy, Poland, 24-100
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Ruda Slaska, Poland, 41-703
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Skierniewice, Poland, 96-100
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Szczecin, Poland, 71-531
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Walbrzych, Poland, 58-309
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Warsaw, Poland, 04-439
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Wejherowo, Poland, 84-200
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Wroclaw, Poland, 51-124
Portugal
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Aveiro, Portugal, 3814-501
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Carnaxide, Portugal, 2790-134
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Coimbra, Portugal, 3000-075
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Leiria, Portugal, 2410-197
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Ponta Delgada, Portugal, 9500-370
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Santarem, Portugal, 2005-177
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Setubal, Portugal, 2910-446
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Vila Franca De Xira, Portugal, 5000-508
Puerto Rico
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Caguas, Puerto Rico, 00725
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Mayaguez, Puerto Rico, 00680
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San Juan, Puerto Rico, 00921-3201
Romania
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Bacau, Romania, 600114
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Baia Mare, Romania, 430110
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Braila, Romania, 810249
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Brasov, Romania, 500326
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Bucharest, Romania
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Buzau, Romania, 120144
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Cluj-Napoca, Romania, 400006
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Focsani, Romania, 620034
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Pitesti, Romania, 110084
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Suceava, Romania, 7202237
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Targoviste, Romania, 130083
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Gatchina, Russian Federation, 188300
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Kazan, Russian Federation, 420029
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Kemerovo, Russian Federation, 650002
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Krasnoyarsk, Russian Federation, 660062
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Moscow, Russian Federation, 127644
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Nizhny Novgorod, Russian Federation, 603005
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Novokuznetsk, Russian Federation, 654057
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Novosibirsk, Russian Federation, 630090
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Omsk, Russian Federation, 644018
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Rostov-On-Don, Russian Federation, 344068
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Saint Petersburg, Russian Federation, 197110
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Saratov, Russian Federation, 410028
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Tomsk, Russian Federation, 634012
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Tyumen, Russian Federation, 625000
Serbia
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Belgrade, Serbia, 11040
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Kragujevac, Serbia, 34000
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Nis, Serbia, 18000
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Niska Banja, Serbia, 18205
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Zemun, Serbia, 11080
Singapore
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Singapore, Singapore, 119074
Slovakia
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Bratislava, Slovakia, 83348
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Levice, Slovakia, 934 01
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Martin, Slovakia, 03601
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Nitra, Slovakia, 95001
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Nove Zamky, Slovakia, 94034
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Presov, Slovakia, 08181
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Ruzomberok, Slovakia, 03426
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Zilina, Slovakia, 010 01
South Africa
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Alberton, South Africa, 1449
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Bloemfontein, South Africa, 9301
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Cape Town, South Africa, 7405
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Durban, South Africa, 4071
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George, South Africa, 6529
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Johannesburg, South Africa, 2193
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Parktown West, South Africa, 2193
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Somerset West, South Africa, 7129
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Worcester, South Africa, 6850
Spain
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Barcelona, Spain, 08227
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Gerona, Spain, 17600
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Málaga, Spain, 29010
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Palma De Mallorca, Spain, 07198
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Reus, Spain, 43201
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San Boi De Llobregat, Spain, 08830
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Sevilla, Spain, 41008
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Valencia, Spain, 46014
Sweden
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Bollnas, Sweden, 82181
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Karlstad, Sweden, 65185
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Lund, Sweden, 22241
Switzerland
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Bellinzona, Switzerland, CH-6500
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Winterthur, Switzerland, 8401
Taiwan
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Kaohsiung, Taiwan, 80756
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Taipei, Taiwan, 220
Thailand
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50200
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Khon Kaen, Thailand, 40002
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Nakhon Ratchasima, Thailand, 30000
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Pathumthani, Thailand, 12120
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Udon Thani, Thailand, 41000
Tunisia
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La Marsa, Tunisia, 2046
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Menzel Bourguiba, Tunisia, 7050
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Monastir, Tunisia, 5000
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Sfax, Tunisia, 3051
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Sousse, Tunisia, 4054
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Tunis, Tunisia, 2070
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Tunis Monfleury, Tunisia, 1008
Turkey
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Adana, Turkey, 1330
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Ankara, Turkey, 06800
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Bolu, Turkey, 14280
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Bursa, Turkey, 16059
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Edirne, Turkey, 22030
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Erzurum, Turkey, 25050
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Isparta, Turkey, 32100
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Istanbul, Turkey, 34300
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Kırıkkale, Turkey, 71100
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Kocaeli, Turkey, 41380
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Konya, Turkey, 42075
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Samsun, Turkey, 55139
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Trabzon, Turkey, 61080
Ukraine
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Cherkasy, Ukraine, 18009
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Dnipropetrovsk, Ukraine, 49006
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Donetsk, Ukraine, 83114
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Ivano-Frankivsk, Ukraine, 76018
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Kharkiv, Ukraine, 61176
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Kiev, Ukraine, 02660
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Kryvyy Rig, Ukraine, 50031
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Kyiv, Ukraine, 3115
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Lugansk, Ukraine, 91045
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Lutsk, Ukraine, 43024
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Lviv, Ukraine, 79015
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Mykolayiv, Ukraine, 54003
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Odesa, Ukraine, 65025
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Poltava, Ukraine, 36038
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Simferopol, Ukraine, 95026
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Vinnytsya, Ukraine, 21029
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Zaporozhye, Ukraine, 69000
United Kingdom
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Stockton-On-Tees, Cleveland, United Kingdom, TS19 8PE
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Torquay, Cnwll, United Kingdom, TQ2 7AA
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Durham, County Durham, United Kingdom, DH1 5TW
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Chesterfield, Derbyshire, United Kingdom, S44 5BL
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Plymouth, Devon, United Kingdom, PL6 8DH
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Brighton, East Sussex, United Kingdom, BN2 5BE
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Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
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Colchester, Essex, United Kingdom, C04 5JL
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Romford, Essex, United Kingdom, RM7 0AG
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London, Greater London, United Kingdom, SE13 6LH
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Southall, Greater London, United Kingdom, UB1 3HW
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Newport, Gwent, United Kingdom, NP20 2UB
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Portsmouth, Hampshire, United Kingdom, P06 3LY
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Orpington, Kent, United Kingdom, BR6 8ND
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Lincoln, Lincolnshire, United Kingdom, LN2 5QY
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Wirral, Merseyside, United Kingdom, CH49 5PE
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York, North Yorkshire, United Kingdom, YO31 8HE
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PD
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Yeovil, Somerset, United Kingdom, BA21 4AT
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Dundee, Tays, United Kingdom, DD1 9SY
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Nuneaton, Warwickshire, United Kingdom, CV10 7BL
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Warwick, Warwickshire, United Kingdom, CV34 5BW
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Livingston, West Lothian, United Kingdom, EH54 6PP
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Birmingham, West Midlands, United Kingdom, B75 7RR
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Dudley, West Midlands, United Kingdom, DY1 2HQ
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West Bromwich, West Midlands, United Kingdom, B71 4HJ
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Wolverhampton, West Midlands, United Kingdom, WV10 0QP
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Bradford, West Yorkshire, United Kingdom, BD9 6RJ
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Northampton, United Kingdom, NN1 5BD
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Sunderland, United Kingdom, SR4 7TP
Sponsors and Collaborators
Eli Lilly and Company
Daiichi Sankyo Co., Ltd.
Duke Clinical Research Institute
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00699998     History of Changes
Other Study ID Numbers: 11058, H7T-MC-TABY(b)
Study First Received: June 16, 2008
Results First Received: March 21, 2013
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
ACS

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Aspirin
Ticlopidine
Clopidogrel
Prasugrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014