GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
NCT ID: NCT00089986
Last Updated: 2017-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1415 participants
INTERVENTIONAL
2004-09-01
2007-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Interventions
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Intravenous GR270773- Phospholipid Emulsion
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have at least one new hypoperfusion abnormality or at least one new onset organ failure resulting from the current septic episode.
* Must be available and able to receive the first dose of study medication no more than 12 hours after the confirmation of a new hypoperfusion abnormality or new onset organ failure and within 36 hours after the initiation of new parenteral antibacterial therapy for the suspected or confirmed Gram-negative infection believed to be responsible for this episode of sepsis.
Exclusion Criteria
* Subject has neutropenia (e.g., subject recently receiving cytotoxic chemotherapy with absolute neutrophil count \<500/mcL or expected to decline to \<500/mcL in the next 3 days).
* Subject has known active hemolytic disease, immune hemolytic anemias, hemoglobinopathies (sickle cell anemia and thalassemia major).
* Subject has a known bone marrow disorder of inadequate red cell production (eg, aplastic anemia, myelodysplasia).
* Subject is at increased risk of complications from GR270773-related hemolysis due to the inability to increase cardiac function sufficiently to meet the demands for oxygen delivery.
* Subject has a baseline hemoglobin (measured after adequate volume resuscitation) \<9.0 g/dL (5.59 mmol/L).
* Subject is currently being treated with XIGRIS (Drotrecogin alfa (activated)) or its use is considered imminent (ie., a decision to treat with XIGRIS has been made).
* Subject has a history of allergic reaction to eggs (or egg products), soybeans, INTRALIPID, or any component of GR270773.
* Subject has been designated as 'not full support do not resuscitate' (DNR), or other equivalent status which prohibits the use of life supporting interventions (e.g., mechanical ventilation, dialysis/hemofiltration, or others) thereby limiting the treatment options available.
Note: Subjects with advanced directives prohibiting only chest compression (CPR) are eligible for the study.
* Subject has preexisting severe liver disease such as cirrhosis, primary biliary cirrhosis or known preexisting Child-Pugh class B or C liver dysfunction.
* Subject is moribund (a state in which death is perceived to be imminent) or has a life expectancy of less than 3 months due to an underlying disease.
* Subject is currently receiving one of the following prohibited concomitant medications; parenteral nutrition supplements containing lipid emulsions (e.g., INTRALIPID), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Bentonville, Arkansas, United States
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Little Rock, Arkansas, United States
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Fresno, California, United States
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Fullerton, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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San Jose, California, United States
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Stanford, California, United States
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Torrance, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Fort Collins, Colorado, United States
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Stamford, Connecticut, United States
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Waterbury, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Atlantis, Florida, United States
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Bay Pines, Florida, United States
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Fort Lauderdale, Florida, United States
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Melbourne, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Decatur, Georgia, United States
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Rome, Georgia, United States
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Honolulu, Hawaii, United States
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Honolulu, Hawaii, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Naperville, Illinois, United States
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North Chicago, Illinois, United States
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Oak Park, Illinois, United States
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Peoria, Illinois, United States
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Indianapolis, Indiana, United States
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New Albany, Indiana, United States
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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East Lansing, Michigan, United States
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Flint, Michigan, United States
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Kalamazoo, Michigan, United States
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Duluth, Minnesota, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Camden, New Jersey, United States
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Piscataway, New Jersey, United States
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Somers Point, New Jersey, United States
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Albany, New York, United States
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Buffalo, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Corvallis, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Monroeville, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Lackland Air Force Base, Texas, United States
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Lubbock, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Lynchburg, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Salem, Virginia, United States
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Bellingham, Washington, United States
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Everett, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Huntington, West Virginia, United States
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Marshfield, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Villa Sarmiento-Haedo, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Moron-Provincia de Buenos Aires, , Argentina
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St Leonards, New South Wales, Australia
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Footscray, Victoria, Australia
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Heidelberg, Victoria, Australia
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Nedlands, Victoria, Australia
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Fremantle, Western Australia, Australia
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Innsbruck, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Aalst, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Ottignies, , Belgium
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Yvoir, , Belgium
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Curitiba, Paraná, Brazil
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Ribeirão Preto, São Paulo, Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Calgary, Alberta, Canada
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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New Westminster, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Santiago, Región Metro de Santiago, Chile
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Santiago, Región Metro de Santiago, Chile
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Brno, , Czechia
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Ostrava - Poruba, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Helsinki, , Finland
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Joensuu, , Finland
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Jyväskylä, , Finland
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Kuopio, , Finland
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Lappeenranta, , Finland
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Mikkeli, , Finland
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Oulu, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Angers, , France
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Argenteuil, , France
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Bourg-en-Bresse, , France
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Caen, , France
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Créteil, , France
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Le Chesnay, , France
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Lille, , France
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Limoges, , France
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Lyon, , France
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Marseille, , France
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Marseille, , France
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Montauban, , France
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Montpellier, , France
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Nîmes, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Saint-Michel, , France
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Heidelberg, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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Erlangen, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Nuremberg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Giessen, Hesse, Germany
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Marburg, Hesse, Germany
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Göttingen, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Greifswald, Mecklenburg-Vorpommern, Germany
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Neubrandenburg, Mecklenburg-Vorpommern, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Schwerin, Mecklenburg-Vorpommern, Germany
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Wismar, Mecklenburg-Vorpommern, Germany
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Bielefeld, North Rhine-Westphalia, Germany
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Bonn, North Rhine-Westphalia, Germany
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Bonn, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Wuppertal, North Rhine-Westphalia, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
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Mainz, Rhineland-Palatinate, Germany
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Homburg, Saarland, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Kiel, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Bad Berka, Thuringia, Germany
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Erfurt, Thuringia, Germany
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Jena, Thuringia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bremen, , Germany
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Hamburg, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Haidari, , Greece
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Kifissia, , Greece
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Rio, Patras, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Kowloon, , Hong Kong
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Pokfulam, , Hong Kong
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Shatin, , Hong Kong
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Tuen Mun, New Territories, , Hong Kong
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Budapest, , Hungary
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Bangalore, , India
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Chennai, , India
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Mangalore, , India
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Mumbai, , India
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Pune, , India
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Pune, , India
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Afula, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Kfar Saba, , Israel
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Zrifin, , Israel
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Kuala Lumpur, , Malaysia
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Kubang Kerian, , Malaysia
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Apeldoorn, , Netherlands
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Ede, , Netherlands
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Leeuwarden, , Netherlands
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Rotterdam, , Netherlands
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Utrecht, , Netherlands
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Auckland, , New Zealand
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Tauranga, , New Zealand
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Almada, , Portugal
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Amadora, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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San Juan, , Puerto Rico
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Iași, , Romania
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Barnaul, , Russia
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Krasnodar, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Perm, , Russia
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Perm, , Russia
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Saint Petersburgh, , Russia
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Smolensk, , Russia
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Tomsk, , Russia
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Yekaterinburg, , Russia
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Celje, , Slovenia
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Ljubljana, , Slovenia
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Maribor, , Slovenia
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Novo Mesto, , Slovenia
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Slovenj Gradec, , Slovenia
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Šempeter Pri Novi Gorici, , Slovenia
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Johannesburg, Gauteng, South Africa
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Auckland Park, Johannesburg, , South Africa
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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George, , South Africa
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PO Medunsa, , South Africa
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Getafe, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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Seville, , Spain
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Seville, , Spain
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Tarrasa, , Spain
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Terrassa, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Tau-Yuan County, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Aberdeen, Aberdeenshire, United Kingdom
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Reading, Berkshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Wigan, Lancashire, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Oxford, Oxfordshire, United Kingdom
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Bath, Somerset, United Kingdom
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Livingston, West Lothian, United Kingdom
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Leeds, , United Kingdom
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Leeds, , United Kingdom
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Sheffield, , United Kingdom
Countries
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Other Identifiers
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EMD20001
Identifier Type: -
Identifier Source: org_study_id
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