Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
NCT ID: NCT01854918
Last Updated: 2019-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3681 participants
INTERVENTIONAL
2013-04-23
2018-05-31
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
NONE
Study Groups
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Standard of Care
Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period.
Evolocumab
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Standard of Care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Evolocumab + Standard of Care
Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
Evolocumab
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Standard of Care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Interventions
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Evolocumab
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Standard of Care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have an unstable medical condition, in the judgment of the investigator
* Known sensitivity to any of the products to be administered during dosing
* Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
18 Years
85 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Carmichael, California, United States
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Encinitas, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Newport Beach, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Santa Rosa, California, United States
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Spring Valley, California, United States
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Thousand Oaks, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Ventura, California, United States
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Littleton, Colorado, United States
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Daytona Beach, Florida, United States
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DeLand, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ponte Vedra, Florida, United States
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Port Charlotte, Florida, United States
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Sanford, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Gainesville, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Sterling, Illinois, United States
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Indianapolis, Indiana, United States
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Munster, Indiana, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Monroe, Louisiana, United States
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Auburn, Maine, United States
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Bangor, Maine, United States
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Portland, Maine, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Towson, Maryland, United States
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Ayer, Massachusetts, United States
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Quincy, Massachusetts, United States
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Ypsilanti, Michigan, United States
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Edina, Minnesota, United States
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Olive Branch, Mississippi, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Endwell, New York, United States
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Manlius, New York, United States
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New Windsor, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Williamsville, New York, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Akron, Ohio, United States
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Cadiz, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Mansfield, Ohio, United States
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Marion, Ohio, United States
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Sandusky, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Hillsboro, Oregon, United States
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Duncansville, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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York, Pennsylvania, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Rapid City, South Dakota, United States
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Rapid City, South Dakota, United States
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Jackson, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Renton, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Camperdown, New South Wales, Australia
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Maroubra, New South Wales, Australia
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Sydney, New South Wales, Australia
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Sydney, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Carina Heights, Queensland, Australia
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Sherwood, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Ashford, South Australia, Australia
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Fullarton, South Australia, Australia
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Heidelberg Heights, Victoria, Australia
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Melbourne, Victoria, Australia
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Perth, Western Australia, Australia
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Salzburg, , Austria
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Anthée, , Belgium
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Blankenberge, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Chênée, , Belgium
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Ghent, , Belgium
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Gozée, , Belgium
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Gribomont, , Belgium
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Halen, , Belgium
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Ham, , Belgium
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Hasselt, , Belgium
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La Louvière, , Belgium
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Linkebeek, , Belgium
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Ostend, , Belgium
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Tessenderlo, , Belgium
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Tremelo, , Belgium
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Vilvoorde, , Belgium
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Burnaby, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Cambridge, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Sarnia, 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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Woodstock, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Granby, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Lachine, 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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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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Chomutov, , Czechia
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Hradec Králové, , Czechia
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Kladno, , Czechia
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Litoměřice, , Czechia
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Moravské Budějovice, , Czechia
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Olomouc, , Czechia
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Pardubice, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Slaný, , Czechia
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Svitavy, , Czechia
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Aalborg, , Denmark
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Aarhus N, , Denmark
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Ballerup Municipality, , Denmark
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Glostrup Municipality, , Denmark
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Vejle, , Denmark
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Brest, , France
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Bron, , France
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Caen, , France
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Dijon, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Paris, , France
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Vénissieux, , France
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Bad Krozingen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Hellersdorf, , Germany
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Heppenheim an der Bergstrasse, , Germany
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Homburg, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Messkirch, , Germany
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München, , Germany
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Witten, , Germany
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Hong Kong, , Hong Kong
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New Territories, , Hong Kong
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Baja, , Hungary
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Berettyóújfalu, , Hungary
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Budapest, , Hungary
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Eger, , Hungary
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Gyöngyös, , Hungary
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Hódmezővásárhely, , Hungary
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Jászberény, , Hungary
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Komárom, , Hungary
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Mosonmagyaróvár, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Bologna, , Italy
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Cagliari, , Italy
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Chieti, , Italy
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Cinisello Balsamo (MI), , Italy
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Ferrara, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Pisa, , Italy
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Trieste, , Italy
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Noda, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyusyu-shi, Fukuoka, Japan
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Koriyama-shi, Fukushima, Japan
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Koriyama-shi, Fukushima, Japan
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Koriyama-shi, Fukushima, Japan
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Koriyama-shi, Fukushima, Japan
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Koriyama-shi, Fukushima, Japan
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Maebashi, Gunma, Japan
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Takasaki-shi, Gunma, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Tsuchiura-shi, Ibaraki, Japan
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Morioka, Iwate, Japan
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Takamatsu, Kagawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Yokohama, Kanagawa, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Sendai, Miyagi, Japan
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Sendai, Miyagi, Japan
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Tomigusuku-shi, Okinawa, Japan
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Ibaraki-shi, Osaka, Japan
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Toyonaka-shi, Osaka, Japan
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Koshigaya-shi, Saitama, Japan
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Niiza-shi, Saitama, Japan
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Arakawa-ku, Tokyo, Japan
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Chiyoda-ku, Tokyo, Japan
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Chofu-shi, Tokyo, Japan
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Edogawa-ku, Tokyo, Japan
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Hachioji-shi, Tokyo, Japan
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Katsushika-ku, Tokyo, Japan
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Koto-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Shibuya-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Toshima-ku, Tokyo, Japan
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Amsterdam, , Netherlands
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Den Helder, , Netherlands
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Groningen, , Netherlands
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Groningen, , Netherlands
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Hoogeveen, , Netherlands
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Hoorn, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Utrecht, , Netherlands
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Waalwijk, , Netherlands
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Zwijndrecht, , Netherlands
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Christchurch, , New Zealand
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Ålesund, , Norway
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Oslo, , Norway
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Lodz, , Poland
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Barnaul, , Russia
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Kemerovo, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Centurion, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Midrand, Gauteng, South Africa
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Sunninghill, Gauteng, South Africa
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eManzimtoti, KwaZulu-Natal, South Africa
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Observatory, Western Cape, South Africa
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Paarl, Western Cape, South Africa
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Parow, Western Cape, South Africa
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Somerset West, Western Cape, South Africa
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Bloemfontein, , South Africa
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Seoul, , South Korea
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Seoul, , South Korea
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Córdoba, Andalusia, Spain
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Zaragoza, Aragon, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Reus, Catalonia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Uddevalla, , Sweden
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Bellinzona, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Lugano, , Switzerland
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Muensterlingen, , Switzerland
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Reinach, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
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Zurich, , Switzerland
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Birmingham, , United Kingdom
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Birmingham, , United Kingdom
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Blackpool, , United Kingdom
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Cardiff, , United Kingdom
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Chesterfield, , United Kingdom
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Chorley, , United Kingdom
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Coventry, , United Kingdom
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Doncaster, , United Kingdom
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Glasgow, , United Kingdom
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Glasgow, , United Kingdom
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Glasgow, , United Kingdom
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Liverpool, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Reading, , United Kingdom
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Telford, , United Kingdom
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Wakefield, , United Kingdom
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West Bromwich, , United Kingdom
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Whitby, , United Kingdom
Countries
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References
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Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.
Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-004357-83
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120138
Identifier Type: -
Identifier Source: org_study_id
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