Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
OSLER-2
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
2 other identifiers
interventional
3,681
24 countries
362
Brief Summary
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2013
Longer than P75 for phase_3
362 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2013
CompletedFirst Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedResults Posted
Study results publicly available
June 11, 2019
CompletedJune 11, 2019
May 1, 2019
5.1 years
May 1, 2013
May 20, 2019
May 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
Secondary Outcomes (2)
Percent Change From Baseline in LDL-C at Weeks 48 and 104
Baseline of the parent study and weeks 48 amd 104
Change From Baseline in LDL-C at Weeks 48 and 104
Baseline of the parent study and weeks 48 amd 104
Study Arms (2)
Standard of Care
ACTIVE COMPARATORParticipants 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 + Standard of Care
EXPERIMENTALParticipants 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.
Interventions
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Eligibility Criteria
You may qualify if:
- \- Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 \[NCT01763827\], 20110115 \[NCT01763866\], 20110116 \[NCT01763905\], 20110117 \[NCT01763918\], 20110109 \[NCT01516879\], 20120122 \[NCT01953328\], 20120332 \[NCT01984424\], 20120348 \[NCT01849497\], or 20120356 \[NCT01879319\]).
You may not qualify if:
- Experienced a treatment-related serious adverse event that led to study drug discontinuation in the parent study
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (363)
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Birmingham, Alabama, 35216, United States
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Birmingham, Alabama, 35294, United States
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Chandler, Arizona, 85224, United States
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Phoenix, Arizona, 85020, United States
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Tucson, Arizona, 85712, United States
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Little Rock, Arkansas, 72205, United States
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Beverly Hills, California, 90211, United States
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Carmichael, California, 95608, United States
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Encinitas, California, 92024, United States
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Huntington Beach, California, 92648, United States
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Los Angeles, California, 90048, United States
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Mission Viejo, California, 92691, United States
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Newport Beach, California, 92663, United States
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San Diego, California, 92111, United States
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Santa Ana, California, 92705, United States
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Santa Rosa, California, 95405, United States
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Spring Valley, California, 91978, United States
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Thousand Oaks, California, 91360, United States
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Torrance, California, 90509, United States
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Tustin, California, 92780, United States
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Ventura, California, 93003, United States
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Littleton, Colorado, 80120, United States
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Daytona Beach, Florida, 32117, United States
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DeLand, Florida, 32720, United States
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Jacksonville, Florida, 32216, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33173, United States
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Ponte Vedra, Florida, 32081, United States
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Port Charlotte, Florida, 33952, United States
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Sanford, Florida, 32771, United States
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Atlanta, Georgia, 30328, United States
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Atlanta, Georgia, 30338, United States
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Atlanta, Georgia, 30342, United States
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Gainesville, Georgia, 30501, United States
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Savannah, Georgia, 31406, United States
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Chicago, Illinois, 60654, United States
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Sterling, Illinois, 61081, United States
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Indianapolis, Indiana, 46260, United States
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Munster, Indiana, 46321, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66160, United States
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Lexington, Kentucky, 40504, United States
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Louisville, Kentucky, 40213, United States
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Monroe, Louisiana, 71201, United States
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Auburn, Maine, 04210, United States
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Bangor, Maine, 04401, United States
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Portland, Maine, 04101, United States
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Bethesda, Maryland, 20817, United States
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Columbia, Maryland, 21045, United States
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Towson, Maryland, 21204, United States
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Ayer, Massachusetts, 01432, United States
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Quincy, Massachusetts, 02169, United States
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Ypsilanti, Michigan, 48197, United States
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Edina, Minnesota, 55435, United States
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Olive Branch, Mississippi, 38654, United States
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Tupelo, Mississippi, 38801, United States
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St Louis, Missouri, 63110, United States
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Henderson, Nevada, 89052, United States
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Las Vegas, Nevada, 89148, United States
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Endwell, New York, 13760, United States
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Manlius, New York, 13104, United States
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New Windsor, New York, 12553, United States
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New York, New York, 10029, United States
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Rochester, New York, 14609, United States
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Williamsville, New York, 14221, United States
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Raleigh, North Carolina, 27609, United States
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Raleigh, North Carolina, 27612, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58103, United States
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Akron, Ohio, 44311, United States
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Cadiz, Ohio, 43907, United States
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Canton, Ohio, 44710, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45227, United States
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Cincinnati, Ohio, 45236, United States
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Cleveland, Ohio, 44195, United States
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Dayton, Ohio, 45414, United States
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Mansfield, Ohio, 44906, United States
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Marion, Ohio, 43302, United States
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Sandusky, Ohio, 44870, United States
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Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73103, United States
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Hillsboro, Oregon, 97123, United States
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Duncansville, Pennsylvania, 16635, United States
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Lansdale, Pennsylvania, 19446, United States
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Pittsburgh, Pennsylvania, 15216, United States
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York, Pennsylvania, 17405, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29425, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Rapid City, South Dakota, 57701, United States
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Rapid City, South Dakota, 57702, United States
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Jackson, Tennessee, 38305, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78731, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77074, United States
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San Antonio, Texas, 78229, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23294, United States
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Suffolk, Virginia, 23435, United States
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Renton, Washington, 98057, United States
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Seattle, Washington, 98104, United States
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Tacoma, Washington, 98405, United States
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Camperdown, New South Wales, 2015, Australia
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Maroubra, New South Wales, 2035, Australia
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Sydney, New South Wales, 2010, Australia
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Sydney, New South Wales, 2022, Australia
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Auchenflower, Queensland, 4066, Australia
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Carina Heights, Queensland, 4152, Australia
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Sherwood, Queensland, 4075, Australia
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Woolloongabba, Queensland, 4102, Australia
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Ashford, South Australia, 5035, Australia
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Fullarton, South Australia, 5063, Australia
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Heidelberg Heights, Victoria, 3081, Australia
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Melbourne, Victoria, 3004, Australia
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Perth, Western Australia, 6000, Australia
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Salzburg, 5020, Austria
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Anthée, 5520, Belgium
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Blankenberge, 8370, Belgium
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Brussels, 1080, Belgium
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Brussels, 1200, Belgium
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ChĂªnĂ©e, 4032, Belgium
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Ghent, 9000, Belgium
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Gozée, 6534, Belgium
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Gribomont, 6887, Belgium
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Halen, 3545, Belgium
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Ham, 3945, Belgium
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Hasselt, 3500, Belgium
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La Louvière, 7100, Belgium
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Linkebeek, 1630, Belgium
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Ostend, 8400, Belgium
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Tessenderlo, 3980, Belgium
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Tremelo, 3120, Belgium
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Vilvoorde, 1800, Belgium
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Burnaby, British Columbia, V5G 1T4, Canada
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Kelowna, British Columbia, V1Y 1V6, Canada
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Surrey, British Columbia, V3V 1N1, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
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Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
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St. John's, Newfoundland and Labrador, A1A 3R5, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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London, Ontario, N5W 6A2, Canada
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London, Ontario, N6A 5K8, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Oshawa, Ontario, L1J 2K1, Canada
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Peterborough, Ontario, K9J 0B2, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Toronto, Ontario, M8V 3X8, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Woodstock, Ontario, N4S 5P5, Canada
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Chicoutimi, Quebec, G7H 7K9, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Greenfield Park, Quebec, J4V 2G8, Canada
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Lachine, Quebec, H8S 2E4, Canada
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Montreal, Quebec, H2W 1R7, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Montreal, Quebec, H4N 2W2, Canada
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Pointe-Claire, Quebec, H9R 3J1, Canada
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Québec, Quebec, G1V 4M6, Canada
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Brno, 602 00, Czechia
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Brno, 603 00, Czechia
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Chomutov, 430 02, Czechia
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Hradec KrĂ¡lovĂ©, 500 05, Czechia
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Kladno, 272 01, Czechia
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Litoměřice, 412 01, Czechia
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Moravské Budějovice, 676 02, Czechia
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Olomouc, 775 20, Czechia
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Pardubice, 530 02, Czechia
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Pilsen, 305 99, Czechia
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Prague, 128 08, Czechia
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Prague, 130 00, Czechia
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Prague, 140 21, Czechia
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Prague, 150 06, Czechia
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SlanĂ½, 274 01, Czechia
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Svitavy, 568 25, Czechia
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Aalborg, 9000, Denmark
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Aarhus N, 8200, Denmark
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Ballerup Municipality, 2750, Denmark
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Glostrup Municipality, 2600, Denmark
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Vejle, 7100, Denmark
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Brest, 29200, France
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Bron, 69677, France
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Caen, 14033, France
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Dijon, 21034, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Paris, 75571, France
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Paris, 75651, France
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VĂ©nissieux, 69200, France
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Bad Krozingen, 79189, Germany
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Berlin, 10787, Germany
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Berlin, 13353, Germany
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Cologne, 50937, Germany
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Dresden, 01307, Germany
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Hellersdorf, 12627, Germany
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Heppenheim an der Bergstrasse, 64646, Germany
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Homburg, 66421, Germany
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Leipzig, 04103, Germany
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Magdeburg, 39112, Germany
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Messkirch, 88605, Germany
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MĂ¼nchen, 80638, Germany
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Witten, 58455, Germany
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Baja, 6500, Hungary
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BerettyĂ³Ăºjfalu, 4100, Hungary
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Budapest, 1085, Hungary
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Eger, 3300, Hungary
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Gyöngyös, 3200, Hungary
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HĂ³dmezÅ‘vĂ¡sĂ¡rhely, 6800, Hungary
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JĂ¡szberĂ©ny, 5100, Hungary
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KomĂ¡rom, 2921, Hungary
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MosonmagyarĂ³vĂ¡r, 9200, Hungary
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PĂ©cs, 7624, Hungary
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Szeged, 6720, Hungary
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Bologna, 40138, Italy
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Cagliari, 09134, Italy
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Chieti, 66100, Italy
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Cinisello Balsamo (MI), 20092, Italy
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Ferrara, 44124, Italy
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Milan, 20162, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Perugia, 06129, Italy
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Pisa, 56100, Italy
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Pisa, 56124, Italy
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Trieste, 34149, Italy
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Noda, Chiba, 278-0004, Japan
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Fukuoka, Fukuoka, 810-0014, Japan
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Fukuoka, Fukuoka, 810-0066, Japan
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Fukuoka, Fukuoka, 819-8551, Japan
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Kitakyusyu-shi, Fukuoka, 807-0856, Japan
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Koriyama-shi, Fukushima, 963-0209, Japan
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Koriyama-shi, Fukushima, 963-8026, Japan
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Koriyama-shi, Fukushima, 963-8041, Japan
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Koriyama-shi, Fukushima, 963-8832, Japan
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Koriyama-shi, Fukushima, 963-8862, Japan
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Maebashi, Gunma, 371-0022, Japan
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Takasaki-shi, Gunma, 370-3524, Japan
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Sapporo, Hokkaido, 003-0026, Japan
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Sapporo, Hokkaido, 003-0825, Japan
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Sapporo, Hokkaido, 060-0063, Japan
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Tsuchiura-shi, Ibaraki, 300-0047, Japan
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Morioka, Iwate, 020-0066, Japan
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Takamatsu, Kagawa-ken, 760-0018, Japan
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Takamatsu, Kagawa-ken, 760-0076, Japan
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Yokohama, Kanagawa, 231-0023, Japan
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Kyoto, Kyoto, 615-8125, Japan
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Sendai, Miyagi, 983-0039, Japan
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Sendai, Miyagi, 983-0835, Japan
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Sendai, Miyagi, 989-3122, Japan
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Tomigusuku-shi, Okinawa, 901-0243, Japan
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Ibaraki-shi, Osaka, 567-0876, Japan
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Toyonaka-shi, Osaka, 560-0082, Japan
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Koshigaya-shi, Saitama, 343-0828, Japan
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Niiza-shi, Saitama, 352-0014, Japan
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Arakawa-ku, Tokyo, 116-0002, Japan
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Chiyoda-ku, Tokyo, 101-0041, Japan
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Chofu-shi, Tokyo, 182-0006, Japan
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Edogawa-ku, Tokyo, 133-0061, Japan
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Hachioji-shi, Tokyo, 192-0046, Japan
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Katsushika-ku, Tokyo, 124-0024, Japan
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Koto-ku, Tokyo, 135-0011, Japan
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Minato-ku, Tokyo, 105-7390, Japan
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Minato-ku, Tokyo, 108-0075, Japan
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ÅŒta-ku, Tokyo, 144-0034, Japan
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Setagaya-ku, Tokyo, 155-0031, Japan
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Shibuya-ku, Tokyo, 150-0012, Japan
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Shinagawa-ku, Tokyo, 140-0011, Japan
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Shinagawa-ku, Tokyo, 141-0001, Japan
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Shinagawa-ku, Tokyo, 141-6003, Japan
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Shinagawa-ku, Tokyo, 142-0053, Japan
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Toshima-ku, Tokyo, 171-0021, Japan
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Amsterdam, 1105 AZ, Netherlands
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Den Helder, 1782 GZ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Groningen, 9728 NT, Netherlands
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Hoogeveen, 7909 AA, Netherlands
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Hoorn, 1625 HV, Netherlands
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Nijmegen, 6525 EZ, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Tilburg, 5022 GC, Netherlands
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Utrecht, 3584 CX, Netherlands
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Waalwijk, 5141 BM, Netherlands
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Zwijndrecht, 3331 LZ, Netherlands
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Christchurch, 8011, New Zealand
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Ă…lesund, 6003, Norway
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Oslo, 0373, Norway
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Lodz, 91-078, Poland
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Barnaul, 656055, Russia
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Kemerovo, 650002, Russia
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Moscow, 121552, Russia
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Novosibirsk, 630047, Russia
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Saint Petersburg, 197022, Russia
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Saratov, 410054, Russia
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Centurion, Gauteng, 0157, South Africa
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Johannesburg, Gauteng, 2193, South Africa
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Midrand, Gauteng, 1685, South Africa
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Sunninghill, Gauteng, 2157, South Africa
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eManzimtoti, KwaZulu-Natal, 4126, South Africa
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Observatory, Western Cape, 7925, South Africa
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Paarl, Western Cape, 7646, South Africa
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Parow, Western Cape, 7505, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Bloemfontein, 9301, South Africa
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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CĂ³rdoba, Andalusia, 14004, Spain
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Zaragoza, Aragon, 50009, Spain
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L'Hospitalet de Llobregat, Catalonia, 08907, Spain
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Reus, Catalonia, 43204, Spain
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Madrid, 28007, Spain
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Madrid, 28029, Spain
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Madrid, 28040, Spain
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Gothenburg, 413 45, Sweden
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Lund, 222 21, Sweden
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Ă–rebro, 701 46, Sweden
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Stockholm, 111 57, Sweden
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Stockholm, 141 86, Sweden
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Stockholm, 171 45, Sweden
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Uddevalla, 451 50, Sweden
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Bellinzona, 6500, Switzerland
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Geneva, 1211, Switzerland
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Lausanne, 1011, Switzerland
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Lugano, 6900, Switzerland
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Muensterlingen, 8596, Switzerland
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Reinach, 4153, Switzerland
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Sankt Gallen, 9007, Switzerland
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Zurich, 8063, Switzerland
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Zurich, 8091, Switzerland
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Kaohsiung City, 83301, Taiwan
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Taipei, 100, Taiwan
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Birmingham, B15 2SQ, United Kingdom
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Birmingham, B15 2TH, United Kingdom
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Blackpool, FY3 7EN, United Kingdom
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Cardiff, CF14 5GJ, United Kingdom
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Chesterfield, S40 4AA, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Doncaster, DN9 1EP, United Kingdom
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Glasgow, G12 8TA, United Kingdom
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Glasgow, G20 0SP, United Kingdom
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Glasgow, G45 9AW, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 7EH, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Newcastle upon Tyne, NE1 4LP, United Kingdom
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Reading, RG2 0TG, United Kingdom
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Telford, TF1 6TF, United Kingdom
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Wakefield, WF1 4DG, United Kingdom
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West Bromwich, B71 4HJ, United Kingdom
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Whitby, YO21 1SD, United Kingdom
Related Publications (5)
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.
PMID: 29353350BACKGROUNDSattar 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.
PMID: 28844508RESULTHovingh 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.
PMID: 29066265RESULTSchmidt 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.
PMID: 33078867DERIVEDSabatine 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.
PMID: 25773607DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 16, 2013
Study Start
April 23, 2013
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
June 11, 2019
Results First Posted
June 11, 2019
Record last verified: 2019-05