Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
NCT ID: NCT00241722
Last Updated: 2017-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
805 participants
INTERVENTIONAL
2005-08-01
2007-02-01
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
QUADRUPLE
Study Groups
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Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
Alvimopan
Placebo
Placebo was administered orally BID for 12 months.
Placebo
Interventions
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Alvimopan
Placebo
Eligibility Criteria
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Inclusion Criteria
* Taking opioid therapy for persistent non-cancer pain.
* Has bowel dysfunction mainly due to opioids.
* Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
* Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).
Exclusion Criteria
* Not ambulatory.
* Participated in another trial with an investigational drug in the past 30 days.
* Taking opioids for the management of drug addiction or cancer-related pain.
* Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
* Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
* Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Muscle Shoals, Alabama, United States
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Northport, Alabama, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Scottsdale, Arizona, United States
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Sun City, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Buena Park, California, United States
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Burbank, California, United States
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Los Gatos, California, United States
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Orange, California, United States
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Palm Springs, California, United States
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Pismo Beach, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Vista, California, United States
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Stratford, Connecticut, United States
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Trumbull, Connecticut, United States
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Brandon, Florida, United States
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Chiefland, Florida, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Deerfield Beach, Florida, United States
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DeLand, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Holly Hill, Florida, United States
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Hollywood, Florida, United States
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Jupiter, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Saint Cloud, Florida, United States
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West Palm Beach, Florida, United States
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Dawsonville, Georgia, United States
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Marietta, Georgia, United States
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Stockbridge, Georgia, United States
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Suwanee, Georgia, United States
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Boise, Idaho, United States
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Meridian, Idaho, United States
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Arlington Heights, Illinois, United States
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Bloomington, Illinois, United States
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Chicago, Illinois, United States
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Rockford, Illinois, United States
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Elkhart, Indiana, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Madisonville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Pasadena, Maryland, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Brockton, Massachusetts, United States
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Wellesley Hills, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Blanc, Michigan, United States
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Portage, Michigan, United States
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Traverse City, Michigan, United States
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Chaska, Minnesota, United States
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Olive Branch, Mississippi, United States
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Manchester, Missouri, United States
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Nixa, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Dover, New Hampshire, United States
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Blackwood, New Jersey, United States
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Elizabeth, New Jersey, United States
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Albuquerque, New Mexico, United States
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Lake Success, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Greensboro, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, 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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Centerville, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Clinton, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Oregon City, Oregon, United States
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Portland, Oregon, United States
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Carnegie, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Woonsocket, Rhode Island, United States
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Chattanooga, Tennessee, United States
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Clarksville, Tennessee, United States
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Kingsport, Tennessee, United States
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Arlington, Texas, United States
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Brownwood, Texas, United States
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Dallas, Texas, United States
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Grand Prairie, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Lancaster, Texas, United States
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Richardson, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellingham, Washington, United States
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Edmonds, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Charleston, West Virginia, United States
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Broadmeadow, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Carina Heights, Queensland, Australia
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Kippa-Ring, Queensland, Australia
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Bedford Park, South Australia, Australia
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Port Lincoln, South Australia, Australia
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Toorak Gardens, South Australia, Australia
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Box Hill, Victoria, Australia
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Carlton, Victoria, Australia
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Fremantle, Western Australia, Australia
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Vienna, , Austria
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Vienna, , Austria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Langley, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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Mississauga, Ontario, Canada
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North Bay, Ontario, Canada
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North York, 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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Charlottetown, Prince Edward Island, Canada
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Bonaventure, Quebec, Canada
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Chandler, Quebec, Canada
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Drummondville, Quebec, Canada
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Mirabel, Quebec, Canada
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Montreal, Quebec, Canada
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Saint Romuald, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Ishøj, , Denmark
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Helsinki, , Finland
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Kowloon, , Hong Kong
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Kwun Tong, , Hong Kong
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Pokfulam, , Hong Kong
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Shatin, , Hong Kong
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Budapest, , Hungary
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Cork, , Ireland
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Roosendaal, , Netherlands
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Utrecht, , Netherlands
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Christchurch, , New Zealand
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Hamilton, , New Zealand
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Tauranga, , New Zealand
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Gdansk, , Poland
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Krakow, , Poland
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Wroclaw, , Poland
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Alcorcón, , Spain
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Barcelona, , Spain
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Ferrol, , Spain
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Granada, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Santander, , Spain
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Valencia, , Spain
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Jönköping, , Sweden
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Karlstad, , Sweden
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Linköping, , Sweden
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Stockholm, , Sweden
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Bern, , Switzerland
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Reading, Berkshire, United Kingdom
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Slough, Berkshire, United Kingdom
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Cardiff, Glamorgan, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Sunbury-on-Thames, Middlesex, United Kingdom
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Coventry, Warwickshire, United Kingdom
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Bexhill-on-Sea, East Sussex, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Yaxley, Peterborough, , United Kingdom
Countries
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Other Identifiers
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SB-767905/014
Identifier Type: OTHER
Identifier Source: secondary_id
3753-013
Identifier Type: -
Identifier Source: org_study_id
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