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
PHASE4
1200 participants
INTERVENTIONAL
2003-08-31
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Open label single arm study
lamotrigine
Lamotrigine
Interventions
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lamotrigine
Lamotrigine
Eligibility Criteria
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Inclusion Criteria
* Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
* If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
Exclusion Criteria
* Presence of untreated thyroid disease.
* Patient is actively suicidal or homicidal.
* Patient has history of severe hepatic or renal insufficiency.
* Patient is currently participating in another clinical trial.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Albertville, Alabama, United States
GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
GSK Investigational Site
Fairhope, Alabama, United States
GSK Investigational Site
Huntsville, Alabama, United States
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Tuscaloosa, Alabama, United States
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
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Phoenix, Arizona, United States
GSK Investigational Site
Rogers, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
GSK Investigational Site
Bakersfield, California, United States
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Beverly Hills, California, United States
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Burbank, California, United States
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Campbell, California, United States
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Cerritos, California, United States
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El Centro, California, United States
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Fairfield, California, United States
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La Mesa, California, United States
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Laguna Hills, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Petaluma, California, United States
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Poway, California, United States
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Riverside, California, United States
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Sacramento, 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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San Jose, California, United States
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Santa Ana, California, United States
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Santa Barbara, California, United States
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Sherman Oaks, California, United States
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Torrance, California, United States
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West Hollywood, California, United States
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Boulder, Colorado, United States
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Fort Collins, Colorado, United States
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Hamden, Connecticut, United States
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Mansfield Center, Connecticut, United States
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Norwich, Connecticut, United States
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Wethersfield, Connecticut, United States
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Newark, Delaware, United States
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Wilmington, Delaware, United States
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Washington D.C., District of Columbia, United States
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Altamonte Springs, Florida, United States
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Boca Raton, Florida, United States
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Boca Raton, Florida, United States
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Boynton Beach, Florida, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Casselberry, Florida, United States
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Clearwater, Florida, United States
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Coral Springs, Florida, United States
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Davie, Florida, United States
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Daytona Beach, Florida, United States
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Destin, Florida, United States
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Fort Walton Beach, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Ocala, Florida, United States
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Ocala, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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Pensacola, Florida, United States
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Plantation, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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Syracuse, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Wilton Manors, Florida, United States
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Winter Park, Florida, United States
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Winter Park, Florida, United States
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Zephyrhills, 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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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Macon, Georgia, United States
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Roswell, Georgia, United States
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Stockbridge, Georgia, United States
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Warner Robins, Georgia, United States
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Boise, Idaho, United States
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Boise, Idaho, United States
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Boise, Idaho, United States
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Alton, Illinois, United States
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Bourbonnais, Illinois, United States
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Chicago, Illinois, United States
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East Moline, Illinois, United States
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Evergreen Park, Illinois, United States
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Fairview Heights, Illinois, United States
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Granite City, Illinois, United States
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Joliet, Illinois, United States
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Libertyville, Illinois, United States
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Lisle, Illinois, United States
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Oakbrook Terrace, Illinois, United States
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Orland Park, Illinois, United States
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Park Ridge, Illinois, United States
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Rockford, Illinois, United States
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Schaumburg, Illinois, United States
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Vernon Hills, Illinois, United States
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Wheaton, Illinois, United States
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Danville, Indiana, United States
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Evansville, Indiana, United States
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Fort Wayne, Indiana, United States
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Lafayette, Indiana, United States
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Mishawaka, Indiana, United States
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Plymouth, Indiana, United States
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Valparaiso, Indiana, United States
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Cedar Rapids, Iowa, United States
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Dubuque, Iowa, United States
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Leavenworth, Kansas, United States
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Overland Park, Kansas, United States
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Shawnee Mission, Kansas, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Hopkinsville, Kentucky, United States
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Lexington, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Houma, Louisiana, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Batlimore, Maryland, United States
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Burtonsville, Maryland, United States
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Ellicott City, Maryland, United States
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Gaithersburg, Maryland, United States
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Glen Burnie, Maryland, United States
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Laurel, Maryland, United States
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Rockville, Maryland, United States
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Towson, Maryland, United States
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Towson, Maryland, United States
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Adrian, Michigan, United States
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Bay City, Michigan, United States
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Benton Harbor, Michigan, United States
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Bloomfield Hills, Michigan, United States
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Brownstown Township, Michigan, United States
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Clinton Township, Michigan, United States
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East Lansing, Michigan, United States
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Farmington Hills, Michigan, United States
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Flint, Michigan, United States
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Flint, Michigan, United States
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Mount Clemens, Michigan, United States
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Rochester Hills, Michigan, United States
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Royal Oak, Michigan, United States
GSK Investigational Site
Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
GSK Investigational Site
Oakdale, Minnesota, United States
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Flowood, Mississippi, United States
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Gulfport, Mississippi, United States
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Joplin, Missouri, United States
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Kansas City, Missouri, United States
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Saint Charles, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, 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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Manchester, New Hampshire, United States
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Long Branch, New Jersey, United States
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Princeton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Las Cruces, New Mexico, United States
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Albany, New York, United States
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Amityville, New York, United States
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Farmingdale, New York, United States
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Latham, New York, United States
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New Rochelle, New York, United States
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New York, New York, United States
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Olean, New York, United States
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Port Jefferson, New York, United States
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Smithtown, New York, United States
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The Bronx, New York, United States
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Cary, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Cornelius, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Forest City, North Carolina, United States
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Goldsboro, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Greenville, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Avon Lake, Ohio, United States
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Cincinnati, Ohio, United States
GSK Investigational Site
Cincinnati, Ohio, United States
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Cuyahoga Falls, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Warren, Ohio, United States
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Youngstown, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
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Milwaukie, Oregon, United States
GSK Investigational Site
Portland, Oregon, United States
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Colmar, Pennsylvania, United States
GSK Investigational Site
Doyletown, Pennsylvania, United States
GSK Investigational Site
Kingston, Pennsylvania, United States
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McKeesport, Pennsylvania, United States
GSK Investigational Site
Media, Pennsylvania, United States
GSK Investigational Site
Natrona Heights, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
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Reading, Pennsylvania, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Moncks Corner, South Carolina, United States
GSK Investigational Site
North Charleston, South Carolina, United States
GSK Investigational Site
Bristol, Tennessee, United States
GSK Investigational Site
Cordova, Tennessee, United States
GSK Investigational Site
Johnson City, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Madison, Tennessee, United States
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Murfreesboro, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
GSK Investigational Site
Bedford, Texas, United States
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Conroe, 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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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Humble, Texas, United States
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Irving, Texas, United States
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Kingwood, Texas, United States
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Nacogdoches, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Williston, Vermont, United States
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Arlington, Virginia, United States
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Ashburn, Virginia, United States
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Charlottesville, Virginia, United States
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Charlottesville, Virginia, United States
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Christiansburg, Virginia, United States
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Danville, Virginia, United States
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Falls Church, Virginia, United States
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Midlothian, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Portsmouth, Virginia, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellingham, Washington, United States
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Everett, Washington, United States
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Renton, 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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Charleston, West Virginia, United States
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Weirton, West Virginia, United States
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Mequion, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Racine, Wisconsin, United States
GSK Investigational Site
Waukesha, Wisconsin, United States
GSK Investigational Site
Wauwatosa, Wisconsin, United States
GSK Investigational Site
West Allis, Wisconsin, United States
Countries
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Study Documents
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Document Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Other Identifiers
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SCA40917
Identifier Type: -
Identifier Source: org_study_id
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