TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
Early Access of TMC114 in Combination With Low-dose Ritonavir (TMC/r)) and Other Antiretrovirals (ARVs) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to no Treatment Options.
2 other identifiers
expanded_access
N/A
22 countries
394
Brief Summary
The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
394 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
First Submitted
Initial submission to the registry
October 27, 2005
CompletedFirst Posted
Study publicly available on registry
October 28, 2005
CompletedApril 11, 2014
April 1, 2014
October 27, 2005
April 10, 2014
Conditions
Keywords
Interventions
600/100 mg tablets of TMC114/rtv BID until commercial available to the subject
Eligibility Criteria
You may qualify if:
- Patient with documented HIV-1 infection
- has limited or no treatment options due to virological failure or intolerance to multiple antiretroviral regimens
- is at least 3 class experienced and has previously received 2 different protease inhibitor-based regimens
- has a CD4 cell count \<= 200 cells/mm3
- is not achieving adequate virologic suppression on his/her current regimen and is at risk of clinical or immunologic progression.
You may not qualify if:
- Patient has primary HIV-1 infection (unless documented resistance to all currently approved protease inhibitors participated or is currently participating in a trial with TMC114
- Patient used investigational medication within the last 30 days (except for abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations, and tipranavir)
- Patient suffers from any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or has evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels, or has grade 3 or 4 laboratory abnormalities as defined by National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) grading scheme
- Female patients that are pregnant or breast-feeding, or of childbearing potential without using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (394)
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Baldwin Park, California, United States
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Beverly Hills, California, United States
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Carmichael, California, United States
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Fontana, California, United States
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Fountain Valley, California, United States
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French Camp, California, United States
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Glendale, California, United States
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Harbor City, California, United States
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Hayward, California, United States
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Loma Linda, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angles, California, United States
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Newport Beach, California, United States
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Oakland, California, United States
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Palm Springs, California, United States
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Palo Alto, California, United States
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Panorama City, California, United States
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Paramount, California, United States
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Richmond, California, United States
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Salinas, California, United States
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San Diego, California, United States
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San Diego, La Jolla, California, United States
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San Francisco, California, United States
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San Mateo, California, United States
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San Rafael, California, United States
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Santa Ana, California, United States
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Santa Clara, California, United States
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Santa Clarita, California, United States
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Santa Rosa, California, United States
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Stanford, California, United States
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Sunnyvale, California, United States
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Tarzana, California, United States
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Ukiah, California, United States
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West Hollywood, California, United States
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Woodland Hills, California, United States
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Denver, Colorado, United States
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Glastonbury, Connecticut, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Norwalk, Connecticut, United States
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Norwich, Connecticut, United States
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Stanford, Connecticut, United States
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Vernon Rockville, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Brandon, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Laudersale, Florida, United States
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Fort Myers, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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LaBelle, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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North Miami Beach, Florida, United States
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North Palm Beach, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Port Saint Lucie, Florida, United States
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Safety Harbor, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Austell, Georgia, United States
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Decatur, Georgia, United States
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Jesup, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Riverdale, Georgia, United States
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Tucker, Georgia, United States
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Honolulu, Hawaii, United States
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Kahului, Hawaii, United States
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Kapaa, Hawaii, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Granite City, Illinois, United States
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Joliet, Illinois, United States
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Rockford, Illinois, United States
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Round Lake Beach, Illinois, United States
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Springfield, Illinois, United States
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Topeka, Kansas, United States
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Henderson, Kentucky, United States
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Paducah, Kentucky, United States
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New Orleans, Louisiana, United States
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Bangor, Maine, United States
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Lewiston, Maine, United States
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Monmouth, Maine, United States
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Portland, Maine, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Elkton, Maryland, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Cambridge, Massachusetts, United States
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Springfield, Massachusetts, United States
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Berkley, Michigan, United States
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Detroit, Michigan, United States
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Grosse Pointe Woods, Michigan, United States
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Marquette, Michigan, United States
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Minneapolis, Minnesota, United States
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Greenwood, Mississippi, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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East Orange, New Jersey, United States
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Galloway, New Jersey, United States
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Hackensack, New Jersey, United States
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Hamilton, New Jersey, United States
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Hoboken, New Jersey, United States
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Jersey City, New Jersey, United States
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Long Branch, New Jersey, United States
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Maplewood, New Jersey, United States
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Neptune City, New Jersey, United States
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Newark, New Jersey, United States
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Perth Amboy, New Jersey, United States
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Somers Point, New Jersey, United States
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Voorhees Township, New Jersey, United States
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West Orange, New Jersey, United States
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Westfield, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Briarcliff, New York, United States
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Bronxville, New York, United States
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Brooklyn, New York, United States
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Flushing, New York, United States
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Harris, New York, United States
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Manhasset, New York, United States
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Mount Vernon, 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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Syracuse, New York, United States
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The Bronx, New York, United States
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Valhalla, New York, United States
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Yonkers, New York, United States
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Asheville, North Carolina, United States
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Chapel Hill, 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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Huntersville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Easton, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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West Columbia, South Carolina, United States
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Hermitage, Tennessee, United States
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Johnson City, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Bryan, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Galveston, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Lackland City, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, United States
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Annandale, Virginia, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Hampton, 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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Seattle, Washington, United States
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Eau Claire, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Antwerp, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Yvoir, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Whitby, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Rouyn-Noranda, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Vancouver, Canada
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Vancouver British, Canada
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Prague, Czechia
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Aalborg, Denmark
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Aarhus, Denmark
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Copenhagen, Denmark
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Hvidovre, Denmark
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Odense, Denmark
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Aachen, Germany
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Berlin, Germany
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Bochum, Germany
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Bonn, Germany
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Bremen, Germany
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Chemnitz, Germany
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Cologne, Germany
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Dortmund, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Giessen, Germany
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Hamburg, Germany
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Hanover, Germany
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Kiel, Germany
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Koblenz, Germany
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Konstanz, Germany
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Kÿln, Germany
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Leipzig, Germany
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Mainz, Germany
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Mannheim, Germany
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Munich, Germany
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München, Germany
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Münster, Germany
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Nuremberg, Germany
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Osnabrück, Germany
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Regensburg, Germany
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Saarbrücken, Germany
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Salzgitter, Germany
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Stuttgart, Germany
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Wuppertal, Germany
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Würzburg, Germany
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Athens, Greece
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Piraeus, Greece
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Thessalonikis, Greece
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Budapest, Hungary
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Luxembourg, Luxembourg
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Ipoh, Malaysia
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Kuala Lumpur, Malaysia
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Pulau Pinang, Malaysia
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Col Tacuba, Mexico
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Guadalajara, Mexico
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Mex Ctity, Mexico
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Mexico City, Mexico
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México, Mexico
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Monterrey Nuevo León, Mexico
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Oaxaca City, Mexico
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Puebla City, Mexico
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Veracruz, Mexico
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Eindhoven, Netherlands
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Enschede, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Ponce Pr, Puerto Rico
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Rio Piedras Pr, Puerto Rico
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San Juan, Puerto Rico
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Kazan', Russia
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Krasnodar, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Novosibirsk Region, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Smolensk, Russia
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Tver', Russia
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Volgograd, Russia
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Voronezh, Russia
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Yekaterinburg, Russia
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Ljubljana, Slovenia
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A Coruña, Spain
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Alicante, Spain
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Badajoz, Spain
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Barakaldo Vizcaya S/N, Spain
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Barcelona, Spain
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Bilbao, Spain
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Calella (Barcelona), Spain
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Castellon, Spain
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Cáceres, Spain
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Córdoba, Spain
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Cuenca, Spain
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Donostia Guipuzcoa, Spain
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El Palmar Murcia N/A, Spain
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Elche, Spain
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Figueres, Spain
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Fuenlabrada, Spain
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Gijon Asturias, Spain
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Girona, Spain
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Granada, Spain
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Guadalajara, Spain
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Huelva, Spain
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Huesca, Spain
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Ibiza Town, Spain
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Jérez, Spain
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Las Palmas de Gran Canaria, Spain
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León, Spain
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Lleida, Spain
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Logroño, Spain
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Madrid, Spain
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Manresa, Spain
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Maó, Spain
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Málaga, Spain
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Murcia, Spain
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Oviedo, Spain
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Palma de Mallorca, Spain
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Palma de Mallorca Illes Balear, Spain
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Pamplona, Spain
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Puerto Real, Spain
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Sabadell, Spain
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Salamanca, Spain
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San Cristóbal de La Laguna, Spain
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Santa Cruz de Tenerife, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Tarragona, Spain
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Terrassa, Spain
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Valencia, Spain
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Valladolid, Spain
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Vic, Spain
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Vigo, Spain
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Villafranca Del Penedes, Spain
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Vitoria-Gasteiz, Spain
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Vizcaya N/A, Spain
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Zamora, Spain
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Zaragoza, Spain
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Gothenburg, Sweden
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Linköping, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Aarau, Switzerland
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Basel, Switzerland
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Bern, Switzerland
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Bruderholz, Switzerland
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Chur, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Lugano, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Zurich Zh, Switzerland
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Kaohsiung City, Taiwan
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Kaohsiung County, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Caracas, Venezuela
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2005
First Posted
October 28, 2005
Last Updated
April 11, 2014
Record last verified: 2014-04