JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab
NCT ID: NCT01070836
Last Updated: 2016-09-29
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
35895 participants
OBSERVATIONAL
2010-03-31
2015-11-30
Brief Summary
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The secondary objectives of this study are to: Estimate the incidence of PML in natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody positive, based on a meta-analysis of data obtained from this study and other data sources; Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program; Determine changes in anti-JCV antibody status over time.
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A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
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Clinical Disease Activity With Long Term Natalizumab Treatment
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JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)
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Detailed Description
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Conditions
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Study Groups
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natalizumab
US participants with relapsing MS receiving commercial natalizumab
natalizumab
Administered as specified in the treatment arm
Interventions
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natalizumab
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients receiving natalizumab and their prescribers must be enrolled in the TOUCH Prescribing Program.
* Patients with suspected or confirmed PML who are at or referred to a participating STRATIFY-2 site may enroll into STRATIFY-2 for purposes of PML sample collection.
Exclusion Criteria
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Cullman, Alabama, United States
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Tucaloosa, Alabama, United States
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Anchorage, Alaska, United States
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Flagstaff, Arizona, United States
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Gilbert, 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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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Fayetteville, Arkansas, United States
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Little Rock, Arkansas, United States
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Sherwood, Arkansas, United States
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Auburn, California, United States
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Berkeley, California, United States
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Carmel, California, United States
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Carmichael, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Loma Linda, California, United States
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Los Alamitos, 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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Marina del Rey, California, United States
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Modesto, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Palo Alto, California, United States
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Pasadena, California, United States
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Pasadena, California, United States
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Redding, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Barbara, California, United States
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St. Helena, California, United States
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Stanford, California, United States
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Stockton, California, United States
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Thousand Oaks, California, United States
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Tracy, California, United States
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Arvada, Colorado, United States
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Aurora, Colorado, United States
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Basalt, Colorado, United States
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Centennial, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Greeley, Colorado, United States
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Parker, Colorado, United States
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Pueblo, Colorado, United States
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Danbury, Connecticut, United States
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Derby, Connecticut, United States
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Fairfield, Connecticut, United States
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Hartford, Connecticut, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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New London, Connecticut, United States
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Norwich, Connecticut, United States
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Dover, Delaware, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Clearwater, Florida, United States
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Fort Lauderdale, 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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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Lighthouse PT, Florida, United States
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Maitland, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Palm Bay, Florida, United States
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Palm Beach Gardens, Florida, United States
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Pompano Beach, Florida, United States
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Ponte Vedra Beach, Florida, United States
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Port Charlotte, Florida, United States
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Sarasota, 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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Sunrise, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Winter Haven, Florida, United States
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Winter Park, Florida, United States
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Athens, Georgia, 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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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Johns Creek, Georgia, United States
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Macon, Georgia, United States
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Savannah, Georgia, United States
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Snellville, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Meridian, Idaho, United States
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Nampa, Idaho, United States
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Bloomington, Illinois, United States
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Bloomington, Illinois, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Elk Grove Village, Illinois, United States
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Elmhurst, Illinois, United States
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Evanston, Illinois, United States
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Flossmoor, Illinois, United States
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Herrin, Illinois, United States
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Lake Barrington, Illinois, United States
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Lombard, Illinois, United States
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Melrose Park, Illinois, United States
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Niles, Illinois, United States
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North Aurora, Illinois, United States
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Palos Heights, Illinois, United States
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Peoria, Illinois, United States
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St. Charles, Illinois, United States
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Anderson, Indiana, United States
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Bloomington, Indiana, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Merrillville, Indiana, United States
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Mishawaka, Indiana, United States
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Valparaiso, Indiana, United States
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Ames, Iowa, United States
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Des Moines, Iowa, United States
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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West Burlington, Iowa, United States
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Hays, Kansas, United States
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Kansas City, Kansas, United States
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Lenexa, Kansas, United States
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Overland Park, 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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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Paducah, Kentucky, United States
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Alexandria, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Lacombe, Louisiana, United States
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Lafayette, Louisiana, United States
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New Orleans, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Belfast, Maine, United States
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Lewiston, Maine, United States
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Scarborough, Maine, United States
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Westbrook, Maine, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Frederick, Maryland, United States
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Hagerstown, Maryland, United States
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Attleboro, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Brookline, Massachusetts, United States
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Burlington, Massachusetts, United States
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Milford, Massachusetts, United States
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Peabody, Massachusetts, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Bingham Farms, Michigan, United States
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Cinton Township, Michigan, United States
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Detroit, Michigan, United States
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Detroit, 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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Grand Rapids, Michigan, United States
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Kalamazoo, Michigan, United States
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Kalamazoo, Michigan, United States
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Midland, Michigan, United States
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Muskegon, Michigan, United States
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Rochester Hills, Michigan, United States
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Roseville, Michigan, United States
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Saginaw, Michigan, United States
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Southfield, Michigan, United States
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Traverse City, Michigan, United States
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West Bloomfield, Michigan, United States
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Woodhaven, Michigan, United States
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Golden Valley, Minnesota, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Greenwood, Mississippi, United States
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Hattiesburg, Mississippi, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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Nixa, 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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St Louis, Missouri, United States
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Washington, Missouri, United States
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Billings, Montana, United States
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Great Falls, Montana, United States
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Missoula, Montana, United States
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Hastings, Nebraska, United States
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Lincoln, Nebraska, United States
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Norfolk, Nebraska, United States
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North Platte, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Scottsbluff, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Reno, Nevada, United States
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Lebanon, New Hampshire, United States
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Bayonne, New Jersey, United States
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Denville, New Jersey, United States
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Edison, New Jersey, United States
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Flemington, New Jersey, United States
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Freehold, New Jersey, United States
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Lawrenceville, New Jersey, United States
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Livingston, New Jersey, United States
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New Brunswick, New Jersey, United States
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Newark, New Jersey, United States
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Paterson, New Jersey, United States
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Stratford, New Jersey, United States
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Teaneck, New Jersey, United States
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West Long Branch, 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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Albany, New York, United States
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Albany, New York, United States
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Amherst, New York, United States
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Bay Shore, New York, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Camillus, New York, United States
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Cedarhurst, New York, United States
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Corning, New York, United States
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East Meadow, New York, United States
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East Syracuse, New York, United States
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Flushing, New York, United States
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Fresh Meadows, New York, United States
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Great Neck, New York, United States
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Kingston, New York, United States
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Lake Success, New York, United States
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Latham, New York, United States
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Mineola, New York, United States
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Mount Kisco, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Newark, New York, United States
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Patchogue, New York, United States
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Plainview, New York, United States
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Poughkeepsie, New York, United States
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Rochester, New York, United States
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Rochester, New York, United States
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Rochester, New York, United States
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Rochester, New York, United States
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Rye Brook, New York, United States
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Schenectady, New York, United States
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Staten Island, New York, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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West Seneca, New York, United States
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White Plains, New York, United States
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Williamsville, New York, United States
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Woodmere, New York, United States
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Advance, North Carolina, United States
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Asheville, North Carolina, United States
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Boone, 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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Charlotte, 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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Durham, 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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Henderson, North Carolina, United States
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Hendersonville, North Carolina, United States
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High Point, North Carolina, United States
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Mooresville, North Carolina, United States
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Pinehurst, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, 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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Bismarck, North Dakota, United States
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Fargo, North Dakota, United States
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Grand Forks, North Dakota, United States
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Akron, Ohio, United States
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Bellevue, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Franklin, Ohio, United States
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Gahanna, Ohio, United States
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Newark, Ohio, United States
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Toledo, Ohio, United States
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Toledo, Ohio, United States
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Uniontown, Ohio, United States
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Youngstown, Ohio, United States
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Zanesville, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Clackamas, Oregon, United States
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Corvallis, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Roseburg, Oregon, United States
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Tulatin, Oregon, United States
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Abington, Pennsylvania, United States
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Allentown, Pennsylvania, United States
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Allentown, Pennsylvania, United States
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Altoona, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Brackenridge, Pennsylvania, United States
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Collegeville, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Greensburg, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Lititz, Pennsylvania, United States
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Meadowbrook, Pennsylvania, United States
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Monaca, Pennsylvania, United States
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Monroeville, Pennsylvania, United States
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Paoli, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Tarentum, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Washington, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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York, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Port Royal, South Carolina, United States
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Spartanburg, South Carolina, United States
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Spartanburg, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Bartlett, Tennessee, United States
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Chattanooga, Tennessee, United States
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Chattanooga, Tennessee, United States
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Columbia, Tennessee, United States
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Franklin, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Colleyville, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kerrville, Texas, United States
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Mansfield, Texas, United States
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Round Rock, 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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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Ivins, Utah, United States
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Provo, Utah, 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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Salt Lake City, Utah, United States
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Washington Terrace, Utah, United States
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Burlington, Vermont, United States
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Alexandria, Virginia, United States
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Alexandria, Virginia, United States
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Carrollton, Virginia, United States
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Centreville, Virginia, United States
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Charlottesville, Virginia, United States
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Christiansburg, Virginia, United States
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Fairfax, Virginia, United States
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Fredericksburg, Virginia, United States
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McLean, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Stafford, Virginia, United States
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Vienna, Virginia, United States
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Winchester, Virginia, United States
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Auburn, Washington, United States
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Bellingham, Washington, United States
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Burien, Washington, United States
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Federal Way, Washington, United States
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Kirkland, Washington, United States
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Mount Vernon, Washington, United States
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Renton, Washington, United States
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Richland, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Silverdale, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wenatchee, Washington, United States
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Huntington, West Virginia, United States
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Point Pleasant, West Virginia, United States
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Green Bay, Wisconsin, United States
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Green Bay, Wisconsin, United States
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La Crosse, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Neenah, Wisconsin, United States
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Waukesha, Wisconsin, United States
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Cheyenne, Wyoming, United States
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Arecibo, , Puerto Rico
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Bayamón, , Puerto Rico
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Guaynabo, , Puerto Rico
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Mayagüez, , Puerto Rico
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Ponce, , Puerto Rico
Countries
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Other Identifiers
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101JC402
Identifier Type: -
Identifier Source: org_study_id
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