JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab
STRATIFY-2
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2
1 other identifier
observational
35,895
2 countries
478
Brief Summary
The primary objective of this study is to demonstrate that the incidence of progressive multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in participants who have detectable antibodies to JCV (antibody positive). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Longer than P75 for all trials
478 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
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedSeptember 29, 2016
September 1, 2016
5.7 years
February 17, 2010
September 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate that the incidence of PML in natalizumab-treated participants who do not have detectable antibodies to JC virus (JCV) (antibody negative) is lower than in patents who have detectable antibodies to JCV (antibody positive)
Up to 4 years
Secondary Outcomes (3)
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
Up to 4 years
Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program
Up to 4 years
Determine changes in anti-JCV antibody status over time
Up to 4 years
Study Arms (1)
natalizumab
US participants with relapsing MS receiving commercial natalizumab
Interventions
Administered as specified in the treatment arm
Eligibility Criteria
US participants with relapsing MS receiving commercial natalizumab.
You may qualify if:
- Relapsing MS patients receiving commercial natalizumab
- 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.
You may not qualify if:
- \- Patients may participate in any other clinical trial or study sponsored by Biogen Idec ; however, if the anti-JCV antibody test is included in the other clinical study and that study is performing a longitudinal analysis of those samples, the patient should withdraw from STRATIFY-2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (478)
Research Site
Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35233, United States
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Cullman, Alabama, 35058, United States
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Tucaloosa, Alabama, 35406, United States
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Anchorage, Alaska, 99508, United States
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Flagstaff, Arizona, 86001, United States
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Gilbert, Arizona, 85234, United States
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Phoenix, Arizona, 85004, United States
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Phoenix, Arizona, 85013, United States
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Phoenix, Arizona, 85018, United States
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Phoenix, Arizona, 85032, United States
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Scottsdale, Arizona, 85258, United States
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Tucson, Arizona, 85718, United States
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Tucson, Arizona, 85741, United States
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Fayetteville, Arkansas, 72703, United States
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Little Rock, Arkansas, 72205, United States
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Sherwood, Arkansas, 72120, United States
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Auburn, California, 95602, United States
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Berkeley, California, 94705, United States
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Carmel, California, 93923, United States
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Carmichael, California, 95608, United States
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Fountain Valley, California, 92708, United States
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Fresno, California, 93701, United States
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Fresno, California, 93720, United States
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Fullerton, California, 92835, United States
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La Jolla, California, 92037, United States
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Loma Linda, California, 92354, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90033, United States
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Los Angeles, California, 90073, United States
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Marina del Rey, California, 90292, United States
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Modesto, California, 95355, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91328, United States
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Palo Alto, California, 94301, United States
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Pasadena, California, 91101, United States
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Pasadena, California, 91105, United States
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Redding, California, 96001, United States
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Sacramento, California, 95816, United States
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San Diego, California, 82117, United States
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San Francisco, California, 94109, United States
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San Francisco, California, 94115, United States
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San Francisco, California, 94117, United States
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Santa Barbara, California, 93105, United States
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St. Helena, California, 94574, United States
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Stanford, California, 94305, United States
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Stockton, California, 95204, United States
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Thousand Oaks, California, 91360, United States
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Tracy, California, 95376, United States
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Arvada, Colorado, 80002, United States
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Aurora, Colorado, 80045, United States
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Basalt, Colorado, 81621, United States
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Centennial, Colorado, 80112, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80920, United States
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Denver, Colorado, 80205, United States
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Fort Collins, Colorado, 80525, United States
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Fort Collins, Colorado, 80528, United States
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Greeley, Colorado, 80631, United States
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Parker, Colorado, 80138, United States
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Pueblo, Colorado, 81004, United States
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Danbury, Connecticut, 06810, United States
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Derby, Connecticut, 06418, United States
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Fairfield, Connecticut, 06824, United States
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Hartford, Connecticut, 06105, United States
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Hartford, Connecticut, 06112, United States
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New Haven, Connecticut, 06510, United States
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New London, Connecticut, 06320, United States
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Norwich, Connecticut, 06360, United States
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Dover, Delaware, 19901, United States
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Newark, Delaware, 19713, United States
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Washington D.C., District of Columbia, 20007, United States
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Washington D.C., District of Columbia, 20037, United States
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Bradenton, Florida, 34205, United States
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Clearwater, Florida, 33756, United States
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Fort Lauderdale, Florida, 33308, United States
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Fort Walton Beach, Florida, 32547, United States
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Gainesville, Florida, 32607, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32209, United States
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Jacksonville Beach, Florida, 32250, United States
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Lighthouse PT, Florida, 33064, United States
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Maitland, Florida, 32751, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33133, United States
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Miami, Florida, 33136, United States
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Naples, Florida, 34102, United States
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Ocala, Florida, 34471, United States
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Orange Park, Florida, 32073, United States
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Orlando, Florida, 32806, United States
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Ormond Beach, Florida, 32174, United States
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Palm Bay, Florida, 32905, United States
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Palm Beach Gardens, Florida, 33410, United States
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Pompano Beach, Florida, 33060, United States
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Ponte Vedra Beach, Florida, 32082, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34239, United States
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Sarasota, Florida, 34243, United States
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St. Petersburg, Florida, 33705, United States
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St. Petersburg, Florida, 33713, United States
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Sunrise, Florida, 33351, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33609, United States
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Tampa, Florida, 33612, United States
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Vero Beach, Florida, 32960, United States
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Winter Haven, Florida, 33880, United States
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Winter Park, Florida, 32792, United States
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Athens, Georgia, 30606, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30312, United States
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Atlanta, Georgia, 30322, United States
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Atlanta, Georgia, 30327, United States
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Columbus, Georgia, 31909, United States
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Johns Creek, Georgia, 30097, United States
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Macon, Georgia, 31210, United States
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Savannah, Georgia, 31406, United States
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Snellville, Georgia, 30078, United States
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Honolulu, Hawaii, 96813, United States
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Boise, Idaho, 83706, United States
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Idaho Falls, Idaho, 83404, United States
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Meridian, Idaho, 83642, United States
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Nampa, Idaho, 83687, United States
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Bloomington, Illinois, 61701, United States
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Bloomington, Illinois, 61704, United States
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Champaign, Illinois, 61820, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60616, United States
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Chicago, Illinois, 60637, United States
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Elk Grove Village, Illinois, 60007, United States
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Elmhurst, Illinois, 60126, United States
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Evanston, Illinois, 60201, United States
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Flossmoor, Illinois, 60422, United States
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Herrin, Illinois, 62948, United States
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Lake Barrington, Illinois, 60010, United States
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Lombard, Illinois, 60148, United States
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Melrose Park, Illinois, 60160, United States
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Niles, Illinois, 60714, United States
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North Aurora, Illinois, 60542, United States
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Palos Heights, Illinois, 60463, United States
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Peoria, Illinois, 61606, United States
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St. Charles, Illinois, 60175, United States
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Anderson, Indiana, 46016, United States
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Bloomington, Indiana, 47403, United States
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Elkhart, Indiana, 46514, United States
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Evansville, Indiana, 47715, United States
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Fort Wayne, Indiana, 76845, United States
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Indianapolis, Indiana, 46256, United States
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Indianapolis, Indiana, 46260, United States
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Lafayette, Indiana, 47905, United States
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Merrillville, Indiana, 46410, United States
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Mishawaka, Indiana, 46545, United States
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Valparaiso, Indiana, 46383, United States
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Ames, Iowa, 80010, United States
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Des Moines, Iowa, 50309, United States
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Des Moines, Iowa, 50314, United States
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Iowa City, Iowa, 52242, United States
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West Burlington, Iowa, 52655, United States
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Hays, Kansas, 67601, United States
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Kansas City, Kansas, 66160, United States
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Lenexa, Kansas, 66214, United States
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Overland Park, Kansas, 66212, United States
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Topeka, Kansas, 66606, United States
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Wichita, Kansas, 67206, United States
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Wichita, Kansas, 67208, United States
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Wichita, Kansas, 67214, United States
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Lexington, Kentucky, 40513, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40207, United States
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Paducah, Kentucky, 42003, United States
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Alexandria, Louisiana, 71301, United States
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Baton Rouge, Louisiana, 70809, United States
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Baton Rouge, Louisiana, 70810, United States
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Lacombe, Louisiana, 70445, United States
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Lafayette, Louisiana, 70506, United States
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New Orleans, Louisiana, 70112, United States
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New Orleans, Louisiana, 70115, United States
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Shreveport, Louisiana, 71103, United States
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Belfast, Maine, 04915, United States
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Lewiston, Maine, 04240, United States
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Scarborough, Maine, 04074, United States
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Westbrook, Maine, 04092, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21287, United States
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Bethesda, Maryland, 20814, United States
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Frederick, Maryland, 21702, United States
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Hagerstown, Maryland, 21742, United States
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Attleboro, Massachusetts, 02703, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02135, United States
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Boston, Massachusetts, 02215, United States
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Brookline, Massachusetts, 02445, United States
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Burlington, Massachusetts, 01805, United States
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Milford, Massachusetts, 01757, United States
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Peabody, Massachusetts, 01960, United States
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Springfield, Massachusetts, 01104, United States
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Worcester, Massachusetts, 01605, United States
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Ann Arbor, Michigan, 48109, United States
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Bingham Farms, Michigan, 48025, United States
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Cinton Township, Michigan, 48035, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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East Lansing, Michigan, 48824, United States
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Farmington Hills, Michigan, 48334, United States
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Grand Rapids, Michigan, 49525, United States
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Kalamazoo, Michigan, 49007, United States
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Kalamazoo, Michigan, 49048, United States
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Midland, Michigan, 48640, United States
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Muskegon, Michigan, 49444, United States
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Rochester Hills, Michigan, 48307, United States
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Roseville, Michigan, 48066, United States
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Saginaw, Michigan, 48604, United States
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Southfield, Michigan, 48034, United States
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Traverse City, Michigan, 49684, United States
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West Bloomfield, Michigan, 48322, United States
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Woodhaven, Michigan, 48183, United States
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Golden Valley, Minnesota, 55422, United States
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Minneapolis, Minnesota, 55404, United States
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Minneapolis, Minnesota, 55414, United States
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Rochester, Minnesota, 55905, United States
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Greenwood, Mississippi, 38930, United States
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Hattiesburg, Mississippi, 39401, United States
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Tupelo, Mississippi, 38801, United States
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Kansas City, Missouri, 64111, United States
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Nixa, Missouri, 65714, United States
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Springfield, Missouri, 65807, United States
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St Louis, Missouri, 63104, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63131, United States
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St Louis, Missouri, 63141, United States
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Washington, Missouri, 63090, United States
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Billings, Montana, 59101, United States
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Great Falls, Montana, 59405, United States
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Missoula, Montana, 59802, United States
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Hastings, Nebraska, 68901, United States
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Lincoln, Nebraska, 68521, United States
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Norfolk, Nebraska, 68701, United States
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North Platte, Nebraska, 69101, United States
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Omaha, Nebraska, 68131, United States
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Omaha, Nebraska, 68198, United States
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Scottsbluff, Nebraska, 69361, United States
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Las Vegas, Nevada, 89102, United States
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Reno, Nevada, 89502, United States
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Reno, Nevada, 89509, United States
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Lebanon, New Hampshire, 03766, United States
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Bayonne, New Jersey, 07002, United States
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Denville, New Jersey, 07834, United States
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Edison, New Jersey, 08820, United States
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Flemington, New Jersey, 08822, United States
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Freehold, New Jersey, 07728, United States
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Lawrenceville, New Jersey, 08648, United States
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Livingston, New Jersey, 07039, United States
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New Brunswick, New Jersey, 08901, United States
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Newark, New Jersey, 07103, United States
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Paterson, New Jersey, 07503, United States
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Stratford, New Jersey, 08084, United States
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Teaneck, New Jersey, 07666, United States
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West Long Branch, New Jersey, 07764, United States
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Albuquerque, New Mexico, 87106, United States
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Albany, New York, 12205, United States
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Albany, New York, 12206, United States
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Albany, New York, 12208, United States
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Amherst, New York, 14226, United States
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Bay Shore, New York, 11706, United States
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Brooklyn, New York, 11215, United States
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Brooklyn, New York, 11219, United States
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Brooklyn, New York, 11220, United States
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Buffalo, New York, 14203, United States
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Camillus, New York, 13031, United States
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Cedarhurst, New York, 11516, United States
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Corning, New York, 14830, United States
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East Meadow, New York, 11554, United States
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East Syracuse, New York, 13057, United States
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Flushing, New York, 11365, United States
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Fresh Meadows, New York, 11365, United States
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Great Neck, New York, 11021, United States
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Kingston, New York, 12401, United States
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Lake Success, New York, 11042, United States
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Latham, New York, 12110, United States
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Mineola, New York, 11501, United States
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Mount Kisco, New York, 10549, United States
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New Hyde Park, New York, 11040, United States
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New York, New York, 10016, United States
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New York, New York, 10019, United States
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New York, New York, 10022, United States
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New York, New York, 10029, United States
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New York, New York, 10065, United States
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Newark, New York, 14513, United States
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Patchogue, New York, 11772, United States
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Plainview, New York, 11803, United States
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Poughkeepsie, New York, 12601, United States
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Rochester, New York, 14608, United States
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Rochester, New York, 14623, United States
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Rochester, New York, 14626, United States
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Rochester, New York, 14642, United States
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Rye Brook, New York, 10573, United States
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Schenectady, New York, 12308, United States
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Staten Island, New York, 10306, United States
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Stony Brook, New York, 11794, United States
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Syracuse, New York, 13210, United States
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West Seneca, New York, 14224, United States
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White Plains, New York, 10604, United States
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Williamsville, New York, 14221, United States
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Woodmere, New York, 11598, United States
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Advance, North Carolina, 27006, United States
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Asheville, North Carolina, 28806, United States
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Boone, North Carolina, 28607, United States
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Chapel Hill, North Carolina, 27599, United States
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Charlotte, North Carolina, 28203, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, 28207, United States
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Concord, North Carolina, 28025, United States
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Durham, North Carolina, 37710, United States
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Greensboro, North Carolina, 27405, United States
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Greenville, North Carolina, 27834, United States
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Henderson, North Carolina, 27536, United States
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Hendersonville, North Carolina, 28792, United States
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High Point, North Carolina, 27262, United States
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Mooresville, North Carolina, 28117, United States
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Pinehurst, North Carolina, 28374, United States
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Raleigh, North Carolina, 27607, United States
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Salisbury, North Carolina, 28144, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Bismarck, North Dakota, 58501, United States
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Fargo, North Dakota, 58103, United States
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Grand Forks, North Dakota, 58201, United States
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Akron, Ohio, 44320, United States
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Bellevue, Ohio, 44811, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44119, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Columbus, Ohio, 43221, United States
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Dayton, Ohio, 45417, United States
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Franklin, Ohio, 45005, United States
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Gahanna, Ohio, 43230, United States
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Newark, Ohio, 43055, United States
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Toledo, Ohio, 43617, United States
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Toledo, Ohio, 43623, United States
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Uniontown, Ohio, 44685, United States
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Youngstown, Ohio, 44504, United States
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Zanesville, Ohio, 43701, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74137, United States
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Bend, Oregon, 97701, United States
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Clackamas, Oregon, 97015, United States
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Corvallis, Oregon, 97330, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97225, United States
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Portland, Oregon, 97239, United States
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Roseburg, Oregon, 97471, United States
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Tulatin, Oregon, 97034, United States
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Abington, Pennsylvania, 19001, United States
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Allentown, Pennsylvania, 18103, United States
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Allentown, Pennsylvania, 18104, United States
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Altoona, Pennsylvania, 16602, United States
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Bethlehem, Pennsylvania, 18015, United States
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Brackenridge, Pennsylvania, 15014, United States
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Collegeville, Pennsylvania, 19426, United States
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Danville, Pennsylvania, 17822, United States
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Duncansville, Pennsylvania, 16635, United States
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Erie, Pennsylvania, 16507, United States
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Greensburg, Pennsylvania, 15601, United States
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Harrisburg, Pennsylvania, 17111, United States
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Hershey, Pennsylvania, 17033, United States
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Johnstown, Pennsylvania, 15904, United States
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Lititz, Pennsylvania, 17543, United States
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Meadowbrook, Pennsylvania, 19046, United States
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Monaca, Pennsylvania, 15061, United States
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Monroeville, Pennsylvania, 15146, United States
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Paoli, Pennsylvania, 19301, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19124, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Sellersville, Pennsylvania, 18960, United States
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Tarentum, Pennsylvania, 15084, United States
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Upland, Pennsylvania, 19013, United States
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Washington, Pennsylvania, 15301, United States
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West Reading, Pennsylvania, 19611, United States
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York, Pennsylvania, 17402, United States
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East Providence, Rhode Island, 02914, United States
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Providence, Rhode Island, 02903, United States
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Columbia, South Carolina, 29203, United States
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Greenville, South Carolina, 29605, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Port Royal, South Carolina, 29935, United States
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Spartanburg, South Carolina, 29302, United States
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Spartanburg, South Carolina, 29307, United States
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Sioux Falls, South Dakota, 57104, United States
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Sioux Falls, South Dakota, 57105, United States
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Bartlett, Tennessee, 38134, United States
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Chattanooga, Tennessee, 37403, United States
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Chattanooga, Tennessee, 37404, United States
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Columbia, Tennessee, 38401, United States
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Franklin, Tennessee, 37064, United States
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Knoxville, Tennessee, 37923, United States
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Knoxville, Tennessee, 37934, United States
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Nashville, Tennessee, 37205, United States
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Nashville, Tennessee, 73215, United States
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Amarillo, Texas, 79106, United States
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Arlington, Texas, 76012, United States
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Austin, Texas, 78705, United States
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Bedford, Texas, 76021, United States
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Colleyville, Texas, 76034, United States
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Dallas, Texas, 75214, United States
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Dallas, Texas, 75243, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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Kerrville, Texas, 78028, United States
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Mansfield, Texas, 76063, United States
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Round Rock, Texas, 78681, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78231, United States
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San Antonio, Texas, 78258, United States
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Wichita Falls, Texas, 79301, United States
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Ivins, Utah, 84738, United States
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Provo, Utah, 84604, United States
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Salt Lake City, Utah, 84103, United States
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Salt Lake City, Utah, 84108, United States
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Salt Lake City, Utah, 84124, United States
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Washington Terrace, Utah, 84405, United States
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Burlington, Vermont, 05401, United States
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Alexandria, Virginia, 22304, United States
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Alexandria, Virginia, 22310, United States
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Carrollton, Virginia, 23314, United States
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Centreville, Virginia, 20120, United States
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Charlottesville, Virginia, 22903, United States
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Christiansburg, Virginia, 24073, United States
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Fairfax, Virginia, 22031, United States
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Fredericksburg, Virginia, 22401, United States
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McLean, Virginia, 22101, United States
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Newport News, Virginia, 23601, United States
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Norfolk, Virginia, 23502, United States
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Norfolk, Virginia, 23507, United States
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Richmond, Virginia, 23226, United States
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Roanoke, Virginia, 24018, United States
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Stafford, Virginia, 22556, United States
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Vienna, Virginia, 22182, United States
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Winchester, Virginia, 22601, United States
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Auburn, Washington, 98001, United States
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Bellingham, Washington, 98225, United States
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Burien, Washington, 98166, United States
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Federal Way, Washington, 98003, United States
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Kirkland, Washington, 98034, United States
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Mount Vernon, Washington, 98274, United States
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Renton, Washington, 98055, United States
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Richland, Washington, 99352, United States
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Seattle, Washington, 98101, United States
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Seattle, Washington, 98122, United States
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Seattle, Washington, 98195, United States
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Silverdale, Washington, 98383, United States
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Spokane, Washington, 99202, United States
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Spokane, Washington, 99204, United States
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Spokane, Washington, 99208, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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Huntington, West Virginia, 25702, United States
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Point Pleasant, West Virginia, 25550, United States
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Green Bay, Wisconsin, 54301, United States
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Green Bay, Wisconsin, 54308, United States
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La Crosse, Wisconsin, 54601, United States
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Madison, Wisconsin, 53715, United States
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Milwaukee, Wisconsin, 53215, United States
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Milwaukee, Wisconsin, 53226, United States
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Neenah, Wisconsin, 54956, United States
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Waukesha, Wisconsin, 53188, United States
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Cheyenne, Wyoming, 82001, United States
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Arecibo, 00612, Puerto Rico
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Bayamón, 00961, Puerto Rico
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Guaynabo, 00968, Puerto Rico
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Mayagüez, 00680, Puerto Rico
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Ponce, 00717, Puerto Rico
Biospecimen
Plasma, Serum, Urine, Whole Blood, Peripheral blood mononuclear cell (PBMC)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 18, 2010
Study Start
March 1, 2010
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
September 29, 2016
Record last verified: 2016-09