Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
ACCESS 2008
AVINZA Control of Chronic Pain, Effectiveness and Safety Study (ACCESS 2008) A Multi-Center Study to Evaluate the Effectiveness and Tolerability of AVINZA for Chronic Moderate-Severe Pain: A Focus on Risk Minimization Assessment, Intervention and Outcomes
1 other identifier
interventional
1,570
2 countries
384
Brief Summary
The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Mar 2008
Shorter than P25 for phase_4 pain
384 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
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 13, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
February 15, 2010
CompletedJune 11, 2012
June 1, 2012
8 months
March 13, 2008
November 30, 2009
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)
Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3
Baseline (Week 0) to Visit 3 (Week 6)
Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)
Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4
Baseline (Week 0) to Visit 4 (Week 10)
Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)
Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study
Baseline (Week 0) to Visit 5 (Week 14 / End of Study)
Number of Subjects With Treatment Emergent Adverse Events
Adverse events that occur or worsen after the first dose of Avinza
Up to 4 months
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)
Risk level was determined by the investigator using the subject's SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score \<= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score \<= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score \>= 22; High Risk: SOAPP-R score \>= 22 with positive signals of aberrant behavior.
Visit 3 (Week 6)
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)
Risk level was determined by the investigator using the subject's SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score \<= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score \<= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score \>= 22; High Risk: SOAPP-R score \>= 22 with positive signals of aberrant behavior.
Visit 4 (Week 10)
Secondary Outcomes (3)
Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.
Up to 4 months
Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.
3 months post study
Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.
6 months post study
Study Arms (1)
1
EXPERIMENTALInterventions
30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.
Eligibility Criteria
You may qualify if:
- Patient is an adult (greater than or equal to 21 years old
- Patient has chronic (greater than or equal to 3 months) moderate-severe pain who, at the discretion of the Investigator, requires an around-the-clock opioid for optimal analgesia. Patients may be opioid naïve (not currently on an opioid) or opioid tolerant. Opioid naïve patients with a pain score of greater than or equal to 4 on an 11-point NRS (numerical rating scale. OR Opioid tolerant patients experiencing suboptimal response (i.e. pain score of greater than or equal to 4) or unacceptable side effects to sustained release opioids or short-acting opioids.
- Patient is able to read and understand English and comply with protocol requirements.
You may not qualify if:
- Hypersensitivity to morphine, morphine salts, or any components of AVINZA
- Respiratory depression (slowed breathing)
- Acute or severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD)
- Currently has or is suspected of having paralytic ileus
- Requires a daily dose of AVINZA greater than 1600mg/day
- Patient is abusing alcohol
- Pregnancy or breast feeding
- Currently taking AVINZA
- Patient unwilling to sign the Treatment Agreement
- Life expectancy is less than 2 months
- Migraine as the primary pain score
- Patient resides in a hospital or nursing home
- Patient has had more than 2 surgeries for low back pain
- Patient is anticipated to require major surgery or steroid injections for chronic pain over the next 12 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (384)
Unknown Facility
Adamsville, Alabama, 35005, United States
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Phoenix, Arizona, 85044, United States
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Scottsdale, Arizona, 85258, United States
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Sun City, Arizona, 85351, United States
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Sun Lakes, Arizona, 85248, United States
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Tucson, Arizona, 85705, United States
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Tucson, Arizona, 85712, United States
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Burlingame, California, 94010, United States
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Castro Valley, California, 94546, United States
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Fountain Valley, California, 92708, United States
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Hemet, California, 92543, United States
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Lakewood, California, 90712, United States
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Livermore, California, 94550, United States
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Los Gatos, California, 95032, United States
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Murrieta, California, 92562, United States
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Murrieta, California, 92563, United States
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Nevada City, California, 95959, United States
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Oakland, California, 94609, United States
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Rocklin, California, 95677, United States
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Sacramento, California, 95821, United States
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San Diego, California, 92108, United States
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San Francisco, California, 94115, United States
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West Hollywood, California, 90046, United States
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Whittier, California, 90602, United States
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Yuba City, California, 95993, United States
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Aurora, Colorado, 80012, United States
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Colorado Springs, Colorado, 80919, United States
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Denver, Colorado, 80220, United States
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Denver, Colorado, 80239, United States
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Fort Collins, Colorado, 80524, United States
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Fort Collins, Colorado, 80525, United States
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Northglenn, Colorado, 80234, United States
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Thornton, Colorado, 80229, United States
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Wheat Ridge, Colorado, 80003, United States
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Wheat Ridge, Colorado, 80033, United States
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Manchester, Connecticut, 06040, United States
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Milford, Connecticut, 06460, United States
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New Haven, Connecticut, 06511, United States
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North Haven, Connecticut, 06473, United States
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Norwich, Connecticut, 06360, United States
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Georgetown, Delaware, 19947, United States
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Milton, Delaware, 19968, United States
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Wilmington, Delaware, 19806, United States
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Wilmington, Delaware, 19808, United States
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Wilmington, Delaware, 19810, United States
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Apopka, Florida, 32703, United States
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Bradenton, Florida, 34205, United States
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Brandon, Florida, 33511, United States
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Cape Coral, Florida, 33990, United States
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Daytona Beach, Florida, 32117, United States
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DeLand, Florida, 32720, United States
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Delray Beach, Florida, 33484, United States
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Deltona, Florida, 32725, United States
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Dunnellon, Florida, 34432, United States
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Estero, Florida, 33928, United States
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Eustis, Florida, 32726, United States
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Loxahatchee Groves, Florida, 33470, United States
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Maitland, Florida, 32751, United States
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Margate, Florida, 33063, United States
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Miami, Florida, 33176, United States
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Mt. Dora, Florida, 32757, United States
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New Smyrna Beach, Florida, 32168, United States
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North Miami Beach, Florida, 33179, United States
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Oakland Park, Florida, 33308, United States
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Oldsmar, Florida, 34677, United States
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Orlando, Florida, 32804, United States
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Ormond Beach, Florida, 32174, United States
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Oviedo, Florida, 32765, United States
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Pembroke Pines, Florida, 33024, United States
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Port Richey, Florida, 34668, United States
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Royal Palm Beach, Florida, 33411, United States
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South Miami, Florida, 33143, United States
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Tampa, Florida, 33614, United States
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Tampa, Florida, 33619, United States
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Tampa, Florida, 33626, United States
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West Palm Beach, Florida, 33411, United States
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Augusta, Georgia, 30906, United States
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Augusta, Georgia, 30909, United States
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Cave Spring, Georgia, 30124, United States
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Conyers, Georgia, 30013, United States
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Covington, Georgia, 30016, United States
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Decatur, Georgia, 30034, United States
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Rome, Georgia, 30165, United States
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Statesboro, Georgia, 30458, United States
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Sugar Hill, Georgia, 30518, United States
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Rexburg, Idaho, 83440, United States
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Clinton, Illinois, 61727, United States
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Crestwood, Illinois, 60445, United States
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Creve Coeur, Illinois, 61610, United States
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Danville, Illinois, 61832, United States
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DeKalb, Illinois, 60115, United States
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Elmwood Park, Illinois, 60707, United States
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Flossmoor, Illinois, 60422, United States
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Gurnee, Illinois, 60031, United States
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Lockport, Illinois, 60491, United States
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Maryville, Illinois, 62062, United States
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Morton, Illinois, 61550, United States
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Naperville, Illinois, 60540, United States
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Oak Park, Illinois, 60304, United States
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Oak Park, Illinois, 60707, United States
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Pekin, Illinois, 61554, United States
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Peoria, Illinois, 61605, United States
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Peoria, Illinois, 61614, United States
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St. Charles, Illinois, 60175, United States
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Washington, Illinois, 61521, United States
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Washington, Illinois, 61571, United States
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Zion, Illinois, 60099, United States
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Anderson, Indiana, 46011, United States
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Anderson, Indiana, 46012, United States
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Anderson, Indiana, 46016, United States
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Evansville, Indiana, 47712, United States
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Franklin, Indiana, 46131, United States
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Highland, Indiana, 46322, United States
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Indianapolis, Indiana, 46237, United States
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La Porte, Indiana, 46350, United States
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Lawrenceburg, Indiana, 47025, United States
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Newburgh, Indiana, 47630, United States
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Rushville, Indiana, 46173, United States
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Seymour, Indiana, 47274, United States
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Whiteland, Indiana, 46184, United States
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Des Moines, Iowa, 50309, United States
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Le Claire, Iowa, 52753, United States
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Newton, Iowa, 50208, United States
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Kansas City, Kansas, 66106, United States
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Kansas City, Kansas, 66112, United States
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Kansas City, Kansas, 66172, United States
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Lansing, Kansas, 66043, United States
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Shawnee, Kansas, 66216, United States
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Florence, Kentucky, 41042, United States
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London, Kentucky, 40741, United States
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Louisville, Kentucky, 40258, United States
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Monticello, Kentucky, 42633, United States
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Russell Springs, Kentucky, 42642, United States
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Somerset, Kentucky, 42503, United States
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Baltimore, Maryland, 21208, United States
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Chester, Maryland, 21619, United States
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Havre de Grace, Maryland, 21078, United States
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Ocean City, Maryland, 21842, United States
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Brockton, Massachusetts, 02301, United States
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Springfield, Massachusetts, 11044, United States
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Bloomfield Hills, Michigan, 48302, United States
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Clarkston, Michigan, 48346, United States
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Clinton, Michigan, 49236, United States
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Dearborn, Michigan, 48126, United States
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Dearborn Heights, Michigan, 48127, United States
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Farmington Hills, Michigan, 48375, United States
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Grand Rapids, Michigan, 49546, United States
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Lansing, Michigan, 48906, United States
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Lansing, Michigan, 48910, United States
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Lansing, Michigan, 48911, United States
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Lansing, Michigan, 48917, United States
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Leslie, Michigan, 49251, United States
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Livonia, Michigan, 48152, United States
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Mason, Michigan, 48854, United States
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Muskegon, Michigan, 49441, United States
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Muskegon, Michigan, 49444, United States
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Northville, Michigan, 48167, United States
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Okemos, Michigan, 48664, United States
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Okemos, Michigan, 48864, United States
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Owosso, Michigan, 48867, United States
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Pigeon, Michigan, 48755, United States
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Rochester Hills, Michigan, 48306, United States
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Southgate, Michigan, 48195, United States
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Sterling Heights, Michigan, 48314, United States
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Troy, Michigan, 48085, United States
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Waterford, Michigan, 48328, United States
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Cold Spring, Minnesota, 56320, United States
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Ballwin, Missouri, 63011, United States
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Cape Girardeau, Missouri, 63701, United States
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Chesterfield, Missouri, 63017, United States
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Clinton, Missouri, 64735, United States
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Florissant, Missouri, 63031, United States
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Hazelwood, Missouri, 63043, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64112, United States
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Kansas City, Missouri, 64133, United States
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Kansas City, Missouri, 64151, United States
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Kansas City, Missouri, 64158, United States
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Mexico, Missouri, 65265, United States
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Mount Vernon, Missouri, 65712, United States
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Platte City, Missouri, 64079, United States
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Raymore, Missouri, 64083, United States
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Saint Charles, Missouri, 63301, United States
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Saint Joseph, Missouri, 64506, United States
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St Louis, Missouri, 63112, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63141, United States
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Warrenton, Missouri, 63383, United States
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Washington, Missouri, 63090, United States
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Weston, Missouri, 64098, United States
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Henderson, Nevada, 89015, United States
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Henderson, Nevada, 89074, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89128, United States
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Atco, New Jersey, 08004, United States
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Blackwood, New Jersey, 08012, United States
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Bloomfield, New Jersey, 07003, United States
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Brigantine, New Jersey, 08203, United States
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East Orange, New Jersey, 07018, United States
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Green Brook, New Jersey, 08812, United States
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Irvington, New Jersey, 07101, United States
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Irvington, New Jersey, 07111, United States
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Iselin, New Jersey, 08830, United States
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Jersey City, New Jersey, 07304, United States
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Jersey City, New Jersey, 07306, United States
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Kenilworth, New Jersey, 07033, United States
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Lakewood, New Jersey, 08701, United States
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Mays Landing, New Jersey, 08330, United States
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Millburn, New Jersey, 07041, United States
Unknown Facility
Millburn, New Jersey, 07083, United States
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Nutley, New Jersey, 07110, United States
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Scotch Plains, New Jersey, 08826, United States
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South Bound Brook, New Jersey, 08880, United States
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Totowa, New Jersey, 07512, United States
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Union, New Jersey, 07083, United States
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Wenonah, New Jersey, 08090, United States
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Westville, New Jersey, 08093, United States
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Brooklyn, New York, 11232, United States
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Glendale, New York, 11385, United States
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Kenmore, New York, 14217, United States
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Mayville, New York, 14757, United States
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New York, New York, 10019, United States
Unknown Facility
New York, New York, 10021, United States
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Orchard Park, New York, 14127, United States
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Port Jefferson Station, New York, 11776, United States
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Rochester, New York, 14615, United States
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Staten Island, New York, 10306, United States
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Staten Island, New York, 10308, United States
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Suffern, New York, 10901, United States
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Asheboro, North Carolina, 27203, United States
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Jacksonville, North Carolina, 28546, United States
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Raleigh, North Carolina, 27607, United States
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Raleigh, North Carolina, 27612, United States
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Akron, Ohio, 44304, United States
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Akron, Ohio, 44310, United States
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Ashtabula, Ohio, 44004, United States
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Bowling Green, Ohio, 43402, United States
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Canal Winchester, Ohio, 43110, United States
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Cincinnati, Ohio, 45236, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cuyahoga Falls, Ohio, 44223, United States
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Dayton, Ohio, 45410, United States
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Defiance, Ohio, 43512, United States
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Fairfield, Ohio, 45014, United States
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Fremont, Ohio, 43420, United States
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Gahanna, Ohio, 43230, United States
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Genoa, Ohio, 43430, United States
Unknown Facility
Hamilton, Ohio, 45013, United States
Unknown Facility
Hamilton, Ohio, 45015, United States
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Kent, Ohio, 44240, United States
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Kingston, Ohio, 45644, United States
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Lancaster, Ohio, 43130, United States
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Maumee, Ohio, 43537, United States
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New Lexington, Ohio, 43764, United States
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Perrysburg, Ohio, 43551, United States
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Pickerington, Ohio, 43147, United States
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Springboro, Ohio, 45066, United States
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Stow, Ohio, 44224, United States
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Toledo, Ohio, 43606, United States
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Toledo, Ohio, 43614, United States
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Toledo, Ohio, 43615, United States
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Toledo, Ohio, 43617, United States
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Toledo, Ohio, 43623, United States
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Warren, Ohio, 44483, United States
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Youngstown, Ohio, 44510, United States
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Youngstown, Ohio, 44514, United States
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Stillwater, Oklahoma, 74074, United States
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Estacada, Oregon, 97023, United States
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Eugene, Oregon, 97401, United States
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Lake Oswego, Oregon, 97035, United States
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Milwaukie, Oregon, 97222, United States
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Oregon City, Oregon, 97045, United States
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Portland, Oregon, 97202, United States
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Portland, Oregon, 97213, United States
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Portland, Oregon, 97220, United States
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Salem, Oregon, 97301, United States
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Tualatin, Oregon, 97062, United States
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Aliquippa, Pennsylvania, 15001, United States
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Archbald, Pennsylvania, 18403, United States
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Aston Mills, Pennsylvania, 19014, United States
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Avoca, Pennsylvania, 18641, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Bensalem, Pennsylvania, 19020, United States
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Carbondale, Pennsylvania, 18407, United States
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Chicora, Pennsylvania, 16025, United States
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Clarks Summit, Pennsylvania, 18411, United States
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Collegeville, Pennsylvania, 19426, United States
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Conneaut Lake, Pennsylvania, 16316, United States
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Cowansville, Pennsylvania, 16218, United States
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Downingtown, Pennsylvania, 19335, United States
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Doylestown, Pennsylvania, 18901, United States
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Drexel Hill, Pennsylvania, 19026, United States
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Drums, Pennsylvania, 18222, United States
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Dublin, Pennsylvania, 18917, United States
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Elizabeth, Pennsylvania, 15037, United States
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Elkins Park, Pennsylvania, 19027, United States
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Ford City, Pennsylvania, 16226, United States
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Greensburg, Pennsylvania, 15601, United States
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Honesdale, Pennsylvania, 18431, United States
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King of Prussia, Pennsylvania, 19406, United States
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Levittown, Pennsylvania, 19055, United States
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McKeesport, Pennsylvania, 15131, United States
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Montrose, Pennsylvania, 18801, United States
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Moon Township, Pennsylvania, 15108, United States
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Morrisville, Pennsylvania, 19067, United States
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Mount Pleasant, Pennsylvania, 15666, United States
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New Castle, Pennsylvania, 16101, United States
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New Wilmington, Pennsylvania, 16142, United States
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Norristown, Pennsylvania, 19401, United States
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Philadelphia, Pennsylvania, 19124, United States
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Philadelphia, Pennsylvania, 19128, United States
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Philadelphia, Pennsylvania, 19134, United States
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Philadelphia, Pennsylvania, 19145, United States
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Philadelphia, Pennsylvania, 19147, United States
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Philadelphia, Pennsylvania, 19148, United States
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Philadelphia, Pennsylvania, 19152, United States
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Phoenixville, Pennsylvania, 19460, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Pittsburgh, Pennsylvania, 15226, United States
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Pittsburgh, Pennsylvania, 15236, United States
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Pittsburgh, Pennsylvania, 15239, United States
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Royersford, Pennsylvania, 19468, United States
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Scranton, Pennsylvania, 18508, United States
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Scranton, Pennsylvania, 18510, United States
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Shippensburg, Pennsylvania, 17257, United States
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Southampton, Pennsylvania, 18966, United States
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Springfield, Pennsylvania, 19064, United States
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Stoneboro, Pennsylvania, 16193, United States
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Union City, Pennsylvania, 16438, United States
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Warminster, Pennsylvania, 18974, United States
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Wilkes-Barre, Pennsylvania, 18702, United States
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Yardley, Pennsylvania, 19067, United States
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Camden, South Carolina, 29020, United States
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Charleston, South Carolina, 29414, United States
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Charleston, South Carolina, 29464, United States
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Columbia, South Carolina, 29219, United States
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Greer, South Carolina, 29651, United States
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Marion, South Carolina, 28571, United States
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Marion, South Carolina, 29571, United States
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West Columbia, South Carolina, 29169, United States
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Ashland City, Tennessee, 37015, United States
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Collierville, Tennessee, 38017, United States
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Dyersburg, Tennessee, 38024, United States
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Hendersonville, Tennessee, 37075, United States
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Hermitage, Tennessee, 37076, United States
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Lebanon, Tennessee, 37087, United States
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McKenzie, Tennessee, 38201, United States
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Memphis, Tennessee, 38122, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37220, United States
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Newport, Tennessee, 37821, United States
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Springfield, Tennessee, 37172, United States
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Sweetwater, Tennessee, 37874, United States
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Woodbury, Tennessee, 37190, United States
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Arlington, Texas, 76012, United States
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Fort Worth, Texas, 76104, United States
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Irving, Texas, 75061, United States
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Rusk, Texas, 75785, United States
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Southlake, Texas, 76092, United States
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Layton, Utah, 84041, United States
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Layton, Utah, 94041, United States
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South Jordan, Utah, 84095, United States
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West Jordan, Utah, 84088, United States
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West Valley City, Utah, 84120, United States
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Annandale, Virginia, 22003, United States
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Ashburn, Virginia, 20147, United States
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Fairfax, Virginia, 22030, United States
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Fairfax, Virginia, 22033, United States
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Falls Church, Virginia, 22046, United States
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Lynchburg, Virginia, 24501, United States
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Reston, Virginia, 20190, United States
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Edmonds, Washington, 98020, United States
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Marysville, Washington, 98270, United States
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Olympia, Washington, 98506, United States
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Seattle, Washington, 98107, United States
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Huntington, West Virginia, 25705, United States
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Milwaukee, Wisconsin, 53208, United States
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Milwaukee, Wisconsin, 53216, United States
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Carolina, 00986, Puerto Rico
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Cidra, 00739, Puerto Rico
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Hato Rey, 00917, Puerto Rico
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Juncos, 00777, Puerto Rico
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Ponce, 00717, Puerto Rico
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San Juan, 00926, Puerto Rico
Related Publications (11)
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PMID: 27782769DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professional Information Services
- Organization
- King Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Sherry Siegel, MD
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2008
First Posted
March 20, 2008
Study Start
March 1, 2008
Primary Completion
November 1, 2008
Study Completion
December 1, 2008
Last Updated
June 11, 2012
Results First Posted
February 15, 2010
Record last verified: 2012-06