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A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)

NCT ID: NCT00094367

Last Updated: 2010-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-10-31

Brief Summary

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This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.

Detailed Description

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A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.

Conditions

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HIV Infection

Keywords

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1592U89 GR109714 abacavir lamivudine fixed-dose combination once-daily twice-daily HIV infection naive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Abacavir/Lamivudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have HIV-1 infection.
* Had not received any prior HIV treatment for more than 14 days.
* At least 1000 copies of HIV-1 RNA.
* Willing to provide signed informed consent.

Exclusion Criteria

* Enrolled in other investigational drug studies.
* Female subjects who are pregnant or breastfeeding.
* History of allergy or hypersensitivity to abacavir or lamivudine.
* Certain medical conditions that would make subjects ineligible.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, PharmD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Montgomery, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Arleta, California, United States

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Beverly Hills, California, United States

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Beverly Hills, California, United States

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Fresno, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Oakland, California, United States

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Oakland, California, United States

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Palm Springs, California, United States

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Panorama City, California, United States

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Paramount, California, United States

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Riverside, California, United States

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Salinas, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Santa Rosa, California, United States

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Tarzana, California, United States

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Tarzana, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Glastonbury, Connecticut, United States

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New Haven, Connecticut, United States

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Norwalk, Connecticut, United States

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Stamford, Connecticut, United States

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Stratford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Coral Gables, Florida, United States

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Coral Springs, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Inmokalee, Florida, United States

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Key West, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Pampano, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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Pompano Beach, Florida, United States

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Port Saint Lucie, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Austell, Georgia, United States

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Columbus, Georgia, United States

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Decatur, Georgia, United States

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Lawrenceville, Georgia, United States

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Riverdale, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Elgin, Illinois, United States

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Joliet, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Henderson, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Clinton, Maryland, United States

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Silver Spring, Maryland, United States

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Lowell, Massachusetts, United States

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Springfield, Massachusetts, United States

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Berkeley, Michigan, United States

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Grand Rapids, Michigan, United States

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Lansing, Michigan, United States

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Saint Louis, Michigan, United States

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Chesterfield, Missouri, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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East Orange, New Jersey, United States

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Englewood, New Jersey, United States

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Galloway, New Jersey, United States

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Hoboken, New Jersey, United States

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Jersey City, New Jersey, United States

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Jersey City, New Jersey, United States

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Newark, New Jersey, United States

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Newark, New Jersey, United States

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Newark, New Jersey, United States

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Somers Point, New Jersey, United States

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Westfield, New Jersey, United States

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Santa Fe, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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Manhasset, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Huntersville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Danville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Greenville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Annandale, Virginia, United States

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Fairfax, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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101822

Identifier Type: -

Identifier Source: org_study_id