Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

NCT ID: NCT00067457

Last Updated: 2015-04-16

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

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Detailed Description

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Conditions

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Irritable Colon Irritable Bowel Syndrome (IBS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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alosetron

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
* Failed conventional therapy.
* Willing to make daily calls on a touch-tone telephone.

Exclusion Criteria

* History of or current chronic or severe constipation.
* Bloody diarrhea, abdominal pain with rectal bleeding.
* Thrombophlebitis.
* Abnormal thyroid stimulating hormone (TSH) value.
* Alcohol and/or substance abuse within past two years.
* Pregnant or lactating.
* History/treatment of malignancy within past five years.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Pell City, Alabama, United States

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Tallassee, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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North Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Carlsbad, California, United States

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Concord, California, United States

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Encinitas, California, United States

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Fresno, California, United States

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Garden Grove, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Roseville, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, 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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San Francisco, California, United States

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Santa Ana, California, United States

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Spring Valley, California, United States

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Torrance, California, United States

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Van Nuys, California, United States

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Centennial, Colorado, United States

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Colorado Springs, Colorado, United States

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Littleton, Colorado, United States

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Longmont, Colorado, United States

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Bristol, Connecticut, United States

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Belleair Bluffs, Florida, United States

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Boca Raton, Florida, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Melbourne, Florida, United States

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North Miami Beach, Florida, United States

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Spring Hill, Florida, United States

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Stuart, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Blue Ridge, Georgia, United States

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Dunwoody, Georgia, United States

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Fayetteville, Georgia, United States

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Rome, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Coeur d'Alene, Idaho, United States

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Meridian, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Libertyville, Illinois, United States

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Moline, Illinois, United States

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Morton Grove, Illinois, United States

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Oakbrook Terrace, Illinois, United States

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Peoria, Illinois, United States

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Rockford, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Jeffersonville, Indiana, United States

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Clive, Iowa, United States

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Haysville, Kansas, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Florence, Kentucky, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Madisonville, Kentucky, United States

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Covington, Louisiana, United States

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Lafayette, Louisiana, United States

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Monroe, Louisiana, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Annapolis, Maryland, United States

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Lanham, Maryland, United States

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Oxon Hill, Maryland, United States

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Severna Park, Maryland, United States

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Silver Spring, Maryland, United States

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Towson, Maryland, United States

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Towson, Maryland, United States

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Wheaton, Maryland, United States

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Burlington, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Northville, Michigan, United States

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Petoskey, Michigan, United States

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Saginaw, Michigan, United States

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Brooklyn Center, Minnesota, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Blackwood, New Jersey, United States

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Cedar Knolls, New Jersey, United States

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Oakhurst, New Jersey, United States

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Passaic, New Jersey, United States

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South Bound Brook, New Jersey, United States

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Willingboro, New Jersey, United States

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Albuquerque, New Mexico, United States

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Pomona, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Gastonia, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bellbrook, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Wandsworth, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Bensalem, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Feasterville, Pennsylvania, United States

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Levittown, Pennsylvania, United States

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Media, Pennsylvania, United States

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Morrisville, Pennsylvania, United States

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Penndel, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Stoneboro, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Summerville, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Bristol, Tennessee, United States

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Clarksville, Tennessee, United States

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Jackson, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Conroe, Texas, United States

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Humble, Texas, United States

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North Richland Hills, Texas, United States

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Pasadena, Texas, United States

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Sugar Land, Texas, United States

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The Woodlands, Texas, United States

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Salt Lake City, Utah, United States

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Chesapeake, Virginia, United States

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Danville, Virginia, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Weber City, Virginia, United States

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Bellevue, Washington, United States

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Gig Harbor, Washington, United States

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Lacey, Washington, United States

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Tacoma, Washington, United States

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La Crosse, Wisconsin, United States

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Madison, Wisconsin, United States

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Nedlands, Western Australia, Australia

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Countries

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United States Australia

Other Identifiers

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S3B30048

Identifier Type: -

Identifier Source: org_study_id

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