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Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

NCT ID: NCT00948818

Last Updated: 2013-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

803 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-08-31

Brief Summary

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The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome Characterized by Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Linaclotide

Linaclotide 290 micrograms

Group Type EXPERIMENTAL

Linaclotide 290 micrograms

Intervention Type DRUG

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type DRUG

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Interventions

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Linaclotide 290 micrograms

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Intervention Type DRUG

Matching placebo

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:

1. Relieved with defecation
2. Onset associated with a change in frequency of stool
3. Onset associated with a change in form (appearance) of stool
* Patient reports \< 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)
* Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms

Exclusion Criteria

* Patient has history of loose or watery stools for \>25% of BMs
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ironwood Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul F.C. Eng, PhD

Role: STUDY_DIRECTOR

Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Locations

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Forest Investigative Site 037

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 036

Birmingham, Alabama, United States

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Forest Investigative Site 135

Hueytown, Alabama, United States

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Forest Investigative Site 014

Huntsville, Alabama, United States

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Forest Investigative Site 080

Chandler, Arizona, United States

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Forest Investigative Site 053

Mesa, Arizona, United States

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Forest Investigative Site 078

Peoria, Arizona, United States

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Forest Investigative Site 101

Phoenix, Arizona, United States

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Forest Investigative Site 128

Phoenix, Arizona, United States

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Forest Investigative Site 051

Scottsdale, Arizona, United States

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Forest Investigative Site 136

Tucson, Arizona, United States

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Forest Investigative Site 087

Tucson, Arizona, United States

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Forest Investigative Site 094

Burbank, California, United States

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Forest Investigative Site 026

Encinitas, California, United States

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Forest Investigative Site 096

Foothill Ranch, California, United States

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Forest Investigative Site 057

Los Angeles, California, United States

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Forest Investigative Site 097

Mission Hills, California, United States

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Forest Investigative Site 005

Orange, California, United States

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Forest Investigative Site 024

Westlake Village, California, United States

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Forest Investigative Site 021

Boulder, Colorado, United States

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Forest Investigative Site 019

Colorado Springs, Colorado, United States

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Forest Investigative Site 034

Denver, Colorado, United States

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Forest Investigative Site 074

Longmont, Colorado, United States

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Forest Investigative Site 010

Wheat Ridge, Colorado, United States

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Forest Investigative Site 058

Waterbury, Connecticut, United States

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Forest Investigative Site 042

Boca Raton, Florida, United States

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Forest Investigative Site 003

Bradenton, Florida, United States

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Forest Investigative Site 137

Brandon, Florida, United States

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Forest Investigative Site 070

Brooksville, Florida, United States

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Forest Investigative Site 018

Fort Myers, Florida, United States

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Forest Investigative Site 030

Jupiter, Florida, United States

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Forest Investigative Site 077

Kissimmee, Florida, United States

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Forest Investigative Site 133

Miami, Florida, United States

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Forest Investigative Site 031

Miami, Florida, United States

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Forest Investigative Site 129

New Smyrna Beach, Florida, United States

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Forest Investigative Site 108

Ocala, Florida, United States

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Forest Investigative Site 092

Orlando, Florida, United States

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Forest Investigative Site 038

Panama City, Florida, United States

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Forest Investigative Site 027

Pembroke Pines, Florida, United States

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Forest Investigative Site 045

St. Petersburg, Florida, United States

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Forest Investigative Site 015

Tampa, Florida, United States

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Forest Investigative Site 104

Trinity, Florida, United States

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Forest Investigative Site 068

Zephyrhills, Florida, United States

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Forest Investigative Site 032

Atlanta, Georgia, United States

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Forest Investigative Site 103

Atlanta, Georgia, United States

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Forest Investigative Site 033

Marietta, Georgia, United States

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Forest Investigative Site 020

Marietta, Georgia, United States

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Forest Investigative Site 040

Woodstock, Georgia, United States

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Forest Investigative Site 055

Idaho Falls, Idaho, United States

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Forest Investigative Site 043

Rockford, Illinois, United States

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Forest Investigative Site 047

Evansville, Indiana, United States

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Forest Investigative Site 046

Iowa City, Iowa, United States

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Forest Investigative Site 029

Arkansas City, Kansas, United States

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Forest Investigative Site 009

Newton, Kansas, United States

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Forest Investigative Site 023

Wichita, Kansas, United States

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Forest Investigative Site 093

Wichita, Kansas, United States

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Forest Investigative Site 067

Lexington, Kentucky, United States

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Forest Investigative Site 114

Madisonville, Kentucky, United States

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Forest Investigative Site 132

Baton Rouge, Louisiana, United States

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Forest Investigative Site 124

Shreveport, Louisiana, United States

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Forest Investigative Site 013

Chevy Chase, Maryland, United States

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Forest Investigative Site 006

Hagerstown, Maryland, United States

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Forest Investigative Site 073

Lutherville, Maryland, United States

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Forest Investigative Site 001

Boston, Massachusetts, United States

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Forest Investigative Site 125

Kalamazoo, Michigan, United States

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Forest Investigative Site 064

Chaska, Minnesota, United States

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Forest Investigative Site 004

St Louis, Missouri, United States

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Forest Investigative Site 085

Vineland, New Jersey, United States

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Forest Investigative Site 052

Albuquerque, New Mexico, United States

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Forest Investigative Site 035

Brooklyn, New York, United States

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Forest Investigative Site 017

Great Neck, New York, United States

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Forest Investigative Site 011

Great Neck, New York, United States

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Forest Investigative Site 134

Setauket, New York, United States

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Forest Investigative Site 122

Boone, North Carolina, United States

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Forest Investigative Site 072

Fayetteville, North Carolina, United States

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Forest Investigative Site 016

Greensboro, North Carolina, United States

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Forest Investigative Site 119

Hickory, North Carolina, United States

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Forest Investigative Site 088

Raleigh, North Carolina, United States

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Forest Investigative Site 056

Wilmington, North Carolina, United States

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Forest Investigative Site 065

Winston-Salem, North Carolina, United States

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Forest Investigative Site 028

Cincinnati, Ohio, United States

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Forest Investigative Site 044

Cleveland, Ohio, United States

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Forest Investigative Site 123

Columbus, Ohio, United States

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Forest Investigative Site 130

Dayton, Ohio, United States

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Forest Investigative Site 082

Oklahoma City, Oklahoma, United States

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Forest Investigative Site 102

Tulsa, Oklahoma, United States

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Forest Investigative Site 039

Pittsburgh, Pennsylvania, United States

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Forest Investigative Site 121

Greenville, South Carolina, United States

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Forest Investigative Site 069

Greer, South Carolina, United States

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Forest Investigative Site 131

Greer, South Carolina, United States

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Forest Investigative Site 025

Nashville, Tennessee, United States

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Forest Investigative Site 099

Austin, Texas, United States

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Forest Investigative Site 002

Dallas, Texas, United States

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Forest Investigative Site 041

Houston, Texas, United States

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Forest Investigative Site 110

Houston, Texas, United States

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Forest Investigative Site 063

Lake Jackson, Texas, United States

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Forest Investigative Site 095

San Antonio, Texas, United States

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Forest Investigative Site 076

San Antonio, Texas, United States

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Forest Investigative Site 089

Salt Lake City, Utah, United States

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Forest Investigative Site 091

Salt Lake City, Utah, United States

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Forest Investigative Site 100

Salt Lake City, Utah, United States

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Forest Investigative Site 054

Charlottesville, Virginia, United States

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Forest Investigative Site 061

Christianburg, Virginia, United States

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Forest Investigative Site 007

Newport News, Virginia, United States

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Forest Investigative Site 060

Norfolk, Virginia, United States

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Forest Investigative Site 075

Norfolk, Virginia, United States

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Forest Investigative Site 050

Richmond, Virginia, United States

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Forest Investigative Site 049

Bellevue, Washington, United States

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Forest Investigative Site 098

Lakewood, Washington, United States

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Forest Investigative Site 066

Wenatchee, Washington, United States

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Forest Investigative Site 083

Milwaukee, Wisconsin, United States

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Forest Investigative Site 113

Greater Sudbury, Ontario, Canada

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Forest Investigative Site 107

Hamilton, Ontario, Canada

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Forest Investigative Site 112

Newmarket, Ontario, Canada

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Forest Investigative Site 106

Ottawa, Ontario, Canada

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Forest Investigative Site 115

Sarnia, Ontario, Canada

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Forest Investigative Site 008

Toronto, Ontario, Canada

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Forest Investigative Site 116

Toronto, Ontario, Canada

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Countries

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United States Canada

References

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Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.

Reference Type DERIVED
PMID: 24075889 (View on PubMed)

Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.

Reference Type DERIVED
PMID: 23116208 (View on PubMed)

Other Identifiers

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LIN-MD-31

Identifier Type: -

Identifier Source: org_study_id

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