Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3876 participants
INTERVENTIONAL
2005-02-28
2015-11-30
Brief Summary
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Detailed Description
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The IRIS trial will test a new treatment strategy based on evidence linking insulin resistance to increased risk for stroke and other vascular diseases. Insulin resistance is a condition in which insulin, a normal human hormone, does not work effectively because the body is resistant to its effects. This condition can lead to diabetes and is thought to cause blood vessel disease, including stroke and heart attack, in patients with and without diabetes.
Insulin resistance affects up to 50% of stroke patients and is effectively modified with thiazolidinedione (TZD) drugs used to treat type 2 diabetes. In addition to reducing insulin resistance, these drugs have other favorable effects on blood vessels, reduce blood vessel inflammation, and potentially prevent atherosclerosis. Currently marketed TZDs include rosiglitazone and pioglitazone.
The IRIS is a clinical trial that will enroll 3936 subjects at approximately 170 hospitals in Australia, Canada, Germany, Israel, Italy, the United Kingdom (UK) and the US. After an initial screening blood test, each participant will be randomly assigned to take either pioglitazone or placebo tablets. Recruitment will be completed during 2005-2012, and all participants will be followed for a minimum of 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pioglitazone
pioglitazone
pioglitazone
a thiazolidinedione drug
Placebo
inactive substance
placebo
an inactive substance
Interventions
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pioglitazone
a thiazolidinedione drug
placebo
an inactive substance
Eligibility Criteria
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Inclusion Criteria
2. Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization
3. Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity (HOMA).
4. Both ability and willingness to provide informed consent.
Exclusion Criteria
1. Severely disabling stroke as indicated by an inability to participate in scheduled follow-up activities.
2. Persons whose ischemic stroke or TIA was related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation.
3. Diabetes mellitus as defined by recent use of medication for diabetes as an out-patient (\*see note below) or two fasting plasma blood sugars \> 126 mg/dL.
4. HgbA1c \> 7.0%.
5. Irreversible medical conditions likely to affect short-term survival or ability to participate in the study protocol. These include:
* Cancer or other chronic disease with poor prognosis (predicted survival of less than four years).
* Severe neurologic or psychiatric disease that would complicate the evaluation of study outcomes (e.g., dementia or schizophrenia).
6. History of intolerance to any thiazolidinedione.
7. Pregnancy or desire to become pregnant.
8. Oral contraceptive use.
9. Ongoing use of oral corticosteroids.
10. History of heart failure
11. Active liver disease as defined by known liver disease accompanied by cirrhosis, significant cholestasis, portal hypertension, hepatic encephalopathy, hepatic synthetic dysfunction, or expected significant loss of liver function over the course of the study.
12. History of bladder cancer.
13. Current participation in a conflicting clinical trial. A conflicting clinical trial is defined as a trial with any of following:
* Intervention that is known to affect the incidence of stroke or myocardial infarction.
* Intervention that is an experimental drug.
* Outcome that includes stroke or myocardial infarction.
* Exclusion for participation in another trial.
Temporary Exclusions Persons with temporary exclusions may be enrolled as soon as the exclusion has resolved.
1. Alanine aminotransferase (ALT) \>2.5 times the upper limit of normal.
2. Hemoglobin \<8.5 g/dl.
3. Moderate or severe pitting edema of the feet or legs (IRIS grade 3 or 4).
4. Carotid surgery or carotid stenting procedure scheduled (delay randomization until 2 weeks following procedure).
40 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Takeda Pharmaceuticals North America, Inc.
INDUSTRY
Yale University
OTHER
Responsible Party
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Principal Investigators
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Walter N. Kernan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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University of Alabama
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Shanti Clinical Trials (NINDS-CRC site)
Colton, California, United States
UCSF-Fresno
Fresno, California, United States
Scripps Clinic
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California-Davis
Sacramento, California, United States
University of California
San Diego, California, United States
University of California
San Francisco, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Hartford
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
University of Florida
Jacksonville, Florida, United States
MIMA Century Research Associates
Melbourne, Florida, United States
Pines Neurological Associates (NINDS-CRC site)
Pembroke Pines, Florida, United States
Floria Neurovascular Institute
Tampa, Florida, United States
Cook County (Stroger) Hospital
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Ingalls Memorial Hospital (NINDS-CRC site)
Harvey, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Tri-City Neruology (NINDS-CRC site)
Saint Charles, Illinois, United States
Indiana Medical Research
Elkhart, Indiana, United States
Associates In Neurology (NINDS-CRC site)
Valparaiso, Indiana, United States
Iowa Health Des Moines Clinical Trials Office
Des Moines, Iowa, United States
Ruan Neuroscience Center/Mercy Medical Center
Des Moines, Iowa, United States
University of Iowa
Iowa City, Iowa, United States
Northeast Iowa Medical Education Foundation (NINDS-CRC site)
Waterloo, Iowa, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
University of Kentucky Research Foundation
Lexington, Kentucky, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Penobscot Bay Neurology
Rockport, Maine, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Minneapolis Clinic of Neurology
Robbinsdale, Minnesota, United States
Hattiesburg Clinic (NINDS-CRC site)
Hattiesburg, Mississippi, United States
St. Luke's Brain and Stroke Institute
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
Advanced Neurology Specialists
Great Falls, Montana, United States
University of Nebraska
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Kessler Medical Rehab Research Corp
West Orange, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Albany Medical Center
Albany, New York, United States
SUNY Downstate
Brooklyn, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
SUNY Buffalo
Buffalo, New York, United States
St. Vincent's Hospital Manhattan
New York, New York, United States
Cornell University
New York, New York, United States
University of Rochester
Rochester, New York, United States
Southtowns Neurology of WNY (NINDS-CRC site)
West Seneca, New York, United States
Burke Medical Research Institute
White Plains, New York, United States
Clinical Research of Winston-Salem
Winston-Salem, North Carolina, United States
Guilford Neurologic Associates
Winston-Salem, North Carolina, United States
Altru Health System
Grand Forks, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lankenau Institute for Medical Research
Bryn Mawr, Pennsylvania, United States
Penn Stat-Hershey Medical Center (NINDS-CRC site)
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Tennessee
Memphis, Tennessee, United States
Vanderbilt
Nashville, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
University of Texas, Southwestern
Dallas, Texas, United States
Methodist Neurological Institute
Houston, Texas, United States
University of Texas
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Medical Group
Norfolk, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Flinders Medical Centre
Bedford Park, New South Wales, Australia
Royal Prince Alfred
Camperstown, New South Wales, Australia
John Hunter Hospital (University of Newcastle)
New Lambton Heights, New South Wales, Australia
Box Hill Hospital (Eastern Health)
Box Hill, Victoria, Australia
Western Hospital (University of Melbourne)
Footscray, Victoria, Australia
Austin Health (National Stroke Research Institute)
Heidelberg Heights, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Royal Perth
Perth, Western Australia, Australia
University of Alberta
Edmonton, Alberta, Canada
Center for Neurologic Research
Lethbridge, Alberta, Canada
Vancouver Island Health Research Centre
Victoria, British Columbia, Canada
Robarts Research Institute
London, Ontario, Canada
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
Intermountain Research Consultants
Thunder Bay, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Hôpital Charles LeMoyne
Greenfield Park, Quebec, Canada
McGill-Montreal General
Montreal, Quebec, Canada
McGill-Jewish General
Montreal, Quebec, Canada
Centre Hospitalier Affilie Universitaire de Quebec
Québec, Quebec, Canada
CHUM-Centre de recherche, Hôpital Notre-Dame
Montreal, , Canada
Klinikum Altenburger Land
Altenburg, , Germany
Neurologische Klinik
Bad Neustadt an der Saale, , Germany
University Hospital-Dresden
Dresden, , Germany
University Duesseldorf/Heinrich-Heine University
Düsseldorf, , Germany
University of Erlangen
Erlangen, , Germany
Alfried Krupp Hospital
Essen, , Germany
University Hospital Frankfurt
Frankfurt, , Germany
Freiburg University
Freiburg im Breisgau, , Germany
Ernst-Moritz-Arndt-University Greifswald
Greifswald, , Germany
Martin-Luther-Universitaet Halle-Wittenberg
Halle, , Germany
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
University Heidelberg
Heidelberg, , Germany
Friedrich Schiller-University Jena
Jena, , Germany
University Hospital Mainz
Mainz, , Germany
Klinikum der Universitat Muenchen
Munich, , Germany
University Hospital Muenster
Münster, , Germany
University of Ulm
Ulm, , Germany
Soroka Medical Center
Beersheba, , Israel
B'nai Zion Medical Center
Haifa, , Israel
Bnai-Zion Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Rabin Medical Center-Golda Campus
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Medical Center
Tel Aviv, , Israel
Genoa University Hospital
Genoa, , Italy
University of Laquila
Laquila, , Italy
University Vita Salute San Raffaele
Milan, , Italy
IRCCS FONdazione Istituto Neurologico C. Mondino
Pavia, , Italy
University of Perugia
Perugia, , Italy
University of Rome (S. Andrea Hospital)
Roma, , Italy
University of Rome La Sapienza
Rome, , Italy
Sacred Heart Catholic University
Rome, , Italy
Jazzolino Hospital
Vibo Valentia, , Italy
University of Puerto Rico
San Juan, , Puerto Rico
Royal Bournemouth
Bournemouth, Dorset, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, Kent, United Kingdom
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom
Wansbeck General Hospital
Ashington, Northumberland, United Kingdom
Stobhill Hospital
Glasgow, Scotland, United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
Southern General Hospital
Glasgow, Scotland, United Kingdom
Queen Elizabeth Hospital Gateshead
Gateshead, Tyne and Wear, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Monklands Hospital
Airdrie, , United Kingdom
William Harvey Hospital
Ashford, , United Kingdom
Royal United Hospital
Bath, , United Kingdom
Addenbrookes Foundation NHS Trust (Cambridge)
Cambridge, , United Kingdom
Countess of Chester Foundation Trust
Cheshire, , United Kingdom
Dewsbury District Hospital
Dewsbury, , United Kingdom
Southend University Hospital
Essex, , United Kingdom
Devon PCT
Exeter, , United Kingdom
Royal Devon and Exeter
Exeter, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Calderdale Royal Hospital
Halifax, , United Kingdom
The Royal Liverpool and Broadgreen University Hospitals
Liverpool, , United Kingdom
University Hospital Aintree
Liverpool, , United Kingdom
Kings College London
London, , United Kingdom
Saint Georges University of London
London, , United Kingdom
Luton and Dubstable Hospital
Luton, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Newcastle upon Tyne
Newcastle upon Tyne, , United Kingdom
Torbay Hospital (South Devon Healthcare NHS Foundation Trust)
Torquay, , United Kingdom
North Tyneside General Hospital
Tyne and Wear, , United Kingdom
Countries
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References
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Viscoli CM, Brass LM, Carolei A, Conwit R, Ford GA, Furie KL, Gorman M, Guarino PD, Inzucchi SE, Lovejoy AM, Parsons MW, Peduzzi PN, Ringleb PA, Schwartz GG, Spence JD, Tanne D, Young LH, Kernan WN; IRIS Trial investigators. Pioglitazone for secondary prevention after ischemic stroke and transient ischemic attack: rationale and design of the Insulin Resistance Intervention after Stroke Trial. Am Heart J. 2014 Dec;168(6):823-9.e6. doi: 10.1016/j.ahj.2014.07.016. Epub 2014 Jul 28.
Kernan WN, Viscoli CM, Demarco D, Mendes B, Shrauger K, Schindler JL, McVeety JC, Sicklick A, Moalli D, Greco P, Bravata DM, Eisen S, Resor L, Sena K, Story D, Brass LM, Furie KL, Gutmann L, Hinnau E, Gorman M, Lovejoy AM, Inzucchi SE, Young LH, Horwitz RI; IRIS Trial Investigators. Boosting enrollment in neurology trials with Local Identification and Outreach Networks (LIONs). Neurology. 2009 Apr 14;72(15):1345-51. doi: 10.1212/WNL.0b013e3181a0fda3.
Kernan W, Viscoli C, Brass L, Amatangelo M, Birch A, Clark W, Conwit R, Furie K, Gorman M, Pesapane B, Kleindorfer D, Lovejoy A, Osborne J, Silliman S, Zweifler R, Horwitz R. Boosting enrolment in clinical trials: validation of a regional network model. Clin Trials. 2011 Oct;8(5):645-53. doi: 10.1177/1740774511414925. Epub 2011 Aug 8.
Ridha M, Zhang C, McCullough S, Viscoli CM, Sharma R, Kamel H, Merkler AE. Silent Myocardial Infarction and Risk of Stroke Recurrence: A Post Hoc Analysis of the IRIS Trial. J Am Heart Assoc. 2025 Feb 18;14(4):e037663. doi: 10.1161/JAHA.124.037663. Epub 2025 Feb 8.
Spence JD, Viscoli CM, Inzucchi SE, Dearborn-Tomazos J, Ford GA, Gorman M, Furie KL, Lovejoy AM, Young LH, Kernan WN; IRIS Investigators. Pioglitazone Therapy in Patients With Stroke and Prediabetes: A Post Hoc Analysis of the IRIS Randomized Clinical Trial. JAMA Neurol. 2019 May 1;76(5):526-535. doi: 10.1001/jamaneurol.2019.0079.
Young LH, Viscoli CM, Schwartz GG, Inzucchi SE, Curtis JP, Gorman MJ, Furie KL, Conwit R, Spatz ES, Lovejoy A, Abbott JD, Jacoby DL, Kolansky DM, Ling FS, Pfau SE, Kernan WN; IRIS Investigators. Heart Failure After Ischemic Stroke or Transient Ischemic Attack in Insulin-Resistant Patients Without Diabetes Mellitus Treated With Pioglitazone. Circulation. 2018 Sep 18;138(12):1210-1220. doi: 10.1161/CIRCULATIONAHA.118.034763.
Yaghi S, Furie KL, Viscoli CM, Kamel H, Gorman M, Dearborn J, Young LH, Inzucchi SE, Lovejoy AM, Kasner SE, Conwit R, Kernan WN; IRIS Trial Investigators. Pioglitazone Prevents Stroke in Patients With a Recent Transient Ischemic Attack or Ischemic Stroke: A Planned Secondary Analysis of the IRIS Trial (Insulin Resistance Intervention After Stroke). Circulation. 2018 Jan 30;137(5):455-463. doi: 10.1161/CIRCULATIONAHA.117.030458. Epub 2017 Oct 30.
Kernan WN, Viscoli CM, Dearborn JL, Kent DM, Conwit R, Fayad P, Furie KL, Gorman M, Guarino PD, Inzucchi SE, Stuart A, Young LH; Insulin Resistance Intervention After Stroke (IRIS) Trial Investigators. Targeting Pioglitazone Hydrochloride Therapy After Stroke or Transient Ischemic Attack According to Pretreatment Risk for Stroke or Myocardial Infarction. JAMA Neurol. 2017 Nov 1;74(11):1319-1327. doi: 10.1001/jamaneurol.2017.2136.
Stuart AC, Sico JJ, Viscoli CM, Tayal AH, Inzucchi SE, Ford GA, Furie KL, Cote R, Spence JD, Tanne D, Kernan WN. Taking care of volunteers in a stroke trial: a new assisted-management strategy. Stroke Vasc Neurol. 2016 Oct 25;1(3):108-114. doi: 10.1136/svn-2016-000029. eCollection 2016 Sep.
Furie KL, Viscoli CM, Gorman M, Ford GA, Young LH, Inzucchi SE, Guarino PD, Lovejoy AM, Conwit R, Tanne D, Kernan WN; IRIS Trial Investigators. Effects of pioglitazone on cognitive function in patients with a recent ischaemic stroke or TIA: a report from the IRIS trial. J Neurol Neurosurg Psychiatry. 2018 Jan;89(1):21-27. doi: 10.1136/jnnp-2017-316361. Epub 2017 Sep 22.
Young LH, Viscoli CM, Curtis JP, Inzucchi SE, Schwartz GG, Lovejoy AM, Furie KL, Gorman MJ, Conwit R, Abbott JD, Jacoby DL, Kolansky DM, Pfau SE, Ling FS, Kernan WN; IRIS Investigators. Cardiac Outcomes After Ischemic Stroke or Transient Ischemic Attack: Effects of Pioglitazone in Patients With Insulin Resistance Without Diabetes Mellitus. Circulation. 2017 May 16;135(20):1882-1893. doi: 10.1161/CIRCULATIONAHA.116.024863. Epub 2017 Feb 28.
Viscoli CM, Inzucchi SE, Young LH, Insogna KL, Conwit R, Furie KL, Gorman M, Kelly MA, Lovejoy AM, Kernan WN; IRIS Trial Investigators. Pioglitazone and Risk for Bone Fracture: Safety Data From a Randomized Clinical Trial. J Clin Endocrinol Metab. 2017 Mar 1;102(3):914-922. doi: 10.1210/jc.2016-3237.
Inzucchi SE, Viscoli CM, Young LH, Furie KL, Gorman M, Lovejoy AM, Dagogo-Jack S, Ismail-Beigi F, Korytkowski MT, Pratley RE, Schwartz GG, Kernan WN; IRIS Trial Investigators. Pioglitazone Prevents Diabetes in Patients With Insulin Resistance and Cerebrovascular Disease. Diabetes Care. 2016 Oct;39(10):1684-92. doi: 10.2337/dc16-0798. Epub 2016 Jul 27.
Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP Jr, Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O'Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR; IRIS Trial Investigators. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Apr 7;374(14):1321-31. doi: 10.1056/NEJMoa1506930. Epub 2016 Feb 17.
Kernan WN, Inzucchi SE. Metabolic rehabilitation: science gathers to support a new intervention to prevent stroke. Stroke. 2011 Dec;42(12):3333-5. doi: 10.1161/STROKEAHA.111.632489. Epub 2011 Oct 13. No abstract available.
Other Identifiers
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0201013034
Identifier Type: -
Identifier Source: org_study_id
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