Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)

NCT ID: NCT06272487

Last Updated: 2025-10-01

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-12-19

Brief Summary

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The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.

Detailed Description

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Conditions

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High Cardiovascular Risk Hypertension

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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Zilebesiran

Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.

Group Type EXPERIMENTAL

Zilebesiran

Intervention Type DRUG

Zilebesiran administered by subcutaneous (SC) injection

Placebo

Participants will receive placebo on Day 1 of the 6-month DB treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered by SC injection

Interventions

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Zilebesiran

Zilebesiran administered by subcutaneous (SC) injection

Intervention Type DRUG

Placebo

Placebo administered by SC injection

Intervention Type DRUG

Other Intervention Names

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ALN-AGT01

Eligibility Criteria

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Inclusion Criteria

* History of cardiovascular (CV) disease, high CV risk, or estimated glomerular filtration rate (eGFR) ≥30 to \<60 mL/min/1.73m\^2
* Mean seated office SBP ≥140 mmHg and ≤170 mmHg
* 24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM
* Must be on stable therapy with 2 to 4 classes of antihypertensive medications

Exclusion Criteria

* Secondary hypertension
* Orthostatic hypotension
* Proteinuria \>3 g/day
* Serum potassium \>4.8 milliequivalents per liter (mEq/L)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Clinical Trial Site

Alexander City, Alabama, United States

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Daphne, Alabama, United States

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Foley, Alabama, United States

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Huntsville, Alabama, United States

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Huntsville, Alabama, United States

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Montgomery, Alabama, United States

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Beverly Hills, California, United States

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Covina, California, United States

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Encinitas, California, United States

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Garden Grove, California, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Northridge, California, United States

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Pasadena, 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 Dimas, California, United States

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Santa Ana, California, United States

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Simi Valley, California, United States

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Vacaville, California, United States

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Van Nuys, California, United States

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West Hills, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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Middlebury, Connecticut, United States

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Waterbury, Connecticut, United States

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

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Daytona Beach, Florida, United States

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Fort Myers, 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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Jacksonville, Florida, United States

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Jensen Beach, Florida, United States

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Lake City, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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The Villages, Florida, United States

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Winter Haven, Florida, United States

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Acworth, Georgia, United States

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Atlanta, Georgia, United States

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Douglasville, Georgia, United States

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Gainesville, Georgia, United States

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Savannah, Georgia, United States

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Thomasville, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Richmond, Indiana, United States

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El Dorado, Kansas, United States

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Newton, Kansas, United States

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Wichita, Kansas, United States

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Owensboro, Kentucky, United States

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Monroe, Louisiana, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Flint, Michigan, United States

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Roseville, Michigan, United States

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Ypsilanti, Michigan, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Columbus, Mississippi, United States

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Tupelo, Mississippi, United States

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St Louis, Missouri, United States

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Kalispell, Montana, 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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Portsmouth, New Hampshire, United States

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Berlin, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Monroe, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, 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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Columbus, Ohio, United States

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Marion, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Myrtle Beach, South Carolina, United States

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Rapid City, South Dakota, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Knoxville, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Coppell, 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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El Paso, Texas, United States

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El Paso, 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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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Shenandoah, Texas, United States

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Sherman, Texas, United States

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Splendora, Texas, United States

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Stephenville, Texas, United States

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Clinical Trial Site 1 - Tomball

Tomball, Texas, United States

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Clinical Trial Site 2 - Tomball

Tomball, Texas, United States

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Burlington, Vermont, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Norfolk, Virginia, United States

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Wauwatosa, Wisconsin, United States

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Bruce, Australian Capital Territory, Australia

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Sydney, Australian Capital Territory, Australia

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Brookvale, New South Wales, Australia

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Concord, New South Wales, Australia

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Kanwal, New South Wales, Australia

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Kogarah, New South Wales, Australia

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Sherwood, Queensland, Australia

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Sippy Downs, Queensland, Australia

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Garran, , Australia

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Perth, , Australia

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Winnipeg, Manitoba, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Québec, , Canada

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Bayamón, , Puerto Rico

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Ponce, , Puerto Rico

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Basel, , Switzerland

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Geneva, , Switzerland

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Lausanne, , Switzerland

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Lucerne, , Switzerland

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Luton, Bedfordshire, United Kingdom

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Luton, Bedfordshire, United Kingdom

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Fowey, Cornwall, United Kingdom

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Liskeard, Cornwall, United Kingdom

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Newquay, Cornwall, United Kingdom

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Torpoint, Cornwall, United Kingdom

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Chesterfield, Derbyshire, United Kingdom

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Plymouth, Devon, United Kingdom

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Bristol, Gloucestershire, United Kingdom

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Canterbury, Kent, United Kingdom

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Bellshill, Lanarkshire, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

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Manchester, Lancashire, United Kingdom

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Leicester, Leicestershire, United Kingdom

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Hexham, Northumberland, United Kingdom

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Glasgow, Scotland, United Kingdom

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Carshalton, Surrey, United Kingdom

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Birmingham, , United Kingdom

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Cardriff, , United Kingdom

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Chorley, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Pickering, , United Kingdom

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Countries

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United States Australia Canada Puerto Rico Switzerland United Kingdom

Other Identifiers

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ALN-AGT01-007

Identifier Type: -

Identifier Source: org_study_id

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