Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
ZENITH
ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
2 other identifiers
interventional
11,000
28 countries
592
Brief Summary
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Longer than P75 for phase_3
592 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2025
CompletedFirst Posted
Study publicly available on registry
September 18, 2025
CompletedStudy Start
First participant enrolled
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
April 17, 2026
April 1, 2026
5 years
September 12, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)
Up to approximately 5 years
Secondary Outcomes (5)
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6
Baseline and Month 6
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
Up to approximately 5 years
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)
Up to approximately 5 years
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization
Up to approximately 5 years
Time to All-cause Death
Up to approximately 5 years
Study Arms (2)
Zilebesiran 300 mg
EXPERIMENTALParticipants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.
Placebo
PLACEBO COMPARATORParticipants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.
Interventions
Eligibility Criteria
You may qualify if:
- Is 18 years or older for patients with established cardiovascular disease (CVD)
- Is 55 years or older for patients with high risk for CVD
- Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
- Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
You may not qualify if:
- Has known history of secondary hypertension
- Has symptomatic orthostatic hypotension
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN)
- Has total serum bilirubin \>1.5×ULN
- Has international normalized ratio (INR) \>1.5
- Has serum potassium \>4.8 mEq/L
- Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alnylam Pharmaceuticalslead
- Hoffmann-La Rochecollaborator
Study Sites (597)
Clinical Trial Site
Birmingham, Alabama, 35205, United States
Clinical Trial Site
Birmingham, Alabama, 35211, United States
Clinical Trial Site
Fairhope, Alabama, 36532, United States
Clinical Trial Site
Foley, Alabama, 36535, United States
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Huntsville, Alabama, 35801, United States
Clinical Trial Site
Huntsville, Alabama, 35805, United States
Clinical Trial Site
Sheffield, Alabama, 35660, United States
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Chandler, Arizona, 85224, United States
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Gilbert, Arizona, 85296, United States
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Glendale, Arizona, 85308, United States
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Mesa, Arizona, 85213, United States
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Phoenix, Arizona, 85015, United States
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Phoenix, Arizona, 85020, United States
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Sun City West, Arizona, 85375, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85715, United States
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Tucson, Arizona, 85741, United States
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Yuma, Arizona, 85364, United States
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Little Rock, Arkansas, 72204, United States
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Little Rock, Arkansas, 72205, United States
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Little Rock, Arkansas, 72205, United States
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Beverly Hills, California, 90211, United States
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Chula Vista, California, 91910, United States
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Covina, California, 91723, United States
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Escondido, California, 92025, United States
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Glendale, California, 91206, United States
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La Jolla, California, 92037, United States
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Lancaster, California, 93534, United States
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Long Beach, California, 90815, United States
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Lynwood, California, 90262, United States
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Newhall, California, 91321, United States
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Northridge, California, 91325, United States
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Pasadena, California, 91105, United States
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San Diego, California, 92111, United States
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San Dimas, California, 91773, United States
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San Ramon, California, 94583, United States
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Tarzana, California, 91356, United States
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Toluca Lake, California, 91602, United States
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Torrance, California, 90502, United States
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Tustin, California, 92780, United States
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Vista, California, 92081, United States
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Walnut Creek, California, 94598, United States
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Bridgeport, Connecticut, 06610, United States
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Waterbury, Connecticut, 06708, United States
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Boca Raton, Florida, 33434, United States
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Brandon, Florida, 33511, United States
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Fleming Island, Florida, 32003, United States
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Fort Lauderdale, Florida, 33308, United States
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Hialeah, Florida, 33012, United States
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Hollywood, Florida, 33024, United States
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Homestead, Florida, 33030, United States
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Jacksonville, Florida, 32205, United States
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Jacksonville, Florida, 32216, United States
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Jensen Beach, Florida, 34957, United States
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Leesburg, Florida, 34748, United States
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Melbourne, Florida, 32934, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33134, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33186, United States
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Orlando, Florida, 32825, United States
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Palm Springs, Florida, 33406, United States
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Tampa, Florida, 33615, United States
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Wellington, Florida, 33449, United States
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Atlanta, Georgia, 30342, United States
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Brunswick, Georgia, 31520, United States
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Columbus, Georgia, 31904, United States
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Conyers, Georgia, 30012, United States
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Conyers, Georgia, 30094, United States
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Fayetteville, Georgia, 30214, United States
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Johns Creek, Georgia, 30024, United States
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Lawrenceville, Georgia, 30044, United States
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Macon, Georgia, 31201, United States
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Suwanee, Georgia, 30024, United States
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Thomasville, Georgia, 31792, United States
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Arlington Heights, Illinois, 60005, United States
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Chicago, Illinois, 60611, United States
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Hazel Crest, Illinois, 60429, United States
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Oak Brook, Illinois, 60523, United States
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Orland Park, Illinois, 60462, United States
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Springfield, Illinois, 62701, United States
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Tinley Park, Illinois, 60477, United States
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Avon, Indiana, 46123, United States
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Evansville, Indiana, 47714, United States
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Evansville, Indiana, 47715, United States
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Greenfield, Indiana, 46140, United States
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South Bend, Indiana, 46617, United States
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Valparaiso, Indiana, 46383, United States
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Hutchinson, Kansas, 67502, United States
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Topeka, Kansas, 66606, United States
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Wichita, Kansas, 67214, United States
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Wichita, Kansas, 67218, United States
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Bowling Green, Kentucky, 42101, United States
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Lexington, Kentucky, 40503, United States
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Versailles, Kentucky, 40383, United States
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Hammond, Louisiana, 70403, United States
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Lafayette, Louisiana, 70503, United States
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New Orleans, Louisiana, 70112, United States
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Opelousas, Louisiana, 70570, United States
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Shreveport, Louisiana, 71105, United States
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Slidell, Louisiana, 70458, United States
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Zachary, Louisiana, 70791, United States
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Baltimore, Maryland, 21215, United States
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Baltimore, Maryland, 21229, United States
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Beltsville, Maryland, 20705, United States
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Bowie, Maryland, 20715, United States
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Lanham, Maryland, 20706, United States
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Rockville, Maryland, 20850, United States
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Flint, Michigan, 48504, United States
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Petoskey, Michigan, 49770, United States
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Shelby, Michigan, 48315, United States
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Southfield, Michigan, 48075, United States
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Troy, Michigan, 48085, United States
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Troy, Michigan, 48098, United States
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Richfield, Minnesota, 55423, United States
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Saint Cloud, Minnesota, 56303, United States
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Jackson, Mississippi, 39216, United States
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Olive Branch, Mississippi, 38654, United States
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Port Gibson, Mississippi, 39150, United States
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Ridgeland, Mississippi, 39157, United States
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Tupelo, Mississippi, 38801, United States
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Kansas City, Missouri, 64108, United States
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Kansas City, Missouri, 64111, United States
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Kansas City, Missouri, 64151, United States
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St Louis, Missouri, 63136, United States
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St Louis, Missouri, 63141, United States
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Fremont, Nebraska, 68025, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89102, United States
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Las Vegas, Nevada, 89148, United States
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Portsmouth, New Hampshire, 03801, United States
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Brick, New Jersey, 08724, United States
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Bridgewater, New Jersey, 08807, United States
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Albuquerque, New Mexico, 87106, United States
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New Windsor, New York, 12553, United States
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North Massapequa, New York, 11758, United States
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Poughkeepsie, New York, 12601, United States
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Riverhead, New York, 11901, United States
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Rosedale, New York, 11422, United States
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Saratoga Springs, New York, 12866, United States
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The Bronx, New York, 10461, United States
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West Seneca, New York, 14224, United States
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Westfield, New York, 14787, United States
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Durham, North Carolina, 27704, United States
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Greenville, North Carolina, 27834, United States
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Greenville, North Carolina, 27834, United States
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High Point, North Carolina, 27260, United States
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Jacksonville, North Carolina, 28546, United States
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Kings Mountain, North Carolina, 28086, United States
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Statesville, North Carolina, 28625, United States
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Fargo, North Dakota, 58104, United States
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Beavercreek, Ohio, 45431, United States
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Cincinnati, Ohio, 45212, United States
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Cincinnati, Ohio, 45219, United States
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Columbus, Ohio, 43213, United States
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Dayton, Ohio, 45409, United States
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Dayton, Ohio, 45429, United States
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Lima, Ohio, 45801, United States
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Maumee, Ohio, 43537, United States
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Moraine, Ohio, 45439, United States
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Edmond, Oklahoma, 73013, United States
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Moore, Oklahoma, 73160, United States
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Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73120, United States
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Camp Hill, Pennsylvania, 17701, United States
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Horsham, Pennsylvania, 19044, United States
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Linwood, Pennsylvania, 19061, United States
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Media, Pennsylvania, 19063, United States
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Uniontown, Pennsylvania, 15401, United States
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Columbia, South Carolina, 29205, United States
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Greenville, South Carolina, 29607, United States
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Greer, South Carolina, 29650, United States
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Sioux Falls, South Dakota, 57104, United States
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Chattanooga, Tennessee, 37404, United States
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Chattanooga, Tennessee, 37412, United States
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Knoxville, Tennessee, 37909, United States
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Knoxville, Tennessee, 37923, United States
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Allen, Texas, 75013, United States
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Allen, Texas, 75013, United States
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Amarillo, Texas, 79106, United States
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Arlington, Texas, 76012, United States
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Arlington, Texas, 76015, United States
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Austin, Texas, 78735, United States
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Austin, Texas, 78759, United States
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Beaumont, Texas, 77702, United States
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Carrollton, Texas, 75006, United States
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Dallas, Texas, 75226, United States
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Dallas, Texas, 75246, United States
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Duncanville, Texas, 75137, United States
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El Paso, Texas, 79905, United States
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Euless, Texas, 76040, United States
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Houston, Texas, 77002, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77025, United States
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Houston, Texas, 77036, United States
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Houston, Texas, 77043, United States
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Houston, Texas, 77061, United States
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Houston, Texas, 77070, United States
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Houston, Texas, 77095, United States
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Humble, Texas, 77338, United States
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Katy, Texas, 77450, United States
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Kingwood, Texas, 77339, United States
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Laredo, Texas, 78041, United States
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McAllen, Texas, 78503, United States
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McKinney, Texas, 75069, United States
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McKinney, Texas, 75071, United States
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Mesquite, Texas, 75149, United States
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Missouri City, Texas, 77459, United States
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Paris, Texas, 75462, United States
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Pasadena, Texas, 77504, United States
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Plano, Texas, 75024, United States
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Port Arthur, Texas, 77642, United States
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San Antonio, Texas, 78220, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78231, United States
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San Antonio, Texas, 78258, United States
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Sherman, Texas, 75092, United States
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Sugar Land, Texas, 77479, United States
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Tomball, Texas, 77375, United States
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Waco, Texas, 76712, United States
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Bountiful, Utah, 84010, United States
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Bountiful, Utah, 84025, United States
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Layton, Utah, 84041, United States
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Arlington, Virginia, 22205, United States
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Danville, Virginia, 24541, United States
Clinical Trial Site
Newport News, Virginia, 23606, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23219, United States
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Suffolk, Virginia, 23435, United States
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Suffolk, Virginia, 23435, United States
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Winchester, Virginia, 22601, United States
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Bellevue, Washington, 98007, United States
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Buenos Aires, C1012AAR, Argentina
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Auchenflower, 4066, Australia
Clinical Trial Site
Brookvale, 2100, Australia
Clinical Trial Site
Castle Hill, 2154, Australia
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Gosford, 2250, Australia
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Leabrook, 5068, Australia
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Merewether, 2291, Australia
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Milton, 4064, Australia
Clinical Trial Site
Sippy Downs, 4556, Australia
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Southport, 4217, Australia
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Tarragindi, 4121, Australia
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Waitara, 2077, Australia
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Braunau am Inn, 5280, Austria
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Graz, 8036, Austria
Clinical Trial Site
Saint Stefan Ob Stainz, 8511, Austria
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Vienna, 1060, Austria
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Vienna, 1190, Austria
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Aalst, 9300, Belgium
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Brasschaat, 2930, Belgium
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Huy, 4500, Belgium
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Ieper, 8900, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Porto Alegre, 90430-001, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São José dos Campos, 12243-280, Brazil
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Burgas, 8000, Bulgaria
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Burgas, 8008, Bulgaria
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Dimitrovgrad, 6400, Bulgaria
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Pleven, 5800, Bulgaria
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Rousse, 7003, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1404, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1510, Bulgaria
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Sofia, 1700, Bulgaria
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Sofia, 1756, Bulgaria
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Veliko Tarnovo, 5006, Bulgaria
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Brampton, L6Z 4N5, Canada
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Burlington, L7M 1K9, Canada
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Cambridge, N1R 7R1, Canada
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Chicoutimi, G7H 7K9, Canada
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Etobicoke, M9R 4E1, Canada
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Greenfield Park, J4V 2G8, Canada
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Laval, H7T 2P5, Canada
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Lévis, G6W 0M5, Canada
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Mirabel, J7J 2K8, Canada
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Mississauga, L5K 2L3, Canada
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Moncton, E1G 5C4, Canada
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Peterborough, K9J 0B2, Canada
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Québec, G1R 2J6, Canada
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Sarnia, N7T 4X3, Canada
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Scarborough, M1B 4Z8, Canada
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Sherbrooke, 8193462887, Canada
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Sydney, B1S 0K1, Canada
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Toronto, M6N 1B5, Canada
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Independencia, 8380000, Chile
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Santiago, 7500588, Chile
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Santiago, 7500739, Chile
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Santiago, 7770086, Chile
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Valdivia, 5110683, Chile
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Bílina, 418 01, Czechia
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Brno, 602 00, Czechia
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Brno, 612 00, Czechia
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Chlumec nad Cidlinou, 503 51, Czechia
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Hodonín, 695 01, Czechia
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Krnov, 794 01, Czechia
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Mariánské Lázně, 353 01, Czechia
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Olomouc, 779 00, Czechia
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Ostrava, 702 00, Czechia
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Pardubice, 532 03, Czechia
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Prague, 101 00, Czechia
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Prague, 120 00, Czechia
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Příbram, 261 01, Czechia
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Slaný, 274 01, Czechia
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Zlín, 760 01, Czechia
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København S, 02300, Denmark
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Auxerre, 89000, France
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Bobigny, 93000, France
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Nîmes, 30900, France
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Paris, 75010, France
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Pau, 64046, France
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Poitiers, 86000, France
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Saint-Herblain, 44093, France
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Valenciennes, 59300, France
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Ahaus, 48683, Germany
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Altenburg, 04600, Germany
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Bad Homburg, 61348, Germany
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Berlin, 10629, Germany
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Berlin, 10789, Germany
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Berlin, 13347, Germany
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Bremen, 28277, Germany
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Cologne, 51069, Germany
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Dortmund, 44137, Germany
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Elsterwerda, 04910, Germany
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Essen, 45355, Germany
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Hamburg, 22763, Germany
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Jerichow, 39319, Germany
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Kaiserslautern, 67655, Germany
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Langen, 63225, Germany
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Mühldorf, 84453, Germany
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Offenbach, 63065, Germany
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Papenburg, 26871, Germany
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Pirna, 01796, Germany
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Stuhr, 28816, Germany
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Athens, 115 27, Greece
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Chios, 82131, Greece
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Ioannina, 454 45, Greece
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Marousi, 151 23, Greece
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Nikaia, 184 54, Greece
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Pátrai, 265 04, Greece
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Pylaia, 570 01, Greece
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Thessaloniki, 546 42, Greece
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Voula, 166 73, Greece
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Balatonfüred, 8230, Hungary
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Békéscsaba, 5600, Hungary
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Nyíregyháza, 4400, Hungary
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Orosháza, 5905, Hungary
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Ancona, 60129, Italy
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L’Aquila, 67100, Italy
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Naples, 80131, Italy
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Novara, 28100, Italy
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Palermo, 90127, Italy
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Pisa, 56124, Italy
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Pozzilli, 86077, Italy
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Bunkyō City, 113-8603, Japan
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Chikushino-shi, 818-0058, Japan
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Chūōku, 103-0027, Japan
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Chūōku, 104-0044, Japan
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Chūōku, 810-0066, Japan
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Fukuoka, 812-8582, Japan
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Fukuoka, 814-0180, Japan
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Hachioji-Shi, 192-0918, Japan
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Hachiōji, 193-0811, Japan
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Hakodate-Shi, 041-0821, Japan
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Himeji, 670-8560, Japan
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Izumi, 594-0073, Japan
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Kasuga, 816-0864, Japan
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Kita-ku, 530-0052, Japan
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Kusatsu, 525-8585, Japan
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Minamiku, 861-4193, Japan
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Minato, 108-0073, Japan
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Nagaoka-Shi, 940-8621, Japan
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Nagasaki, 850-0842, Japan
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Osaka, 530-0005, Japan
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Osaka, 530-0012, Japan
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Osaka, 532-0025, Japan
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Osaka, 558-8558, Japan
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Ōta-ku, 144-0051, Japan
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Saku, 385-0051, Japan
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Sapporo, 003-0026, Japan
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Sapporo, 062-8618, Japan
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Sendai, 983-0039, Japan
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Shimotsuke-shi, 329-0498, Japan
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Shinagawa-Ku, 140-8522, Japan
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Shinjuku-ku, 162-8666, Japan
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Tamanashi, 865-0016, Japan
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Yokohama, 236-0004, Japan
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Yokosuka, 239-8567, Japan
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Ede, 6716 RP, Netherlands
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Hoogeveen, 7909 AA, Netherlands
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Hoorn, 1624 NP, Netherlands
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Utrecht, 3584 CX, Netherlands
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Auckland, 1023, New Zealand
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Christchurch, 8011, New Zealand
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Ebdentown, 5018, New Zealand
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Hamilton, 3243, New Zealand
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Silverdale, 0932, New Zealand
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Takapuna, 0620, New Zealand
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Bydgoszcz, 85-092, Poland
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Chrzanów, 32-500, Poland
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Częstochowa, 42-202, Poland
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Dębica, 39-200, Poland
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Gdansk, 80-262, Poland
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Gdansk, 80-382, Poland
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Gdynia, 81-157, Poland
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Giżycko, 11-500, Poland
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Jaksice, 88-181, Poland
Clinical Trial Site
Katowice, 40-040, Poland
Clinical Trial Site
Katowice, 40-156, Poland
Clinical Trial Site
Katowice, 40-555, Poland
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Katowice, 40-648, Poland
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Krakow, 31-501, Poland
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Krakow, 31-721, Poland
Clinical Trial Site
Lodz, 90-127, Poland
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Lodz, 90-302, Poland
Clinical Trial Site
Lodz, 91-363, Poland
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Lublin, 20-068, Poland
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Lublin, 20-412, Poland
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Olsztyn, 10-165, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
Clinical Trial Site
Piotrkow Trybunalski, 97-300, Poland
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Poznan, 60-111, Poland
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Ruda Śląska, 41-709, Poland
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Rzeszów, 35-055, Poland
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Skierniewice, 96-100, Poland
Clinical Trial Site
Sopot, 81-717, Poland
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Staszów, 28-200, Poland
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Świdnik, 21-040, Poland
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Tarnów, 33-100, Poland
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Warsaw, 01-249, Poland
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Warsaw, 02-672, Poland
Clinical Trial Site
Warsaw, 02-677, Poland
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Warsaw, 02-696, Poland
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Warsaw, 02-758, Poland
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Zamość, 22-400, Poland
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Zamość, 22-400, Poland
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Baixa Da Banheira, 2835-127, Portugal
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Coimbra, 3000-150, Portugal
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Coimbra, 3004-561, Portugal
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Creixomil, 4835-044, Portugal
Clinical Trial Site
Leiria, 2400-110, Portugal
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Lisbon, 1500-048, Portugal
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Loures, 2674-514, Portugal
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Riachos, 2350-325, Portugal
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Santa Maria da Feira, 4520-211, Portugal
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Senhora da Hora, 4464-513, Portugal
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Baia Mare, 430124, Romania
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Baia Mare, 430222, Romania
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Brasov, 500091, Romania
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Brasov, 500283, Romania
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Bucharest, 021875, Romania
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Bucharest, 022328, Romania
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Oradea, 410469, Romania
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Ploieşti, 100342, Romania
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Satu Mare, 440192, Romania
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Târgu Mureş, 540136, Romania
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Timișoara, 300362, Romania
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Bardejov, 085 01, Slovakia
Clinical Trial Site
Bratislava, 831 03, Slovakia
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Bratislava, 841 03, Slovakia
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Ilava, 019 01, Slovakia
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Košice, 040 01, Slovakia
Clinical Trial Site
Lučenec, 984 01, Slovakia
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Moldava nad Bodvou, 045 01, Slovakia
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Nitra, 949 01, Slovakia
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Nitra, 949 01, Slovakia
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Prešov, 080 01, Slovakia
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Stará Turá, 916 01, Slovakia
Clinical Trial Site
Vinica, 991 28, Slovakia
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Belville, 7530, South Africa
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Bloemfontein, 9301, South Africa
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Bloemfontein, 9321, South Africa
Clinical Trial Site
Cape Town, 7130, South Africa
Clinical Trial Site
Cape Town, 7500, South Africa
Clinical Trial Site
Cape Town, 7646, South Africa
Clinical Trial Site
Chatsworth, 4084, South Africa
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City of Johannesburg, 1820, South Africa
Clinical Trial Site
Durban, 4001, South Africa
Clinical Trial Site
Durban, 4170, South Africa
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Ekurhuleni, 1459, South Africa
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Ekurhuleni, 1466, South Africa
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Ekurhuleni, 1619, South Africa
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Gauteng, 0157, South Africa
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Johannesburg, 1818, South Africa
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Johannesburg, 2157, South Africa
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Johannesburg, 2192, South Africa
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Johannesburg, 2196, South Africa
Clinical Trial Site
KwaDukuza, 4449, South Africa
Clinical Trial Site
KwaZulu - Natal, 4449, South Africa
Clinical Trial Site
Mogale City, 1739, South Africa
Clinical Trial Site
Mossel Bay, 6506, South Africa
Clinical Trial Site
Nelson Mandela Bay, 6001, South Africa
Clinical Trial Site
Plettenberg Bay, 6600, South Africa
Clinical Trial Site
Pretoria, 0002, South Africa
Clinical Trial Site
Pretoria, 0183, South Africa
Clinical Trial Site
Pretoria, 0186, South Africa
Clinical Trial Site
Worcester, 6850, South Africa
Clinical Trial Site
Anyang-si, 14068, South Korea
Clinical Trial Site
Busan, 47392, South Korea
Clinical Trial Site
Changwon-si, 51472, South Korea
Clinical Trial Site
Cheongju-si, 28644, South Korea
Clinical Trial Site
Goyang-si, 10326, South Korea
Clinical Trial Site
Gwangju, 61453, South Korea
Clinical Trial Site
Gwangmyeong, 14353, South Korea
Clinical Trial Site
Jeonju, 54907, South Korea
Clinical Trial Site
Seoul, 02053, South Korea
Clinical Trial Site
Seoul, 02447, South Korea
Clinical Trial Site
Seoul, 04763, South Korea
Clinical Trial Site
Seoul, 05278, South Korea
Clinical Trial Site
Seoul, 05368, South Korea
Clinical Trial Site
Seoul, 07804, South Korea
Clinical Trial Site
Wŏnju, 26426, South Korea
Clinical Trial Site
Alcalá de Henares, 28880, Spain
Clinical Trial Site
Antequera, 29200, Spain
Clinical Trial Site
Badajoz, 06006, Spain
Clinical Trial Site
Barcelona, 08023, Spain
Clinical Trial Site
Barcelona, 08025, Spain
Clinical Trial Site
Barcelona, 08035, Spain
Clinical Trial Site
Barcelona, 08036, Spain
Clinical Trial Site
Barcelona, 28002, Spain
Clinical Trial Site
Burjassot, 46100, Spain
Clinical Trial Site
Cadiz, 11650, Spain
Clinical Trial Site
Centelles, 08540, Spain
Clinical Trial Site
Córdoba, 14004, Spain
Clinical Trial Site
Figueres, 17600, Spain
Clinical Trial Site
Huelva, 21080, Spain
Clinical Trial Site
L'Hospitalet de Llobregat, 8907, Spain
Clinical Trial Site
Lugo, 27003, Spain
Clinical Trial Site
Madrid, 28003, Spain
Clinical Trial Site
Madrid, 28040, Spain
Clinical Trial Site
Madrid, 28040, Spain
Clinical Trial Site
Madrid, 28041, Spain
Clinical Trial Site
Marbella, 29603, Spain
Clinical Trial Site
Pamplona, 31008, Spain
Clinical Trial Site
San Sebastián de los Reyes, 28702, Spain
Clinical Trial Site
Santiago de Compostela, 15702, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41950, Spain
Clinical Trial Site
Valencia, 46010, Spain
Clinical Trial Site
Valladolid, 47012, Spain
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Vigo, 36213, Spain
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Stockholm, 117 27, Sweden
Clinical Trial Site
Kaohsiung City, 82445, Taiwan
Clinical Trial Site
Taipei, 10002, Taiwan
Clinical Trial Site
Taipei, 104, Taiwan
Clinical Trial Site
Taipei, 106, Taiwan
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Ashburton, TQ13 7AP, United Kingdom
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Belfast, BT2 8BG, United Kingdom
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Bellshill, ML4 3NJ, United Kingdom
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Birmingham, B15 2SQ, United Kingdom
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Birmingham, B21 9RY, United Kingdom
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Bristol, BS2 8HW, United Kingdom
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Bristol, BS37 4AX, United Kingdom
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Bury St Edmunds, IP33 2QZ, United Kingdom
Clinical Trial Site
Cardiff, CF15 9SS, United Kingdom
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Cardiff, CF5 4AD, United Kingdom
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Chichester, PO19 6SE, United Kingdom
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Corby, NN17 2UR, United Kingdom
Clinical Trial Site
Darlington, DL3 6HX, United Kingdom
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Dorchester, DT1 2JY, United Kingdom
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Ely, CB7 5JD, United Kingdom
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Fowey, PL23 1DT, United Kingdom
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Glasgow, G20 7BE, United Kingdom
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Heston, TW5 9ER, United Kingdom
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Honiton, EX14 2NY, United Kingdom
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Ilford, IG1 4HP, United Kingdom
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Isleworth, TW7 6AF, United Kingdom
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Leeds, LS26 9AA, United Kingdom
Clinical Trial Site
Liskeard, PL14 3XA, United Kingdom
Clinical Trial Site
Liverpool, L24 7RB, United Kingdom
Clinical Trial Site
London, EC1A 7BE, United Kingdom
Clinical Trial Site
London, SE6 4LF, United Kingdom
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Luton, LU4 0DZ, United Kingdom
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Manchester, M27 8FF, United Kingdom
Clinical Trial Site
Metropolitan Borough of Wirral, CH62 6EE, United Kingdom
Clinical Trial Site
Middlesbrough, TS5 6HA, United Kingdom
Clinical Trial Site
Milton Keynes, MK15 0DU, United Kingdom
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Newquay, TR7 1RU, United Kingdom
Clinical Trial Site
Northallerton, DL7 8AW, United Kingdom
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Penzance, TR18 3DX, United Kingdom
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Plymouth, PL5 3JB, United Kingdom
Clinical Trial Site
Plympton, PL7 1AD, United Kingdom
Clinical Trial Site
Poole, BH16 5PW, United Kingdom
Clinical Trial Site
Redhill, RH1 5RH, United Kingdom
Clinical Trial Site
Sale, M33 4BR, United Kingdom
Clinical Trial Site
Swansea, SA2 8QA, United Kingdom
Clinical Trial Site
Swindon, SN3 6BB, United Kingdom
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Teeside, TS19 8PE, United Kingdom
Clinical Trial Site
Thetford, IP24 1JD, United Kingdom
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Torpoint, PL11 2TB, United Kingdom
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Wolverhampton, WV9 5HB, United Kingdom
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York, YO24 2RQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Alnylam Pharmaceuticals Inc
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2025
First Posted
September 18, 2025
Study Start
September 22, 2025
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2030
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Phase 2-4 trials: Access to anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.