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NCT07052903PHASE3Recruiting

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Alnylam Pharmaceuticals

Start Date

7/2/2025

Completion Date

11/30/2032

Summary

The purpose of this study is to: * Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events * Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death * Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life

Eligibility Criteria

Age Range: 18 years to 85 years

Inclusion Criteria * Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis. * Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic. * Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) \>300 ng/L and \<8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP \>600 ng/L and \<8500 ng/L. * Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator. Exclusion Criteria * Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3. * Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV. * Has an estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m\^2 at screening. * Has received prior or currently receiving TTR-lowering therapy

Interventions

DRUG

Nucresiran

DRUG

Sterile Normal Saline (0.9% NaCl)

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Conditions

Transthyretin Amyloidosis With Cardiomyopathy

Locations

Clinical Trial Site

La Jolla, California 92037

United States

Clinical Trial Site

Stanford, California 94305

United States

Clinical Trial Site

Norwich, Connecticut 06360

United States

Clinical Trial Site

Washington D.C., District of Columbia 20010

United States

Clinical Trial Site

Brandon, Florida 33511

United States

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Miami, Florida 33125

United States

Clinical Trial Site

Atlanta, Georgia 30309

United States

Clinical Trial Site

Gainesville, Georgia 30501

United States

Clinical Trial Site

Tucker, Georgia 30084

United States

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Evanston, Illinois 60201

United States

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Indianapolis, Indiana 46202

United States

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Indianapolis, Indiana 46260

United States

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Kansas City, Kansas 66160

United States

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Baltimore, Maryland 21287

United States

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Boston, Massachusetts 02115

United States

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Boston, Massachusetts 02118

United States

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Detroit, Michigan 48202

United States

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Rochester, Minnesota 55905

United States

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St Louis, Missouri 63110

United States

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Manhasset, New York 11030

United States

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New York, New York 10029

United States

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New York, New York 10032

United States

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New York, New York 10065

United States

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The Bronx, New York 10467

United States

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Charlotte, North Carolina 28204

United States

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Cleveland, Ohio 44195

United States

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Columbus, Ohio 43210

United States

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Portland, Oregon 97239

United States

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Lancaster, Pennsylvania 17602

United States

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Philadelphia, Pennsylvania 19104

United States

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Charleston, South Carolina 29425

United States

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Dallas, Texas 75246

United States

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Houston, Texas 77030

United States

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Plano, Texas 75024

United States

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Salt Lake City, Utah 84132

United States

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Charlottesville, Virginia 22903

United States

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Falls Church, Virginia 22042

United States

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Norfolk, Virginia 23507

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Richmond, Virginia 23298

United States

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Spokane, Washington 99204

United States

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Buenos Aires, C1025ABI

Argentina

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Buenos Aires, C1093AAS

Argentina

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Buenos Aires, C1199ABB

Argentina

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Buenos Aires, C1428

Argentina

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Córdoba, X5016KET

Argentina

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Rosario, S2000DEJ

Argentina

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Rosario, S2000DSR

Argentina

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Rosario, S2000GAP

Argentina

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Adelaide, 5000

Australia

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Bedford Park, 5042

Australia

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Box Hill, 3128

Australia

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Chermside, 4032

Australia

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Darlinghurst, 2010

Australia

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Joondalup, 6027

Australia

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Liverpool, 2170

Australia

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Westmead, 2145

Australia

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Braunau am Inn, 5280

Austria

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Graz, 8036

Austria

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Vienna, 1090

Austria

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Vienna, 1100

Austria

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Vienna, 1160

Austria

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Vienna, 1210

Austria

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Wels, 4600

Austria

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Aalst, 9300

Belgium

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Bruges, 8000

Belgium

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Brussels, 1200

Belgium

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Dendermonde, 9200

Belgium

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Genk, 3600

Belgium

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Ghent, 9000

Belgium

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Hasselt, 3500

Belgium

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Leuven, 3000

Belgium

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Liège, 4000

Belgium

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Roeselare, 8800

Belgium

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Belo Horizonte, 30220-140

Brazil

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Porto Alegre, 90035-903

Brazil

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Porto Alegre, 90560-032

Brazil

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Ribeirão Preto, 14026-900

Brazil

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Ribeirão Preto, 14051-140

Brazil

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Rio de Janeiro, 20551-030

Brazil

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Salvador, 40170-130

Brazil

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São Paulo, 04038-002

Brazil

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São Paulo, 05403-000

Brazil

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Calgary, T2N 4N1

Canada

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London, N6A 5A5

Canada

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Vancouver, V6Z 1Y6

Canada

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Santiago, 7500588

Chile

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Santiago, 8320000

Chile

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Binhai, 300456

China

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Changsha, 410013

China

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Dongcheng, 100006

China

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Fuzhou, 350004

China

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Haidian, 100191

China

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Hangzhou, 310009

China

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Xicheng, 100034

China

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Brno, 602 00

Czechia

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Ostrava, 708-52

Czechia

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Prague, 128 21

Czechia

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Prague, 140 21

Czechia

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Aarhus N, 8200

Denmark

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København Ø, 2100

Denmark

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Odense C, 5000

Denmark

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Chambray-lès-Tours, 37170

France

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Créteil, 94000

France

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Dijon, 21000

France

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La Tronche, 38700

France

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Marseille, 13005

France

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Martinique, 97261

France

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Montpellier, 34295

France

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Paris, 75015

France

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Paris, 75018

France

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Pessac, 33600

France

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Reims, 51100

France

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Rennes, 35000

France

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Rouen, 76031

France

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Saint-Herblain, 44093

France

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Strasbourg, 67091

France

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Toulouse, 31059

France

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Berlin, 13353

Germany

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Cologne, 50937

Germany

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Dresden, 01307

Germany

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Göttingen, 37075

Germany

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Hanover, 30625

Germany

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Heidelberg, 69120

Germany

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Leipzig, 04103

Germany

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Magdeburg, 39120

Germany

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Munich, 81377

Germany

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Münster, 48149

Germany

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Würzburg, 97080

Germany

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Athens, 115 27

Greece

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Athens, 115 28

Greece

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Heraklion, 714 09

Greece

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Thessaloniki, 546 36

Greece

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Hong Kong, 999077

Hong Kong

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Balatonfüred, 8230

Hungary

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Budapest, 1085

Hungary

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Dublin, D07 R2WY

Ireland

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Dublin, D08 NHY1

Ireland

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Be’er Ya‘aqov, 70300

Israel

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Haifa, 3109601

Israel

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Jerusalem, 91120

Israel

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Petah Tikva, 4941492

Israel

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Ancona, 60126

Italy

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Bologna, 40138

Italy

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Brescia, 25123

Italy

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Florence, 50134

Italy

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Forlì, 47121

Italy

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Lecce, 73100

Italy

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Milan, 20122

Italy

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Naples, 80131

Italy

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Padova, 35128

Italy

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Pavia, 27100

Italy

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Pisa, 56124

Italy

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Rimini, 47923

Italy

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Roma, 00168

Italy

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Rome, 00161

Italy

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Torino, 10126

Italy

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Bunkyō City, 113-8655

Japan

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Fukuoka, 810-0001

Japan

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Fukuoka, 812-8582

Japan

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Kagawa, 761-0793

Japan

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Kashihara, 634-8522

Japan

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Kobe, 650-0017

Japan

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Kumamoto, 860-8556

Japan

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Kurume, 830-0011

Japan

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Matsumoto-shi, 390-8621

Japan

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Nagoya, 466-8560

Japan

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Nankoku, 783-0043

Japan

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Niigata, 951-8520

Japan

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Okayama, 700-8558

Japan

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Sapporo, 060-8543

Japan

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Sapporo, 060-8648

Japan

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Sendai, 980-8574

Japan

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Suita, 564-8565

Japan

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Tokyo, 160-8582

Japan

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Kajang, 43000

Malaysia

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Kuala Lumpur, 59100

Malaysia

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Eindhoven, 5623 EJ

Netherlands

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Groningen, 9713 GZ

Netherlands

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Maastricht, 6229 HX

Netherlands

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Rotterdam, 3015 GD

Netherlands

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Utrecht, 3584 CX

Netherlands

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Auckland, 2025

New Zealand

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Christchurch, 8011

New Zealand

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Hamilton, 3204

New Zealand

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Ålesund, 6017

Norway

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Lørenskog, 1478

Norway

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Lodz, 93-338

Poland

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Carnaxide, 2790-134

Portugal

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Creixomil, 4835-044

Portugal

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Leiria, 2410-197

Portugal

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Lisbon, 1169-024

Portugal

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Lisbon, 1649-035

Portugal

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Vila Real, 5000-508

Portugal

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Viseu, 3504-509

Portugal

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Bucharest, 022328

Romania

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Cluj-Napoca, 400001

Romania

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Košice, 040 11

Slovakia

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Incheon, 22332

South Korea

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Seoul, 03080

South Korea

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Seoul, 03722

South Korea

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Seoul, 06351

South Korea

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Seoul, 06591

South Korea

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A Coruña, 15006

Spain

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Barcelona, 08035

Spain

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Barcelona, 08036

Spain

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Bilbao, 48013

Spain

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El Palmar, 30120

Spain

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Huelva, 21005

Spain

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Jaén, 23007

Spain

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L'Hospitalet de Llobregat, 8907

Spain

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Lleida, 25198

Spain

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Madrid, 28046

Spain

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Madrid, 28222

Spain

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Palma de Mallorca, 07198

Spain

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Pamplona, 31008

Spain

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Salamanca, 37007

Spain

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Santiago de Compostela, 15706

Spain

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Valencia, 46010

Spain

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Valencia, 46026

Spain

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Vigo, 36213

Spain

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Gothenburg, 413 45

Sweden

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Lund, 222 42

Sweden

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Solna, 171 76

Sweden

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Basel, 4051

Switzerland

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Geneva, 1205

Switzerland

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Lucerne, 6000

Switzerland

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Sankt Gallen, 9007

Switzerland

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New Taipei City, 220

Taiwan

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Taichung, 40705

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 112

Taiwan

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Ankara, 06170

Turkey (Türkiye)

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Antalya, 07070

Turkey (Türkiye)

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Istanbul, 34093

Turkey (Türkiye)

Clinical Trial Site

Bellshill, ML4 3NJ

United Kingdom

Clinical Trial Site

Birmingham, B15 2SQ

United Kingdom

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Cardiff, CF15 9SS

United Kingdom

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London, NW10 2PB

United Kingdom

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London, NW3 2QG

United Kingdom

Clinical Trial Site

Manchester, M15 6SE

United Kingdom