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NCT06961214PHASE3Recruiting

Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)

GlaxoSmithKline

Start Date

6/23/2025

Completion Date

2/14/2029

Summary

Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Eligibility Criteria

Age Range: 40 years to 80 years

Inclusion Criteria: * Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the Informed consent * Elevated Blood Eosinophil Count (BEC) * Moderate to severe COPD with frequent exacerbations, defined as: * A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year * A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.70 and a post-bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values * A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening * COPD assessment test (CAT) score \>=10 at Visit 1 * Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years. * Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1 * Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2) * Male and eligible female participants Exclusion Criteria: The following subjects are excluded: * Participants with a current or prior physician diagnosis of asthma * Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease * Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1 * Lung resection: Participants with a history of or plan for lung volume reduction surgery / endobronchial valve procedure. * Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1 * Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88% * Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension * Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\]) * Unstable cardiovascular disease or arrhythmia * Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)

Interventions

BIOLOGICAL

Depemokimab

DRUG

Placebo

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Conditions

Pulmonary Disease, Chronic Obstructive

Locations

GSK Investigational Site

Sheffield, Alabama 35660

United States

GSK Investigational Site

Aurora, Colorado 80012-5455

United States

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Brooksville, Florida 346135

United States

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Doral, Florida 33172

United States

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Fort Lauderdale, Florida 33316

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Miami, Florida 33122

United States

GSK Investigational Site

Miami, Florida 33125

United States

GSK Investigational Site

Miami, Florida 33155

United States

GSK Investigational Site

Miami, Florida 33165

United States

GSK Investigational Site

Miami, Florida 33175-3434

United States

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Miami, Florida 33176

United States

GSK Investigational Site

Miami, Florida 33176

United States

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Miami Lakes, Florida 33016

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Naples, Florida 34102

United States

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New Port Richey, Florida 34653

United States

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Ocala, Florida 34471

United States

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Orlando, Florida 32825-4457

United States

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Ormond Beach, Florida 32174

United States

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Palmetto Bay, Florida 33157

United States

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Pembroke Pines, Florida 33024

United States

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St. Petersburg, Florida 33704

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Adairsville, Georgia 30103

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Atlanta, Georgia 30344-3607

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Cordele, Georgia 31015

United States

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Morrow, Georgia 30260

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Boise, Idaho 83702

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Chicago, Illinois 60608

United States

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Baton Rouge, Louisiana 70816

United States

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Lafayette, Louisiana 70506

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Shreveport, Louisiana 71105

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Bangor, Maine 04401

United States

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Rockville, Maryland 20854

United States

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Fall River, Massachusetts 02723-1511

United States

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Allen Park, Michigan 48101

United States

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Detroit, Michigan 48202

United States

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Garden City, Michigan 48135

United States

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Troy, Michigan 48085

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Las Vegas, Nevada 89144

United States

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Moorestown, New Jersey 08057-3130

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Sewell, New Jersey 08080

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Mount Kisco, New York 10549

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New Windsor, New York 12553

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Shelby, North Carolina 28152

United States

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DuBois, Pennsylvania 15801-2277

United States

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Philadelphia, Pennsylvania 19140

United States

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Spartanburg, South Carolina 29303-4225

United States

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Union, South Carolina 29379-7409

United States

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Knoxville, Tennessee 37919

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Austin, Texas 78744

United States

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Dallas, Texas 75254

United States

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El Paso, Texas 79902-1123

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Houston, Texas 77094-1385

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Lampasas, Texas 76550-2722

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Richmond, Texas 77407

United States

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San Antonio, Texas 78229

United States

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Webster, Texas 77598

United States

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Morgantown, West Virginia 26505-0423

United States

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Lobos, Buenos Aires B7240AAN

Argentina

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San Miguel de Tucumán, Tucumán Province T4000IAP

Argentina

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Berazategui, 1886

Argentina

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Buenos Aires, C1028AAP

Argentina

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Buenos Aires, C1425BAD

Argentina

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Buenos Aires, C1426ABP

Argentina

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Córdoba, X5000DCE

Argentina

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Córdoba, X5800AEV

Argentina

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Quilmes, 1878

Argentina

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Quilmes, B1878FNR

Argentina

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Rosario, S2013BRH

Argentina

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Rosario Provincia de Santa FE, S2000DEJ

Argentina

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Santa Fe, S3000ASF

Argentina

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Sante Fe, S3000

Argentina

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Coffs Harbour, New South Wales 2450

Australia

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Maroubra, New South Wales 2035

Australia

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Westmead, New South Wales 2145

Australia

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Midland, Western Australia 6056

Australia

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Klagenfurt, Carinthia 9020

Austria

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Linz, Upper Austria 4020

Austria

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Graz, 8036

Austria

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Innsbruck, 6020

Austria

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Linz, 4020

Austria

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Linz, 4021

Austria

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Vienna, A-1090

Austria

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Dupnitsa, 2600

Bulgaria

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Haskovo, 6300

Bulgaria

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Lovech, 5500

Bulgaria

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Montana, 3400

Bulgaria

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Montana, 3400

Bulgaria

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Pazardzhik, 4400

Bulgaria

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Pleven, 5800

Bulgaria

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Rousse, 7002

Bulgaria

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Rousse, 7002

Bulgaria

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Sofia, 1142

Bulgaria

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Sofia, 1233

Bulgaria

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Sofia, 1510

Bulgaria

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Sofia, 1680

Bulgaria

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Jindřichův Hradec, 377 01

Czechia

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Kralupy nad Vltavou, 278 01

Czechia

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Nymburk, 288 02

Czechia

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Prague, 12000

Czechia

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Varnsdorf, 407 47

Czechia

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Munich, Bavaria 80335

Germany

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Fürstenwalde, Brandenburg 15517

Germany

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Darmstadt, Hesse 64283

Germany

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Giessen, Hesse 35398

Germany

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Offenbach, Hesse 63065

Germany

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Rheine, North Rhine-Westphalia 48431

Germany

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Bendorf, Rhineland-Palatinate 56170

Germany

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Halle, Saxony-Anhalt 06108

Germany

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Schleswig, Schleswig-Holstein 24837

Germany

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Berlin, 10119

Germany

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Berlin, 10625

Germany

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Berlin, 10717

Germany

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Berlin, 10961

Germany

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Berlin, 12203

Germany

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Berlin, 12627

Germany

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Berlin, 13187

Germany

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Essen, 45127

Germany

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Geesthacht, 21502

Germany

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Immenhausen, 34376

Germany

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Leipzig, 04207

Germany

GSK Investigational Site

Leipzig, 04299

Germany

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Leipzig, 04347

Germany

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Lübeck, 23552

Germany

GSK Investigational Site

Alexandroupoli, 68100

Greece

GSK Investigational Site

Athens, 115 21

Greece

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Ioannina, 45500

Greece

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Marousi, 151 25

Greece

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Thessaloniki, 54642

Greece

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Ashkelon, 7830604

Israel

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Beer-Yaakov, 703000

Israel

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Beersheba, 84101

Israel

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Hadera, 3820302

Israel

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Haifa, 30000

Israel

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Haifa, 3109601

Israel

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Haifa, 3436212

Israel

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Jerusalem, 90000

Israel

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Jerusalem, 91031

Israel

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Kfar Saba, 44281

Israel

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Petah Tikva, 49100

Israel

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Ramat Gan, 52621

Israel

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Tel Aviv, 6423906

Israel

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Castelvenere, BN 82037

Italy

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Foggia, FG 71122

Italy

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Roma, RM 00133

Italy

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Roma, RM 00161

Italy

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Catania, 95123

Italy

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Ferrara, 44124

Italy

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Genova, 16132

Italy

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Roma, 00128

Italy

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Rozzano, 20089

Italy

GSK Investigational Site

Daugavpils, LV5410

Latvia

GSK Investigational Site

Riga, LV 1079

Latvia

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Riga, LV-1002

Latvia

GSK Investigational Site

Takapuna, Auckland 0622

New Zealand

GSK Investigational Site

Ebdentown, Upper Hutt 5018

New Zealand

GSK Investigational Site

Auckland, 1051

New Zealand

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Auckland, 1051

New Zealand

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Christchurch, 8023

New Zealand

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Hamilton, 3240

New Zealand

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Rotorua, 3010

New Zealand

GSK Investigational Site

Oradea, Bihor County 410155

Romania

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Oradea, Bihor County 410176

Romania

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Timișoara, Timiș County 300310

Romania

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Bucharest, 061692

Romania

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Cluj-Napoca, 400275

Romania

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Cluj-Napoca, 400371

Romania

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Constanța, 900002

Romania

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Daegu, 42415

South Korea

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Incheon, 21431

South Korea

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Incheon, 21565

South Korea

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Jeonju, 54907

South Korea

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Seoul, 03181

South Korea

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Seoul, 06351

South Korea

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Seoul, 08308

South Korea

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Seoul, 5030

South Korea

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Chiang Mai, 50200

Thailand

GSK Investigational Site

Manchester, Greater Manchester M23 9LT

United Kingdom

GSK Investigational Site

Portsmouth, Hampshire PO6 3LY

United Kingdom

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Uxbridge, Middlesex UB8 3NN

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Bedford, MK40 2FG

United Kingdom

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Corby, NN17 2UR

United Kingdom

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Dagenham, RM9 5NH

United Kingdom

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Edinburgh, EH16 4SA

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Glasgow, G20 7BE

United Kingdom

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Glasgow, G4 0SF

United Kingdom

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Llanelli, SA14 8QF

United Kingdom

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London, E11 1NR

United Kingdom

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London, N8 0RA

United Kingdom

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London, NW10 2PB

United Kingdom

GSK Investigational Site

London, SW10 9NH

United Kingdom

GSK Investigational Site

Oxford, OX3 7LE

United Kingdom

GSK Investigational Site

Oxford, OX3 7LE

United Kingdom

GSK Investigational Site

Salford, M6 8HD

United Kingdom