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NCT06878261PHASE3Recruiting

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

AstraZeneca

Start Date

3/25/2025

Completion Date

6/5/2029

Summary

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Detailed Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Eligibility Criteria

Age Range: 40 years to 80 years

Inclusion Criteria: 1. ≥40 to ≤80 years old 2. COPD diagnosis ≥1 year, 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1 5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy 6. EOS ≥ 150 cells/μL during screening 7. CAT ≥15 at screening 8. Former or current smokers ≥10 pack-years Exclusion Criteria: 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD 2. Asthma, incl. pediatric, or ACOS 3. Any unstable disorder that can impact participants safety or study outcomes 4. Tuberculosis requiring treatment within 12 months prior V2 5. Malignancies current or past Concomitant therapies: * Macrolides (less than 6 months) * Systemic immuno-suppressive, -modulating medications 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Interventions

BIOLOGICAL

Tezepelumab

OTHER

Placebo

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Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Locations

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Cullman, Alabama 35055

United States

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Phoenix, Arizona 85044

United States

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Scottsdale, Arizona 85258

United States

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Inglewood, California 90301

United States

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Los Angeles, California 90048

United States

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Palo Alto, California 94304

United States

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Redding, California 96001

United States

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San Diego, California 92108

United States

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New Britain, Connecticut 06051

United States

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Wilmington, Delaware 19803

United States

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Bay Pines, Florida 33744

United States

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Boynton Beach, Florida 33435

United States

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Clearwater, Florida 33765

United States

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Fleming Island, Florida 32003

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Jacksonville, Florida 32209

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Leesburg, Florida 34748

United States

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Margate, Florida 33063

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Miami, Florida 33126

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Miami, Florida 33155

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Miami Lakes, Florida 33014

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Ocala, Florida 34470

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Palmetto Bay, Florida 33157

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Winter Park, Florida 32789

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Adairsville, Georgia 30103

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Atlanta, Georgia 30349

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Cordele, Georgia 31015

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Decatur, Georgia 30033

United States

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Fort Eisenhower, Georgia 30905

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Savannah, Georgia 31406

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Evanston, Illinois 60201

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Evansville, Indiana 47725

United States

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Indianapolis, Indiana 46202

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Indianapolis, Indiana 46268

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Kansas City, Kansas 66160

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Bowling Green, Kentucky 42101

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Owensboro, Kentucky 42301

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Baltimore, Maryland 21224

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Potomac, Maryland 20854

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Ann Arbor, Michigan 48109

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Minneapolis, Minnesota 55425

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Hannibal, Missouri 63401

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Staten Island, New York 10309

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Syracuse, New York 13203

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Charlotte, North Carolina 28277

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Fayetteville, North Carolina 28303

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Oklahoma City, Oklahoma 73102

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Tulsa, Oklahoma 74133

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Grants Pass, Oregon 97527

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Sayre, Pennsylvania 18840

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Anderson, South Carolina 29621

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Columbia, South Carolina 29204

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Gaffney, South Carolina 29340

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Spartanburg, South Carolina 29303

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Union, South Carolina 29379

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Rapid City, South Dakota 57702

United States

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Knoxville, Tennessee 37919

United States

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Boerne, Texas 78006

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El Paso, Texas 79902

United States

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Houston, Texas 77008

United States

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Houston, Texas 77074

United States

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Houston, Texas 77094

United States

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Lewisville, Texas 75067

United States

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McKinney, Texas 75069

United States

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Mesquite, Texas 75149

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San Antonio, Texas 78258

United States

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Colchester, Vermont 05446

United States

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Williamsburg, Virginia 23188

United States

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Everett, Washington 98208

United States

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Alberdi, X5033DCE

Argentina

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Buenos Aires, C1425BEN

Argentina

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Ciudad de Buenos Aires, C1414AIF

Argentina

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Florida, B1602DQD

Argentina

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La Plata, B1900

Argentina

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La Plata, B1904

Argentina

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Mar del Plata, 7600

Argentina

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Mendoza, M5500CCG

Argentina

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Quilmes, B1878FNR

Argentina

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Rosario, 2000

Argentina

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San Fernando, B1646EBJ

Argentina

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San Juan Bautista, 1888

Argentina

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Coffs Harbour, 02450

Australia

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Frankston, 3199

Australia

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Garran, 2605

Australia

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Nedlands, 6009

Australia

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New Lambton, 2310

Australia

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Spearwood, 6163

Australia

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Wollongong, 2500

Australia

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Woodville South, 5011

Australia

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Genk, 3600

Belgium

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Ghent, 9000

Belgium

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Jette, 1090

Belgium

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Leuven, 3000

Belgium

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Mechelen, 2800

Belgium

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Namur, 5101

Belgium

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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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Pleven, 5800

Bulgaria

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Plovdiv, 4003

Bulgaria

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Rousse, 7000

Bulgaria

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Rousse, 7000

Bulgaria

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Sofia, 1000

Bulgaria

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Sofia, 1202

Bulgaria

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Sofia, 1431

Bulgaria

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Sofia, 1756

Bulgaria

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Stara Zagora, 6003

Bulgaria

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Varna, 9000

Bulgaria

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Veliko Tanovo, 5000

Bulgaria

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Veliko Tarnovo, 5000

Bulgaria

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Vidin, 3700

Bulgaria

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Yambol, 8600

Bulgaria

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Armenia, 630004

Colombia

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Barranquilla, 080020

Colombia

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Bogotá, 110131

Colombia

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Cali, 760042

Colombia

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Ibague, 730006

Colombia

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Manizales, 170004

Colombia

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Medellín, 050022

Colombia

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Medellín, 050030

Colombia

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Aalborg, 9000

Denmark

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Hvidovre, 2650

Denmark

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Næstved, 4700

Denmark

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Odense C, 5000

Denmark

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Vejle, 7100

Denmark

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Brest, 29609

France

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Lyon, 69317

France

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Marseille, 13915

France

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Montpellier, 34295

France

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Paris, 75014

France

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Paris, 75877

France

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Pessac, 33604

France

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Saint-Herblain, 44800

France

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Athens, 11521

Greece

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Athens, 11527

Greece

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Athens, 17562

Greece

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Heraklion, 71110

Greece

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Ioannina, 45500

Greece

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Pátrai, 26332

Greece

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Thessaloniki, 57001

Greece

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Thessaloniki, 57010

Greece

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Hong Kong, 999077

Hong Kong

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Hong Kong,

Hong Kong

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Budapest, 1036

Hungary

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Debrecen, 4032

Hungary

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Edelény, 3780

Hungary

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Gödöllő, 2100

Hungary

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Hatvan, 3000

Hungary

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Mosonmagyaróvár, 9200

Hungary

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Nyíregyháza-Sóstóhegy, 4481

Hungary

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Törökbálint, 2045

Hungary

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Ashkelon, 78278

Israel

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Haifa, 34362

Israel

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Jerusalem, 00000

Israel

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Jerusalem, 90131

Israel

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Kfar Saba, 4428164

Israel

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Ramat Gan, 52621

Israel

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Rehovot, 76100

Israel

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Tel Aviv, 6423906

Israel

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Akashi-shi, 674-0063

Japan

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Chikushino-shi, 818-8502

Japan

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Chiyoda-ku, 1020074

Japan

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Fukui-shi, 910-8526

Japan

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Fukuoka, 811-1394

Japan

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Fukuoka, 819-8555

Japan

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Gifu, 502-8558

Japan

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Iruma-Gun, 350-0495

Japan

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Ishinomaki, 986-8522

Japan

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Kasuga-shi, 816-0864

Japan

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Kitakyushu-shi, 807-8555

Japan

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Kiyose-shi, 204-8522

Japan

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Kiyose-shi, 204-8585

Japan

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Kobe, 650-0047

Japan

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Komatsu-shi, 923-8560

Japan

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Kure-shi, 737-8505

Japan

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Kyoto, 612-8555

Japan

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Matsusaka-shi, 515-8544

Japan

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Meguro-ku, 153-0051

Japan

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Minatoku, 105-8470

Japan

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Minatoku, 108-0073

Japan

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Miyazaki, 889-1692

Japan

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Mizunami-shi, 509-6134

Japan

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Nagaoka-shi, 940-8621

Japan

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Nagasaki, 852-8501

Japan

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Nagoya, 457-0866

Japan

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Nagoya, 457-8511

Japan

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Nagoya, 466-8650

Japan

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Nerima-ku, 177-8521

Japan

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Ohta-ku, 143-0013

Japan

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Okayama, 700-8558

Japan

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Okayama, 701-1192

Japan

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Osaka, 540-0008

Japan

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Sapporo, 064-0804

Japan

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Sendai, 980-8574

Japan

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Sendai, 983-8520

Japan

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Shinjuku-ku, 160-8582

Japan

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Shinjuku-ku, 162-8655

Japan

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Shinjuku-ku, 162-8666

Japan

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Shiogama, 985-8506

Japan

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Takamatsu, 760-0018

Japan

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Takatsuiki-shi, 569-1096

Japan

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Tanabe-shi, 646-8558

Japan

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Toshima-ku, 171-0014

Japan

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Ube, 755-8505

Japan

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Yokohama, 236-0004

Japan

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Yokohama, 245-8575

Japan

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Eindhoven, 5623 EJ

Netherlands

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Maastricht, 6229 HX

Netherlands

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Rotterdam, 3045 PM

Netherlands

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Rotterdam, 3083 AN

Netherlands

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Zutphen, 7207 AE

Netherlands

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Auckland, 0626

New Zealand

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Auckland, 1051

New Zealand

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Auckland, 2025

New Zealand

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Hamilton West, 3204

New Zealand

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Tauranga, 3112

New Zealand

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Cusco, CUSCO 01

Peru

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Lima, 15036

Peru

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Lima, 15036

Peru

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Lima, 15046

Peru

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Lima, 15088

Peru

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Lima, LIMA 01

Peru

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Lima, LIMA 1

Peru

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Lima, LIMA 21

Peru

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Lima, LIMA 33

Peru

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Piura, 20001

Peru

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Bucharest, 011461

Romania

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Bucharest, 050159

Romania

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Cluj-Napoca, 400275

Romania

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Cluj-Napoca, 400332

Romania

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Oradea, 410176

Romania

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Timișoara, 300002

Romania

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Timișoara, 300310

Romania

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Bellville, 7530

South Africa

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Benoni, 1501

South Africa

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Cape Town, 7700

South Africa

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Durban, 4001

South Africa

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Durban, 4093

South Africa

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eMkhomazi, 4170

South Africa

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Kimberley, 8301

South Africa

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Somerset West, 7130

South Africa

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Gothenburg, 413 46

Sweden

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Karlskrona, 371 79

Sweden

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Lund, 22185

Sweden

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Örebro, 703 62

Sweden

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Stockholm, 11446

Sweden

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Stockholm, 171 64

Sweden

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Bang Kra So, 11000

Thailand

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Bangkok, 10330

Thailand

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Hat Yai, 90110

Thailand

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Muang, 22000

Thailand

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Muang, 40002

Thailand

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Mueang, 20000

Thailand

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Rayong, 21000

Thailand

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Adana, 1330

Turkey (Türkiye)

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Ankara, 6620

Turkey (Türkiye)

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Istanbul, 34020

Turkey (Türkiye)

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Kayseri, 38039

Turkey (Türkiye)

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Kocaeli, 41380

Turkey (Türkiye)

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Mersin, 33079

Turkey (Türkiye)

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Can Tho, 900000

Vietnam

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Da Nang, 550000

Vietnam

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Haiphong, 180000

Vietnam

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Hanoi, 100000

Vietnam

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Ho Chi Minh City, 700000

Vietnam

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Ho Chi Minh City, 700000

Vietnam

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Ho Chi Minh City,

Vietnam

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Hồ Chí Minh, 700000

Vietnam

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Huế, 530000

Vietnam