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NCT06455449PHASE3Recruiting

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

AstraZeneca

Start Date

6/20/2024

Completion Date

8/4/2028

Summary

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.

Eligibility Criteria

Age Range: 18 years to 75 years

Capable of giving informed consent. Inclusion Criteria: 1. 18 - 75 years old 2. Body weight ≥40 kg 3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis. 4. Moderate or severe disease activity per core set measurements. 5. Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose. 6. No history of active tuberculosis or severe COVID-19. 7. Male and female participants must follow contraception guidelines. Exclusion Criteria: 1. Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies). 2. PM and DM patients at a high risk of malignancy. 3. Participants with rapidly progressive interstitial lung disease. 4. Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion. 5. Any history of severe case of herpes zoster infection 6. History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV . 7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF. 8. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization. 9. Recent non-opportunistic infection requiring hospitalization or anti-infective treatment. 10. Recent or concurrent enrollment in another clinical study with an investigational product. 11. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Interventions

COMBINATION_PRODUCT

Anifrolumab (blinded)

OTHER

Placebo

COMBINATION_PRODUCT

Anifrolumab (unblinded, open label)

Interested in This Trial?

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Conditions

Polymyositis, Dermatomyositis

Locations

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Phoenix, Arizona 85032

United States

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Irvine, California 92617

United States

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Aurora, Colorado 80045

United States

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Denver, Colorado 80230

United States

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New Haven, Connecticut 06519

United States

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Washington D.C., District of Columbia 20037

United States

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Boca Raton, Florida 33486

United States

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Boynton Beach, Florida 33472

United States

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Gainesville, Florida 32603

United States

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Margate, Florida 33063

United States

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Miami, Florida 33126

United States

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Miami, Florida 33133

United States

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Orlando, Florida 32819

United States

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Palm Beach Gardens, Florida 33410

United States

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Plant City, Florida 33563

United States

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Atlanta, Georgia 30322

United States

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Willowbrook, Illinois 60527

United States

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Fairway, Kansas 66205

United States

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Baltimore, Maryland 21224

United States

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Boston, Massachusetts 02115

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Ann Arbor, Michigan 48109

United States

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Sterling Heights, Michigan 48313

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Great Neck, New York 11021

United States

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Charlotte, North Carolina 28207

United States

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Charlotte, North Carolina 28211

United States

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Durham, North Carolina 27710

United States

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Cleveland, Ohio 44195

United States

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Middleburg Heights, Ohio 44130

United States

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Philadelphia, Pennsylvania 19107

United States

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Pittsburgh, Pennsylvania 15213

United States

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Charleston, South Carolina 29425

United States

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Summerville, South Carolina 29486

United States

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Allen, Texas 75013

United States

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Amarillo, Texas 79124

United States

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Austin, Texas 78759

United States

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Colleyville, Texas 76034

United States

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El Paso, Texas 79902

United States

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Galveston, Texas 77555

United States

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Harlingen, Texas 78550

United States

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Houston, Texas 77030

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North Richland Hills, Texas 76180

United States

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Beckley, West Virginia 25801

United States

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Milwaukee, Wisconsin 53226

United States

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Buenos Aires, C1180AAX

Argentina

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CABA, C1431FWO

Argentina

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Ciudad de Buenos Aires, C1405BCH

Argentina

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Quilmes, B1878GEG

Argentina

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San Miguel de Tucumán, T4000AXL

Argentina

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Camperdown, 2050

Australia

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Nedlands, 6009

Australia

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New Lambton, 2310

Australia

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Southport, 4222

Australia

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Woodville South, 5011

Australia

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Graz, 8036

Austria

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Vienna, 1090

Austria

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Ghent, 9000

Belgium

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Leuven, 3000

Belgium

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Merksem, B-2170

Belgium

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Joinville, 89202-190

Brazil

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Juiz de Fora, 36010 570

Brazil

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Pelotas, 96040-010

Brazil

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Porto Alegre, 90620-110

Brazil

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Salvador, 40150-150

Brazil

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Salvador, 41253-190

Brazil

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São José do Rio Preto, 15090-000

Brazil

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São Paulo, 01233-907

Brazil

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São Paulo, 5403-000

Brazil

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Haskovo, 6304

Bulgaria

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Plovdiv, 4001

Bulgaria

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Plovdiv, 4002

Bulgaria

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Plovdiv, 4002

Bulgaria

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Rousse, 7000

Bulgaria

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Sofia, 1680

Bulgaria

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Stara Zagora, 6003

Bulgaria

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Calgary, Alberta T2N 4L7

Canada

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Calgary, Alberta T3M1M4

Canada

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Montreal, Quebec H3T 1E2

Canada

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Concepción, 4070022

Chile

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Las Condes, 7560908

Chile

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Osorno, 200025

Chile

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Santiago, 7691236

Chile

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Santiago, 8330034

Chile

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Santiago, 8420383

Chile

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Beijing, 100029

China

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Beijing, 100044

China

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Beijing, 100191

China

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Beijing, CN-100730

China

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Chongqing, 402260

China

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Dongguan, 523009

China

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Guangzhou, 510317

China

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Guangzhou, 510630

China

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Hangzhou, 310014

China

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Hengyang, 421001

China

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Jining, 272011

China

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Nanjing, 210029

China

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Shanghai, 200025

China

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Shanghai, 200032

China

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Shanghai, 200040

China

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Shanghai,

China

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Shijiazhuang, 050001

China

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Wenzhou, 325000

China

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Zhengzhou, 450052

China

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Prague, 12850

Czechia

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Aarhus N, 8200

Denmark

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Copenhagen, 2100

Denmark

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Odense C, 5000

Denmark

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Angers, 49033

France

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Brest, 29609

France

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Le Mans, 72037

France

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Lille, 59037

France

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Lyon, 69437

France

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Paris, 75010

France

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Paris, 75651

France

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Reims, 51100

France

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Rouen, 76000

France

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Strasbourg, 67098

France

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Toulouse, 31059

France

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Bad Nauheim, 61231

Germany

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Berlin, 10117

Germany

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Bonn, 53127

Germany

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Freiburg im Breisgau, 79106

Germany

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Herne, 44649

Germany

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München, 80336

Germany

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Tübingen, 72076

Germany

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Budapest, 1023

Hungary

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Debrecen, 4032

Hungary

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Szeged, 6725

Hungary

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Ahmedabad, 380006

India

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Ahmedabad, 382421

India

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Dehradun, 248016

India

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Delhi, 110029

India

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Gurugram, 122001

India

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Hyderabad, 500082

India

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Kolkata, 700020

India

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Lucknow, 226030

India

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Mumbai, 400 078

India

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Mumbai, 400012

India

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Mumbai, 400053

India

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Mysuru, 570004

India

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New Delhi, 110060

India

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Puducherry, 605006

India

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Secunderabad, 500003

India

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Afula, 18101

Israel

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Haifa, 31048

Israel

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Haifa, 34362

Israel

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Jerusalem, 91120

Israel

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Kfar Saba, 4428164

Israel

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Ramat Gan, 52621

Israel

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Ancona, 60126

Italy

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Bari, 70124

Italy

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Catania, 95100

Italy

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Milan, 20132

Italy

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Milan, 20161

Italy

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Padova, 35128

Italy

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Palermo, 90127

Italy

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Pavia, 27100

Italy

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Pisa, 56126

Italy

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Roma, 00128

Italy

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Roma, 00161

Italy

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Roma, 00189

Italy

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Rozzano, 20089

Italy

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Siena, 53100

Italy

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Asahikawa-Shi, 070-8644

Japan

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Bunkyō City, 113-8431

Japan

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Bunkyō City, 113-8603

Japan

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Chiba, 260-0877

Japan

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Fukuoka, 810-8563

Japan

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Hiroshima, 734-8551

Japan

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Iruma-Gun, 350-0495

Japan

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Kawachinagano-shi, 586-8521

Japan

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Kawasaki-shi, 216-8511

Japan

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Nagoya, 457-0866

Japan

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Nagoya, 467-0001

Japan

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Okayama, 700-8557

Japan

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Omura-shi, 856-8562

Japan

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Sendai, 980-8574

Japan

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Shinjuku-ku, 160-8582

Japan

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Tachikawa-shi, 190-0014

Japan

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Yotsukaido-shi, 284-0003

Japan

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Culiacán, 80020

Mexico

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D.F, 14000

Mexico

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Guadalajara, 44600

Mexico

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Guadalajara, 44650

Mexico

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Guadalajara, 44690

Mexico

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Mexico City, 03310

Mexico

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Mexico City, 06700

Mexico

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México, 06090

Mexico

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México, 11850

Mexico

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Amsterdam, 1105 AZ

Netherlands

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Bialystok, 15-276

Poland

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Krakow, 30-002

Poland

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Krakow, 30-105

Poland

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Lodz, 90-549

Poland

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Poznan, 60-218

Poland

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Poznan, 61-545

Poland

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Warsaw, 00-874

Poland

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Warsaw, 02-637

Poland

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Wroclaw, 50-556

Poland

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Caguas, 00725

Puerto Rico

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San Juan, 00918

Puerto Rico

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Daejeon, 35015

South Korea

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Seoul, 02447

South Korea

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Seoul, 04401

South Korea

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Seoul, 06591

South Korea

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Seoul, 133792

South Korea

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A Coruña, 15006

Spain

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Barcelona, 08003

Spain

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Barcelona, 08035

Spain

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Barcelona, 08041

Spain

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Córdoba, 14004

Spain

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L'Hospitalet de Llobregat, 08907

Spain

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Madrid, 28034

Spain

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Madrid, 28041

Spain

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Sabadell, 08208

Spain

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Valladolid, 47012

Spain

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Stockholm, 171 76

Sweden

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Uppsala, 751 85

Sweden

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Kaohsiung City, 81362

Taiwan

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Kaohsiung City, 833

Taiwan

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New Taipei City, 220

Taiwan

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Taichung, 40447

Taiwan

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Taichung, 40705

Taiwan

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Taipei, 112

Taiwan

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Taoyuan, 333

Taiwan

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Edinburgh, EH4 2XU

United Kingdom

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London, NW3 2QG

United Kingdom

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Wolverhampton, WV10 0QP

United Kingdom

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Hanoi, 100000

Vietnam

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Hanoi, 10000

Vietnam

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Hà Nội, 100000

Vietnam

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Hà Nội, 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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Hochiminh City, 700000

Vietnam

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Hồ Chí Minh, 700000

Vietnam

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Huế, 530000

Vietnam