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)

Last updated: March 18, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Lupus

Treatment

Anifrolumab (blinded)

Anifrolumab (unblinded, open label)

Placebo

Clinical Study ID

NCT06455449
D3463C00003
  • Ages 18-75
  • All Genders

Study 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

Inclusion

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 2017ACR/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 dermatomyositistreatments at a stable dose.

  6. No history of active tuberculosis or severe COVID-19.

  7. Male and female participants must follow contraception guidelines.

Exclusion

Exclusion Criteria:

  1. Participants with documented inclusion body myositis (IBM), immune mediationnecrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years priorto signing the ICF), drug-induced myositis, cancer associated myositis, amyopathicDM, 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-DMconditions (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 cancerin-situ), immunodeficiency, HIV, HBV, active HCV .

  7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completelyresolved within 12 weeks prior to signing the ICF.

  8. Opportunistic infection requiring hospitalization or IV antimicrobial treatmentwithin 3 years prior to randomization.

  9. Recent non-opportunistic infection requiring hospitalization or anti-infectivetreatment.

  10. Recent or concurrent enrollment in another clinical study with an investigationalproduct.

  11. Lactating, breastfeeding, or pregnant females or females who intend to becomepregnant or begin breastfeeding

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Anifrolumab (blinded)
Phase: 3
Study Start date:
June 20, 2024
Estimated Completion Date:
August 04, 2028

Connect with a study center

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    Buenos Aires, C1180AAX
    Argentina

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    Buenos Aires 3435910, 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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    Quilmes 3429652, B1878GEG
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    San Miguel de Tucuman, T4000AXL
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    San Miguel de Tucumán, T4000AXL
    Argentina

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  • Research Site

    San Miguel de Tucumán 3836873, T4000AXL
    Argentina

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    Camperdown, 2050
    Australia

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  • Research Site

    Camperdown 2172563, 2050
    Australia

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    Nedlands, 6009
    Australia

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    Nedlands 2064874, 6009
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    New Lambton, 2310
    Australia

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    New Lambton 2205629, 2310
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    Southport, 4222
    Australia

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    Southport 2148928, 4222
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    Woodville South, 5011
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    Woodville South 9973101, 5011
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    Graz, 8036
    Austria

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    Graz 2778067, 8036
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    Vienna, 1090
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    Vienna 2761369, 1090
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    Wien, 1090
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    Gent, 9000
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    Ghent, 9000
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    Ghent 2797656, 9000
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    Leuven, 3000
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    Leuven 2792482, 3000
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    Merksem, B-2170
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    Merksem 2791301, B-2170
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    Joinville, 89202-190
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    Joinville 3459712, 89202-190
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    Juiz de Fora, 36010 570
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    Juiz de Fora 3459505, 36010 570
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    Pelotas, 96040-010
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    Pelotas 3454244, 96040-010
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    Porto Alegre, 90620-110
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    Porto Alegre 3452925, 90620-110
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    Salvador, 40150-150
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    Salvador 3450554, 41253-190
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    Sao Jose Do Rio Preto, 15090-000
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    Sao Paulo, 01233-907
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    São Paulo 3448439, 5403-000
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    Haskovo, 6304
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    Haskovo 730435, 6304
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    Plovdiv, 4002
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    Plovdiv 728193, 4002
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    Sofia, 1680
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    Sofia 727011, 1680
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    Stara Zagora, 6003
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    Le Mans, 72037
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    Le Mans 3003603, 72037
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    Berlin, 10117
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    Berlin 2950159, 10117
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    Freiburg im Breisgau 2925177, 79106
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    Debrecen 721472, 4032
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    Szeged, 6725
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    Szeged 715429, 6725
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    Ahmedabad, 380006
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    Ahmedabad 1279233, 382421
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    Dehradun, 248016
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    Dehradun 1273313, 248016
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    Gurugram 1270642, 122001
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    Hyderabad, 500082
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    Hyderabad 1269843, 500082
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    Kolkata 1275004, 700020
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    Lucknow 1264733, 226030
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    Mumbai 1275339, 400053
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    Wroclaw, 50-556
    Poland

    Active - Recruiting

  • Research Site

    Wroclaw 3081368, 50-556
    Poland

    Site Not Available

  • Research Site

    Wrocław, 50-556
    Poland

    Site Not Available

  • Research Site

    Łódź, 90-549
    Poland

    Site Not Available

  • Research Site

    Caguas, 00725
    Puerto Rico

    Active - Recruiting

  • Research Site

    Caguas 4563008, 00725
    Puerto Rico

    Site Not Available

  • Research Site

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

  • Research Site

    San Juan 4568127, 00918
    Puerto Rico

    Site Not Available

  • Research Site

    Daejeon, 35015
    South Korea

    Active - Recruiting

  • Research Site

    Daejeon 1835235, 35015
    South Korea

    Site Not Available

  • Research Site

    Seoul, 04401
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 04401
    South Korea

    Site Not Available

  • Research Site

    A Coruña, 15006
    Spain

    Site Not Available

  • Research Site

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • Research Site

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Research Site

    Barcelona 3128760, 08041
    Spain

    Site Not Available

  • Research Site

    Cordoba, 14004
    Spain

    Site Not Available

  • Research Site

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Research Site

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Research Site

    Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Research Site

    L' Hospitalet De Llobregat, 08907
    Spain

    Site Not Available

  • Research Site

    L'Hospitalet de Llobregat, 08907
    Spain

    Active - Recruiting

  • Research Site

    L'Hospitalet de Llobregat 3120619, 08907
    Spain

    Site Not Available

  • Research Site

    La Coruña, 15006
    Spain

    Site Not Available

  • Research Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Research Site

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Research Site

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Research Site

    Sabadell 3111199, 08208
    Spain

    Site Not Available

  • Research Site

    Valladolid, 47012
    Spain

    Active - Recruiting

  • Research Site

    Valladolid 3106672, 47012
    Spain

    Site Not Available

  • Research Site

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Research Site

    Stockholm 2673730, 171 76
    Sweden

    Site Not Available

  • Research Site

    Uppsala, 751 85
    Sweden

    Active - Recruiting

  • Research Site

    Uppsala 2666199, 751 85
    Sweden

    Site Not Available

  • Research Site

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City, 833
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung City 1673820, 81362
    Taiwan

    Site Not Available

  • Research Site

    New Taipei, 220
    Taiwan

    Site Not Available

  • Research Site

    New Taipei City, 220
    Taiwan

    Active - Recruiting

  • Research Site

    New Taipei City 12908892, 220
    Taiwan

    Site Not Available

  • Research Site

    Taichung, 40447
    Taiwan

    Terminated

  • Research Site

    Taichung 1668399,
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 112
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 112
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Research Site

    Edinburgh, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Research Site

    Edinburgh 2650225, EH4 2XU
    United Kingdom

    Site Not Available

  • Research Site

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

  • Research Site

    London 2643743, NW3 2QG
    United Kingdom

    Site Not Available

  • Research Site

    Wolverhampton, WV10 0QP
    United Kingdom

    Active - Recruiting

  • Research Site

    Wolverhampton 2633691, WV10 0QP
    United Kingdom

    Site Not Available

  • Research Site

    Irvine, California 92617
    United States

    Active - Recruiting

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    Irvine 5359777, California 5332921 92617
    United States

    Site Not Available

  • Research Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Research Site

    Denver, Colorado 80230
    United States

    Site Not Available

  • Research Site

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Research Site

    Denver 5419384, Colorado 5417618 80230
    United States

    Site Not Available

  • Research Site

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Research Site

    New Haven 4839366, Connecticut 4831725 06519
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Research Site

    Washington D.C., District of Columbia 20037
    United States

    Site Not Available

  • Research Site

    Washington D.C. 4140963, District of Columbia 4138106 20037
    United States

    Site Not Available

  • Research Site

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Research Site

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Research Site

    Gainesville, Florida 32603
    United States

    Site Not Available

  • Research Site

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Research Site

    Miami, Florida 33126
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Research Site

    Palm Beach Gardens, Florida 33410
    United States

    Active - Recruiting

  • Research Site

    Plant City, Florida 33563
    United States

    Active - Recruiting

  • Research Site

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • Research Site

    Boynton Beach 4148677, Florida 4155751 33472
    United States

    Site Not Available

  • Research Site

    Gainesville 4156404, Florida 4155751 32603
    United States

    Site Not Available

  • Research Site

    Margate 4163407, Florida 4155751 33063
    United States

    Site Not Available

  • Research Site

    Miami 4164138, Florida 4155751 33126
    United States

    Site Not Available

  • Research Site

    Orlando 4167147, Florida 4155751 32819
    United States

    Site Not Available

  • Research Site

    Palm Beach Gardens 4167519, Florida 4155751 33410
    United States

    Site Not Available

  • Research Site

    Plant City 4168773, Florida 4155751 33563
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Research Site

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Research Site

    Willowbrook, Illinois 60527
    United States

    Site Not Available

  • Research Site

    Willowbrook 4916709, Illinois 4896861 60527
    United States

    Site Not Available

  • Research Site

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • Research Site

    Fairway 4271358, Kansas 4273857 66205
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Research Site

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Research Site

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Research Site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Research Site

    Great Neck, New York 11021
    United States

    Site Not Available

  • Research Site

    Great Neck 5119218, New York 5128638 11021
    United States

    Site Not Available

  • Research Site

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Research Site

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Research Site

    Charlotte 4460243, North Carolina 4482348 28207
    United States

    Site Not Available

  • Research Site

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Research Site

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Research Site

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Research Site

    Middleburg Heights 5162851, Ohio 5165418 44130
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Research Site

    Summerville, South Carolina 29486
    United States

    Active - Recruiting

  • Research Site

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Research Site

    Summerville 4597919, South Carolina 4597040 29486
    United States

    Site Not Available

  • Research Site

    Allen, Texas 75013
    United States

    Active - Recruiting

  • Research Site

    Austin, Texas 78759
    United States

    Site Not Available

  • Research Site

    Colleyville, Texas 76034
    United States

    Active - Recruiting

  • Research Site

    Edinburg, Texas 78550
    United States

    Site Not Available

  • Research Site

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Research Site

    Galveston, Texas 77555
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    North Richland Hills, Texas 76180
    United States

    Active - Recruiting

  • Research Site

    Allen 4670300, Texas 4736286 75013
    United States

    Site Not Available

  • Research Site

    Colleyville 4682478, Texas 4736286 76034
    United States

    Site Not Available

  • Research Site

    El Paso 5520993, Texas 4736286 79902
    United States

    Site Not Available

  • Research Site

    North Richland Hills 4715292, Texas 4736286 76180
    United States

    Site Not Available

  • Research Site

    Beckley, West Virginia 25801
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

  • Research Site

    Ha Noi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi, 10000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi 1581130, 10000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi City, 10000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh City 1566083, 700000
    Vietnam

    Site Not Available

  • Research Site

    Hochiminh City, 700000
    Vietnam

    Site Not Available

  • Research Site

    Hue, 530000
    Vietnam

    Site Not Available

  • Research Site

    Huế, 530000
    Vietnam

    Active - Recruiting

  • Research Site

    Huế 1580240, 530000
    Vietnam

    Site Not Available

  • Research Site

    Hà Nội, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Hà Nội 8564175, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hồ Chí Minh, 700000
    Vietnam

    Active - Recruiting

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