Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
NCT ID: NCT05925803
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
314 participants
INTERVENTIONAL
2023-11-08
2027-12-31
Brief Summary
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Detailed Description
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Approximately 306 eligible participants will be randomized in a 1:1 ratio to receive either anifrolumab (or matching placebo) given subcutaneously once weekly for 52 weeks. The study will be stratified by the following factors:
* Interstitial lung disease (ILD) (yes, no) at Week 0 (Day1);
* MMF or MPA/MPS use (yes ,no) at Week 0 (Day 1); and
* Disease duration, defined as the time from the first non-Raynaud's symptom attributable to SSc (\<18 months, ≥ 18 months) at Week 0 (Day 1)
Study treatment will be administered subcutaneously via an accessorized prefilled syringe by study staff or by the participant or carer, either in the clinic or at home, with most doses being administered at home. The study consists of 4 periods: a 6-week screening period, a 52-week, double-blind, placebo-controlled period, a 52-week open-label active treatment period, and a 12-week safety follow-up period. There are a total of 16 study visits with most visits in the treatment period occurring every 8 to 12 weeks. The periods are described below:
* Screening Period: This may involve one or more visits to the study site.
* Double Blind Treatment Period: Treatment Period when participants will receive once weekly injections of anifrolumab or matching placebo. Participation will involve in-clinic study visits at Weeks 0 (Day 1), 1, 4, 8\*, 16, 24, 36, 48 and 52. \*The visit at Week 8 may be either by telephone or in person.
* Open Label Treatment Period: At Week 52, all participants will be given anifrolumab (subcutaneous) once weekly for 52 weeks (last dose at Week 103). Participation will involve in-clinic study visits at Weeks 52, 53\*, 56, 64, 76. 88 and 104. \*The visit at Week 53 may be either by telephone or in person.
* Safety Follow-up Period: All participants will return to the clinic for a 12-week post treatment visit. This will occur post Double Blind Treatment Period (Week 52 or Double Blind Period early discontinuation) or post Open Label Treatment Period (Week 104 or Open Label Period early discontinuation).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anifrolumab (subcutaneous weekly injection)
Anifrolumab subcutaneous injection once weekly
Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label)
At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks
matched placebo control (subcutaneous weekly injection)
matched placebo control subcutaneous injection once weekly
Placebo (blinded)
matched placebo delivered subcutaneously, once weekly for 52 weeks
Interventions
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Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Placebo (blinded)
matched placebo delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label)
At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria
3. Limited or diffuse cutaneous subsets
4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
6. mRSS \> 10 with early disease or rapid progression as defined by the protocol
7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
9. Women of childbearing potential with a negative urine pregnancy test
10. Uninvolved skin at injection sites
Exclusion Criteria
2. Severe cardiopulmonary disease as defined by the protocol
3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) \< 45 mL/min/1.73m2)
4. Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)
5. History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy
6. Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease \[Child Pugh A, B, C hepatic impairment\]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator
7. Hematopoietic stem cell transplantation or solid organ/limb transplantation
8. Any severe case of Herpes Zoster infection as defined by the protocol
9. Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
10. Major surgery within 8 weeks prior to and/or during study enrollment
11. Known active current or history of recurrent infections
12. Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Scottsdale, Arizona, United States
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Chula Vista, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Margate, Florida, United States
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South Miami, Florida, United States
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Tamarac, Florida, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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Babylon, New York, United States
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New York, New York, United States
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Cincinnati, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Allen, Texas, United States
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Houston, Texas, United States
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Graz, , Austria
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Innsbruck, , Austria
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Vienna, , Austria
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Ghent, , Belgium
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Leuven, , Belgium
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, , Canada
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Beijing, , China
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Beijing, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Lanzhou, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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Bordeaux, , France
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Brest, , France
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Paris, , France
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Paris, , France
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Rennes, , France
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Strasbourg, , France
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Toulouse, , France
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Freiburg im Breisgau, , Germany
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Mainz, , Germany
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Minden, , Germany
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Münster, , Germany
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Tübingen, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Ahmedabad, , India
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Delhi, , India
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Gurugram, , India
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Hyderabad, , India
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Kolkata, , India
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Mumbai, , India
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Mysuru, , India
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New Delhi, , India
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Pune, , India
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Secunderabad, , India
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Afula, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Ancona, , Italy
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Brescia, , Italy
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Cona, , Italy
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Milan, , Italy
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Padua, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Bunkyō City, , Japan
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Fukuoka, , Japan
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Iruma-Gun, , Japan
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Kanazawa, , Japan
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Maebashi, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Suita-shi, , Japan
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Takatsuki-shi, , Japan
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Toyoake-shi, , Japan
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Yokohama, , Japan
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Kuala Lumpur, , Malaysia
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Kuching, , Malaysia
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Seremban, , Malaysia
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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San Luis Potosí City, , Mexico
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San Luis Potosí City, , Mexico
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Groningen, , Netherlands
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Bydgoszcz, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Sosnowiec, , Poland
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Warsaw, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Parktown, , South Africa
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Pretoria, , South Africa
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Busan, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Kazımkarabekir, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Merkez, , Turkey (Türkiye)
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Cannock, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Sheffield, , United Kingdom
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hochiminh, , Vietnam
Countries
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Other Identifiers
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2023-505976-31
Identifier Type: OTHER
Identifier Source: secondary_id
D3460C00002
Identifier Type: -
Identifier Source: org_study_id
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