Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
NCT ID: NCT06183931
Last Updated: 2025-12-17
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
1160 participants
INTERVENTIONAL
2024-01-11
2027-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALXN2220
Participants will receive weight-based dose of ALXN2220 via intravenous (IV) infusion every 4 weeks (q4w) for at least 24 months up to a maximum of 48 months.
ALXN2220
Participants will receive ALXN2220 via IV infusion.
Placebo
Participants will receive placebo via IV infusion q4w for at least 24 months up to a maximum of 48 months.
Placebo
Participants will receive placebo via IV infusion.
Interventions
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ALXN2220
Participants will receive ALXN2220 via IV infusion.
Placebo
Participants will receive placebo via IV infusion.
Eligibility Criteria
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Inclusion Criteria
* End-diastolic interventricular septal wall thickness ≥ 12 mm on echocardiography measured at Screening
* NT-proBNP \> 2000 pg/mL at Screening
* Treatment with a loop diuretic for at least 30 days prior to Screening
* History of heart failure NYHA Class II-IV at Screening
* Life expectancy of ≥ 6 months as per the Investigator's judgment
* Males and females of childbearing ability must use contraception
Exclusion Criteria
* Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis
* Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
* Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment
* LVEF \< 30% on echocardiography
* Renal failure requiring dialysis or an eGFR \< 20 mL/min/1.73 m2 at Screening
* Polyneuropathy with PND score IV
18 Years
90 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Irvine, California, United States
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La Jolla, California, United States
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Palo Alto, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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New York, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Danville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Memphis, Tennessee, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Falls Church, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Bedford Park, , Australia
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Box Hill, , Australia
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Brisbane, , Australia
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Darlinghurst, , Australia
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Joondalup, , Australia
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Melbourne, , Australia
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Westmead, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Wels, , Austria
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Bruges, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Aracaju, , Brazil
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Campinas, , Brazil
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Fortaleza, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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Ribeirão Preto, , Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Winnipeg, Manitoba, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Rimouski, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Guiyang, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Jinan, , China
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Nanjing, , China
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Shanghai, , China
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Tianjin, , China
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Wuhan, , China
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Xi'an, , China
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Prague, , Czechia
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Prague, , Czechia
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Aarhus, , Denmark
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Odense C, , Denmark
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Bron, , France
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Chambray-lès-Tours, , France
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Créteil, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Poitiers, , France
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Rennes, , France
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Saint-Herblain, , France
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Toulouse, , France
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Berlin, , Germany
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Cologne, , Germany
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Essen, , Germany
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Giessen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Homburg, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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München, , Germany
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Münster, , Germany
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Würzburg, , Germany
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Athens, , Greece
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Dublin, , Ireland
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Beer Yaakov, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Bologna, , Italy
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Ferrara, , Italy
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Florence, , Italy
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Forlì, , Italy
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Messina, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Torino, , Italy
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Trieste, , Italy
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Bunkyō City, , Japan
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Kumamoto, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Matsumoto-shi, , Japan
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Sapporo, , Japan
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Shinjuku-ku, , Japan
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Suita-shi, , Japan
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Utrecht, , Netherlands
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Lørenskog, , Norway
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Oslo, , Norway
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Trondheim, , Norway
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Gdansk, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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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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Seoul, , South Korea
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Wŏnju, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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El Palmar, , Spain
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Jaén, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Palma de Mallorca, , Spain
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Pamplona, , Spain
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Salamanca, , Spain
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Santiago de Compostela-Coruña, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Skellefteå, , Sweden
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Stockholm, , Sweden
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Basel, , Switzerland
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Bern, , Switzerland
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Lucerne, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Dinar, , Turkey (Türkiye)
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Eskişehir, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Cardiff, , United Kingdom
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Glasgow, , United Kingdom
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Hexham, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Countries
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Other Identifiers
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D6810C00001
Identifier Type: -
Identifier Source: org_study_id