Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
NCT ID: NCT05166889
Last Updated: 2026-01-16
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
1132 participants
INTERVENTIONAL
2022-01-03
2026-03-23
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
TRIPLE
Study Groups
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Tozorakimab Dose 1
Dosing subcutaneously tozorakimab Dose 1 and placebo
Tozorakimab
Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.
Tozorakimab Dose 2
Dosing subcutaneously tozorakimab Dose 2
Tozorakimab
Administered subcutaneously tozorakimab Dose 2 through Week 52.
Placebo
Dosing subcutaneously with equivalent volume to tozorakimab
Placebo
Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.
Interventions
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Tozorakimab
Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.
Tozorakimab
Administered subcutaneously tozorakimab Dose 2 through Week 52.
Placebo
Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.
Eligibility Criteria
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Inclusion Criteria
2. Documented diagnosis of COPD for at least one year prior to enrolment.
3. Post BD FEV1/FVC \< 0.70 and post-BD FEV1 \>20% of predicted normal value.
4. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
5. Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.
6. Smoking history of ≥ 10 pack-years.
7. CAT total score ≥10, with each of the phlegm (sputum) and cough items with a score ≥ 2.
Exclusion Criteria
2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.
7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
8. Significant COVID-19 illness within the 6 months prior to enrolment.
9. Unstable cardiovascular disorder.
10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
11. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
12. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
13. Evidence of active liver disease, including jaundice during screening.
14. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
15. Participants who have evidence of active TB.
16. Participants that have previously received tozorakimab.
17. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
18. Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.
40 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Tempe, Arizona, United States
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Bakersfield, California, United States
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Sacramento, California, United States
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Boynton Beach, Florida, United States
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Ormond Beach, Florida, United States
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Plantation, Florida, United States
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Meridian, Idaho, United States
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Evergreen Park, Illinois, United States
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Normal, Illinois, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Baton Rouge, Louisiana, United States
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Zachary, Louisiana, United States
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Baltimore, Maryland, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Brick, New Jersey, United States
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New York, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Gastonia, North Carolina, United States
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Fargo, North Dakota, United States
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DuBois, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Franklin, Tennessee, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, 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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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Quilmes, , Argentina
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San Fernando, , Argentina
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San Juan Bautista, , Argentina
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San Miguel de Tucumán, , Argentina
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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Dupnitsa, , Bulgaria
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Haskovo, , Bulgaria
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Kozloduy, , Bulgaria
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Lovech, , Bulgaria
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Petrich, , Bulgaria
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Pleven, , Bulgaria
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Rousse, , Bulgaria
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Sliven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Troyan Municipality, , Bulgaria
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Vratsa, , Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Kamloops, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Ajax, Ontario, Canada
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Guelph, Ontario, Canada
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Markham, Ontario, Canada
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Stouffville, Ontario, Canada
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Winchester, Ontario, Canada
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Montreal, PQ, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Terrebonne, Quebec, Canada
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Brno, , Czechia
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Broumov, , Czechia
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Jindřichův Hradec, , Czechia
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Liberec, , Czechia
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Olomouc, , Czechia
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Rokycany, , Czechia
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Aalborg, , Denmark
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Hvidovre, , Denmark
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København NV, , Denmark
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Næstved, , Denmark
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Roskilde, , Denmark
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Vejle, , Denmark
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Hämeenlinna, , Finland
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Helsinki, , Finland
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Kuopio, , Finland
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Tampere, , Finland
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Turku, , Finland
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Turku, , Finland
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Budapest, , Hungary
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Debrecen, , Hungary
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Edelény, , Hungary
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Encs, , Hungary
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Mosonmagyaróvár, , Hungary
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Nyíregyháza-Sóstóhegy, , Hungary
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Százhalombatta, , Hungary
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Ahmedabad, , India
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Belagavi, , India
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Coimbatore, , India
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Dehradun, , India
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Hyderabad, , India
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Jaipur, , India
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Mohali, , India
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Nagpur, , India
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Nashik, , India
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New Delhi, , India
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Surat, , India
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Thane, , India
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Asahikawa-shi, , Japan
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Chikushino-shi, , Japan
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Chūōku, , Japan
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Fujieda-shi, , Japan
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Fukuoka, , Japan
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Hamamatsu, , Japan
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Hamamatsu, , Japan
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Hiroshima, , Japan
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Iizuka-shi, , Japan
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Itabashi-ku, , Japan
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Iwata-shi, , Japan
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Joyo-shi, , Japan
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Kagoshima, , Japan
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Kanazawa, , Japan
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Kawachinagano-shi, , Japan
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Kitakyusyu-shi, , Japan
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Kobe, , Japan
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Koga-shi, , Japan
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Kokubunji-shi, , Japan
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Matsusaka-shi, , Japan
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Mizunami-shi, , Japan
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Nagaoka-shi, , Japan
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Nagoya, , Japan
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Obihiro, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Shinjuku-ku, , Japan
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Shizuoka, , Japan
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Toshima-ku, , Japan
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Toyonaka-shi, , Japan
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Yanagawa-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Benito Juárez, , Mexico
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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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Mérida, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Oaxaca City, , Mexico
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Veracruz, , Mexico
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Alkmaar, , Netherlands
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Harderwijk, , Netherlands
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Heerlen, , Netherlands
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Zutphen, , Netherlands
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Zwolle, , Netherlands
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Ålesund, , Norway
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Bergen, , Norway
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Bodø, , Norway
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Levanger, , Norway
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Lørenskog, , Norway
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Oslo, , Norway
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Tønsberg, , Norway
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Guimarães, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
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Vila Franca de Xira, , Portugal
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Vila Nova de Gaia, , Portugal
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Guaynabo, , Puerto Rico
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Daegu, , South Korea
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Incheon, , South Korea
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Jeonju, , 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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Galdakao, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Pozuelo de Alarcón, , Spain
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Santander, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Ankara, , Turkey (Türkiye)
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Aydin, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2023-503571-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-003797-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9180C00003
Identifier Type: -
Identifier Source: org_study_id
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