Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
PROSPERO
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).
2 other identifiers
interventional
1,713
37 countries
335
Brief Summary
Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2023
Typical duration for phase_3
335 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedStudy Start
First participant enrolled
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2026
ExpectedMarch 13, 2026
March 1, 2026
3 years
January 17, 2023
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualised rate of severe COPD exacerbations in former smokers.
The primary efficacy endpoint is the rate of severe COPD exacerbations.
Up to 104 weeks.
Secondary Outcomes (8)
The annualised rate of severe COPD exacerbations
Up to 104 weeks.
Time to First Severe COPD Exacerbations
Up to 104 weeks.
Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits.
Up to 104 weeks.
Time to first moderate-to-severe COPD exacerbation.
Up to 104 weeks.
Annualised rate of moderate to severe COPD exacerbations.
Up to 104 weeks.
- +3 more secondary outcomes
Study Arms (3)
Tozorakimab Dose 1
EXPERIMENTALInjection subcutaneously Tozorakimab via pre-filled syringe.
Tozorakimab Dose 2
EXPERIMENTALInjection subcutaneously Tozorakimab via pre-filled syringe.
Placebo
PLACEBO COMPARATORInjection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.
Interventions
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.
Eligibility Criteria
You may qualify if:
- Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
- Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
- FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
- Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
- Capable of giving signed informed consent.
You may not qualify if:
- Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.
- Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
- Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
- Known history of:
- Severe allergic reaction to any monoclonal and polyclonal antibody.
- Allergy or reaction to any component of the IP formulation.
- Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
- Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
- Participants who are not able to comply with the study requirements, procedures, and restrictions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (335)
Research Site
Sheffield, Alabama, 35660, United States
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Tempe, Arizona, 85283, United States
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Lincoln, California, 95648, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91324, United States
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Boynton Beach, Florida, 33435, United States
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Cape Coral, Florida, 33990, United States
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Ormond Beach, Florida, 32174, United States
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Pensacola, Florida, 32503, United States
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Plantation, Florida, 33324, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789, United States
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Evergreen Park, Illinois, 60805, United States
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Normal, Illinois, 61761, United States
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Greenwood, Indiana, 46143, United States
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Kansas City, Kansas, 66160, United States
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Bowling Green, Kentucky, 42101, United States
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Baton Rouge, Louisiana, 70836, United States
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Zachary, Louisiana, 70791, United States
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Baltimore, Maryland, 21224, United States
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White Marsh, Maryland, 21162, United States
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North Dartmouth, Massachusetts, 02747, United States
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Farmington Hills, Michigan, 48336, United States
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Grand Rapids, Michigan, 49546, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Buffalo, New York, 14203, United States
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Durham, North Carolina, 27705, United States
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Gastonia, North Carolina, 28054, United States
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Fargo, North Dakota, 58104, United States
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Toledo, Ohio, 43617, United States
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Tulsa, Oklahoma, 74133, United States
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DuBois, Pennsylvania, 15801, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Sayre, Pennsylvania, 18840, United States
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Rock Hill, South Carolina, 29732, United States
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Franklin, Tennessee, 37067, United States
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Amarillo, Texas, 79106, United States
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Boerne, Texas, 78006, United States
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Kingwood, Texas, 77339, United States
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McKinney, Texas, 75069, United States
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Tomball, Texas, 77375, United States
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Colchester, Vermont, 05446, United States
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Williamsburg, Virginia, 23188, United States
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Cudahy, Wisconsin, 53110, United States
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Buenos Aires, C1121 ABE, Argentina
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, C1414AIF, Argentina
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Córdoba, X5003DCE, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600GWV, Argentina
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Mendoza, M5500CCG, Argentina
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Quilmes, B1878FNR, Argentina
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San Fernando, B1646EBJ, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, T4000IAR, Argentina
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Campbelltown, 2560, Australia
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Frankstown, 3199, Australia
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Macquarie University, 2109, Australia
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Melbourne, 3000, Australia
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Nedlands, 6009, Australia
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Southport, 4215, Australia
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Spearwood, 6163, Australia
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Wollongong, 2500, Australia
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Woodville South, 5011, Australia
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Brussels, 1000, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Namur, 5101, Belgium
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Blumenau, 89030-101, Brazil
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Botucatu, 18618-686, Brazil
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Brasília, 71681-603, Brazil
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Curitiba, 80440-220, Brazil
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Porto Alegre, 90035074, Brazil
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Porto Alegre, 9061-000, Brazil
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Porto Alegre, 91010-006, Brazil
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Rio de Janeiro, 22061-080, Brazil
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São Bernardo do Campo, 09750-420, Brazil
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São Paulo, 01409-001, Brazil
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São Paulo, 05403-000, Brazil
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Dupnitsa, 2600, Bulgaria
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Kozloduy, 3320, Bulgaria
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Lovech, 5500, Bulgaria
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Petrich, 2850, Bulgaria
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Pleven, 5800, Bulgaria
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Rousse, 7002, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1606, Bulgaria
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Vratsa, 3000, Bulgaria
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Edmonton, Alberta, T5A 4L8, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Guelph, Ontario, N1H 6J2, Canada
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Winchester, Ontario, K0C 2K0, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, Quebec, G1G 5X1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Chile, 7770484, Chile
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Curicó, 3341643, Chile
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Santiago, 7500010, Chile
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Santiago, 7500698, Chile
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Santiago, 8150000, Chile
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Talca, 3465584, Chile
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Baotou, 14010, China
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Beijing, 100057, China
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Beijing, 100144, China
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Changchun, 130021, China
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Changsha, 410015, China
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Chengdu, 610000, China
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Chengdu, 610014, China
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Chongqing, 400013, China
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Chongqing, 400037, China
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Guangzhou, 510120, China
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Guangzhou, 510180, China
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Haikou, 570311, China
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Hangzhou, 310006, China
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Hohhot, 010010, China
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Kunming, 650032, China
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Linhai, 317000, China
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Nanchang, 330006, China
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Nanjing, 210006, China
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Ningbo, 315010, China
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Shanghai, 200002, China
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Shanghai, 201199, China
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Shenyang, 110000, China
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Shenyang, 110004, China
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Shenzhen, 518020, China
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Shenzhen, 518053, China
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Shijiazhuang, 50051, China
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Suzhou, 215002, China
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Taiyuan, 030001, China
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Wuhan, 430022, China
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Wuxi, 214023, China
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Xiamen, 361004, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yangzhou, 225001, China
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Yinchuan, 750004, China
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Zhanjiang, 524004, China
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Zunyi, 563100, China
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Barranquilla, 80007, Colombia
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Ibagué, 730006, Colombia
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Rionegro, 054047, Colombia
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Zipaquirá, 200251, Colombia
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Brno, 625 00, Czechia
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Jindřichův Hradec, 377 01, Czechia
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Liberec, 460 63, Czechia
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Olomouc, 779 00, Czechia
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Rokycany, 337 01, Czechia
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Aalborg, 9000, Denmark
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Copenhagen, 2400, Denmark
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Hvidovre, 2650, Denmark
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Næstved, 4700, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Hämeenlinna, 13530, Finland
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Helsinki, 00290, Finland
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Kuopio, 70210, Finland
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Turku, 20520, Finland
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Bordeaux, 33076, France
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Brest, 29609, France
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La Tronche, 38700, France
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Lyon, 69317, France
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Marseille, 13326, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Toulouse, 31300, France
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Ahrensburg, 22926, Germany
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Bamberg, 96049, Germany
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Berlin, 10717, Germany
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Berlin, 12157, Germany
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Cologne, 51069, Germany
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Darmstadt, 64283, Germany
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Halle, 06108, Germany
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Marburg, 35037, Germany
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Peine, 31224, Germany
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Alexandroupoli, 68100, Greece
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Athens, 11527, Greece
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Exohi Thessaloniki, 57010, Greece
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Ioannina, 45500, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 57010, Greece
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Budapest, 1036, Hungary
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Debrecen, 4032, Hungary
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Edelény, 3780, Hungary
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Encs, 3860, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Nyíregyháza-Sóstóhegy, 4481, Hungary
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Százhalombatta, 2440, Hungary
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Belagavi, 590010, India
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Coimbatore, 641028, India
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Dehradun, 248001, India
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Jaipur, 302039, India
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Nagpur, 440012, India
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Nashik, 422007, India
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New Delhi, 110029, India
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Thane, 401107, India
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Ashkelon, 78278, Israel
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Beersheba, 8410101, Israel
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Jerusalem, 9103102, Israel
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Kfar Saba, 4428164, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
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Bari, 70124, Italy
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Carrara, 54033, Italy
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Milan, 20142, Italy
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Milan, 20157, Italy
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Naples, 80131, Italy
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Roma, 00168, Italy
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Salerno, 84131, Italy
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Sassari, 07100, Italy
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Statte, 74010, Italy
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Telese Terme, 82037, Italy
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Tradate, 21049, Italy
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Vercelli, 13100, Italy
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Verona, 37124, Italy
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Asahikawa-shi, 078-8510, Japan
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Fujieda-shi, 426-8677, Japan
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Fukuoka, 819-8555, Japan
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Hamamatsu, 430-8525, Japan
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Hiroshima, 734-8530, Japan
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Iizuka-shi, 820-8505, Japan
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Itabashi-ku, 173-8610, Japan
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Iwata-shi, 438-8550, Japan
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Kanazawa, 920-8650, Japan
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Kawachinagano-shi, 586-8521, Japan
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Kobe, 651-0072, Japan
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Matsusaka-shi, 515-8544, Japan
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Mizunami-shi, 509-6134, Japan
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Nagoya, 460-0001, Japan
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Obihiro, 080-0017, Japan
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Okayama, 700-8558, Japan
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Osaka, 531-0073, Japan
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Osaka, 543-8555, Japan
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Osaka, 545-8586, Japan
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Shinjuku-ku, 162-8655, Japan
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Shizuoka, 420-8630, Japan
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Toshima-ku, 170-0003, Japan
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Toyonaka-shi, 560-8552, Japan
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Yokohama, 221-0855, Japan
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Yokohama, 223-0059, Japan
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Yokohama, 232-0024, Japan
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Benito Juárez, 03650, Mexico
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Chihuahua City, 31000, Mexico
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Guadalajara, 44100, Mexico
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Guadalajara, 44200, Mexico
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México, 01710, Mexico
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Monterrey, 64460, Mexico
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Morelia, 58000, Mexico
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Oaxaca City, 68020, Mexico
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Veracruz, 91910, Mexico
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Eindhoven, 5623EJ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Harderwijk, 3844 DG, Netherlands
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Heerlen, 6419 PC, Netherlands
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Zutphen, 7207 AE, Netherlands
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Lørenskog, 1478, Norway
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Oslo, 450, Norway
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Tønsberg, 3103, Norway
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Lima, 15036, Peru
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Lima, 15046, Peru
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Lima, 15088, Peru
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Lima, LIMA 21, Peru
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Baguio City, 2600, Philippines
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Cebu City, 6000, Philippines
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Iloilo City, 5000, Philippines
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Bialystok, 15-044, Poland
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Bydgoszcz, 85-796, Poland
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Katowice, 40-648, Poland
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Krakow, 30-033, Poland
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Lublin, 20-412, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Ostróda, 14-100, Poland
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Poznan, 60-693, Poland
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Rzeszów, 35-205, Poland
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Sosnowiec, 41-208, Poland
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Wroclaw, 53-301, Poland
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Guimarães, 4835-235, Portugal
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Lisbon, 1649-035, Portugal
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Lisbon, 1998-018, Portugal
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Matosinhos Municipality, 4454-509, Portugal
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Vila Franca de Xira, 2600-009, Portugal
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Brasov, 500283, Romania
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Bucharest, 050159, Romania
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Cluj-Napoca, 400371, Romania
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Timișoara, 300002, Romania
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Daegu, 42415, South Korea
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Incheon, 21431, South Korea
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Jeonju, 54907, South Korea
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Seoul, 05030, South Korea
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Seoul, 06591, South Korea
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Seoul, 07061, South Korea
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Galdakao, 48960, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Mérida, 06800, Spain
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Pozuelo de Alarcón, 28223, Spain
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Santander, 39008, Spain
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Valencia, 46010, Spain
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Zaragoza, 50009, Spain
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Gothenburg, 413 46, Sweden
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Gothenburg, 41345, Sweden
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Lund, 222 22, Sweden
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Stockholm, 11239, Sweden
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Hsinchu, 300, Taiwan
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Kaohsiung City, 80756, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taoyuan District, 333, Taiwan
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Yunlin, 640, Taiwan
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Bang Kra So, 11000, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang,, 55000, Thailand
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Muang, 22000, Thailand
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Mueang, 20000, Thailand
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Nakhon Ratchasima, 30000, Thailand
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Ankara, 06620, Turkey (Türkiye)
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Istanbul, 34854, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Bradford, BD9 6RJ, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Corby, NN18 9EZ, United Kingdom
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High Wycombe, HP11 2QW, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Preston, PR2 9QB, United Kingdom
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Shipley, BD18 3SA, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2023
First Posted
February 24, 2023
Study Start
March 6, 2023
Primary Completion
February 26, 2026
Study Completion (Estimated)
May 28, 2026
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.