Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
MIRANDA
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (MIRANDA)
2 other identifiers
interventional
1,454
29 countries
368
Brief Summary
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2023
Typical duration for phase_3
368 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
August 25, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedStudy Start
First participant enrolled
September 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2026
CompletedMarch 18, 2026
March 1, 2026
2.5 years
August 25, 2023
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
The primary endpoint will be assessed in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy \[triple therapy, or dual therapy if triple is not considered appropriate\]).
Over 52 weeks
Secondary Outcomes (26)
Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
Over 52 weeks
Change from baseline in SGRQ total score from in former smokers
Over 52 weeks
Change from baseline in SGRQ total score from in the overall population of current and former smokers.
Over 52 weeks
Annualized rate of severe COPD exacerbations in former smokers
Variable duration period up to study completion, approximately 3 years
Annualized rate of severe COPD exacerbations in former or current smokers
Variable duration period up to study completion, approximately 3 years
- +21 more secondary outcomes
Study Arms (2)
Tozorakimab
EXPERIMENTALDosing subcutaneously tozorakimab
Placebo
PLACEBO COMPARATORDosing subcutaneously with equivalent volume to tozorakimab
Interventions
Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study.
Eligibility Criteria
You may qualify if:
- Participant must be ≥ 40 years of age and capable of giving signed informed consent.
- Documented diagnosis of COPD for at least one year prior to enrolment.
- Post BD FEV1/FVC \< 0.70 and post-BD FEV1 \>20% of predicted normal value
- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
- Documented optimised inhaled dual or triple therapy for at least 3 months prior to enrolment.
- Smoking history of ≥ 10 pack-years.
- CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2
You may not qualify if:
- Clinically important pulmonary disease other than COPD.
- Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection.
- 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
- 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.
- COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
- 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.
- Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
- Significant COVID-19 illness within the 6 months prior to enrolment.
- Unstable cardiovascular disorder.
- Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
- History of active severe inflammatory bowel disease or colitis within one year prior to enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation.
- History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
- History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
- Evidence of active liver disease, including jaundice during screening.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (368)
Research Site
Birmingham, Alabama, 35205, United States
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Decatur, Alabama, 35603, United States
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Sheffield, Alabama, 35660, United States
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Phoenix, Arizona, 85027, United States
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Tucson, Arizona, 85704, United States
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Yuma, Arizona, 85365, United States
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Los Angeles, California, 90027, United States
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Newport Beach, California, 92663, United States
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San Francisco, California, 94109, United States
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Westminster, California, 92683, United States
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Aurora, Colorado, 80014, United States
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Boulder, Colorado, 80301, United States
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Washington D.C., District of Columbia, 20037, 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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Lakeland, Florida, 33805, United States
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Lakeland, Florida, 33813, United States
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Naples, Florida, 34102, United States
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Ocala, Florida, 34470, United States
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Ormond Beach, Florida, 32174, United States
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Atlanta, Georgia, 30344, United States
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Lithonia, Georgia, 30038, United States
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Champaign, Illinois, 61820, United States
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Chicago, Illinois, 60607, United States
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Chicago, Illinois, 60616, United States
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Andover, Kansas, 67002, United States
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Bowling Green, Kentucky, 42101, United States
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Lexington, Kentucky, 40503, United States
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Towson, Maryland, 21286, United States
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Detroit, Michigan, 48202, United States
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Minneapolis, Minnesota, 55425, United States
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Chesterfield, Missouri, 63005, United States
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Chesterfield, Missouri, 63017, United States
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Hannibal, Missouri, 63401, United States
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Papillion, Nebraska, 68046, United States
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Las Vegas, Nevada, 89102, United States
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Toms River, New Jersey, 08755, United States
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The Bronx, New York, 10451, United States
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Charlotte, North Carolina, 28273, United States
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Greenville, North Carolina, 27834, United States
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Huntersville, North Carolina, 28078, United States
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Winston-Salem, North Carolina, 27103, United States
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Dayton, Ohio, 45439, United States
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Lima, Ohio, 45801, United States
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Grants Pass, Oregon, 97527, United States
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Gaffney, South Carolina, 29340, United States
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Union, South Carolina, 29379, United States
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Chattanooga, Tennessee, 37404, United States
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Elizabethton, Tennessee, 37643, United States
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Jackson, Tennessee, 38305, United States
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Dallas, Texas, 75254, United States
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El Paso, Texas, 79902, United States
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Houston, Texas, 77008, United States
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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78258, United States
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Roy, Utah, 84067, United States
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Kenosha, Wisconsin, 53142, United States
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Buenos Aires, C1121 ABE, Argentina
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CABA, C1025ABI, 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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La Plata, B1904, 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, 4000, Argentina
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Brussels, 1070, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Mechelen, 2800, Belgium
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Namur, 5101, Belgium
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Roeselare, 8800, Belgium
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30150-221, Brazil
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Blumenau, 89030-101, Brazil
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Campina Grande do Sul, 83.430-000, Brazil
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Campinas, 13060-080, Brazil
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Fortaleza, 60430-270, Brazil
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Porto Alegre, 90035074, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91010-006, Brazil
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São Bernardo do Campo, 09715090, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 05403-000, Brazil
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Valinhos, 13271-130, Brazil
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Dupnitsa, 2600, Bulgaria
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Haskovo, 6300, Bulgaria
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Panagyurishte, 4500, Bulgaria
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Plovdiv, 4003, Bulgaria
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Sofia, 1756, Bulgaria
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Veliko Tanovo, 5000, Bulgaria
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Yambol, 8600, Bulgaria
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Calgary, Alberta, T3R 1W7, Canada
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Kelowna, British Columbia, V1Y 4N7, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Toronto, Ontario, M5T 3A9, Canada
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Winchester, Ontario, K0C 2K0, Canada
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Lévis, Quebec, G6V 0C9, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Chile, 7770484, Chile
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Concepción, 4070094, Chile
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Quillota, 2260000, Chile
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Santiago, 7500010, Chile
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Santiago, 7501126, Chile
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Santiago, 7750495, Chile
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Santiago, 8380453, Chile
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Viña del Mar, 2540488, Chile
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Beijing, 100029, China
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Changchun, 130021, China
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Changsha, 410015, China
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Changsha, 430033, China
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Chengdu, 610014, China
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Chengdu, 610072, China
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Chengdu, 611130, China
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Chongqing, 400037, China
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Chongqing, 400042, China
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Guangzhou, 510145, China
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Guangzhou, 510163, China
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Guangzhou, 510515, China
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Hefei, 230061, China
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Hohhot, 750306, China
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Huizhou, 516002, China
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Jinan, 250001, China
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Lanzhou, 730030, China
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Liaocheng, 252000, China
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Linhai, 317000, China
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Nanchang, 330006, China
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Nanchong, 637000, China
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Nanjing, 210006, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Ningbo, 315010, China
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Pingxiang, 337055, China
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Qingdao, 266000, China
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Shanghai, 200040, China
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Shanghai, 200240, China
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Shanghai, 200433, China
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Shanghai, 201199, China
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Shenyang, 110004, China
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Shenyang, 110016, China
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Shenzhen, 518020, China
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Shijiazhuang, 050051, China
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Shijiazhuang, 50051, China
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Taizhou, 318000, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xi'an, 710006, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yinchuan, 750004, China
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Zigong, 643000, China
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Aalborg, 9000, Denmark
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Aarhus, 8200, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, 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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Aix-en-Provence, 13100, France
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Brest, 29609, France
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Colmar, 68024, France
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Epagny Metz-Tessy, 74370, France
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La Tronche, 38700, France
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Lyon, 69317, France
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Marseille, 13015, France
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Montpellier, 34295, France
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Quimper, 29000, France
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Reims, 51092, France
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Villefranche-sur-Saône, 69655, France
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Augsburg, 86150, Germany
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Berlin, 10119, Germany
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Berlin, 10717, Germany
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Berlin, 10787, Germany
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Berlin, 10961, Germany
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Berlin, 12157, Germany
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Berlin, 12159, Germany
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Berlin, 12203, Germany
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Berlin, 13187, Germany
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Cologne, 51069, Germany
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Darmstadt, 64283, Germany
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Essen, 45127, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60389, Germany
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Großhansdorf, 22927, Germany
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Halle, 06108, Germany
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Halle, 06120, Germany
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Hanover, 30159, Germany
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Leipzig, 04299, Germany
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Marburg, 35037, Germany
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Moers, 47441, Germany
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München, 80335, Germany
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München-Pasing, 81241, Germany
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Nuremberg, 90419, Germany
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Peine, 31224, Germany
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Solingen, 42699, Germany
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Athens, 11521, Greece
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Athens, 17562, Greece
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Heraklion, 71409, Greece
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Thessaloniki, 57010, Greece
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Budapest, 1203, 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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Gödöllő, 2100, Hungary
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Hajdúnánás, 4080, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Pécs, 7635, Hungary
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Százhalombatta, 2440, Hungary
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Szolnok, 5000, Hungary
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Ajmer, 305001, India
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Calicut, 673 008, India
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Dehradun, 248001, India
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Delhi, 110029, India
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Dwārka, 110075, India
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Hyderabad, 500035, India
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Hyderabad, 500038, India
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Jaipur, 302012, India
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Jaipur, 302039, India
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Kolkata, 700053, India
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Nagpur, 440012, India
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Vijayawada, 520 008, India
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Visakhapatnam, 530017, India
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Cork, T12 DV56, Ireland
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Dublin, D24 NR0A, Ireland
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Galway, H91 YR71, Ireland
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Moneymore, A92 VW28, Ireland
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Cona, 44124, Italy
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Foggia, 71100, Italy
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Modena, 41124, Italy
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Naples, 80131, Italy
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Padua, 35128, Italy
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Pavia, 27100, Italy
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Pisa, 56100, Italy
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Roma, 161, Italy
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Aomori, 030-8553, Japan
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Asahikawa-shi, 070-8644, Japan
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Chikushino-shi, 818-8502, Japan
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Chūōku, 104-0031, Japan
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Fujieda-shi, 426-8677, Japan
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Fukuoka, 814-0180, Japan
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Ginowan-shi, 901-2214, Japan
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Habikino-shi, 583-8588, Japan
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Hakodate-shi, 041-8680, Japan
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Hamamatsu, 430-8525, Japan
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Itabashi-ku, 173-8610, Japan
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Izumi-shi, 594-0073, Japan
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Kagoshima, 892-0847, Japan
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Kobe, 650-0047, Japan
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Kusatsu-shi, 525-8585, Japan
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Kyoto, 612-8555, Japan
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Matsusaka-shi, 515-8544, Japan
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Minoh, 562-0003, Japan
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Minokamo Shi, 505-8510, Japan
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Mizunami-shi, 509-6134, Japan
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Morioka, 020-0066, Japan
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Nagoya, 457-8511, Japan
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Nankoku-shi, 783-8505, Japan
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Nankoku-shi, 783-8509, Japan
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Omuta-shi, 837-0911, Japan
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Sagamihara-shi, 252-0143, Japan
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Sagamihara-shi, 252-0315, Japan
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Sakaide-shi, 762-8550, Japan
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Sapporo, 006-8555, Japan
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Sapporo, 064-0804, Japan
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Shizuoka, 420-8630, Japan
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Tachikawa-shi, 190-8531, Japan
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Toon-shi, 791-0281, Japan
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Toshima-ku, 171-0014, Japan
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Toyonaka-shi, 560-8552, Japan
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Ube, 755-8505, Japan
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Yanagawa-shi, 832-0059, Japan
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Yokohama, 221-0855, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 232-0066, Japan
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Yokohama, 236-0037, Japan
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Alor Star, 5460, Malaysia
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Kajang, 43000, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuantan, 25100, Malaysia
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Seremban, 70300, Malaysia
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Mexico City, 03310, Mexico
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's-Hertogenbosch, 5223 GZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Breda, 4818 CK, Netherlands
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Heerlen, 6419 PC, Netherlands
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Roermond, 6043 CV, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Rotterdam, 3083 AN, Netherlands
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Zutphen, 7207 AE, Netherlands
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Lima, 15046, Peru
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Lima, 15102, Peru
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Lima, LIMA 21, Peru
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Piura, 20001, Peru
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Santa Beatriz, LIMA 14, Peru
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Bialystok, 15-044, Poland
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Bydgoszcz, 85-796, Poland
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Chrzanów, 32-500, Poland
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Kielce, 25-426, Poland
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Krakow, 30-033, Poland
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Krakow, 31-513, Poland
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Pruszków, 05-800, Poland
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Płock, 09-407, Poland
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Rzeszów, 35-205, Poland
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Anyang-si, 14068, South Korea
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Daegu, 42415, South Korea
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Incheon, 21565, South Korea
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Jeonju, 54907, South Korea
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Seoul, 04763, South Korea
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Seoul, 05030, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 06973, South Korea
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Wŏnju, 26426, South Korea
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Badalona(Barcelona), 08916, Spain
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Barcelona, 08035, Spain
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Cáceres, 10003, Spain
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Madrid, 28850, Spain
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Málaga, 29010, Spain
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Mérida, 06800, Spain
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Santander, 39008, Spain
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Zaragoza, 50009, Spain
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Hat Yai, 90110, Thailand
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Khlong Luang, 12120, Thailand
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Muang, 22000, Thailand
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Muang, 40002, Thailand
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Mueang, 20000, Thailand
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Nakhon Ratchasima, 30000, Thailand
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Adana, 1330, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Chernivtsi, 58022, Ukraine
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Ivano-Frankivsk, 76019, Ukraine
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Kyiv, 02002, Ukraine
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Kyiv, 02081, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03680, Ukraine
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Tarasove Village, 45634, Ukraine
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Ternopil, 46001, Ukraine
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Uzhhorod, 88018, Ukraine
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Vinnytsia, 21001, Ukraine
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Vinnytsia, 21029, Ukraine
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Zhytomyr, 100002, Ukraine
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Bradford, BD9 6RJ, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Glasgow, G4 0SF, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, EC1M 6BQ, United Kingdom
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London, NW3 2QG, United Kingdom
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Macclesfield, SK10 3BL, United Kingdom
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Newcastle upon Tyne, NE7 7AF, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Wakefield, WF1 4DG, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Hochiminh, 70000, 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
August 25, 2023
First Posted
September 15, 2023
Study Start
September 22, 2023
Primary Completion
March 6, 2026
Study Completion
May 22, 2026
Last Updated
March 18, 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/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.