A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
PRESTO
A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)
1 other identifier
interventional
1,160
24 countries
363
Brief Summary
This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2025
363 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
June 11, 2025
CompletedStudy Start
First participant enrolled
June 27, 2025
CompletedFirst Posted
Study publicly available on registry
July 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 5, 2027
March 17, 2026
March 1, 2026
2.4 years
June 11, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualised rate of moderate or severe COPD exacerbations
The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
From baseline up to 24 Weeks
Secondary Outcomes (11)
Time to first moderate or severe COPD exacerbation
From baseline up to 24 Weeks
Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalisations
From baseline up to 24 Weeks
Annualised rate of severe COPD exacerbations
From baseline up to 24 Weeks
Annualised rate of COPDCompEx events
From baseline up to 24 Weeks
Time to first COPDCompEx event
From baseline up to 24 Weeks
- +6 more secondary outcomes
Study Arms (4)
Dose 1 of AZD6793
EXPERIMENTALApproximately 290 participants will be randomized to receive Dose 1 of AZD6793
Dose 2 of AZD6793
EXPERIMENTALApproximately 290 participants will be randomized to receive Dose 2 of AZD6793
Dose 3 of AZD6793
EXPERIMENTALApproximately 290 participants will be randomized to receive Dose 3 of AZD6793
Matching Placebo
PLACEBO COMPARATORApproximately 290 participants will be randomized to receive Matching Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Participant must be ≥40 years of age at the time of signing the informed consent.
- Documented primary diagnosis of COPD for at least 12 months prior to enrolment.
- Pre-BD FEV1/FVC \< 0.7 at Visit 1 and pre- and post-BD FEV1/FVC \< 0.7, and post-BD FEV1 ≥ 25% to \< 80% of predicted normal at Visit 2.
- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening.
- Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
- CAT score ≥ 10 at Visit 1.
- Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
- Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and are also exacerbation free for at least 4 weeks (28 days) prior to Visit 3 (randomisation).
- Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
You may not qualify if:
- Clinically important pulmonary disease other than COPD (eg, asthma \[current diagnosis per GINA or other accepted guidelines\], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia).
- Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
- Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
- Significant left heart failure.
- Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.
- Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
- History of another underlying condition that predisposes the participant to infections.
- History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
- Abnormal laboratory findings.
- Participants with evidence of active liver disease and/or evidence of chronic liver disease.
- Participants with history of HIV infection or who test positive for HIV.
- History of lung volume reduction surgery.
- Current or history of malignancy within 5 years before the screening visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (363)
Research Site
Birmingham, Alabama, 35205, United States
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Glendale, Arizona, 85306, United States
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Phoenix, Arizona, 85027, United States
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Phoenix, Arizona, 85044, United States
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Phoenix, Arizona, 85051, United States
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Canoga Park, California, 91303, United States
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La Mesa, California, 91942, United States
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Los Angeles, California, 90017, United States
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Newport Beach, California, 92663, United States
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Norco, California, 92860, United States
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Tustin, California, 92780, United States
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Lakewood, Colorado, 80228, United States
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Brandon, Florida, 33511, United States
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Cape Coral, Florida, 33990, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Jacksonville, Florida, 32216, United States
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Lake City, Florida, 32055, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33182, United States
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Miami Lakes, Florida, 33014, United States
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Naples, Florida, 34102, United States
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Ocala, Florida, 34471, United States
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Ormond Beach, Florida, 32174, United States
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Plantation, Florida, 33324, United States
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Sarasota, Florida, 34239, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33606, 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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Suwanee, Georgia, 30024, United States
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West Des Moines, Iowa, 50266, United States
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Lexington, Kentucky, 40503, United States
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Zachary, Louisiana, 70791, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21224, United States
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Burlington, Massachusetts, 01805, United States
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Farmington Hills, Michigan, 48336, United States
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Garden City, Michigan, 48135, United States
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Grand Rapids, Michigan, 49546, United States
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Chesterfield, Missouri, 63005, United States
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Hannibal, Missouri, 63401, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63141, United States
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Kalispell, Montana, 59901, United States
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Mount Kisco, New York, 10549, United States
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New Bern, North Carolina, 28562, United States
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Cleveland, Ohio, 44106, United States
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Marion, Ohio, 43302, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74133, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97202, United States
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Camp Hill, Pennsylvania, 17011, United States
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DuBois, Pennsylvania, 15801, United States
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Philadelphia, Pennsylvania, 19114, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Scottdale, Pennsylvania, 15683, United States
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Smithfield, Pennsylvania, 15478, United States
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Lancaster, South Carolina, 29720, United States
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Spartanburg, South Carolina, 29303, United States
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Rapid City, South Dakota, 57702, United States
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Chattanooga, Tennessee, 37421, United States
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Franklin, Tennessee, 37067, United States
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Johnson City, Tennessee, 37604, United States
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Boerne, Texas, 78006, United States
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Dallas, Texas, 75254, United States
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Denison, Texas, 75020, United States
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El Paso, Texas, 79902, United States
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Houston, Texas, 77002, United States
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Houston, Texas, 77008, United States
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Houston, Texas, 77030, United States
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Kingwood, Texas, 77339, United States
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Lewisville, Texas, 75067, United States
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Mansfield, Texas, 76063, United States
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McKinney, Texas, 75069, United States
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Pearland, Texas, 77584, United States
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Colchester, Vermont, 05446, United States
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Norfolk, Virginia, 23504, United States
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Williamsburg, Virginia, 23188, United States
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Morgantown, West Virginia, 26505, United States
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Madison, Wisconsin, 53715, United States
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Alberdi, X5033DCE, Argentina
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CABA, C1426, Argentina
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Capital Federal, C1060ABN, Argentina
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Ciudad de Buenos Aires, 1060, Argentina
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Ciudad de Buenos Aires, C1094AAD, 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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Ranelagh, 1886, Argentina
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Rosario, 2000, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Cairns, 4870, Australia
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Norwood, 5067, Australia
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Osborne Park, 6017, Australia
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South Brisbane, 4101, Australia
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Wollongong, 2500, Australia
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Dupnitsa, 2600, Bulgaria
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Haskovo, 6300, Bulgaria
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Plovdiv, 4003, Bulgaria
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Sofia, 1756, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Yambol, 8600, Bulgaria
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Edmonton, Alberta, T6G 2G3, Canada
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Winnipeg, Manitoba, R3L 1Z5, Canada
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Truro, Nova Scotia, B2N 1L2, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Guelph, Ontario, N1H 6J2, Canada
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Hamilton, Ontario, L8L 5G4, Canada
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Stoney Creek, Ontario, L8G 2V6, 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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Sherbrooke, Quebec, J1H 5N4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Trois-Rivières, Quebec, G9A 4P3, Canada
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Victoriaville, Quebec, G6P 3Z8, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Chile, 7770484, Chile
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Concepción, 4070280, 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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Talca, 3481349, Chile
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Temuco, 4810345, Chile
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Viña del Mar, 2540488, Chile
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Baotou, 014040, China
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Beijing, 100024, China
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Beijing, 100029, China
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Beijing, 100029, China
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Beijing, 101100, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410015, China
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Chengdu, 610021, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400042, China
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Fuzhou, 350031, China
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Guangzhou, 510163, China
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Guangzhou, 510280, China
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Hangzhou, 310009, China
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Hohhot, 010050, China
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Jinan, 250013, 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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Nanning, 530021, China
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Qingdao, 266011, China
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Shanghai, 200025, China
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Shanghai, 200433, China
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Shenyang, 110004, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xuzhou, 221000, China
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Zhengzhou, 450003, China
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Aalborg, 9000, Denmark
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Aarhus, 8200, Denmark
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Esbjerg, 6700, Denmark
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Hvidovre, 2650, Denmark
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Odense C, 5000, Denmark
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Roskilde, 4000, Denmark
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Ahrensburg, 22926, Germany
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Bendorf, 56170, Germany
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Berlin, 10119, 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, 13187, Germany
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Darmstadt, 64283, Germany
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Halle, 06108, Germany
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Hanover, D-30173, Germany
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Landsberg, 86899, Germany
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Leipzig, 04347, Germany
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Lübeck, 23552, Germany
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Marburg, 35037, Germany
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Obertshausen, 63179, Germany
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Rosenheim, 83022, Germany
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Schleswig, 24837, Germany
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Wiesbaden, 65183, Germany
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Witten, 58452, Germany
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Athens, 11521, Greece
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Athens, 11527, Greece
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Athens, 17562, Greece
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Ioannina, 45500, Greece
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Thessaloniki, 57001, Greece
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Thessaloniki, 57010, Greece
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Balassagyarmat, 2660, Hungary
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Budapest, 1044, 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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Nyíregyháza-Sóstóhegy, 4481, Hungary
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Pécs, 7635, Hungary
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Szombathely, 9700, Hungary
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Törökbálint, 2045, 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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Dwārka, 110075, India
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Hyderabad, 500055, India
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Hyderabad, 500068, India
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Kochi, 682018, India
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Mumbai, 400008, India
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Nagpur, 440019, India
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Vijayawada, 520 008, India
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Busto Arsizio, 21052, Italy
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Cuneo, 12100, Italy
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Milan, 20122, Italy
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Monza, 20900, Italy
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Naples, 80131, Italy
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Pavia, 27100, Italy
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Roma, 00161, Italy
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Statte, 74010, Italy
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Telese Terme, 82037, Italy
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Chiba, 260-0852, Japan
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Fukuoka, 814-0180, Japan
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Fukushima, 960-1295, Japan
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Ginowan-shi, 901-2214, Japan
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Hachioji-shi, 193-0998, Japan
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Hamamatsu, 431-3192, Japan
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Hiroshima, 734-8530, Japan
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Izumi-shi, 594-0073, Japan
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Kamakura, 247-8533, Japan
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Kanazawa, 920-8650, Japan
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Kasuga-shi, 816-0813, Japan
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Kawasaki-shi, 216-8511, Japan
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Kiyosu-shi, 452-0001, Japan
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Kochi, 780-8077, Japan
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Kōtoku, 136-0075, Japan
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Kumamoto, 861-8520, Japan
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Kyoto, 612-8555, Japan
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Maebashi, 371-8511, Japan
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Matsuyama, 790-8524, Japan
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Minoh, 562-0003, Japan
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Minokamo Shi, 505-8510, Japan
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Miura, 238-0111, Japan
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Mizunami-shi, 509-6134, Japan
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Osaka, 545-8586, Japan
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Ōita, 870-0033, Japan
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Sagamihara-shi, 252-0143, Japan
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Sapporo, 063-0005, Japan
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Sasebo-shi, 857-8511, Japan
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Shimotsuga-gun, 321-0293, Japan
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Shinjuku-ku, 160-0023, Japan
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Tachikawa-shi, 190-8531, Japan
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Toon-shi, 791-0281, Japan
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Toyota, 471-0062, Japan
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Ube, 755-8505, Japan
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Yokkaichi-shi, 510-8561, Japan
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Yokohama, 227-8501, Japan
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Yokohama, 245-8575, Japan
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Chihuahua City, 31210, Mexico
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Durango, 34000, Mexico
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Guadalajara, 44100, Mexico
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Guadalajara, 44200, Mexico
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Mexico City, 04100, Mexico
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Mexico City, 14050, Mexico
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Monterrey, 64060, Mexico
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Monterrey, 64460, Mexico
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Monterrey, 64465, Mexico
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Monterrey, 64710, Mexico
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Lima, 15024, Peru
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Lima, 15036, Peru
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Lima, 15082, Peru
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Lima, 15088, Peru
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Lima, 15102, Peru
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Lima, 15324, Peru
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Lima, LIMA 1, Peru
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Lima, Lima 33, Peru
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Bialystok, 15-044, Poland
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Bydgoszcz, 85-796, Poland
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Chęciny, 26-060, Poland
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Elblag, 82-300, Poland
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Karczew, 05-480, Poland
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Katowice, 40-081, Poland
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Katowice, 40-648, Poland
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Komorniki, 62-052, Poland
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Ksawerów, 95-054, Poland
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Lodz, 92-213, Poland
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Ostróda, 14-100, Poland
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Piaseczno, 05-500, Poland
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Poznan, 60-693, Poland
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Płock, 09-407, Poland
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Rzeszów, 35-205, Poland
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Sosnowiec, 41-208, Poland
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Szczecin, 71-434, Poland
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Warsaw, 00-719, Poland
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Anyang-si, 14068, South Korea
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Cheongju-si, 28644, South Korea
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Chuncheon, 200-704, South Korea
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Daegu, 42415, South Korea
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Daegu, 42601, South Korea
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Jeonju, 54907, South Korea
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Seongnam-si, 13520, South Korea
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Seoul, 03181, South Korea
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Seoul, 06591, South Korea
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Seoul, 07061, South Korea
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Seoul, 08308, South Korea
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Seoul, 143-729, South Korea
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Seoul, 150-713, South Korea
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Wŏnju, 26426, South Korea
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Benalmádena, 29631, Spain
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Granollers, 08402, Spain
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Madrid, 28007, 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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Changhua, 500, Taiwan
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 824, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 433004, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11696, Taiwan
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Taoyuan District, 333, Taiwan
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Yung Kang City, 71044, Taiwan
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Adana, 1330, Turkey (Türkiye)
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Ankara, 06530, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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İzmit, 41380, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Chernivtsi, 58029, Ukraine
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Ivano-Frankivsk, 76018, 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, 02091, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03680, Ukraine
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Lutsk, 43000, Ukraine
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Ternopil, 46000, Ukraine
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Uzhhorod, 88018, 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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Harrow, HA1 3UJ, United Kingdom
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London, EC1M 6BQ, United Kingdom
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London, NW3 2QG, United Kingdom
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Newcastle upon Tyne, NE1 4LP, United Kingdom
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Thetford, IP24 1JD, United Kingdom
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Wythenshawe, M23 9QZ, United Kingdom
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Da Nang, 55000, Vietnam
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Dong Thập, 83000, Vietnam
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Hanoi, 100000, Vietnam
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Huế, 530000, Vietnam
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Rach Gia, 920000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Singh, MD
Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2025
First Posted
July 24, 2025
Study Start
June 27, 2025
Primary Completion (Estimated)
November 5, 2027
Study Completion (Estimated)
November 5, 2027
Last Updated
March 17, 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. 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.