Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
TILIA
A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
3 other identifiers
interventional
3,527
39 countries
464
Brief Summary
The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
Longer than P75 for phase_3
464 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
November 11, 2022
CompletedFirst Posted
Study publicly available on registry
November 22, 2022
CompletedStudy Start
First participant enrolled
December 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 4, 2027
July 21, 2026
July 1, 2026
4.9 years
November 11, 2022
July 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
To evaluate the effect of tozorakimab versus placebo as an add on to Standard of Care (SoC) in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO.
by Day 28
Secondary Outcomes (18)
Proportion of participants who die
by Day 60
Number of days alive and outside of Intensive Care Unit (ICU)
over 28 day period
Number of days alive and free of supplemental oxygen
over 28 day period
Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
over 28 day and 60 day period
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
by Day 60
- +13 more secondary outcomes
Study Arms (2)
Tozorakimab
EXPERIMENTALApproximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.
Placebo
PLACEBO COMPARATORApproximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Adult participants ≥ 18 years old at the time of signing the informed consent form.
- Patients hospitalised with viral lung infection.
- Hypoxaemia requiring treatment with supplemental O2.
- Hypoxaemia is defined as:
- SpO2 ≤ 90% OR
- SpO2 ≤ 92% AND one or both of the following:
- Radiographic infiltrates by CXR/CT compatible with viral lung infection per investigator judgement.
- Use of accessory muscles of respiration or RR (respiratory rate) \> 22.
- \- Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen.
You may not qualify if:
- Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant's condition.
- Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
- Ongoing IMV/ECMO at randomisation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (464)
Research Site
Mobile, Alabama, 36608, United States
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Phoenix, Arizona, 85008, United States
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Phoenix, Arizona, 85013, United States
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Tucson, Arizona, 85719, United States
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Chula Vista, California, 91911, United States
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Fresno, California, 93701, United States
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La Mesa, California, 91942, 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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Torrance, California, 90505, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80206, United States
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Washington D.C., District of Columbia, 20037, United States
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Bradenton, Florida, 34209, United States
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Bradenton, Florida, 34209, United States
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Gainesville, Florida, 32611, United States
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Jacksonville, Florida, 32224, United States
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Lakeland, Florida, 33805, United States
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Miami, Florida, 33144, United States
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South Pasadena, Florida, 33707, United States
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St. Petersburg, Florida, 33709, United States
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Tampa, Florida, 33617, United States
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Atlanta, Georgia, 30322, United States
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Boise, Idaho, 83702, United States
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Chicago, Illinois, 60612, United States
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Elmhurst, Illinois, 60126, United States
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Evanston, Illinois, 60201, United States
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Fort Wayne, Indiana, 46804, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40202, United States
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Baton Rouge, Louisiana, 70808, United States
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New Orleans, Louisiana, 70121, United States
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Shreveport, Louisiana, 71103, United States
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Annapolis, Maryland, 21401, United States
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Silver Spring, Maryland, 20910, United States
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Springfield, Massachusetts, 01199, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48202, United States
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Detroit, Michigan, 48202, United States
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Royal Oak, Michigan, 48073, United States
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Saint Paul, Minnesota, 55101, United States
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Columbia, Missouri, 65212, United States
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Kansas City, Missouri, 64108, United States
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St Louis, Missouri, 63110, United States
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Brooklyn, New York, 11203, United States
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Buffalo, New York, 14203, United States
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New York, New York, 10016, United States
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New York, New York, 10039, United States
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Potsdam, New York, 13676, United States
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Chapel Hill, North Carolina, 27514, United States
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Durham, North Carolina, 27705, United States
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Greenville, North Carolina, 27834, United States
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Winston-Salem, North Carolina, 27157, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Toledo, Ohio, 43614, United States
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Oklahoma City, Oklahoma, 73104, United States
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Corvallis, Oregon, 97330, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19107, United States
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Providence, Rhode Island, 02903, United States
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Greenville, South Carolina, 29605, United States
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Sioux Falls, South Dakota, 57105, United States
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Amarillo, Texas, 79106, United States
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Dallas, Texas, 75203, United States
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Dallas, Texas, 75204, United States
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El Paso, Texas, 79905, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77090, United States
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Salt Lake City, Utah, 84107, United States
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Charlottesville, Virginia, 22908, United States
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Green Bay, Wisconsin, 54311, United States
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Milwaukee, Wisconsin, 53295, United States
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Buenos Aires, C1046, Argentina
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Buenos Aires, C1120AAF, Argentina
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Buenos Aires, C1180AAV, Argentina
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CABA, C1221ADC, Argentina
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CABA, C1425EOE, Argentina
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La Plata, B1900AVG, Argentina
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Mar del Plata, B7600GWV, Argentina
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Munro, B1605FRE, Argentina
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Rosario, S2000CVB, Argentina
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Adelaide, 5000, Australia
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Bedford Park, 5042, Australia
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New Lambton Heights, 2305, Australia
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Port Macquarie, 2444, Australia
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South Brisbane, 4101, Australia
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Kortrijk, 8500, Belgium
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Ottignies, 1340, Belgium
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Roeselare, 8800, Belgium
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Yvoir, 5530, Belgium
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Belo Horizonte, 30150-221, Brazil
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Campinas, 13060-904, Brazil
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Caxias do Sul, 95070-560, Brazil
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Curitiba, 80215-901, Brazil
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Curitiba, 80730-150, Brazil
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Indaiatuba, 13331-501, Brazil
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Jaú, 17201-130, Brazil
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Natal, 59025-050, Brazil
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Niterói, 24020-096, Brazil
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Passo Fundo, 99010-260, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 9061-000, Brazil
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Recife, 50070-070, Brazil
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Ribeirão Preto, 14049-901, Brazil
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Rio de Janeiro, 21040-900, Brazil
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Salvador, 40170-130, Brazil
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São Caetano do Sul, 09521-160, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 04004-030, Brazil
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São Paulo, 09323-900, Brazil
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Montana, 3400, Bulgaria
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Pernik, 2300, Bulgaria
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Pleven, 5800, Bulgaria
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Rousse, 7002, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1154, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Varna, 9010, Bulgaria
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Calgary, Alberta, T2N 1N4, Canada
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New Westminster, British Columbia, V3L 3W7, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Winnipeg, Manitoba, R3J 3M7, Canada
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Brampton, Ontario, L6R 3J9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Ottawa, Ontario, K1Y 4E9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Lévis, Quebec, G6V 3Z1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Anyang, 455099, China
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Beijing, 100015, China
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Beijing, 100029, China
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Beijing, 101199, China
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Beijing, China
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Changchun, 130041, China
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Changsha, 410004, China
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Changsha, 410015, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Chongqing, 400010, China
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Fuyang, 236012, China
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Guangzhou, 510180, China
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Guangzhou, 510515, China
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Haikou, 570311, China
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Hangzhou, 310006, China
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Hangzhou, 310016, China
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Hefei, 230001, China
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Jinhua, 321099, China
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Jining, 272006, China
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Nanchang, 330006, China
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Nantong, 226001, China
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Ningbo, 315010, China
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Qingdao, 266011, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shanghai, 200240, China
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Shanghai, 201199, China
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Shanghai, CN-200433, China
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Shenzhen, 518020, China
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Tianjin, 300050, China
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Weifang, 261041, China
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Wuhan, 430023, China
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Wuhan, 430030, China
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Xinxiang, 453100, China
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Yantai, 264000, China
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Yinchuan, 750004, China
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Yueyang, 414000, China
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Zhengzhou, 450000, China
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Bogota DC, 111121, Colombia
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Floridablanca, 681004, Colombia
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Medellín, 050021, Colombia
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Soledad, 083001, Colombia
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Villavicencio, 500001, Colombia
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Benešov, 256 01, Czechia
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Kolín, 280 02, Czechia
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Kyjov, 697 01, Czechia
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Mladá Boleslav, 293 01, Czechia
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Prague, 100 34, Czechia
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Prague, 150 30, Czechia
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Prague, 18000, Czechia
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Aalborg, 9000, Denmark
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Aarhus N, 8200, Denmark
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Copenhagen, 2400, Denmark
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Copenhagen Ø, 2100, Denmark
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Herning, 7400, Denmark
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Hillerød, 3400, Denmark
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Hvidovre, 2650, Denmark
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Kolding, 6000, Denmark
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Odense C, 5000, Denmark
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Vejle, 7100, Denmark
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Alexandria, 21131, Egypt
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Cairo, 11561, Egypt
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Cairo, 11566, Egypt
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New Cairo, 11566, Egypt
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Amiens, 80054, France
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Angers, 49033, France
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Brest, 29609, France
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Créteil, 94000, France
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Dijon, 21000, France
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La Tronche, 38700, France
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Le Coudray, 28630, France
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Montpellier, 34295, France
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Nantes, 44800, France
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Orléans, 45100, France
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Strasbourg, 67091, France
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Strasbourg, 67098, France
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Tours, 37000, France
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Augsburg, 86156, Germany
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Berlin, 10117, Germany
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Berlin, 12351, Germany
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Cologne, 51109, Germany
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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Kiel, 24105, Germany
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Leverkusen, 51375, Germany
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Marburg, 35043, Germany
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Regensburg, 93053, Germany
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Rosenheim, 83022, Germany
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Rostock, 18057, Germany
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Athens, 11527, Greece
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Athens, 12462, Greece
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Exohi Thessaloniki, 57010, Greece
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Heraklion, 71500, Greece
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Ioannina, 45500, Greece
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Thessaloniki, 57010, Greece
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Hong Kong, 999077, Hong Kong
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Shatin, 00000, Hong Kong
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Balassagyarmat, 2660, Hungary
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Budapest, 1082, Hungary
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Budapest, 1121, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Kaposvár, 7400, Hungary
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Kistarcsa, 2143, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7624, Hungary
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Ahmedabad, 380054, India
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Ahmedabad, 382415, India
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Belagavi, 590010, India
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Chennai, 600113, India
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Dehradun, 248001, India
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Gurgaon, 122001, India
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Gurugram, 122001, India
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Hyderabad, 500035, India
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Hyderabad, 500068, India
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Kanpur, 208002, India
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Mumbai, 400008, India
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New Delhi, 110017, India
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New Delhi, 110029, India
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New Delhi, 110060, India
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Pune, 411043, India
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Thane, 401107, India
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Vijayawada, 520 008, India
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Afula, 18341, Israel
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Ashkelon, 7830604, Israel
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Beersheba, 8410101, Israel
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Haifa, 34362, Israel
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Holon, 58100, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Arezzo, 52100, Italy
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Brescia, 25123, Italy
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Naples, 80131, Italy
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Roma, 00128, Italy
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Roma, 00149, Italy
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Rozzano, 20089, Italy
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Torino, 10149, Italy
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Chiba, 260-0852, Japan
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Fukuoka, 814-0180, Japan
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Gifu, 502-8558, Japan
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Ginowan-shi, 901-2725, Japan
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Hanyu-shi, 348-8505, Japan
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Hiroshima, 734-8530, Japan
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Hiroshima, 734-8551, Japan
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Hitachi-shi, 317-0077, Japan
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Isehara-shi, 259-1193, Japan
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Izumisano, 598-8577, Japan
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Izumo-shi, 693-8501, Japan
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Kamakura-shi, 247-8533, Japan
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Kamogawa-shi, 296-8602, Japan
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Kanazawa, 920-8641, Japan
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Kanazawa, 920-8650, Japan
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Kasuga-shi, 816-0864, Japan
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Kawasaki-shi, 216-8511, Japan
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Koshigaya-shi, 343-8555, Japan
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Kumagaya-shi, 360-0197, Japan
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Kumamoto, 860-0008, Japan
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Kusatsu-shi, 525-8585, Japan
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Kyoto, 602-8566, Japan
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Kyoto, 612-8555, Japan
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Maebashi, 371-0811, Japan
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Meguro-ku, 152-8902, Japan
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Mitaka-shi, 181-8611, Japan
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Nagoya, 466-8560, Japan
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Nerima-ku, 179-0072, Japan
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Okayama, 702-8055, Japan
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Okazaki-shi, 444-0827, Japan
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Omuta-shi, 837-0911, Japan
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Osaka, 534-0021, Japan
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Osaka, 543-0035, Japan
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Osaka, 545-8586, Japan
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Sapporo, 062-0931, Japan
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Sapporo, 063-0005, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 162-8655, Japan
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Suita-shi, 565-0871, Japan
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Tachikawa-shi, 190-8531, Japan
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Takamatsu, 760-0018, Japan
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Urasoe-shi, 901-2132, Japan
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Ureshino-shi, 843-0393, Japan
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Yokohama, 236-0004, Japan
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Yokohama, 241-0811, Japan
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Yokohama, 245-8575, Japan
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Kota Kinabalu, 88200, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Terengganu, 20400, Malaysia
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Kuantan, 25200, Malaysia
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Kubang Kerian, 16150, Malaysia
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Malacca, 75400, Malaysia
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Petaling Jaya, 47500, Malaysia
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Pulau Pinang, 10450, Malaysia
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Sarawak Miri, 98000, Malaysia
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Selangor Darul Ehsan, 42300, Malaysia
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Shah Alam, 40000, Malaysia
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Aguascalientes, 20259, Mexico
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Guadalajara, 44280, Mexico
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Guadalajara, 44340, Mexico
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Mexico City, 06720, Mexico
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Mexico City, 06726, Mexico
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Monterrey, 64460, Mexico
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San Luis Potosí City, 78250, Mexico
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Tlalpan, 14050, Mexico
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Tlalpan, 14080, Mexico
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Xalapa, 91020, Mexico
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Cusco, CUSCO 01, Peru
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El Agustino, LIMA 10, Peru
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Lima, 15074, Peru
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Lima, 15088, Peru
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Lima, 15324, Peru
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Lima, LIMA 01, Peru
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Lima, LIMA 11, Peru
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Lima, LIMA 1, Peru
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Lima, LIMA 31, Peru
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Piura, 05, Peru
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Cebu, 6000, Philippines
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Iloilo City, Philippines
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Manila, 1000, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1109, Philippines
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Chrzanów, 32-500, Poland
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Lodz, 91-347, Poland
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Rzeszów, 35-241, Poland
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Warsaw, 00-416, Poland
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Warsaw, 01-138, Poland
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Warsaw, 04-141, Poland
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Wroclaw, 51-149, Poland
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Łańcut, 37-100, Poland
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Łęczna, 21-010, Poland
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Bayamón, 00961, Puerto Rico
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Bucharest, 010825, Romania
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Bucharest, 21105, Romania
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Cluj-Napoca, 400000, Romania
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Constanța, 900709, Romania
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Iași, 700116, Romania
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Sibiu, 550245, Romania
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Timișoara, 300310, Romania
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Jeddah, 21423, Saudi Arabia
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Riyadh, 11426, Saudi Arabia
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Riyadh, 12231, Saudi Arabia
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Riyadh, 12372, Saudi Arabia
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Bratislava, 82606, Slovakia
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Johannesburg, Soweto, 2013, South Africa
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Observatory, 7925, South Africa
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Parktown, 2193, South Africa
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Westdene, 2092, South Africa
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Daegu, 42415, South Korea
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Jeonju, 54907, South Korea
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Seoul, 143-729, South Korea
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Barcelona, 08003, Spain
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Barcelona, 08036, Spain
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Madrid, 28034, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Ourense, 32005, Spain
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Palma de Mallorca, 07010, Spain
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Pamplona, 31008, Spain
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Santander, 39008, Spain
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Valencia, 46010, Spain
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Helsingborg, 25187, Sweden
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Huddinge, 14157, Sweden
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Lund, 22185, Sweden
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Malmö, 20502, Sweden
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Solna, 17176, Sweden
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Stockholm, 11861, Sweden
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Stockholm, 18288, Sweden
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Umeå, 90185, Sweden
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Västerås, 72189, Sweden
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 81362, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 0116, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Taoyuan City, 330, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Banphaeo, 74120, Thailand
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Chiang Mai, 50200, Thailand
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Khlong Luang, 12120, Thailand
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Khon Kaen, 40002, Thailand
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Phutthamonthon, 73170, Thailand
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Ubonratchathani, 34000, Thailand
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Ankara, 06800, Turkey (Türkiye)
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Diyarbakır, 21280, Turkey (Türkiye)
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Istanbul, 34010, Turkey (Türkiye)
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Istanbul, 34069, Turkey (Türkiye)
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Istanbul, 34303, Turkey (Türkiye)
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Istanbul, 34899, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Izmir, 35110, Turkey (Türkiye)
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İzmit, 41000, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Ortahisar, 61080, Turkey (Türkiye)
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Bristol, BS105NB, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Glasgow, G4 0SF, United Kingdom
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Glasgow, G51 4TF, United Kingdom
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Hampshire, SO16 6YD, United Kingdom
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Huddersfield, HD3 3EA, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Leicester, LE3 9QP, United Kingdom
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London, W1T 7HA, United Kingdom
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London, W2 1NY, United Kingdom
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London, W6 8RF, United Kingdom
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Oxford, OX3 9DU, United Kingdom
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Prescot, L35 5DR, United Kingdom
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Tyne and Wear, NE29 8NH, United Kingdom
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Wythenshawe, M23 9LT, United Kingdom
Research Site
Haiphong, 180000, Vietnam
Research Site
Haiphong, 180000, Vietnam
Research Site
Hanoi, 100000, Vietnam
Research Site
Hanoi, 10000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Hochiminh City, 700000, Vietnam
Research Site
Huế, 530000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2022
First Posted
November 22, 2022
Study Start
December 13, 2022
Primary Completion (Estimated)
November 4, 2027
Study Completion (Estimated)
November 4, 2027
Last Updated
July 21, 2026
Record last verified: 2026-07
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.