A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event
NCT ID: NCT07000123
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
3046 participants
INTERVENTIONAL
2025-05-28
2027-01-11
Brief Summary
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The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.
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Detailed Description
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The study will be conducted at approximately 470 centres in approximately 21 countries.
The screening period is up to 14 days (and may be conditionally extended), starts at the date of signed informed consent, and ends on the day before the randomisation visit. Participants will be randomised in a 1:1 ratio to either AZD0780 or placebo for a treatment period of 52 weeks and a 10-day safety follow-up. Those randomised to the AZD0780 group will receive AZD0780 xx mg orally once daily during the treatment period, while those in the placebo group will receive matching placebo. The study will include approximately 2800 randomised participants. An independent data monitoring committee will, on a regular basis, review accumulating data from the study, evaluate adverse effects of the IMP, and make recommendations regarding whether to halt or modify the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD0780
Participants will receive daily oral dose of AZD0780
AZD0780
Participants will receive daily oral dose of AZD0780
Placebo
Participants will receive daily oral dose of placebo
Placebo
Participants will receive daily oral dose of placebo
Interventions
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AZD0780
Participants will receive daily oral dose of AZD0780
Placebo
Participants will receive daily oral dose of placebo
Eligibility Criteria
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Inclusion Criteria
* History of clinical ASCVD or at risk for a first ASCVD event:
1. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.
2. A participant is considered at risk for a first ASCVD event if the participant has one or more of the following conditions: atherosclerotic vascular disease (≥ 50% stenosis in ≥ 2 coronary artery territories or in ≥ 2 vascular beds \[coronary, carotid, lower extremity\], diagnosed by any imaging modality), diabetes mellitus, hypertension, cigarette smoking, chronic kidney disease (moderate to severe stage), or obesity. Investigators can also use the ACC/AHA or ESC or other relevant national clinical guidelines for risk assessment to identify participants with at least moderate risk for ASCVD.
* Fasting serum LDL-C by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in participants without clinical ASCVD but at risk for a first ASCVD event
* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid).
Thus, the background lipid-lowering therapy must consist of one of the following:
\- A high intensity LDL lowering regimen
(i) A high intensity statin regimen, as defined by country specific guidelines OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid :
OR:
\- A maximum tolerated statin regimen - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended.
Participants must achieve a stable background lipid lowering therapy \> 28 days before screening.
Exclusion Criteria
* Any of the following laboratory values at screening:
* Calculated eGFR \< 15 mL/min/1.73 m2
* AST or ALT \> 3 × ULN
* TBL \> 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN)
* Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L)
* Creatine kinase \> 5 × ULN
* Urine albumin-to-creatinine ratio ≥ 500 mg/g
* Uncontrolled type 2 diabetes mellitus defined as HbA1C ≥ 9.5% at screening
* Inadequately treated hypothyroidism defined as TSH \> 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening
* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study.
* Use of gemfibrozil within 1 week prior to screening or planned use during the study.
* Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks of the screening visit or planned use during the study or inclisiran within 18 months of the screening visit or planned use during the study. Any other approved PCSK-9 inhibitor use within 5 half-lives prior to the screening visit or planned use during the study.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Huntsville, Alabama, United States
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Irondale, Alabama, United States
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Mobile, Alabama, United States
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Sun City West, Arizona, United States
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Garden Grove, California, United States
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Gardena, California, United States
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Lancaster, California, United States
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Lincoln, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Torrance, California, United States
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West Hills, California, United States
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Hamden, Connecticut, United States
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Boca Raton, Florida, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Seminole, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Peachtree Corners, Georgia, United States
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Chicago, Illinois, United States
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Winfield, Illinois, United States
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Evansville, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Ames, Iowa, United States
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El Dorado, Kansas, United States
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Wichita, Kansas, United States
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Owensboro, Kentucky, United States
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Hammond, Louisiana, United States
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Kenner, Louisiana, United States
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Lafayette, Louisiana, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Zachary, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Beltsville, Maryland, United States
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Potomac, Maryland, United States
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Chesterfield, Missouri, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Missoula, Montana, United States
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Buffalo, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Morganton, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Salisbury, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Fargo, North Dakota, United States
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Blue Ash, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Lima, Ohio, United States
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Camp Hill, Pennsylvania, United States
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Horsham, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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Anderson, South Carolina, United States
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Fort Mill, South Carolina, United States
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Mauldin, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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North Charleston, South Carolina, United States
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Rapid City, South Dakota, United States
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Bristol, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Beaumont, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Irving, Texas, United States
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Katy, Texas, United States
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Mesquite, Texas, United States
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Paris, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Sugar Land, Texas, United States
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Charlottesville, Virginia, United States
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Hampton, Virginia, United States
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Norfolk, Virginia, United States
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Suffolk, Virginia, United States
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Redmond, Washington, United States
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CABA, , Argentina
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CABA, , Argentina
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Ciudad Autonoma de Bs As, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Godoy Cruz, , Argentina
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Mar del Plata, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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San Nicolás, , Argentina
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San Vicente, , Argentina
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Zárate, , Argentina
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Coffs Harbour, , Australia
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Ipswich, , Australia
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Joondalup, , Australia
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Leabrook, , Australia
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Liverpool, , Australia
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Maroubra, , Australia
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Melbourne, , Australia
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Woolloongabba, , Australia
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Brasília, , Brazil
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Campina Grande do Sul, , Brazil
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Campinas, , Brazil
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Goiânia, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Dupnitsa, , Bulgaria
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Dupnitsa, , Bulgaria
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Haskovo, , Bulgaria
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Sliven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Cambridge, Ontario, Canada
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Courtice, Ontario, Canada
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Guelph, Ontario, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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North York, Ontario, Canada
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North York, Ontario, Canada
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Sarnia, Ontario, Canada
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Stoney Creek, Ontario, Canada
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Stouffville, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Joliette, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Independencia, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Valdivia, , Chile
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Victoria, , Chile
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Benešov, , Czechia
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Brandýs nad Labem, , Czechia
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Chlumec nad Cidlinou, , Czechia
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České Budějovice, , Czechia
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Hodonín, , Czechia
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Jílové u Prahy, , Czechia
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Klatovy, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Praha Uhříněves, , Czechia
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Příbram, , Czechia
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Teplice, , Czechia
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Trutnov, , Czechia
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Uherské Hradiště, , Czechia
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Amberg, , Germany
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Bad Homburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Essen, , Germany
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Essen, , Germany
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Falkensee, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Greifswald, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Hohenmölsen, , Germany
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Kaiserslautern, , Germany
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Karlsruhe, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Mannheim, , Germany
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Markkleeberg, , Germany
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Munich, , Germany
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München, , Germany
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Münster, , Germany
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Münster, , Germany
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Nuremberg, , Germany
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Offenbach, , Germany
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Potsdam, , Germany
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Schwerin, , Germany
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Stuhr, , Germany
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Stuttgart, , Germany
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Wermsdorf, , Germany
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Witten, , Germany
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Balatonfüred, , Hungary
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Dunaújváros, , Hungary
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Kalocsa, , Hungary
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Kaposvár, , Hungary
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Nyíregyháza, , Hungary
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Nyíregyháza-Sóstóhegy, , Hungary
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Orosháza, , Hungary
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Pécs, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Székesfehérvár, , Hungary
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Zalaegerszeg, , Hungary
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Belagavi, , India
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Dehradun, , India
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Kanpur, , India
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Kochi, , India
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New Delhi, , India
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Ami-machi, , Japan
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Asahi-shi, , Japan
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Chūōku, , Japan
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Hamamatsu, , Japan
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Ichikawa-shi, , Japan
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Kanazawa, , Japan
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Kanazawa, , Japan
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Kasuya-gun, , Japan
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Kishiwada-shi, , Japan
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Kitakyushu, , Japan
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Komatsu-shi, , Japan
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Kure-shi, , Japan
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Minatoku, , Japan
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Minatoku, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Suwa-shi, , Japan
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Tamanashi, , Japan
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Tsukuba, , Japan
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Urasoe-Shi, , Japan
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Ushiku-shi, , Japan
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Utsunomiya, , Japan
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Yokohama, , Japan
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Bandar Aman Jaya, , Malaysia
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Ipoh, , Malaysia
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Kuching, , Malaysia
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Sarawak Miri, , Malaysia
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Seri Manjung, , Malaysia
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Sibu, , Malaysia
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Sungai Buloh, , Malaysia
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Bialystok, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Katowice, , Poland
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Kędzierzyn-Koźle, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Płock, , Poland
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Rzeszów, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Lučenec, , Slovakia
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Malacky, , Slovakia
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Námestovo, , Slovakia
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Prešov, , Slovakia
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Rožňava, , Slovakia
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Svidník, , Slovakia
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Vinica, , Slovakia
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Anyang-si, , South Korea
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Bucheon-si, , South Korea
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Busan, , South Korea
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Busan, , South Korea
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Changwon-si, , South Korea
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Cheonan-si, , South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Gangwon-do, , South Korea
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Goyang-si, , South Korea
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Gwangju, , South Korea
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Jeju City, , South Korea
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Jeonju, , South Korea
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Jinju, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Santiago(A Coruña), , Spain
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Seville, , Spain
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Seville, , Spain
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Seville, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Adana, , Turkey (Türkiye)
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Afyonkarahisar, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Eskişehir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Odunpazari, , Turkey (Türkiye)
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Yenimahalle, , Turkey (Türkiye)
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Chernivtsi, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Chesterfield, , United Kingdom
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Chippenham, , United Kingdom
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Corby, , United Kingdom
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Coventry, , United Kingdom
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Harrow, , United Kingdom
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Hull, , United Kingdom
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London, , United Kingdom
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Northwood, , United Kingdom
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Orpington, , United Kingdom
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Poole, , United Kingdom
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Rotherham, , United Kingdom
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Shipley, , United Kingdom
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Thetford, , United Kingdom
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Trowbridge, , United Kingdom
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Weston-super-Mare, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hochiminh, , Vietnam
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Huế, , Vietnam
Countries
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Other Identifiers
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2025-520521-21
Identifier Type: REGISTRY
Identifier Source: secondary_id
D7960C00012
Identifier Type: -
Identifier Source: org_study_id
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