Triple-drug inhaler aims to tame severe asthma in teens and adults

NCT ID NCT04609878

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether a three-in-one inhaler (budesonide, glycopyrronium, and formoterol) works better than two standard two-drug inhalers for people with asthma that is not well controlled. Adults and adolescents aged 12 to 80 with moderate-to-severe asthma will use the triple inhaler or one of the comparison inhalers for up to 24 weeks. The main goals are to measure improvements in lung function and reductions in severe asthma attacks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
What this could lead to: If successful, this triple-combination inhaler could offer better asthma control and fewer severe attacks for people whose current treatment isn't enough.
What could go wrong: This is a large Phase 3 trial, but results may not apply to everyone. The added benefit over existing dual therapies may be modest, and side effects from the extra drug are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,274 people

The number who actually took part.

Started

Dec 2020

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control. 2. Documented history of physician-diagnosed asthma \> and/or = 1 year prior to V1. 3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1. 4. ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization). 5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization) * Participants ≥ 18 years of age: \< 80% * Participants 12 to \<18 years of age: \< 90% 6. FEV1 post-albuterol at V2 or V3 (if repeat needed). * Participants \> and/or = 18 years of age: Increase \> and/or = 12% and \> and/or = 200 mL. * Participants 12 to \<18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3. * Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization. 7. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol. 8. Demonstrate acceptable MDI/pMDI administration technique. 9. Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation). 10. eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization). 11. No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization. Exclusion Criteria: 1\. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1. 2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate. 2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration. 3\. Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana). 4\. Current evidence of Chronic Obstructive Pulmonary Disease (COPD). 5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1. 5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study. 5c. Depot corticosteroid use for any reason within 3 months of V1. 6\. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1. 7\. Use of oral beta2-agonist within 3 months of V1. 8\. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration. 9\. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1. 10\. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s). 11\. Hospitalization for asthma within 2 months of Visit 1. 12\. Known history of drug or alcohol abuse within 12 months of Visit 1. 13\. Regular use of a nebulizer or a home nebulizer for receiving asthma medications. 14\. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration. 15\. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration. 16\. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI. 17\. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members. 18\. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator. Please refer to the study protocol for the complete inclusion and exclusion criteria list.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

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Saraland, Alabama, 36571, United States
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Phoenix, Arizona, 85018, United States
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Phoenix, Arizona, 85027, United States
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Sun City West, Arizona, 85375, United States
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Tucson, Arizona, 85715, United States
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Tucson, Arizona, 85745, United States
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Little Rock, Arkansas, 72209, United States
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Covina, California, 91723, United States
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Encinitas, California, 92024, United States
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Fresno, California, 93701, United States
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Laguna Hills, California, 92653, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90027, United States
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Mission Hills, California, 91345, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91324, United States
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San Diego, California, 92119, United States
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Stockton, California, 95207, United States
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Thousand Oaks, California, 91360, United States
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Upland, California, 91786, United States
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Westminster, California, 92683, United States
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Colorado Springs, Colorado, 80923, United States
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Lakewood, Colorado, 80228, United States
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Brandon, Florida, 33511, United States
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Miami, Florida, 33175, United States
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Tampa, Florida, 33607, United States
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Adairsville, Georgia, 30103, United States
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Atlanta, Georgia, 30344, United States
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Columbus, Georgia, 31904, United States
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Lawrenceville, Georgia, 30046, United States
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Rincon, Georgia, 31326, United States
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Savannah, Georgia, 31406, United States
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Tyrone, Georgia, 30290, United States
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Chicago, Illinois, 60657, United States
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River Forest, Illinois, 60305, United States
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Brownsburg, Indiana, 46112, United States
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Indianapolis, Indiana, 46202, United States
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Louisville, Kentucky, 40217, United States
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Crowley, Louisiana, 70526, United States
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Lafayette, Louisiana, 70508, United States
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Lake Charles, Louisiana, 70601, United States
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Bangor, Maine, 04401, United States
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Potomac, Maryland, 20854, United States
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Waldorf, Maryland, 20601, United States
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Boston, Massachusetts, 02115, United States
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Hannibal, Missouri, 63401, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59808, United States
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Bellevue, Nebraska, 68123, United States
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Lincoln, Nebraska, 68510, United States
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Las Vegas, Nevada, 89106, United States
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Toms River, New Jersey, 08755, United States
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Albuquerque, New Mexico, 87108, United States
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New Hyde Park, New York, 11042, United States
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New Windsor, New York, 12553, United States
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New York, New York, 10016, United States
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The Bronx, New York, 10455, United States
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Charlotte, North Carolina, 28277, United States
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Denver, North Carolina, 28037, United States
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Gastonia, North Carolina, 28054, United States
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Raleigh, North Carolina, 27607, United States
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Fargo, North Dakota, 58104, United States
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Cincinnati, Ohio, 45229, United States
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Cincinnati, Ohio, 45231, United States
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Maumee, Ohio, 43537, United States
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Toledo, Ohio, 43617, United States
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Edmond, Oklahoma, 73034, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74133, United States
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Grants Pass, Oregon, 97527, United States
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DuBois, Pennsylvania, 15801, United States
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Pittsburgh, Pennsylvania, 15236, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Scottdale, Pennsylvania, 15683, United States
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Smithfield, Pennsylvania, 15478, United States
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East Providence, Rhode Island, 02914, United States
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Anderson, South Carolina, 29621, United States
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Greenville, South Carolina, 29607, United States
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North Charleston, South Carolina, 29406, United States
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Franklin, Tennessee, 37067, United States
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Amarillo, Texas, 79106, United States
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Austin, Texas, 78759, United States
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Boerne, Texas, 78006, United States
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Cypress, Texas, 77429, United States
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Dallas, Texas, 75231, United States
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El Paso, Texas, 79912, United States
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Harlingen, Texas, 78550, United States
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Houston, Texas, 77021, United States
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Houston, Texas, 77030, United States
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Kerrville, Texas, 78028, United States
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Lampasas, Texas, 76550, United States
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Nederland, Texas, 77627, United States
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Pearland, Texas, 77584, United States
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Red Oak, Texas, 75154, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Spring, Texas, 77386, United States
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Tomball, Texas, 77375, United States
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Ogden, Utah, 84404, United States
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West Valley City, Utah, 84120, United States
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Colchester, Vermont, 05446, United States
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Manassas, Virginia, 20110, United States
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Kingwood, West Virginia, 26537, United States
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Morgantown, West Virginia, 26505, United States
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Cudahy, Wisconsin, 53110, United States
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Buenos Aires, C1121ABE, Argentina
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CABA, 1056, Argentina
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, 1425, Argentina
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Ciudad de Buenos Aires, C1280AEB, Argentina
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Ciudad de Buenos Aires, C1414AIF, Argentina
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Córdoba, X5003DCE, Argentina
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Florida, B1602DQD, Argentina
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Mar del Plata, 7600, 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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Rosario, S2000DEJ, Argentina
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San Fernando, B1646EBJ, Argentina
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Liège, 4000, Belgium
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Namur, 5101, Belgium
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Dupnitsa, 2600, Bulgaria
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Dupnitsa, 2602, Bulgaria
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Haskovo, 6305, Bulgaria
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Kozloduy, 3320, Bulgaria
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Lovech, 5500, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Petrich, 2850, Bulgaria
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Pleven, 5800, Bulgaria
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Rousse, 7000, Bulgaria
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Rousse, 7002, Bulgaria
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Sevlievo, 5403, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 3700, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1421, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Vidin, 3700, Bulgaria
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Vratsa, 3000, Bulgaria
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Edmonton, Alberta, T5A 4L8, Canada
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Sherwood Park, Alberta, T8H 2M7, Canada
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Kelowna, British Columbia, V1Y 4N7, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Winnipeg, Manitoba, R2V 4W3, Canada
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Winnipeg, Manitoba, R3L 1Z5, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Hamilton, Ontario, L8S 1G5, Canada
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London, Ontario, N6A 1V2, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Niagara Falls, Ontario, L2H 1H5, Canada
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Toronto, Ontario, M5G 1E2, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4W2, Canada
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Québec, Quebec, G2J 0C4, Canada
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Chile, 7770484, Chile
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Curicó, 3341643, Chile
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Quillota, 2260000, Chile
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Santiago, 7500571, Chile
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Santiago, 7500698, Chile
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Santiago, 8207257, Chile
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Talca, 3481349, Chile
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Balassagyarmat, 2660, Hungary
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Budapest, 1204, 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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Komárom, 2900, Hungary
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Pécs, 7635, Hungary
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Szeged, 6720, Hungary
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Szeged, 6722, Hungary
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Szigetvár, 7900, Hungary
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Ahmedabad, 382415, India
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Aligarh, 202002, India
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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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Gurgaon, 122001, India
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Jaipur, 302039, India
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Mohali, 160062, India
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Nagpur, 440012, India
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New Delhi, 110029, India
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New Delhi, 110060, India
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New Delhi, 110075, India
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Thane, 401107, India
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Visakhapatnam, 530002, India
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Bari, 70124, Italy
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Casatenovo, 23880, Italy
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Cona, 44124, Italy
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Monserrato, 09042, Italy
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Naples, 80131, Italy
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Pisa, 56100, Italy
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Roma, 00133, Italy
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Roma, 00168, Italy
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Chino-shi, 391-0011, Japan
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Chūōku, 103-0022, Japan
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Chūōku, 103-0027, Japan
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Chūōku, 104-0031, Japan
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Fukui-shi, 910-8526, Japan
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Fukuoka, 811-1394, Japan
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Fukuoka, 819-8555, Japan
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Habikino-shi, 583-8588, Japan
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Hamamatsu, 431-3192, Japan
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Higashiibaraki-gun, 311-3117, Japan
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Himeji-shi, 672-8064, Japan
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Hiroshima-shi, Naka-ku, 730-0853, Japan
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Hitachi-Naka, 312-0057, Japan
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Ikoma-shi, 630-0293, Japan
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Kishiwada-shi, 596-8501, Japan
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Kitakyushu, 802-0052, Japan
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Kiyose-shi, 204-8585, Japan
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Kokubunji-shi, 185-0014, Japan
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Kyoto, 601-8213, Japan
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Kyoto, 612-8555, Japan
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Meguro-ku, 153-0051, Japan
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Nagoya, 457-0866, Japan
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Nankoku-shi, 783-8509, Japan
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Obihiro, 080-0017, Japan
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Omuta-shi, 837-0911, Japan
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Osaka, 530-0001, Japan
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Osaka, 531-0073, Japan
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Osaka, 551-0032, Japan
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Ōita, 870-8511, Japan
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Saga, 849-0917, Japan
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Sakaide-shi, 762-8550, Japan
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Sapporo, 064-0804, Japan
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Setagaya-ku, 157-0072, Japan
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Setagaya-ku, 158-0097, Japan
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Shibuya-ku, 150-0013, Japan
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Shimotsuga-gun, 321-0293, Japan
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Shinagawa-ku, 140-0001, Japan
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Shinagawa-ku, 140-8522, Japan
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Shinjuku-ku, 160-0004, Japan
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Shinjuku-ku, 160-8582, Japan
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Takarazuka-shi, 665-0827, Japan
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Tanabe-shi, 646-8558, Japan
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Toon-shi, 791-0281, Japan
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Toshima-ku, 170-0002, Japan
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Toshima-ku, 170-0003, Japan
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Toshima-ku, 171-0014, Japan
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Tsuchiura-shi, 300-8585, Japan
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Utsunomiya, 329-1193, Japan
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Yanagawa-shi, 832-0059, Japan
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Yokohama, 223-0059, Japan
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Yokohama, 231-8682, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 240-8555, Japan
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Auckland, 0626, New Zealand
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Grafton, 1010, New Zealand
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Nawton, 3200, New Zealand
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Nelson, 7011, New Zealand
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Rotorua, 3040, New Zealand
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Wellington, 6021, New Zealand
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Lima, 15036, Peru
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Lima, 15046, Peru
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Lima, 15088, Peru
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Lima, 15131, Peru
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Lima, LIMA 21, Peru
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Lima, LIMA 31, Peru
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Piura, 20001, Peru
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Baguio City, 2600, Philippines
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Davao City, PH-8000, Philippines
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Iloilo City, 5000, Philippines
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Las Piñas, 1742, Philippines
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Lipa City, 4217, Philippines
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Los Baños, 4030, Philippines
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Manila, 1000, Philippines
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Manila, 1014, Philippines
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Marilao, 3019, Philippines
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Quezon City, 1101, Philippines
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Quezon City, Philippines
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Bialystok, 15-044, Poland
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Bialystok, 15-430, Poland
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Bydgoszcz, 85-079, Poland
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Częstochowa, 42-217, Poland
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Karczew, 05-480, Poland
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Katowice, 40-648, Poland
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Kielce, 25-734, Poland
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Krakow, 30-727, Poland
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Krakow, 31-011, Poland
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Krakow, 31-141, Poland
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Piaseczno, 05-500, Poland
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Poznan, 60-214, Poland
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Poznan, 60-693, Poland
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Poznan, 61-578, Poland
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Rzeszów, 35-051, Poland
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Rzeszów, 35-055, Poland
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Rzeszów, 35-205, Poland
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Sosnowiec, 41-200, Poland
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Sosnowiec, 41-208, Poland
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Strzelce Opolskie, 47-100, Poland
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Szczecin, 70-111, Poland
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Tarnów, 33-100, Poland
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Wroclaw, 53-301, Poland
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Wroclaw, 54-239, Poland
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Caguas, 00726, Puerto Rico
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Guaynabo, 00968, Puerto Rico
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San Juan, 00918, Puerto Rico
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Brasov, 500051, Romania
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Brasov, 500283, Romania
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Brasov, 500366, Romania
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Bucharest, 050159, Romania
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Timișoara, 300002, Romania
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Cheongju-si, 28644, South Korea
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Gangwon-do, 26426, South Korea
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Jeonju, 54907, South Korea
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Seoul, 03312, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Suwon, 16499, South Korea
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Uijeongbu-si, 11765, South Korea
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Ulsan, 44033, South Korea
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Barcelona, 08017, Spain
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Benalmádena, 29631, Spain
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Coslada, 28822, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Marbella (Málaga), 29603, Spain
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Málaga, 29010, Spain
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Pozuelo de Alarcón, 28223, Spain
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Santander, 39008, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Zaragoza, 50015, Spain
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Changhua, 50006, Taiwan
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 833, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 110, Taiwan
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Taoyuan, Taiwan
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Bang Kra So, 11000, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chanthaburi, 22000, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 55000, Thailand
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Mueang, 20000, Thailand
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Hochiminh, 700000, Vietnam

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