Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
NCT ID: NCT04609878
Last Updated: 2025-04-20
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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COMPLETED
PHASE3
2274 participants
INTERVENTIONAL
2020-12-15
2025-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
BGF MDI 320/28.8/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
BGF MDI 320/14.4/9.6 μg
BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
BGF MDI 320/14.4/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)
BFF MDI 320/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler
Symbicort®
Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg
BFF pMDI 320/9 μg
Budesonide/formoterol fumarate pressurized metered dose inhaler
Interventions
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BGF MDI 320/28.8/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
BGF MDI 320/14.4/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
BFF MDI 320/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler
BFF pMDI 320/9 μg
Budesonide/formoterol fumarate pressurized metered dose inhaler
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Saraland, Alabama, United States
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Phoenix, 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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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Covina, California, United States
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Encinitas, California, United States
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Fresno, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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San Diego, California, United States
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Stockton, California, United States
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Thousand Oaks, California, United States
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Upland, California, United States
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Westminster, California, United States
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Colorado Springs, Colorado, United States
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Lakewood, Colorado, United States
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Brandon, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Adairsville, Georgia, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Lawrenceville, Georgia, United States
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Rincon, Georgia, United States
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Savannah, Georgia, United States
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Tyrone, Georgia, United States
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Chicago, Illinois, United States
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River Forest, Illinois, United States
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Brownsburg, Indiana, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Crowley, Louisiana, United States
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Lafayette, Louisiana, United States
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Lake Charles, Louisiana, United States
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Bangor, Maine, United States
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Potomac, Maryland, United States
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Waldorf, Maryland, United States
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Boston, Massachusetts, United States
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Hannibal, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Bellevue, Nebraska, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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New Hyde Park, New York, United States
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New Windsor, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Denver, North Carolina, United States
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Gastonia, North Carolina, United States
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Raleigh, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Maumee, Ohio, United States
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Toledo, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Grants Pass, Oregon, United States
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DuBois, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Anderson, South Carolina, United States
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Greenville, South Carolina, United States
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North Charleston, South Carolina, United States
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Franklin, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Boerne, Texas, United States
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Cypress, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kerrville, Texas, United States
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Lampasas, Texas, United States
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Nederland, Texas, United States
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Pearland, Texas, United States
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Red Oak, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Spring, Texas, United States
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Tomball, Texas, United States
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Ogden, Utah, United States
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West Valley City, Utah, United States
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Colchester, Vermont, United States
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Manassas, Virginia, United States
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Kingwood, West Virginia, United States
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Morgantown, West Virginia, United States
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Cudahy, Wisconsin, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Florida, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Ranelagh, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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San Fernando, , Argentina
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Liège, , Belgium
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Namur, , Belgium
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Dupnitsa, , Bulgaria
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Dupnitsa, , Bulgaria
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Haskovo, , Bulgaria
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Kozloduy, , Bulgaria
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Lovech, , Bulgaria
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Pazardzhik, , Bulgaria
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Petrich, , Bulgaria
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Pleven, , Bulgaria
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Rousse, , Bulgaria
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Rousse, , Bulgaria
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Sevlievo, , Bulgaria
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Sliven, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Vidin, , Bulgaria
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Vratsa, , Bulgaria
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Edmonton, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Ajax, Ontario, Canada
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Curicó, , Chile
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Quillota, , 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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Talca, , Chile
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Edelény, , Hungary
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Encs, , Hungary
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Gödöllő, , Hungary
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Hajdúnánás, , Hungary
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Komárom, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Szeged, , Hungary
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Szigetvár, , Hungary
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Ahmedabad, , India
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Aligarh, , India
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Belagavi, , India
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Coimbatore, , India
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Dehradun, , India
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Gurgaon, , India
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Jaipur, , India
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Mohali, , India
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Nagpur, , India
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New Delhi, , India
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New Delhi, , India
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New Delhi, , India
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Thāne, , India
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Visakhapatnam, , India
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Bari, , Italy
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Casatenovo, , Italy
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Cona, , Italy
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Monserrato, , Italy
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Napoli, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Chino-shi, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Fukui-shi, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Habikino-shi, , Japan
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Hamamatsu, , Japan
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Higashiibaraki-gun, , Japan
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Himeji-shi, , Japan
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Hiroshima-shi, Naka-ku, , Japan
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Hitachi-Naka, , Japan
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Ikoma-shi, , Japan
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Kishiwada-shi, , Japan
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Kitakyushu, , Japan
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Kiyose-shi, , Japan
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Kokubunji-shi, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Meguro-ku, , Japan
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Nagoya, , Japan
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Nankoku-shi, , Japan
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Obihiro, , Japan
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Omuta-shi, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Ōita, , Japan
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Saga, , Japan
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Sakaide-shi, , Japan
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Sapporo, , Japan
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Setagaya-ku, , Japan
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Setagaya-ku, , Japan
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Shibuya-ku, , Japan
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Shimotsuga-gun, , Japan
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Shinagawa-ku, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Takarazuka-shi, , Japan
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Tanabe-shi, , Japan
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Toon-shi, , Japan
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Toshima-ku, , Japan
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Toshima-ku, , Japan
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Toshima-ku, , Japan
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Tsuchiura-shi, , Japan
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Utsunomiya, , Japan
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Yanagawa-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Auckland, , New Zealand
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Grafton, , New Zealand
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Nawton, , New Zealand
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Nelson, , New Zealand
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Rotorua, , New Zealand
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Wellington, , New Zealand
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Piura, , Peru
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Baguio City, , Philippines
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Davao City, , Philippines
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Iloilo City, , Philippines
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Las Piñas, , Philippines
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Lipa City, , Philippines
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Los Baños, , Philippines
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Manila, , Philippines
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Manila, , Philippines
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Marilao, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Częstochowa, , Poland
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Karczew, , Poland
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Katowice, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Piaseczno, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Rzeszów, , Poland
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Rzeszów, , Poland
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Sosnowiec, , Poland
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Sosnowiec, , Poland
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Strzelce Opolskie, , Poland
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Szczecin, , Poland
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Tarnów, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Caguas, , Puerto Rico
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Guaynabo, , Puerto Rico
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San Juan, , Puerto Rico
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Brasov, , Romania
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Brasov, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Timișoara, , Romania
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Cheongju-si, , South Korea
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Gangwon-do, , South Korea
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Jeonju, , 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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Suwon, , South Korea
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Uijeongbu-si, , South Korea
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Ulsan, , South Korea
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Barcelona, , Spain
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Benalmádena, , Spain
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Coslada, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Marbella (Málaga), , Spain
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Málaga, , Spain
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Pozuelo de Alarcón, , Spain
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Santander, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Zaragoza, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bang Kra So, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chanthaburi, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Muang, , Thailand
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Mueang, , Thailand
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Hanoi, , Vietnam
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Hà Nội, , 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
Countries
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References
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Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Other Identifiers
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2023-505787-11
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-001520-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5982C00007
Identifier Type: -
Identifier Source: org_study_id
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