Phase
Condition
Asthma
Treatment
BGF MDI 320/14.4/9.6 μg
BFF MDI 320/9.6 μg
BGF MDI 320/28.8/9.6 μg
Clinical Study ID
Ages 12-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not ofchildbearing potential or using a form of highly effective birth control.
Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) withmedium-to-high ICS doses for at least 4 weeks prior to V1.
ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
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 > and/or = 18 years of age: < 80%
Participants 12 to <18 years of age: < 90%
- FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants > and/or = 18years of age: Increase > and/or = 12% and > and/or = 200 mL.
Participants 12 to <18 years of age: Increase =12% either in the 12 monthsprior to Visit 1 or at Visit 2, or at Visit 3.
Note: Even if there is documented history of reversibility, all participantsmust be assessed for reversibility at Visit 2 (and Visit 3, if reversibility isnot demonstrated at Visit 2) to provide reversibility baseline data forcharacterization.
Willing and, in the opinion of the Investigator, able to adjust current asthmatherapy, as required by the protocol.
Demonstrate acceptable MDI/pMDI administration technique.
Received no asthma medication other than run-in BFF MDI BID and albuterol as neededduring screening (except for allowed medications as defined in Table 9 and systemiccorticosteroid or ICS for the treatment of an asthma exacerbation).
eDiary 14-day compliance ≥70% during screening (defined as completing the dailyeDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffsof run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior torandomization).
No respiratory infection in the 4 weeks prior to randomization, or asthmaexacerbation treated with systemic corticosteroid and/or additional ICS treatment inthe 4 weeks prior to randomization.
Exclusion
Exclusion Criteria:
- Completed treatment for respiratory infection or asthma exacerbation with systemiccorticosteroids 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 halflives of V1, whichever is longer and must not be used during study duration.
Current smokers, former smokers with >10 pack-years history, or former smokers whostopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettesor other vaping devices, and marijuana).
Current evidence of 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.
Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12weeks prior to Visit 1.
Use of oral beta2-agonist within 3 months of V1.
Use of any immunomodulators or immunosuppressive medication within 3 months or 5half-lives, whichever is longer, and must not be used during the study duration.
Narrow angle glaucoma not adequately treated and/or change in vision that may berelevant, in the opinion of the Investigator, within 3 months of Visit 1.
Life-threatening asthma defined as a history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest, hypoxicseizures, or asthma-related syncopal episode(s).
Hospitalization for asthma within 2 months of Visit 1.
Known history of drug or alcohol abuse within 12 months of Visit 1.
Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 anddoes not agree to stop during the study duration.
Participation in another clinical study with a study intervention administered inthe last 30 days or 5 half-lives, whichever is longer. Any other study interventionthat is not identified in the protocol is prohibited for use during study duration.
Participants with a known hypersensitivity to beta2-agonists, corticosteroids,anticholinergics, or any component of the MDI or pMDI.
Study Investigators, sub-Investigators, coordinators, and their employees orimmediate family members.
For women only - currently pregnant (confirmed with positive highly sensitivepregnancy test), breast-feeding, or planned pregnancy during the study or not usingacceptable contraception measures, as judged by the Investigator.
Please refer to the study protocol for the complete inclusion and exclusion criteria list
Study Design
Study Description
Connect with a study center
Research Site
Bludenz, 6700
AustriaSite Not Available
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Feldbach, A-8330
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Linz, 4020
AustriaSite Not Available
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Thalheim, 4600
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Belo Horizonte, 30380-090
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Blumenau, 89030-101
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Botucatu, 18618-970
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Goiania, 74110 030
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Maringa, 87015-000
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Porto Alegre, 90430-001
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Rio de Janeiro, 21949-900
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Santo Andre, 09080-110
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Sao Bernardo do Campo, 09750-420
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Sorocaba, 18040-425
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São Paulo, 05403-000
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Uberlandia, 38411-186
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Anhui, 230061
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Baotou, 014010
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Beijing, 100020
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Bengbu, 233060
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Changchun,
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Changsha, 430033
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Changzhi, 46000
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Chengdu, 610072
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Chifeng, 024000
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Chizhou, 247099
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Chongqing, 400038
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Chuangchun, 130041
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Dongguan, 523413
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Dongyang, 322100
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Fuzhou, 350025
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Gongguan,
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Guangzhou, 510280
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Guiyang, 550004
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Haikou, 570208
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Hangzhou, 310009
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Hefei, 230000
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Hohhot, 010017
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Huai'an, 223300
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Huizhou, 516001
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Jinan, 250014
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Jinhua, 321000
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Jining, 272029
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Jiujiang, 332000
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Kunming, 650051
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Lanzhou, 730000
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Liuzhou, 545006
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Luoyang, 471003
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Nan Chong, 637000
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Nanchang, 330006
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Nanjing, 210009
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Nanning, 530021
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Nantong, 226001
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Qingdao, 266000
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Quanzhou, 362000
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Shanghai, 200025
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Shangrao, 334000
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Shantou, 515041
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Shaoxing, 312000
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Shengyang, 110004
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Shenyang, 110015
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Shenzhen, 518039
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Shihezi, 830000
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Shijiazhuang, 50051
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Tai'an, 271000
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Taiyuan, 030001
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Taizhou, 318020
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Urumqi, 830054
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Wenzhou, 325027
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Wuhan, 430010
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Wuhu, 241000
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Wulumuqi,
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Xian, 710061
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Xinxiang, 453002
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Xuzhou, 221000
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Yangzhou, 225001
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Yantai, 264000
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Yinchuan, 750001
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Yueyang, 414000
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Zhangzhou, 363099
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Zhanjiang, 524001
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Zhengzhou, 450000
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Zhengzhou City, 450000
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Zhuji, 311899
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Zibo, 255200
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Barranquilla, 080020
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Bogota, 110221
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Cartagena, 130013
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Manizales, 17001
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Medellin, 050621
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Rionegro, 054047
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San Gil, 684031
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San José, 10103
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Santa Ana, 10903
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Brandys nad Labem, 250 01
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Jindrichuv Hradec, 377 01
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Liberec, 460 01
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Lovosice, 410 02
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Mlada Boleslav, 293 01
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Novy Bor, 473 01
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Praha 11, 148 00
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Praha 9, 190 00
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Rokycany, 337 22
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Strakonice, 38601
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Teplice, 415 01
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Varnsdorf, 407 47
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Bamberg, 96049
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Berlin, 12203
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Darmstadt, 64283
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Duisburg, 47057
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Frankfurt, 60596
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Frankfurt am Main, 60596
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Frankfurt/Main, 60389
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Fürstenwalde/Spree, 15517
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Geesthacht, 21502
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Hannover, 30449
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Heidelberg, 69115
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Koblenz, 56068
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Landsberg, 86899
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Leipzig, 04207
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Mainz, 55128
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Marburg, 35037
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München-Pasing, 81241
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Alexandroupolis, 68100
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Corfu, 49100
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Exohi Thessaloniki, 57010
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Heraklion, 71110
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Ioannina, 45500
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Patras, 26500
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Thessaloniki, 56429
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Ashqelon, 7830604
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Be'er Ya'akov, 70300
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Beer Sheva, 84101
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Haifa, 34362
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Holon, 5837738
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Jerusalem, 9103102
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Kfar Saba, 4428164
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Petach-Tikva, 4920235
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Petah Tikva, 4920235
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Ramat-Gan, 52621
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Rehovot, 76100
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Tel Aviv, 6423906
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Ciudad de Mexico, 6700
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Durango, 43080
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Guadalajara, 44200
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Puebla, 72190
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San Luis Potosí, 78250
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Veracruz, 91910
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Villahermosa, 86035
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Zapopan, 45138
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Amadora, 2720-276
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Barcelos, 4750-333
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Braga, 4710
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Coimbra, 3040-316
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Figueira da Foz, 3094-001
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Guarda, 6300-035
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Guimaraes, 4835-044
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Lisboa, 1649-035
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Matosinhos, 4454-509
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Vila Nova de Gaia, 4434-502
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Ponce, 00780
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Barnaul, 656045
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Chelyabinsk, 454106
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Izhevsk, 426035
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Kazan, 420008
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Kemerovo, 650002
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Kirov, 610014
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Moscow, 115522
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Omsk, 644050
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Penza, 440067
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Perm, 614000
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Saint Petersburg, 194354
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Saratov, 410028
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St. Petersburg, 197022
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Tomsk, 634050
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Ulyanovsk, 432009
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Yekaterinburg, 620149
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Ar Riyāḑ, 11426
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Dhahran, 131932
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Jeddah, 21423
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Makkah, 24246
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Riyadh, 1121
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Bardejov, 085 01
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Bojnice, 972 01
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Humenne, 066 01
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Kezmarok, 060 01
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Kosice, 04022
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Levice, 934 01
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Liptovsky Hradok, 03301
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Nove Zamky, 94001
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Poprad, 058 01
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Presov, 081 81
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Ruzomberok, 034 26
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Surany, 94201
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Topolcany, 95501
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Zilina, 010 01
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Bellville, 7530
South AfricaSite Not Available
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Bloemfontein, 9301
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Cape Town, 7700
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Durban, 4091
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Johannesburg, 2001
South AfricaSite Not Available
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Lenasia, 1821
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Lenasia Ext8, 1820
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Lenasia South, 1835
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Panorama, 7500
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Parow, 7505
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Pretoria, 0186
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Soweto, 2013
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Tygervalley, 7530
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Umkomaas, 4170
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Lund, 222 22
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Solna, 17164
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Stockholm, 111 20
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Uppsala, 75237
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Adana, 1260
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Ankara, 06
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Bursa, 16059
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Istanbul, 34098
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Izmir, 35110
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Manisa, 45030
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Mersin, 33343
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Pamukkale, 20070
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İstanbul, 34844
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Blackpool, FY3 7EN
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Bradford, BD9 6RJ
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Corby, NN17 2UR
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Hull, HU16 5JQ
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Leicester, LE5 4LJ
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Rhyl, LL18 1DA
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York, YO24 3WX
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Muscle Shoals, Alabama 35661
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Chandler, Arizona 85224
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Anaheim, California 92805
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Rancho Cucamonga, California 91730
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Roseville, California 95661
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Sacramento, California 95823
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San Diego, California 92123
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Ventura, California 93003
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Walnut Creek, California 94598
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Centennial, Colorado 80112
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Colorado Springs, Colorado 80910
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Wheat Ridge, Colorado 80033
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Farmington, Connecticut 06030
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Newark, Delaware 19713
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Boca Raton, Florida 33487
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Clearwater, Florida 33756
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Cutler Bay, Florida 33189
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Davenport, Florida 33896
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DeBary, Florida 32713
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Hialeah, Florida 33016
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Kissimmee, Florida 34746
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Lakeland, Florida 33813
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Miami, Florida 33135
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Miami Lakes, Florida 33016
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North Port, Florida 34287
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Ocala, Florida 34471
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Orlando, Florida 32807
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Ormond Beach, Florida 32174
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Panama City, Florida 32405
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Pembroke Pines, Florida 33024
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Saint Petersburg, Florida 33704
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Tampa, Florida 33615
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Acworth, Georgia 30101
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Alpharetta, Georgia 30022
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Atlanta, Georgia 30350
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Buford, Georgia 30518
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Fayetteville, Georgia 30214
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Griffin, Georgia 30224
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Hinesville, Georgia 31313
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Johns Creek, Georgia 30022
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Newnan, Georgia 30265
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Peachtree City, Georgia 30269
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Peachtree Corners, Georgia 30071
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Snellville, Georgia 30078
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Stone Mountain, Georgia 30083
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Boise, Idaho 83706
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Chicago, Illinois 60621
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Normal, Illinois 61761
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Peoria, Illinois 61636
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Springfield, Illinois 62704
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White Marsh, Maryland 21162
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Bloomfield Hills, Michigan 48301
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United StatesSite Not Available
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North Massapequa, New York 11758
United StatesSite Not Available
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Port Jefferson, New York 11766
United StatesSite Not Available
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Charlotte, North Carolina 28226
United StatesSite Not Available
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Elizabeth City, North Carolina 27909
United StatesSite Not Available
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Greensboro, North Carolina 27405
United StatesSite Not Available
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High Point, North Carolina 27262
United StatesSite Not Available
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Huntersville, North Carolina 28078
United StatesSite Not Available
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Monroe, North Carolina 28112
United StatesSite Not Available
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Columbus, Ohio 43215
United StatesSite Not Available
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Oklahoma City, Oklahoma 73106
United StatesSite Not Available
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Portland, Oregon 97202
United StatesSite Not Available
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Hatboro, Pennsylvania 19040
United StatesSite Not Available
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Jenkintown, Pennsylvania 19046
United StatesSite Not Available
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Philadelphia, Pennsylvania 19107
United StatesSite Not Available
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Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
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Johnston, Rhode Island 02919
United StatesSite Not Available
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Rock Hill, South Carolina 29732
United StatesSite Not Available
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Spartanburg, South Carolina 29303
United StatesSite Not Available
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Hendersonville, Tennessee 37075
United StatesSite Not Available
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Knoxville, Tennessee 37909
United StatesSite Not Available
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Allen, Texas 75013
United StatesSite Not Available
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Amarillo, Texas 79106
United StatesSite Not Available
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Andrews, Texas 79714
United StatesSite Not Available
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Austin, Texas 78704
United StatesSite Not Available
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Cedar Park, Texas 78613
United StatesSite Not Available
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Conroe, Texas 77384
United StatesSite Not Available
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Corsicana, Texas 75110
United StatesSite Not Available
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Dallas, Texas 75254
United StatesSite Not Available
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Denison, Texas 75020
United StatesSite Not Available
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Forney, Texas 75126
United StatesSite Not Available
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Houston, Texas 77074
United StatesSite Not Available
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Lewisville, Texas 75067
United StatesSite Not Available
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McAllen, Texas 78504
United StatesSite Not Available
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McKinney, Texas 75069
United StatesSite Not Available
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Mesquite, Texas 75149
United StatesSite Not Available
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North Richland Hills, Texas 76180
United StatesSite Not Available
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Pearland, Texas 77584
United StatesSite Not Available
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Pflugerville, Texas 78660
United StatesSite Not Available
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Pharr, Texas 78577
United StatesSite Not Available
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Plano, Texas 75093
United StatesSite Not Available
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Richardson, Texas 75080
United StatesSite Not Available
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San Antonio, Texas 78258
United StatesSite Not Available
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Sugar Land, Texas 77478
United StatesSite Not Available
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Tomball, Texas 77375
United StatesSite Not Available
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Victoria, Texas 77901
United StatesSite Not Available
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Roy, Utah 84067
United StatesSite Not Available
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Abingdon, Virginia 24210
United StatesSite Not Available
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Burke, Virginia 22015
United StatesSite Not Available
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Richmond, Virginia 23114
United StatesSite Not Available
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Williamsburg, Virginia 23188
United StatesSite Not Available
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Greenfield, Wisconsin 53228
United StatesSite Not Available
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Milwaukee, Wisconsin 53228
United StatesSite Not Available
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