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NCT04609904
PHASE3

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.

Official title: A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma

Key Details

Gender

All

Age Range

12 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

2187

Start Date

2021-03-01

Completion Date

2025-03-20

Last Updated

2026-07-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

BGF MDI 320/28.8/9.6 μg

Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler

DRUG

BGF MDI 320/14.4/9.6 μg

Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler

DRUG

BFF MDI 320/9.6 μg

Budesonide and formoterol fumarate metered dose inhaler

DRUG

BFF pMDI 320/9 μg

Budesonide/formoterol fumarate pressurized metered dose inhaler

Locations (317)

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Chandler, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Bakersfield, California, United States

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Carlsbad, California, United States

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Huntington Beach, California, United States

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Lancaster, California, United States

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Long Beach, California, United States

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Mission Viejo, California, United States

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North Hollywood, California, United States

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Northridge, California, United States

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Rancho Cucamonga, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Ventura, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Wheat Ridge, Colorado, United States

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Newark, Delaware, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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Cutler Bay, Florida, United States

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DeBary, Florida, United States

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Hialeah, Florida, United States

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Lakeland, Florida, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Acworth, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Snellville, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Normal, Illinois, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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Marrero, Louisiana, United States

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Zachary, Louisiana, United States

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Baltimore, Maryland, United States

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White Marsh, Maryland, United States

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Fall River, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Rochester, Michigan, United States

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Troy, Michigan, United States

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St Louis, Missouri, United States

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Warrensburg, Missouri, United States

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North Las Vegas, Nevada, United States

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Portsmouth, New Hampshire, United States

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Ocean City, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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The Bronx, New York, United States

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Greensboro, North Carolina, United States

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Huntersville, North Carolina, United States

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Monroe, North Carolina, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Jenkintown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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Forney, Texas, United States

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McKinney, Texas, United States

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North Richland Hills, Texas, United States

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Pearland, Texas, United States

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Victoria, Texas, United States

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Roy, Utah, United States

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Abingdon, Virginia, United States

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Burke, Virginia, United States

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Williamsburg, Virginia, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Botucatu, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Santo André, Brazil

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São Paulo, Brazil

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Sorocaba, Brazil

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Baotou, China

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Beijing, China

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Changsha, China

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Changsha, China

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Changsha, China

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Changzhi, China

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Chengdu, China

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Chengdu, China

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Chizhou, China

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Chongqing, China

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Chongqing, China

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Dongguan, China

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Dongyang, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Haikou, China

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Haikou, China

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Hangzhou, China

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Hangzhou, China

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Hefei, China

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Hefei, China

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Hefei, China

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Huai'an, China

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Huizhou, China

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Jinan, China

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Jinhua, China

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Kunming, China

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Lanzhou, China

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Luoyang, China

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Nanchang, China

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Nanjing, China

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Nanjing, China

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Nanjing, China

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Nanjing, China

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Nanning, China

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Qingdao, China

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Qingdao, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shaoxing, China

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Shenyang, China

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Shenzhen, China

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Shenzhen, China

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Shenzhen, China

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Shijiazhuang, China

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Taiyuan, China

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Taiyuan, China

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Taizhou, China

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Wuhan, China

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Wuhan, China

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Yangzhou, China

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Zhuji, China

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Barranquilla, Colombia

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Cartagena, Colombia

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Medellín, Colombia

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Brandýs nad Labem, Czechia

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Jindřichův Hradec, Czechia

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Lovosice, Czechia

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Mladá Boleslav, Czechia

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Nový Bor, Czechia

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Prague, Czechia

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Prague, Czechia

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Rokycany, Czechia

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Strakonice, Czechia

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Teplice, Czechia

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Varnsdorf, Czechia

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Bamberg, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Darmstadt, Germany

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Frankfurt am Main, Germany

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Geesthacht, Germany

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Hanover, Germany

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Heidelberg, Germany

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Koblenz, Germany

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Landsberg, Germany

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Leipzig, Germany

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Mainz, Germany

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München-Pasing, Germany

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Witten, Germany

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Alexandroupoli, Greece

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Corfu, Greece

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Exohi Thessaloniki, Greece

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Ashkelon, Israel

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Beersheba, Israel

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Haifa, Israel

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Haifa, Israel

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Holon, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Cuernavaca, Mexico

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Durango, Mexico

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Guadalajara, Mexico

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Mazatlán, Mexico

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Mérida, Mexico

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Monterrey, Mexico

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Monterrey, Mexico

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Monterrey, Mexico

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Veracruz, Mexico

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Villahermosa, Mexico

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Zapopan, Mexico

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Amadora, Portugal

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Braga, Portugal

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Coimbra, Portugal

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Figueira da Foz Municipality, Portugal

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Guimarães, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Matosinhos Municipality, Portugal

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Ponce, Puerto Rico

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Ponce, Puerto Rico

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Chelyabinsk, Russia

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Izhevsk, Russia

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Kazan', Russia

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Kemerovo, Russia

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Moscow, Russia

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Moscow, Russia

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Omsk, Russia

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Penza, Russia

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Perm, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Saratov, Russia

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Tomsk, Russia

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Ulyanovsk, Russia

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Bojnice, Slovakia

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Kežmarok, Slovakia

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Košice, Slovakia

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Levice, Slovakia

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Levice, Slovakia

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Nové Zámky, Slovakia

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Poprad, Slovakia

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Prešov, Slovakia

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Ružomberok, Slovakia

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Šurany, Slovakia

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Topoľčany, Slovakia

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Žilina, Slovakia

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Bloemfontein, South Africa

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Cape Town, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Durban, South Africa

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Durban, South Africa

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Durban, South Africa

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eMkhomazi, South Africa

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Johannesburg, South Africa

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Lenasia, South Africa

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Lenasia Ext8, South Africa

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Panorama, South Africa

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Pretoria, South Africa

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Tygervalley, South Africa

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Mersin, Turkey (Türkiye)

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Pamukkale, Turkey (Türkiye)

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Blackpool, United Kingdom

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Bradford, United Kingdom

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Corby, United Kingdom

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Hull, United Kingdom

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Leicester, United Kingdom

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Rhyl, United Kingdom