Last updated on October 2018

A Phase III Parallel Group Study Comparing the Efficacy Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma


Brief description of study

A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA dry powder inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. This is a phase III, multi-center, active-controlled, double-blind, parallel-group study to compare the efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This study has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization, Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all protocol defined inclusion/exclusion criteria will enter a 3-week run-in period and will receive fixed dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) (fluticasone/salmeterol, 250/50 micrograms (mcg), via the DISKUS DPI) one inhalation twice a day. At Visit 2 (Enrolment), eligible subjects will be enrolled into the 2-week stabilization period to receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the morning). At the conclusion of the stabilization period (Visit 3), all subjects who meet the pre-defined randomization criteria will be randomized 1:1:1:1:1:1 during the treatment period to receive either FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg; 200/31.25/25 mcg) or FF/VI (100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the morning. The duration of the treatment period is variable but will be a minimum of 24 weeks and a maximum of 52 weeks. Subjects will have up to 6 on-treatment clinic visits scheduled at Visits 3, 4, 5, 6, 7 and 8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52, respectively). A follow-up visit will be conducted approximately 7 days after the end of treatment period or, if applicable, after the early withdrawal visit. Subjects will be provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study. Approximately 2250 subjects will be randomized, with approximately 375 subjects randomized to each of the 6 double-blind treatment arms to ensure approximately 337 evaluable subjects per treatment arm. DISKUS and ELLIPTA are registered trademarks of GSK groups of companies.

Clinical Study Identifier: NCT02924688

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Birmingham, AL United States

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Mobile, AL United States

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Gilbert, AZ United States

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Scottsdale, AZ United States

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Little Rock, AR United States

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Encinitas, CA United States

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Escondido, CA United States

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Huntington Beach, CA United States

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La Jolla, CA United States

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Long Beach, CA United States

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Los Angeles, CA United States

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Rolling Hills Estates, CA United States

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Roseville, CA United States

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San Diego, CA United States

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Colorado Springs, CO United States

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Denver, CO United States

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Aventura, FL United States

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Hollywood, FL United States

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Miami, FL United States

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Tallahassee, FL United States

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Adairsville, GA United States

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Columbus, GA United States

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Normal, IL United States

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River Forest, IL United States

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Owensboro, KY United States

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Sunset, LA United States

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Baltimore, MD United States

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Columbia, MD United States

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Minneapolis, MN United States

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Saint Charles, MO United States

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Ocean City, NJ United States

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Asheville, NC United States

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Charlotte, NC United States

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Huntersville, NC United States

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Raleigh, NC United States

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Shelby, NC United States

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Wilmington, NC United States

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Canton, OH United States

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Cincinnati, OH United States

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Dublin, OH United States

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Oklahoma City, OK United States

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Medford, OR United States

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Portland, OR United States

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Pittsburgh, PA United States

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Warwick, RI United States

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Easley, SC United States

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Greenville, SC United States

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Orangeburg, SC United States

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Spartanburg, SC United States

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El Paso, TX United States

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Waco, TX United States

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Abingdon, VA United States

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Richmond, VA United States

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Seattle, WA United States

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Coffs Harbour, Australia

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Randwick, Australia

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Westmead, Australia

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Sherwood, Australia

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Bedford Park, Australia

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Clayton, Australia

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Melbourne, Australia

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Murdoch, Australia

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Golden Beach, Australia

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Saint John's, NL Canada

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Ajax, ON Canada

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Brampton, ON Canada

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Burlington, ON Canada

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Hamilton, ON Canada

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London, ON Canada

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Sarnia, ON Canada

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Toronto, ON Canada

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Waterloo, ON Canada

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Windsor, ON Canada

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Montreal, QC Canada

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St. Charles-Borromee, QC Canada

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Victoriaville, QC Canada

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Darmstadt, Germany

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Frankfurt, Germany

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Neu-Isenburg, Germany

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Gelsenkirchen, Germany

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Rheine, Germany

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Koblenz, Germany

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Leipzg, Germany

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Leipzig, Germany

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Geesthacht, Germany

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Schleswig, Germany

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Berlin, Germany

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Eboli (SA), Italy

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Parma, Italy

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Roma, Italy

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Milano, Italy

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Civitanova Marche (MC), Italy

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Orbassano (TO), Italy

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Palermo, Italy

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Pisa, Italy

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Aichi, Japan

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Chiba, Japan

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Fukui, Japan

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Fukuoka, Japan

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Gifu, Japan

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Hiroshima, Japan

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Hokkaido, Japan

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Hyogo, Japan

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Ibaraki, Japan

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Kagawa, Japan

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Kanagawa, Japan

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Kyoto, Japan

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Miyagi, Japan

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Nagano, Japan

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Nagasaki, Japan

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Oita, Japan

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Okayama, Japan

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Okinawa, Japan

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Osaka, Japan

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Saga, Japan

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Saitama, Japan

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Shimane, Japan

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Shizuoka, Japan

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Tokyo, Japan

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Toyama, Japan

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Yamagata, Japan

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Yamaguchi, Japan

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Yamanashi, Japan

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Busan, Korea, Republic of

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Cheongju-si, Chungcheongbuk-do, Korea, Republic of

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Daegu, Korea, Republic of

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Daejon, Korea, Republic of

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Gwangju, Korea, Republic of

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Seoul, Korea, Republic of

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Suwon-si, Gyeonggi-do, Korea, Republic of

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Wonju-si, Kanwon-do, Korea, Republic of

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Alkmaar, Netherlands

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Almere, Netherlands

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Beek, Netherlands

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Breda, Netherlands

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Eindhoven, Netherlands

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Hengelo, Netherlands

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Leiden, Netherlands

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Rotterdam, Netherlands

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Utrecht, Netherlands

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Bialystok, Poland

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Bydgoszcz, Poland

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Grudziadz, Poland

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Koscian, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Ostrowiec Swietokrzyski, Poland

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Poznan, Poland

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Rzeszow, Poland

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Slupsk, Poland

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Sopot, Poland

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Szczecin, Poland

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Tarnow, Poland

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Zgierz, Poland

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Bacau, Romania

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Brasov, Romania

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Bucharest, Romania

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Bucuresti, Romania

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Cluj Napoca, Romania

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Craiova, Romania

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Deva, Romania

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Galati, Romania

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Iasi, Romania

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Oradea, Romania

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Slobozia, Romania

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Suceava, Romania

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Targu Mures, Romania

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Timisoara, Romania

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Arkhangelsk, Russian Federation

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Belgorod, Russian Federation

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Blagoveshchensk, Russian Federation

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Chelyabinsk, Russian Federation

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Chita, Russian Federation

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Ekaterinburg, Russian Federation

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Irkutsk, Russian Federation

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Ivanovo, Russian Federation

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Izhevsk, Russian Federation

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Kazan, Russian Federation

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Kemerovo, Russian Federation

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Khantymansiysk, Russian Federation

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Krasnodar, Russian Federation

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Krasnoyarsk, Russian Federation

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Moscow, Russian Federation

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Orenburg, Russian Federation

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Perm, Russian Federation

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Petrozavodsk, Russian Federation

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Saint Petersburg, Russian Federation

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Saint-Petersburg, Russian Federation

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Samara, Russian Federation

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Saratov, Russian Federation

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St Petersburg, Russian Federation

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Tomsk, Russian Federation

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Tver, Russian Federation

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Ufa, Russian Federation

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Ulan-Ude, Russian Federation

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Ulyanovsk, Russian Federation

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Yaroslavl, Russian Federation

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Middelburg, South Africa

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Bellville, South Africa

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Bloemfontein, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Mowbray, South Africa

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Panorama, South Africa

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Pretoria West, South Africa

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Reiger Park, South Africa

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Somerset West, South Africa

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Tygerberg, South Africa

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Alcobendas, Spain

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Badalona, Spain

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Barcelona, Spain

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Burgos, Spain

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Centelles, Spain

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Gerona, Spain

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Hospitalet de Llobregat, Spain

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Las Palmas, Spain

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Loja/ Granada, Spain

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Salamanca, Spain

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Santander, Spain

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Santiago de Compostela, Spain

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Valladolid, Spain

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Zaragoza, Spain

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Aberdeen, United Kingdom

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Romford, United Kingdom

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Wishaw, United Kingdom

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Blackpool, United Kingdom

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Northwood, United Kingdom

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Corby, United Kingdom

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Stoke on Trent, United Kingdom

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Bexhill, United Kingdom

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Trowbridge, United Kingdom

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Bradford, United Kingdom

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Liverpool., United Kingdom

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Sidcup, Kent, United Kingdom

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Stevenage, United Kingdom

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Tucson, AZ United States

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Oxnard, CA United States

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Brandon, FL United States

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Jupiter, FL United States

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Ocoee, FL United States

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Dayton, OH United States

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Hendersonville, TN United States

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Austin, TX United States

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Houston, TX United States

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San Antonio, TX United States

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Mississauga, ON Canada

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Luebeck, Germany

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Hamburg, Germany

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Pavia, Italy

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Tradate (VA), Italy

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Mie, Japan

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Nara, Japan

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Pitesti, Romania

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Montgomery, AL United States

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San Jose, CA United States

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Michigan City, IN United States

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Topeka, KS United States

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Louisville, KY United States

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Chevy Chase, MD United States

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Rochester, MI United States

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High Point, NC United States

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Monroeville, PA United States

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Dallas, TX United States

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Plano, TX United States

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Ciudad Autonoma de Buenos Aires, Argentina

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Florida, FL Argentina

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Mar del Plata, Argentina

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Cordoba, Argentina

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San Rafael, Argentina

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Rosario, Argentina

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Berazategui, Argentina

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Buenos Aires, Argentina

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Mendoza, Argentina

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Santa Fe, Argentina

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Tucuman, Argentina

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Bari, Italy

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Port Elizabeth, South Africa

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Lincoln, NE United States

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Reno, NV United States

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New York, NY United States

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Gastonia, NC United States

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Winston-Salem, NC United States

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Lampasas, TX United States

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McKinney, TX United States

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Williamsburg, VA United States

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Lafayette, CO United States

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South Bend, IN United States

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Missouri City, TX United States

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Killeen, TX United States

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Live Oak, TX United States

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Madrid, Spain

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Aurora, CO United States

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Charleston, SC United States

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Pharr, TX United States

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Paducah, KY United States

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Buffalo, NY United States

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Andreson, SC United States

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Paraná, Argentina

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Ciudad Autónoma de Buenos Aires, Argentina

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Trois Rivières, QC Canada

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Québec, Canada

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Pozuelo De Alarcón/Madrid, Spain

Recruitment Status: Closed


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