Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

NCT ID: NCT00242801

Last Updated: 2009-04-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1692 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-04-30

Brief Summary

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This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.

Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Gefitinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* · Life expectancy of at least 8 weeks.

* Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
* Not suitable for chemotherapy
* WHO Performance status 0,1, 2 or 3

Exclusion Criteria

* Newly diagnosed CNS mets
* Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
* ALT/AST greater than 5 x upper limit of normal
* ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Oncology Medical Science Direction

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Capital Federal, Buenos Aires, Argentina

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Bahía Blanca, , Argentina

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Buenos Aires, , Argentina

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La Plata, , Argentina

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Mar del Plata, , Argentina

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Rosario, , Argentina

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Santa Fe, , Argentina

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Concord, New South Wales, Australia

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Potts Point, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Chermside, Queensland, Australia

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South Brisbane, Queensland, Australia

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Ashford, South Australia, Australia

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Woodville, South Australia, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Prahran, Victoria, Australia

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Wodonga, Victoria, Australia

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Woodville South, , Australia

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Fortaleza, Ceará, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Sorocaba, São Paulo, Brazil

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , 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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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Monoton, New Brunswick, Canada

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Greater Sudbury, Ontario, Canada

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Mississauga, Ontario, Canada

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Newmarket, Ontario, Canada

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Saint Catherines, Ontario, Canada

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Toronto, Ontario, Canada

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York, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Various Cities, , Chile

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Talinn, , Estonia

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Tartu, , Estonia

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Muchen, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Münster, North Rhine-Westphalia, Germany

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Bad Segeberg, Schleswig-Holstein, Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Gauting, , Germany

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Grobhansdorf, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Hemer, , Germany

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Mutzschen, , Germany

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Athens, , Greece

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Heraklion, , Greece

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Marousi, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Debrecen, , Hungary

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Deszk, , Hungary

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Kecskemét, , Hungary

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Mosdós, , Hungary

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Mosonmagyaróvár, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Törökbálint, , Hungary

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Ujronafj, , Hungary

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Zalaegerszeg, , Hungary

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Zalaegerszeg-Pozva, , Hungary

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India, , India

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Karnataka, , India

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Kolkata, , India

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Vellore, , India

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Cork, Cork, Ireland

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Dooradoyle, Limerick, Ireland

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Beaumont Road, , Ireland

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Dublin, , Ireland

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Elm Park, , Ireland

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Daugavpils, , Latvia

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Liepāja, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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George Town, , Malaysia

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Kampung Baharu Nilai, , Malaysia

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Kuala Lumpur, , Malaysia

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Torreón, Coahuila, Mexico

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Durango, Durango, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Neuvo Leon, Mexico

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Mérida, Yucatán, Mexico

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Acapulco, , Mexico

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Guadalajara, , Mexico

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León, , Mexico

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México, , Mexico

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Alkmaar, , Netherlands

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Amsterdam, , Netherlands

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Enschede, , Netherlands

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Groningen, , Netherlands

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Leiden, , Netherlands

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Nieuwegein, , Netherlands

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Rotterdam, , Netherlands

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Ålesund, , Norway

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Bergen, , Norway

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Gjettum, , Norway

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Hamar, , Norway

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Haugesund, , Norway

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Kristiansand, , Norway

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Nordbyhagen, , Norway

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Oslo, , Norway

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Skien, , Norway

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Stavanger, , Norway

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Tromsø, , Norway

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Trondheim, , Norway

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Various Cities, , Peru

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Manila, , Philippines

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Pasig, , Philippines

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Quezon City, , Philippines

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Gdansk, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Zabrze, , Poland

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Craiova, , Romania

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Iași, , Romania

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Timișoara, , Romania

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Moscow, , Russia

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Saint Petersburg, , Russia

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Singapore, , Singapore

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Bratislava, , Slovakia

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Dolný Kubín, , Slovakia

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Kojice, , Slovakia

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Martin, , Slovakia

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Michalovce, , Slovakia

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Nitra, , Slovakia

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Nitra-Zobor, , Slovakia

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Nové Zámky, , Slovakia

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Poprad, , Slovakia

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Poprad - Kvetnica, , Slovakia

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Prejov, , Slovakia

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Trnava, , Slovakia

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Žilina, , Slovakia

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Västerås, Västmanland County, Sweden

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Gothenburg, , Sweden

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Huddinge, , Sweden

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Jönköping, , Sweden

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Karlstad, , Sweden

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Linköping, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Banqiao District, Taipei, Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Various Cities, , Ukraine

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Cambridge, Cambrideshire, United Kingdom

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Exeter, Devon, United Kingdom

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Colchester, Essex, United Kingdom

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Romford, Essex, United Kingdom

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Gorleston-on-Sea, Great Yarmouth, United Kingdom

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Fulwood, Lanc, United Kingdom

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Norwich, Norfolk, United Kingdom

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Nottingham, Northamptonshire, United Kingdom

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Belfast, Northern Ireland, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Aberdeen, , United Kingdom

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Birmingham, , United Kingdom

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Bradford, , United Kingdom

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Brighton, , United Kingdom

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Coventry, , United Kingdom

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Dundee, , United Kingdom

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Essex, , United Kingdom

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Glasgow, , United Kingdom

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Guildford, , United Kingdom

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Gwynedd, , United Kingdom

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Harrogate, , United Kingdom

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Huddersfield, , United Kingdom

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Hull, , United Kingdom

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Lancaster, , United Kingdom

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Leicester, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Nottingham, , United Kingdom

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Oxford, , United Kingdom

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Reading, , United Kingdom

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Southampton, , United Kingdom

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Swansea, , United Kingdom

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Wolverhampton, , United Kingdom

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York, , United Kingdom

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Various Cities, , Venezuela

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Countries

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Argentina Australia Brazil Bulgaria Canada Chile Estonia Germany Greece Hungary India Ireland Latvia Lithuania Malaysia Mexico Netherlands Norway Peru Philippines Poland Romania Russia Singapore Slovakia Sweden Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom Venezuela

Other Identifiers

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ISEL

Identifier Type: -

Identifier Source: secondary_id

1839IL/0709

Identifier Type: -

Identifier Source: org_study_id

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