Clinical trial NCT00252876: GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes
Official title: An Open-Label, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 1 mg in Patients With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.


Eligibility criteria: Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Completed the last two visits of randomized treatment period in GALLANT 2/22, 5, 7, 8 or 14 studies.

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Previous enrollment in this long-term extension study
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Primary outcomes:
measure: Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Secondary outcomes:
measure: Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c, lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol)
measure: Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol
measure: C-reactive protein
measure: Central obesity (waist circumference, hip circumference, waist/hip ratio)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Columbiana
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Carlisle
country: United States
facility: Research Site
state: Arkansas
city: Sherwood
country: United States
facility: Research Site
state: Arkansas
city: Chula Vista
country: United States
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state: California
city: Escondido
country: United States
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state: California
city: Huntington Beach
country: United States
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city: Los Angeles
country: United States
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city: Mission Viejo
country: United States
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city: Orange
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city: Pasadena
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city: Redondo Beach
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city: Sacramento
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city: Colorado Springs
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city: Wheat Ridge
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city: Clearwater
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state: Florida
city: Gainesville
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city: Hollywood
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city: Jacksonville
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city: Atlanta
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city: Brunswick
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city: Evansville
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city: Witchita
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city: Bossier City
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city: New Orleans
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city: Kettering
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city: Dallas
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city: Moron
country: Argentina
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country: Argentina
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city: Ciudad de Buenos Aires
country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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country: Australia
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country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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city: São Paulo
country: Brazil
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city: Calgary
country: Canada
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state: Alberta
city: Coquitlam
country: Canada
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state: British Columbia
city: Surrey
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city: Winnipeg
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state: Manitoba
city: Bay Roberts
country: Canada
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state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
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state: Newfoundland and Labrador
city: St. John's
country: Canada
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state: Newfoundland and Labrador
city: Bolton
country: Canada
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state: Ontario
city: Brampton
country: Canada
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city: Hamilton
country: Canada
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state: Ontario
city: Hastings
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city: Kingston
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city: London
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city: North York
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city: Ottawa
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city: Smith Falls
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city: Toronto
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city: Chomedey-Laval
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state: Quebec
city: Laval
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city: Sherbrooke
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city: Brno
country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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city: Usti nad Labem
country: Czech Republic
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country: Estonia
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country: Estonia
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city: Tallinn
country: Estonia
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country: Estonia
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city: Viljandi
country: Estonia
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city: Helsinki
country: Finland
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city: Hämeenlinna
country: Finland
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country: Finland
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city: Joensuu
country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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city: Belgrade
country: Former Serbia and Montenegro
facility: Research Site
city: Athens
country: Greece
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city: Piraeus
country: Greece
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city: Hong Kong
country: Hong Kong
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city: Balatonfüred
country: Hungary
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city: Budapest
country: Hungary
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country: Hungary
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city: Kaposvár
country: Hungary
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city: Kecskemét
country: Hungary
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country: Hungary
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country: Hungary
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city: Székesfehérvár
country: Hungary
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city: Bangalore
country: India
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country: India
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country: India
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country: India
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country: Indonesia
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city: Malang
country: Indonesia
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city: Ashkelon
country: Israel
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city: Haifa
country: Israel
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city: Holon
country: Israel
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city: Jerusalem
country: Israel
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city: Rishon-Lezion
country: Israel
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city: Tel Aviv
country: Israel
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city: Tel Hashomer
country: Israel
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city: Zefat
country: Israel
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city: Arenzano
country: Italy
facility: Research Site
city: Chiavari (GE)
country: Italy
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country: Italy
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city: Firenze
country: Italy
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city: Messina
country: Italy
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city: Milano
country: Italy
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city: Monteccio Emilia
country: Italy
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city: Napoli
country: Italy
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country: Italy
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city: Pescara
country: Italy
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city: Piacenza
country: Italy
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country: Italy
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city: Reggio Calabria
country: Italy
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city: Reggio Emilia
country: Italy
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city: Roma
country: Italy
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city: Scandiano
country: Italy
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country: Italy
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city: Seoul
country: Korea, Republic of
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country: Korea, Republic of
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country: Latvia
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country: Latvia
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country: Latvia
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country: Latvia
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country: Latvia
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country: Latvia
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country: Latvia
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city: Vilnius
country: Lithuania
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country: Malaysia
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state: Kota Bharu
city: Kuala Lumpur
country: Malaysia
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country: Malaysia
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city: Beek en Donk
country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Philippines
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country: Philippines
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country: Philippines
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country: Philippines
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country: Philippines
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city: Katowice
country: Poland
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state: Ochojec
city: Bialystok
country: Poland
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city: Bydgoszcz
country: Poland
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city: Gdansk
country: Poland
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country: Poland
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country: Poland
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country: Poland
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city: Poznan
country: Poland
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city: Radom
country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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city: Zielona Gora
country: Poland
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city: Almada
country: Portugal
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country: Portugal
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city: Elvas
country: Portugal
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city: Lisbon
country: Portugal
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city: Portalegre
country: Portugal
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city: Moscow
country: Russian Federation
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city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
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city: Singapore
country: Singapore
facility: Research Site
city: Dolny Kubin
country: Slovakia
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city: Levice
country: Slovakia
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city: Lubochna
country: Slovakia
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city: Lucenec
country: Slovakia
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city: Nove Zamky
country: Slovakia
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city: Povazska Bystrica
country: Slovakia
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city: Sahy
country: Slovakia
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city: Trencin
country: Slovakia
facility: Research Site
city: Velky Meder
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Chatsworth
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Gauteng
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
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city: Pretoria
country: South Africa
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Ilanz
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Monthey
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Atherstone
country: United Kingdom
facility: Research Site
city: Ayr
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Berks
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Bucks
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
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city: Coventry
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
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city: Edinburgh
country: United Kingdom
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city: Glasgow
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
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city: Liverpool
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Radstock
country: United Kingdom
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city: Shrewsbury
country: United Kingdom
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city: Surrey
country: United Kingdom
facility: Research Site
city: West Bromwich
country: United Kingdom
facility: Research Site
city: Wiltshire
country: United Kingdom
facility: Research Site
city: Wrexham
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: