Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00374322




Registration number
NCT00374322
Ethics application status
Date submitted
7/09/2006
Date registered
11/09/2006
Date last updated
18/08/2014

Titles & IDs
Public title
Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
Scientific title
A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer
Secondary ID [1] 0 0
EGF105485
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Breast 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lapatinib
Other interventions - placebo

Placebo comparator: Placebo - 6 tablets daily for 12 months

Experimental: Lapatinib - Lapatinib 1500 mg (6 tablets) daily for 12 months


Treatment: Drugs: lapatinib
Lapatinib 1500 mg (6 tablets) daily for 12 months

Other interventions: placebo
6 tablets daily for 12 months
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Timepoint [1] 0 0
From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])
Secondary outcome [1] 0 0
Number of Participants Who Died (Overall Survival)
Timepoint [1] 0 0
From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])
Secondary outcome [2] 0 0
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
Timepoint [2] 0 0
From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])
Secondary outcome [3] 0 0
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
Timepoint [3] 0 0
From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])
Secondary outcome [4] 0 0
Time to Central Nervous System (CNS) Recurrence
Timepoint [4] 0 0
From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])
Secondary outcome [5] 0 0
Number of Participants With CNS Recurrence
Timepoint [5] 0 0
From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])
Secondary outcome [6] 0 0
Modified Disease-free Survival (MDFS)
Timepoint [6] 0 0
From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)
Secondary outcome [7] 0 0
Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Timepoint [7] 0 0
From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)
Secondary outcome [8] 0 0
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Timepoint [8] 0 0
Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Secondary outcome [9] 0 0
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Timepoint [9] 0 0
Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Secondary outcome [10] 0 0
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
Timepoint [10] 0 0
Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Secondary outcome [11] 0 0
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Timepoint [11] 0 0
At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit
Secondary outcome [12] 0 0
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Timepoint [12] 0 0
At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit
Secondary outcome [13] 0 0
Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Timepoint [13] 0 0
From the first dose of study treatment up to 12 months
Secondary outcome [14] 0 0
Number of Participants Experiencing Primary or Secondary Cardiac Events
Timepoint [14] 0 0
From the date of randomization up to 12 months
Secondary outcome [15] 0 0
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Timepoint [15] 0 0
Screening and Month 12/Early Withdrawal Visit

Eligibility
Key inclusion criteria
* Have histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma (TX or T1-4) of the breast at the time of the initial diagnosis and have undergone adequate excision of tumor;
* Had tumors that overexpress ErbB2 defined as 3+ by IHC or c-erbB2 gene amplification by FISH (ErbB2 expression/amplification must be documented prior to study entry; however, a tumor tissue sample must be sent to a central laboratory for subsequent re-analysis of ErbB2 status);
* Have Stage I through Stage IIIc disease according to the American Joint Committee on Cancer (6th edition) staging criteria for breast cancer and meet one of the following criteria:

node-positive disease defined as: one positive lymph node by sentinel node biopsy OR at least 1 positive lymph node found among at least 6 axillary nodes examined on axillary node dissection OR status post axillary radiotherapy for sterilization if clinically evaluated as cN1 or cN2 (if sentinel node biopsy is positive, subject may either undergo an axillary node dissection or radiotherapy to the axilla).

node-positive disease evaluated as: ipsilateral axillary lymph nodes cN0-2 by clinical evaluation and axillary lymph nodes pNX, pN0(i+), or pN1-3 by pathological evaluation [patients with pN3 (Stage IIIc disease) must be disease free following completion of neoadjuvant or adjuvant chemotherapy for at least 12 months and must not have been lost to follow up].

OR node-negative disease defined as: negative sentinel node biopsy OR no positive lymph nodes found among at least 6 axillary nodes examined on axillary node dissection OR status post axillary radiotherapy for sterilization if clinically evaluated as cN0.

node-negative disease categorized as: high-risk disease (tumor >2.0 cm if ER and/or progesterone receptor (PgR) positive disease is present or tumor >1.0 cm if ER and PgR negative disease) OR intermediate-risk disease (tumor 1.0-2.0 cm and ER and/or PgR positive disease).

* Women with synchronous bilateral invasive breast cancer or synchronous DCIS of either the contralateral or ipsilateral breast at the time of the initial diagnosis are also eligible;
* Have undergone either mastectomy OR lumpectomy;
* Have received and completed treatment with a neoadjuvant or adjuvant chemotherapy regimen containing either an anthracycline or a taxane; or any cyclophosphamide, methotrexate and 5-fluorouracil (CMF) regimen;
* May continue to receive endocrine therapy while taking study medication, if endocrine therapy was initiated as either adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer or for ovarian function suppression; however, endocrine therapy may not be initiated while taking study medication. Endocrine therapy agents may be switched while participating in this study (e.g., stop tamoxifen and start letrozole);
* May have received prior radiotherapy as treatment for primary tumor; however, is not required for study entry;
* May continue to receive radiotherapy while taking study medication, if radiotherapy was initiated as adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer;
* May continue to receive bisphosphonates only for treatment of documented osteoporosis, but not as treatment or prophylaxis of bone metastases;
* All women eligible for adjuvant treatment with trastuzumab, including those diagnosed and treated within the last six months, must be considered for such treatment prior to being offered participation in this study. Participation in this study will be allowed only if the physician and patient have considered and discussed at length the advantages of trastuzumab, but have mutually decided against initiating trastuzumab therapy.
* Have clinical and radiologic assessments that are negative for local or regional recurrence of disease or metastatic disease at the time of study entry;
* if signs or symptoms suggestive of either recurrence of disease or metastatic disease are present, the appropriate radiological imaging must be performed
* if the following laboratory results are present, the appropriate radiological imaging must be performed:
* for AST/ALT =2×ULN or ALP =2×ULN (not in the bone fraction), an abdominal CT or MRI must be done
* for ALP=2×ULN in the bone fraction, a bone scan must be done; a confirmatory x-ray, CT scan or MRI scan or biopsy is required if the results of the bone scan are inconclusive
* Have a unilateral/bilateral mammogram within 12 months prior to study entry;
* Have an analysis of both ER and PgR on the primary tumor prior to study entry;
* Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition scans;
* Have an Eastern Cooperative Oncology Group Performance Status of 0 to 1;
* Women with a history of non-breast malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence. Women with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin;
* Are able to swallow and retain oral medication;
* Have a paraffin-embedded tissue block from an archived tumor tissue from the primary tumor or twenty (20) slides of paraffin-embedded tissue available for biomarker analysis;
* Have adequate organ function defined as: absolute neutrophil count =1.5× 10^9/L; hemoglobin =9 g/dL; platelets =75 × 10^9/L; albumin =2.5 g/dL; serum bilirubin =1.25 ×ULN; aspartate aminotransferase and alanine aminotransferase =3 × ULN and serum creatinine =2.0 mg/dL or calculated creatinine clearance =40 mL/min
* Have signed the informed consent form (ICF);
* Women of child-bearing potential must have a negative serum pregnancy test at screening and agree to complete abstinence from intercourse or consistent and correct use of an acceptable methods of birth control from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication:
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have clinical and radiologic evidence of local or regional recurrence of disease or metastatic disease at the time of study entry;
* Had metachronous invasive breast cancer (breast cancers diagnosed at different times);
* Have a prior history of other breast cancer malignancies, including DCIS;
* Are unable to provide archived tumor tissue samples for assay;
* Had prior therapy with an ErbB1 and/or ErbB2 inhibitor; women who experienced a hypersensitivity or allergic reaction to trastuzumab during the first infusion and were unable to complete this infusion are eligible;
* Receive concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication;
* Have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
* Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded;
* Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety;
* Have an active or uncontrolled infection;
* Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
* Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
* Are pregnant or breastfeeding;
* Receive concurrent treatment with an investigational agent; women, who are in follow-up in another clinical trial where the primary endpoint has been met and the interval between assessments is =12 months and radiological imaging is not required at these assessments, are eligible;
* Receive concurrent treatment with a selected list of strong inducers and inhibitors of CYP3A4;
* Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
3166
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Campbelltown
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Kogarah
Recruitment hospital [4] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [5] 0 0
GSK Investigational Site - North Sydney
Recruitment hospital [6] 0 0
GSK Investigational Site - Douglas
Recruitment hospital [7] 0 0
GSK Investigational Site - Herston
Recruitment hospital [8] 0 0
GSK Investigational Site - Redcliffe
Recruitment hospital [9] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [10] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [11] 0 0
GSK Investigational Site - Elizabeth Vale
Recruitment hospital [12] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [13] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [14] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [15] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [16] 0 0
GSK Investigational Site - Footscray
Recruitment hospital [17] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [18] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [19] 0 0
GSK Investigational Site - Ringwood East
Recruitment hospital [20] 0 0
GSK Investigational Site - Wodonga
Recruitment hospital [21] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [22] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2060 - North Sydney
Recruitment postcode(s) [6] 0 0
4814 - Douglas
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4020 - Redcliffe
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
5042 - Bedford Park
Recruitment postcode(s) [11] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [12] 0 0
5011 - Woodville
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3002 - East Melbourne
Recruitment postcode(s) [15] 0 0
3065 - Fitzroy
Recruitment postcode(s) [16] 0 0
3011 - Footscray
Recruitment postcode(s) [17] 0 0
3084 - Heidelberg
Recruitment postcode(s) [18] 0 0
3050 - Parkville
Recruitment postcode(s) [19] 0 0
3135 - Ringwood East
Recruitment postcode(s) [20] 0 0
3690 - Wodonga
Recruitment postcode(s) [21] 0 0
6009 - Nedlands
Recruitment postcode(s) [22] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
Country [3] 0 0
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Arkansas
Country [4] 0 0
United States of America
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California
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Colorado
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United States of America
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Connecticut
Country [7] 0 0
United States of America
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District of Columbia
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Córdova
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Argentina
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Neuquén
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Quilmes
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Argentina
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San Miguel de Tucumán
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Belgium
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Bruxelles
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Rio Grande Do Sul
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São Paulo
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Rio de Janeiro
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Canada
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Newfoundland and Labrador
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Nova Scotia
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Quebec
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Saskatchewan
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Chile
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Región Metro De Santiago
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Chile
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Valparaíso
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Guangdong
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Hubei
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Shanghai
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China
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Tianjin
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Croatia
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Osijek
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Croatia
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Pula
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Croatia
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Rijeka
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Croatia
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Split
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Croatia
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Zagreb
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Czech Republic
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Brno
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Czech Republic
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Prague 2
Country [66] 0 0
Czech Republic
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Praha 8
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Denmark
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Aalborg
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Denmark
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Copenhagen
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Denmark
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Esbjerg
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Denmark
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Herlev
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Denmark
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Naestved
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Denmark
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Odense
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Roskilde
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Vejle
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Angers
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Besançon
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Bordeaux
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Caen Cedex 05
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France
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Clermont Ferrand
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France
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Colmar Cedex
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Dijon Cedex
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France
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Lille cedex
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France
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Lille
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France
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Lyon Cedex 08
Country [85] 0 0
France
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Lyon
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France
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Marseille Cedex 09
Country [87] 0 0
France
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Montbeliard
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France
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Montpellier Cedex 5
Country [89] 0 0
France
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Nantes cedex
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France
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Nice Cedex 2
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France
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Paris Cedex 15
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France
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Reims
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France
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Rennes
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France
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Saint Grégoire
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France
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Saint-Cloud
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France
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Saint-Herblain
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France
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Strasbourg
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France
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Toulouse Cedex 3
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France
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Toulouse Cedex 9
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France
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Tourcoing
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France
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Vandoeuvre-Les-Nancy
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France
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Villejuif Cedex
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France
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Villejuif
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Mecklenburg-Vorpommern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Saarland
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Thueringen
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Germany
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Berlin
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Germany
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Bremen
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Germany
State/province [119] 0 0
Hamburg
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Greece
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Athens
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Greece
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Chania
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Greece
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Heraklion, Crete
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Hong Kong
State/province [125] 0 0
Wanchai
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Hungary
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Budapest
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Hungary
State/province [127] 0 0
Gyor
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Hungary
State/province [128] 0 0
Kaposvár
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Hungary
State/province [129] 0 0
Kistarcsa
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Hungary
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Pécs
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Hungary
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Szeged
Country [132] 0 0
India
State/province [132] 0 0
Chennai
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India
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Hyderabad
Country [134] 0 0
India
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Jaipur
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India
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Mumbai
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India
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New Delhi
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India
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Pune
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
State/province [141] 0 0
Kfar Saba
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Italy
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Italy
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Sardegna
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Italy
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Umbria
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Italy
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Veneto
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Korea, Republic of
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Goyang-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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songpa-gu, Seoul
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Liepaja
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Latvia
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Riga
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Lithuania
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Lithuania
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Klaipeda
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Yucatán
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Mexico
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Chihuahua
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Mexico
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Mexico City
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Mexico
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Auckland
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New Zealand
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Christchurch
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Hamilton
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Lima
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Philippines
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Baguio City, Benguet
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Philippines
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Cebu
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Philippines
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Pasig City
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Philippines
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Quezon City
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Poland
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Krakow
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Poland
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Poland
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Russian Federation
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Russian Federation
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Slovakia
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South Africa
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South Africa
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South Africa
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South Africa
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Overport
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Parktown
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Port Elizabeth
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Sandton
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Spain
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Spain
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Spain
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Spain
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Llobregat
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Spain
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Madrid
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Spain
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Mataró
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Spain
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Orense
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Spain
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Palma de Mallorca
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Spain
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Santa Cruz de Tenerife
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Spain
State/province [206] 0 0
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Spain
State/province [207] 0 0
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Spain
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Spain
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Ukraine
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Lvov
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Uzhgorod
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United Kingdom
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United Kingdom
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Surrey
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United Kingdom
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United Kingdom
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United Kingdom
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Glasgow
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United Kingdom
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Lindley
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United Kingdom
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United Kingdom
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Maidstone
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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Sheffield
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United Kingdom
State/province [227] 0 0
Shrewsbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00374322