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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00738530




Registration number
NCT00738530
Ethics application status
Date submitted
19/08/2008
Date registered
20/08/2008
Date last updated
23/06/2016

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
Scientific title
A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
Secondary ID [1] 0 0
2004-000282-35
Secondary ID [2] 0 0
BO17705
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bevacizumab [Avastin]
Treatment: Drugs - Interferon alfa 2a [Roferon]
Treatment: Drugs - Placebo

Experimental: Bevacizumab + IFN-Alfa-2A - Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.

Placebo comparator: Placebo + IFN-Alfa-2A - Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.


Treatment: Drugs: Bevacizumab [Avastin]
10 mg/kg IV every 2 weeks

Treatment: Drugs: Interferon alfa 2a [Roferon]
9 MIU SC 3 times/week

Treatment: Drugs: Placebo
IV every 2 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Died
Timepoint [1] 0 0
Baseline up to 4.25 years
Primary outcome [2] 0 0
Overall Survival (OS) Duration
Timepoint [2] 0 0
Baseline until death (up to 4.25 years)
Secondary outcome [1] 0 0
Percentage of Participants With Disease Progression or Death
Timepoint [1] 0 0
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Secondary outcome [2] 0 0
Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Timepoint [2] 0 0
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Secondary outcome [3] 0 0
Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Timepoint [3] 0 0
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Secondary outcome [4] 0 0
Percentage of Participants With Treatment Failure
Timepoint [4] 0 0
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Secondary outcome [5] 0 0
Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Timepoint [5] 0 0
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Secondary outcome [6] 0 0
Percentage of Participants With Objective Response According to mRECIST
Timepoint [6] 0 0
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Secondary outcome [7] 0 0
Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Timepoint [7] 0 0
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Secondary outcome [8] 0 0
Change From Baseline in Karnofsky Performance Status
Timepoint [8] 0 0
Baseline, Week 7, 15, 23, 31, 43

Eligibility
Key inclusion criteria
* metastatic renal cell cancer (clear cell type);
* nephrectomy;
* absence of proteinuria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior systemic treatment for metastatic renal cell cancer;
* major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;
* presence of brain metastases or spinal cord compression;
* ongoing need for full dose anticoagulants;
* uncontrolled hypertension;
* clinically significant cardiovascular disease.

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 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
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
649
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Canberra
Recruitment hospital [4] 0 0
- Frankston
Recruitment hospital [5] 0 0
- Kurralta Park
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Perth
Recruitment hospital [8] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
5041 - Adelaide
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
2606 - Canberra
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3128 - Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment postcode(s) [9] 0 0
2031 - Sydney
Recruitment postcode(s) [10] 0 0
2139 - Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
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Belgium
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Bruxelles
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Belgium
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Wilrijk
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Czech Republic
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Ceské Budejovice
Country [5] 0 0
Czech Republic
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Chomutov
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Czech Republic
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Hradec Kralove
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Czech Republic
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Plzen
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Finland
State/province [8] 0 0
Tampere
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Finland
State/province [9] 0 0
Turku
Country [10] 0 0
France
State/province [10] 0 0
Angers
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux
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France
State/province [12] 0 0
Caen
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France
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Clermont Ferrand
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France
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Grenoble
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France
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Lille
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France
State/province [16] 0 0
Limoges
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France
State/province [17] 0 0
Lyon
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France
State/province [18] 0 0
Marseille
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France
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Nice
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France
State/province [20] 0 0
Poitiers
Country [21] 0 0
France
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Saint Herblain
Country [22] 0 0
France
State/province [22] 0 0
Strasbourg
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France
State/province [23] 0 0
Suresnes
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France
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Toulouse
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France
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Villejuif
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Germany
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Berlin
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Germany
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Darmstadt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Mannheim
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Germany
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Marburg
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Germany
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München
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Germany
State/province [33] 0 0
Planegg
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Hungary
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Budapest
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Hungary
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Szombathely
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Israel
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Holon
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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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Israel
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Zerifin
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Italy
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Livorno
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Perugia
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Torino
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Netherlands
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Amsterdam
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Netherlands
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Nijmegen
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Norway
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Oslo
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Norway
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Stavanger
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Norway
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Trondheim
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Norway
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Ålesund
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Olsztyn
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Poland
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Tarnow
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Poland
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Warszawa
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Russian Federation
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Moscow
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Russian Federation
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Obninsk
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Russian Federation
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St Petersburg
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Málaga
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Pontevedra
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Santander
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Geneve
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Taiwan
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Chang Gung
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
State/province [80] 0 0
London
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United Kingdom
State/province [81] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00738530
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00738530