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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00182312
Registration number
NCT00182312
Ethics application status
Date submitted
13/09/2005
Date registered
16/09/2005
Date last updated
22/03/2018
Titles & IDs
Public title
Caffeine for Apnea of Prematurity (CAP)
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Scientific title
Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants
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Secondary ID [1]
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ISRCTN44364365
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Secondary ID [2]
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CTMG-1999-CAP
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Apnea of Prematurity
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Reproductive Health and Childbirth
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Complications of newborn
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Reproductive Health and Childbirth
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0
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Caffeine citrate injection
Treatment: Drugs: Caffeine citrate injection
Loading dose: 20 mg/kg administered over at least 30 minutes via IV infusion or over at least 10 minutes via slow IV injection.
Daily maintenance dose (to commence at least 24 hours after loading dose): 5 mg/kg, administered over at least 10 minutes via IV infusion, or over at least 5 minutes via slow IV injection. Maintenance dose to be adjusted for body weight every 7 days. If indicated, maintenance dose may be increased to a maximum of 10 mg/kg. May be given orally once full enteral feeds are established.
Duration of treatment: discontinue after infant has tolerated at least 5 consecutive days without positive pressure support AND when the infant is judged by the attending clinician to be no longer a candidate for methylxanthine therapy.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months.
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Assessment method [1]
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Timepoint [1]
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corrected age of 18 months
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Secondary outcome [1]
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bronchopulmonary dysplasia
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Assessment method [1]
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Timepoint [1]
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discharge home
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Secondary outcome [2]
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necrotizing enterocolitis
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Assessment method [2]
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Timepoint [2]
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discharge home
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Secondary outcome [3]
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brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly
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Assessment method [3]
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Timepoint [3]
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discharge home
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Secondary outcome [4]
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retinopathy of prematurity
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Assessment method [4]
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Timepoint [4]
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discharge home
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Secondary outcome [5]
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growth failure
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Assessment method [5]
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Timepoint [5]
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corrected age of 18 months
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Secondary outcome [6]
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functional status at 5 years and at 11-12 years
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Assessment method [6]
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Timepoint [6]
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corrected age of 5 years and chronological age of 11-12 years
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Eligibility
Key inclusion criteria
- birthweight 500 to 1250 grams
- postnatal age day 1 to day 10
- infant considered a candidate for methylxanthine therapy by clinical staff
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Minimum age
No limit
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Maximum age
10
Days
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- dysmorphic features or congenital malformations that adversely affect life expectancy
or neurodevelopment
- unlikely to comply with long-term follow-up
- prior treatment with a methylxanthine
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/1999
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2016
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Sample size
Target
2000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,SA,VIC
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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Women's & Children's Hospital - Adelaide
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Recruitment hospital [3]
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Mercy Hospital for Women - Melbourne
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Recruitment hospital [4]
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Royal Women's Hospital - Melbourne
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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5006 - Adelaide
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Recruitment postcode(s) [3]
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3002 - Melbourne
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Recruitment postcode(s) [4]
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3053 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Germany
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Munich
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Germany
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Tuebingen
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Israel
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Beer Sheva
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Israel
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Kfar-Saba
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Israel
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Rehovot
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Netherlands
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Amsterdam
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Netherlands
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Maastricht
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Sweden
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State/province [16]
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Stockholm
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Switzerland
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Basel
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Switzerland
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Geneva
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Switzerland
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Zurich
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United Kingdom
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Northern Ireland
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United Kingdom
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State/province [21]
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Middlesbrough
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United Kingdom
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State/province [22]
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Newcastle-upon-Tyne
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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National Health and Medical Research Council, Australia
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams
at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting
disabilities. The aim of this research is to reduce this heavy burden of illness. A
multi-center randomized controlled trial has been designed in which 2000 very low birth
weight infants will be enrolled. Our goal is to determine whether the avoidance of
methylxanthine drugs will improve survival without disability to 18 months, corrected for
prematurity.
Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and
breath-holding spells in premature infants. However, there is a striking lack of evidence for
the long-term efficacy and safety of this therapy. Methylxanthines block a naturally
occurring substance, called adenosine, which protects the brain during episodes of oxygen
deficiency. Such episodes are common in infants who are treated with methylxanthines. It is
possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this
trial will clarify whether methylxanthines cause more good than harm in very low birth weight
infants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00182312
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Barbara K Schmidt, MD
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Address
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McMaster University
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00182312
Download to PDF