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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/NCT00179777
Registration number
NCT00179777
Ethics application status
Date submitted
10/09/2005
Date registered
16/09/2005
Date last updated
30/07/2021
Titles & IDs
Public title
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
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Scientific title
TRIGR - Trial to Reduce IDDM in the Genetically at Risk
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Secondary ID [1]
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U01HD040364
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Secondary ID [2]
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MCT-49395
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Universal Trial Number (UTN)
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Trial acronym
TRIGR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Hydrolysed infant formula
Other interventions - Nonhydrolysed infant formula
Experimental: Hydrolysed infant formula - Hydrolysed infant formula
Placebo Comparator: Nonhydrolysed infant formula - Nonhydrolysed cow's milk based infant formula
Other interventions: Hydrolysed infant formula
Participants in the Hydrolysed infant formula -group received the test formula, casein hydrolysate (Nutramigen™, Mead Johnson Nutritionals), not containing antigenic CM protein, whenever breast milk is not available.
Other interventions: Nonhydrolysed infant formula
Participants in the Nonydrolysed infant formula -group received the CM protein containing control formula which has an addition (20 %) of Nutramigen, whenever breast milk is not available.
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Intervention code [1]
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Other interventions
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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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Number of Participants With Type 1 Diabetes Mellitus
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Assessment method [1]
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Number of participants with Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age and in the final year of the study.
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Timepoint [1]
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12 and 18 months and annually from 2 years up to 14 years
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Secondary outcome [1]
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Number of Participants With Diabetes Associated Autoantibodies
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Assessment method [1]
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Diabetes associated autoantibodies (ICA, IAA, GADA, IA-2A) at 3, 6, 9, 12, and 18 months of age, and annually from age 2 to 10-14 years
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Timepoint [1]
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3, 6, 9, 12, 18 months and annually from 2 years up to 14 years
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Eligibility
Key inclusion criteria
- Biological parent and/or full (not half) sibling of the newborn infant had type 1
diabetes as defined by the World Health Organization
- The infant's parent or legal guardians gave signed consent to participate
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Minimum age
No limit
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Maximum age
7
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
- An older sibling of the newborn infant had been included in the TRIGR intervention
- Multiple gestation
- The parents were unwilling or unable to feed the infant cow's milk based products for
any reason (e.g., religious, cultural).
- The newborn infant had a recognizable severe illness such as those due to chromosomal
abnormality, congenital malformation, respiratory failure needing assisted
ventilation, enzyme deficiencies, etc.
- The gestational age of the newborn infant was less than 35 weeks.
- The infant was older than 7 days at randomization.
- Inability of the family to take part in the study (e.g. the family has no access to
any of the Study Centers, the family has no telephone).
- The infant had received any infant formula other than Nutramigen prior to
randomization.
- No HLA sample drawn before the age of 8 days.
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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 assessing the outcomes
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
Not Applicable
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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
6/05/2002
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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
30/09/2017
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Sample size
Target
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Accrual to date
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Final
5156
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Children's Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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State/province [1]
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Florida
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United States of America
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Pennsylvania
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Canada
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Ontario
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Czechia
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Prague
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Estonia
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State/province [5]
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Tartu
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Country [6]
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Finland
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State/province [6]
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Helsinki
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Germany
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State/province [7]
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Hannover
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Hungary
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Budapest
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Italy
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Sardinia
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Italy
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Rome
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Luxembourg
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Luxembourg
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Netherlands
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Rotterdam
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Poland
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Wroclaw
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Spain
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State/province [14]
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Vizcaya
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Spain
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State/province [15]
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Madrid
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Sweden
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Linkoping
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Switzerland
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State/province [17]
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Zurich
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Helsinki
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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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US Congress
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Address [1]
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Other collaborator category [2]
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Government body
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Name [2]
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Canadian Institutes of Health Research (CIHR)
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Juvenile Diabetes Research Foundation
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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European Community (EC)
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Address [5]
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Other collaborator category [6]
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Other
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Name [6]
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European Foundation for the Study of Diabetes
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Address [6]
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Other collaborator category [7]
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Commercial sector/Industry
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Name [7]
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Mead Johnson Nutrition
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Address [7]
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Other collaborator category [8]
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Other
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Name [8]
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Academy of Finland
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Address [8]
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Other collaborator category [9]
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Other
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Name [9]
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Diabetes Research Foundation, Finland
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Address [9]
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Other collaborator category [10]
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Other
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Name [10]
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Dutch Diabetes Research Foundation
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Address [10]
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Ethics approval
Ethics application status
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Summary
Brief summary
The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to
conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The
TRIGR study was targeted at newborns who are at genetic risk for type 1 diabetes because
their mother, father and/or full sibling has type 1 diabetes. All families were encouraged to
breast feed their infants for as long as possible. Prior to birth, the child was randomly
assigned to receive one of two infant formulas, should formula be required prior to 8 months
of age. The study determined whether weaning to a possibly protective infant formula
decreases these children's chances of developing diabetes - as it does in the animal models
for diabetes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00179777
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Trial related presentations / publications
Akerblom HK, Virtanen SM, Ilonen J, Savilahti E, Vaarala O, Reunanen A, Teramo K, Hamalainen AM, Paronen J, Riikjarv MA, Ormisson A, Ludvigsson J, Dosch HM, Hakulinen T, Knip M; National TRIGR Study Groups. Dietary manipulation of beta cell autoimmunity in infants at increased risk of type 1 diabetes: a pilot study. Diabetologia. 2005 May;48(5):829-37. doi: 10.1007/s00125-005-1733-3. Epub 2005 Apr 19. Erratum In: Diabetologia. 2005 Aug;48(8):1676. Riikjarv, MA [added]; Ormisson, A [added]; Ludvigsson, J [added]; Dosch, HM [added]; Hakulinen, T [added]; Knip, M [added].
TRIGR Study Group. Study design of the Trial to Reduce IDDM in the Genetically at Risk (TRIGR). Pediatr Diabetes. 2007 Jun;8(3):117-37. doi: 10.1111/j.1399-5448.2007.00239.x.
Åkerblom HK, Knip M, Becker D, Dosch H-M, Dupré J, Ilonen J, Krischer JP and the TRIGR Study Group. The TRIGR Trial: Testing the Potential Link between Weaning Diet and Type 1 Diabetes. Immun, Endoc, Metab Agents in Med Chem 7:251-263, 2007.
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Public notes
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Contacts
Principal investigator
Name
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Mikael Knip, MD
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Address
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University of Helsinki
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00179777
Download to PDF