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Trial registered on ANZCTR
Registration number
ACTRN12610000295044
Ethics application status
Approved
Date submitted
10/04/2010
Date registered
13/04/2010
Date last updated
11/10/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Health benefits of high intensity exercise for populations at risk of diabetes and cardiovascular disease
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Scientific title
Can adults at risk of cardiovascular disease and diabetes who undertake short sessions of group based high intensity activities, achieve similar changes to their rate of oxygen consumption during maximal activity (VO2 max) over twelve weeks when compared to subjects undertaking a standard walking programme.
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Secondary ID [1]
1601
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nil
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Universal Trial Number (UTN)
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Trial acronym
HITS (High Intensity Training Study)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular risk
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Diabetes risk
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Condition category
Condition code
Cardiovascular
257275
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0
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Coronary heart disease
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Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
There are two seperate invervention groups and a comparator group ie three groups in total. Both intervention groups will undertake three walking based exercise prescriptions per week for twelve weeks consisting of either i) maximal volitional activity (Maximal Volitional Intensity Training group or MVIT)or ii) high intensity activity (High Intensity Intermittent Training group or HIIT). There will be an incremental increase in the MVIT exercise prescriptions over the twelve week study but estimated duration of the intervention per session (including warm up and cool down periods) for both intervention groups is about 30 minutes.
The exercise classes will be led by applied science students under the supervision of exercise physiologists. The applied science students will have received prior training in the administration of exercise prescriptions, from the relevant exercise physiologists.
The MVIT participants will undergo a minimum of three maximal volitional intensity (ie 'all out') exercises of 30 seconds duration, building up to up to six repetitions of 45 seconds. The HITT participants will undertake four 4 minute exercises at an intensity of 85-95% peak heart rate, interspersed with three recovery periods of three minutes at 65-75% peak heart rate.
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Intervention code [1]
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Lifestyle
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Intervention code [2]
256284
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Prevention
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Comparator / control treatment
Three walking based low intensity endurance exercise prescriptions per week for twelve weeks, of approximately 45 minutes duration per session (includiing warm up and cool down periods). Participants will be asked to walk at an intensity that achieves a heart rate (HR) that is 65-75% of their predicted peak HR.
The exercise classes will be led by applied science students under the supervision of exercise physiologists. The applied science students will have received prior training in the administration of exercise prescriptions, from the relevant exercise physiologists.
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Control group
Active
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Outcomes
Primary outcome [1]
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VO2 max (ie rate of oxygen consumption during maximal activity)assessed by a maximal treadmill test using a modified Bruce protocol with on line gas analysis.
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Assessment method [1]
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Timepoint [1]
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Before and immediately after undertaking the twelve week exercise programme
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Secondary outcome [1]
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Body mass index will be measured by trained observers,using a bioimpedance method (InBody) and a calibrated stadiometer.
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Assessment method [1]
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Timepoint [1]
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Before and immediately after undertaking the twelve week exercise programme
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Secondary outcome [2]
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Waist circumference
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Assessment method [2]
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Timepoint [2]
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Before and immediately after undertaking the twelve week exercise programme
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Secondary outcome [3]
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Blood pressure will be measured by trained observers with the subject in the sitting position. Blood pressure will be measured in the right arm, using an automatic sphygmomanometer, after the subject has been sitting at rest for five mintues.
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Assessment method [3]
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Timepoint [3]
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Before and immediately after undertaking the twelve week exercise programme
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Secondary outcome [4]
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Insulin sensitivity (%S), estimated using the Homeostasis Model Assessment (HOMA).
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Assessment method [4]
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Timepoint [4]
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Before and immediately after undertaking the twelve week exercise programme
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Secondary outcome [5]
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Fasting lipids.
Fasting venous blood samples will be collected before and after the exercise intervention. Plamsa samples will be prepared then stored at minus 20 degrees celcius. Batched measurement of lipids ie total cholesterol, high density lipoprotein (HDL)-cholesterol and triglycerides will be undertaken at completion of the study.
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Assessment method [5]
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Timepoint [5]
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Before and immediately after undertaking the twelve week exercise programme
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Eligibility
Key inclusion criteria
Body mass index 28 to 40
Previously inactive
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Minimum age
35
Years
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Maximum age
60
Years
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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
Major health problems that might pose difficulties, including safety difficulties, when exercising to maximal volitional intensity
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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)
Subjects will have their baseline VO2 max calculated off site by an independent exercise physiologist who will then feed this information to the off site biostatistician. As a further safeguard against allocation bias, the researcher allocating the subjects' VO2 max appointment times, will be blind to the details of the block randomisation process (see below)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation by i) baseline VO2 max (above or below 20th centile for age and gender) and ii) gender, based on a block design, undertaken by an off site biostatistician
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Non inferiority
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/04/2010
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Actual
26/03/2010
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Date of last participant enrolment
Anticipated
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Actual
25/04/2010
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Date of last data collection
Anticipated
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Actual
23/08/2010
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Sample size
Target
48
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Accrual to date
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Final
49
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Canterbury
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Health Research Council (New Zealand)
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Address [1]
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PO Box 5541, Wellesley St, Auckland 1141
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Dr Helen Lunt
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Address
Diabetes Centre
550 Hagley Ave
Riccarton
Christchurch 8001
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Country
New Zealand
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Nick Draper
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Address [1]
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School of Sciences and Physical Education
University of Canterbury
Private Bag 4800
Christchurch 8140
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Country [1]
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New Zealand
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Other collaborator category [1]
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Individual
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Name [1]
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Associate Professor Mike Hamlin
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Address [1]
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Lincoln University
PO Box 84
Lincoln 7647
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Country [1]
1199
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New Zealand
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Other collaborator category [2]
1200
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Individual
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Name [2]
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Dr Jerry Shearman
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Address [2]
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School of Applied Sciences and Allied Health
Christchurch Polytechnic Institute of Technology (CPIT)
PO Box 540
Christchurch 8015
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Country [2]
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Upper South B Regional Ethics Committee
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Ethics committee address [1]
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c/- Ministry of Health PO Box 3877 Christchurch
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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16/12/2009
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Approval date [1]
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03/02/2010
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Ethics approval number [1]
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URB/09/12/069
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Summary
Brief summary
One of the barriers identified by individuals to achieving exercise goals is lack of time. Can short bursts of exercising at increased intensity (for example maximal volitional activity) achieve the same level of fitness as traditional walking based fitness programme, over a shorter time period per exercise session?
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Trial website
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Trial related presentations / publications
Main trial publication: Lunt H, Draper N, Marshall HC, Logan FJ, Hamlin MJ, et al. High Intensity Interval Training in a Real World Setting: A Randomized Controlled Feasibility Study in Overweight Inactive Adults, Measuring Change in Maximal Oxygen Uptake. (2014) PLoS ONE 9(1): e83256. doi:10.1371/journal.pone.0083256
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Helen Lunt
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Address
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Diabetes Centre
550 Hagely Ave
Riccarton
Christchurch 8001
New Zealand
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Country
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New Zealand
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Phone
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+64 3 3640860
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Helen Marshall
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Address
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University of Canterbury
Private Bag 4800
Christchurch 8140
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Country
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New Zealand
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Phone
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+64 2 26741007
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Helen Lunt
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Address
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Diabetes Centre
550 Hagley Ave
Riccarton
Christchurch 8001
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Country
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New Zealand
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Phone
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0064 3 3640860
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Fax
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0064 3 3640171
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF