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Trial registered on ANZCTR
Registration number
ACTRN12610000263099
Ethics application status
Approved
Date submitted
25/03/2010
Date registered
31/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Ocular measures for detection of driving impairment due to sleep loss, alcohol and benzodiazepine use
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Scientific title
Ocular measures for detection of driving impairment due to sleep loss, alcohol and benzodiazepine use in healthy drivers
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Secondary ID [1]
1545
0
Nil
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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:
Effect of sleep restriction on driving performance
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Effect of high therapeutic Temazepam dose on driving performance
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Validation of ocular measures of drowsiness
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Condition category
Condition code
Public Health
257191
257191
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0
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Other public health
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Neurological
257192
257192
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0
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Studies of the normal brain and nervous system
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Mental Health
257193
257193
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Three treatment arms completed in random order by each participant, with treatments separated by at least one week: 1) Single 20mg dose Temazepam administered orally & observed for 5hrs; 2)Orally administered alcohol doses resulting in two peak blood alcohol concentrations (BACs), 0.05% & 0.08%, observed for 8hrs total with 1.5hrs between peak BACs; 3) Restricted sleep (4hrs) observed for 8hrs.
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Intervention code [1]
256207
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Behaviour
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Intervention code [2]
256208
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Other interventions
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Comparator / control treatment
Each participant undergoes all treatments: 1) Single orally administered 20mg dose Temazepam controlled against single orally administered 20mg microcellulose placebo capsule; 2) Restricted sleep (4hrs) controlled against normal sleep (no treatment); 3) Restricted sleep (4hrs) and Single orally administered 20mg dose Temazepam compared to 0.05% and 0.08% BAC; 4) Ocular measure of drowsiness (Optalert) compared to electroecephalogram (EEG) and attentional performance measures.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Simulated driving performance on 60min AusEd driving simulator task - measured by: average steering deviation from participant's median lane position (cm), average speed deviation outside the 60-80km/h speed zone, median reaction time for braking after sudden appearance of trucks, & number of crashes of all types.
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Assessment method [1]
258084
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Timepoint [1]
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Once each at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
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Primary outcome [2]
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Ocular measures of drowsiness (via Optalert system)
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Assessment method [2]
258085
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Timepoint [2]
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Assessed during the performance of driving simulation, Psychomotor Vigilance Task (PVT), John's Test of Vigilance (JTV) and Osler (Oxford Sleep Resistance) test.
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Primary outcome [3]
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Number and duration of alpha and theta periods (microsleeps) in EEG
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Assessment method [3]
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Timepoint [3]
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Assessed during the performance of driving simulation, PVT, JTV and Osler.
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Secondary outcome [1]
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Performance on the PVT
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Assessment method [1]
263681
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Timepoint [1]
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Once each at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
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Secondary outcome [2]
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Performance on the JTV
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Assessment method [2]
263682
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Timepoint [2]
263682
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Once each at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
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Secondary outcome [3]
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Performance on the Osler
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Assessment method [3]
263683
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Timepoint [3]
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At baseline before Temazepam/placebo administration, at 9am the day after sleep restriction to 4hrs, and at 2.30pm the day after sleep restriction to 4hrs.
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Secondary outcome [4]
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Stop driving questionnaire score
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Assessment method [4]
263684
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Timepoint [4]
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Assessed after performance of test battery (driving simulation, PVT & JTV) at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
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Secondary outcome [5]
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Karolinska Sleepiness Scale score
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Assessment method [5]
263685
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Timepoint [5]
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Assessed upon arrival for testing in each of the three treatment arms, and after performance of test battery (driving simulation, PVT & JTV) at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
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Secondary outcome [6]
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Sleepiness symptoms questionnaire score
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Assessment method [6]
263686
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Timepoint [6]
263686
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Assessed after performance of test battery (driving simulation, PVT & JTV) at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
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Eligibility
Key inclusion criteria
1) Current Australian driving licence, provisional or unrestricted;
2) Alcohol intake in standard drinks >0 average, <5/day for males and <3/day for females.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1) Epilepsy;
2) Diabetes requiring insulin;
3) Chronic psychiatric illness;
4) Visual impairment which does not correct with glasses;
5) Unable to speak and read English;
6) Drink more than 5 caffeinated beverages per day;
7) Significant daytime sleepiness (Epworth Sleepiness Scale score > 11);
8) Chronic neurological illness;
9) Chronic liver disease, diabetes requiring insulin or renal impairment;
10) Pregnancy or breast feeding;
11) Sleep apnoea, narcolepsy;
12) Use of sedating medication.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised 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?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/04/2009
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Actual
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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
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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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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Vicroads
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Address [1]
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60 Denmark Street
Kew, Victoria 3101
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Country [1]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Institute for Breathing and Sleep
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Address
Austin Hospital
PO Box 5555
Heidelberg, Victoria 3084
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Country
Australia
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Secondary sponsor category [1]
255995
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Government body
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Name [1]
255995
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Vicroads
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Address [1]
255995
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60 Denmark Street
Kew, Victoria 3101
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Country [1]
255995
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
258720
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
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Research Ethics Unit
Austin Hospital
PO Box 5555
Heidelberg, Victoria 3084
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
258720
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Approval date [1]
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06/01/2009
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Ethics approval number [1]
258720
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H2009/03435
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Summary
Brief summary
The results of the study will examine the association between performance impairment on a simulated driving task and eye measures of drowsiness, induced by acute sleep loss, alcohol and hypnotic drug administration. These findings will help to determine the validity of eye measures as a countermeasure to fatigue-states, with the aim of reducing sleep-related motor vehicle accidents.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
30981
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Address
30981
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Country
30981
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Phone
30981
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Fax
30981
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Email
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Contact person for public queries
Name
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Bronwyn Stevens
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Address
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Institute of Breathing and Sleep
Bowen Centre
Dept. Respiratory and Sleep Medicine
Austin Hospital
PO Box 5555
Heidelberg, Victoria 3084
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Country
14228
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Australia
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Phone
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+61 3 9496 3528
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Fax
14228
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Email
14228
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[email protected]
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Contact person for scientific queries
Name
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Bronwyn Stevens
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Address
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Institute of Breathing and Sleep
Bowen Centre
Dept. Respiratory and Sleep Medicine
Austin Hospital
PO Box 5555
Heidelberg, Victoria 3084
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Country
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Australia
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Phone
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+61 3 9496 3528
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Fax
5156
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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