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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/NCT01927510
Registration number
NCT01927510
Ethics application status
Date submitted
15/08/2013
Date registered
22/08/2013
Date last updated
22/08/2018
Titles & IDs
Public title
TEAM: A Trial of Early Activity and Mobility in ICU
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Scientific title
Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.
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Secondary ID [1]
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NCT01927510
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Universal Trial Number (UTN)
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Trial acronym
TEAM-RCT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critically Ill
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Early mobilisation
Experimental: early mobilisation - intervention of early mobilisation
No Intervention: Control - Standard care
Behaviour: Early mobilisation
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Intervention code [1]
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Behaviour
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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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Highest daily level of activity measured using the ICU mobillity scale
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Assessment method [1]
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ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)
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Timepoint [1]
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Duration of ICU stay (an average of 10 days)
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Primary outcome [2]
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Total Duration of Active Mobilisation
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Assessment method [2]
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Timepoint [2]
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Radomisation to removal of invasive ventilation (an average of 7 days)
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Primary outcome [3]
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Mean (or Median) Daily Duration of Active Mobilisation
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Assessment method [3]
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Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.
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Timepoint [3]
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Randomisation to removal of invasive ventilation (daily for an average of 7 days)
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Primary outcome [4]
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Total Duration of Active Mobilisation
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Assessment method [4]
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Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours
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Timepoint [4]
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Randomisation to ICU discharge, an average of 10 days
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Primary outcome [5]
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Mean (or Median) Daily Duration of Active Mobilisation
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Assessment method [5]
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Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)
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Timepoint [5]
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Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days
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Primary outcome [6]
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Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day
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Assessment method [6]
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Measured using the ICU mobility scale (0-10)
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Timepoint [6]
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Randomisation to Extubation, an average of 7 days
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Secondary outcome [1]
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Physical Function
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Assessment method [1]
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Highest level of activity, measured using the IADL
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Timepoint [1]
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At 6 months from randomisation
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Secondary outcome [2]
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Recruitment Rates
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Assessment method [2]
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Timepoint [2]
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Entirety of Study
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Secondary outcome [3]
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Staff Utilisation Costs
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Assessment method [3]
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Number of staff required for mobilisation, minutes spent with the patient on active mobilisation activities, and type of staff such as assistant, physiotherapist or nurse, and specific equipment used during mobilisation ie: tilt table/standing frame.
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Timepoint [3]
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ICU admission (approximately 10 days)
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Secondary outcome [4]
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Ventilator and IC free days at Day 28
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Assessment method [4]
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Intensive care free defined as ward ready; free of inotropes, RRT and mechanical ventilation for 24 hours and remaining free of these supports until the time of actual ICU discharge
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Timepoint [4]
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Randomisation to Day 28
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Secondary outcome [5]
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Health related quality of life
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Assessment method [5]
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EQ5D measured using a trained, blinded assessor via telephone interview
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Timepoint [5]
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6 Months after ICU admission
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Secondary outcome [6]
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Return to previous work level
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Assessment method [6]
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Has the participant returned to the work level prior to critical illness?
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Timepoint [6]
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At 6 months from randomisation
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Eligibility
Key inclusion criteria
- Adults > or + to 18 years old admitted to the ICU
- Invasively ventilated and expected to be ventilated the day after tomorrow
- Written informed consent from person responsible/ net of kin (or consent as per
individual HREC if delayed or telephone consent is acceptable)
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Minimum age
18
Years
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Maximum age
No limit
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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
1. INSTABILITY A. Cardiovascular
- Unresolved rhythm disturbance with any bradycardia requiring pharmacological
support
- Any tachycardia with ventricular rate > 150 beats/min
- Lactacte > 4.0 due to inadequate tissue perfusion
- Any external mechanical cardiovascular support (eg. VA ECMO or intra-aortic
balloon pump)
- Norad > 0.2mcg/kg/min (or unit equivalent) or any dose of norad between 0.1 and
0.2mcg/kg/min with more than a 25% increase in last 6 hours
- Cardiac index < 2.0L/min/m^2
B. Respiratory
- FiO2 > 0.6
- PEEP > 15
- Requirement for hypoxaemic rescue interventions eg. NO, prone, ECMO,
prostacyclin, HFOV
- RR > 45
2. Proven or suspected actue brain injury such as stroke, sub-arachnoid haemorrhage,
encephalitis, or moderate to severe traumatic brain injury
3. Proven or suspected actue spinal cord injury
4. Proven or suspected Guillain-Barre Syndrome
5. Second or subsequent ICU admission during a single hospital admission
6. Unable to follow simple verbal commands in English
7. Death inevitable and imminent
8. Inability to walk without assistance of another person prior to onset of acute illness
necessitating ICU admission
9. Cognitive impairment prior to current acute illness
10. Agitation which int he opinion of the treating clinician precludes safe implementation
of EGDM
11. Written rest in bed orders due to documented injury or process the precludes
mobilisation such as suspected or proven instability of spine or pelvis
12. In the opinion of the treating clinician it is unsafe to commence EGDM
13. Has met all the inclusion criteria with no concomitant exclusion criteria for a period
of more than 48 hours
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Study design
Purpose of the study
Treatment
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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 assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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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
1/08/2013
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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
1/02/2015
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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The Austin Hospital - Heidelberg
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Fremantle Hospital - Fremantle
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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6160 - Fremantle
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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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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian and New Zealand Intensive Care Society Clinical Trials Group
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their
care. They develop muscle weaknesses even after only a few days of mechanical ventilation
that may prolong their time in ICU and in hospital, delay functional recovery and delay their
return home and to work. Weakness may be avoided with simple strategies of early exercise in
ICU. This pilot study aims to test the hypothesis that early mobilisation may improve
functional recovery in this patient group and gather pilot data to support a larger
randomised trial across Australia and New Zealand.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01927510
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Trial related presentations / publications
Hodgson CL, Bailey M, Bellomo R, Berney S, Buhr H, Denehy L, Gabbe B, Harrold M, Higgins A, Iwashyna TJ, Papworth R, Parke R, Patman S, Presneill J, Saxena M, Skinner E, Tipping C, Young P, Webb S; Trial of Early Activity and Mobilization Study Investigators. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU. Crit Care Med. 2016 Jun;44(6):1145-52. doi: 10.1097/CCM.0000000000001643.
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Public notes
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Contacts
Principal investigator
Name
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Carol L Hodgson, PhD
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Address
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Australian and New Zealand Intensive Care Research Centre
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Country
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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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Address
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Country
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Phone
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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/NCT01927510
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