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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/NCT04454788
Registration number
NCT04454788
Ethics application status
Date submitted
16/06/2020
Date registered
2/07/2020
Date last updated
22/06/2021
Titles & IDs
Public title
Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients With Large Vessel Occlusion
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Scientific title
Extending the Time Window for Tenecteplase by Effective Reperfusion of peNumbrAL Tissue in Patients With Large Vessel Occlusion
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Secondary ID [1]
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2019.125
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Universal Trial Number (UTN)
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Trial acronym
ETERNAL-LVO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke
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Condition category
Condition code
Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase
Treatment: Drugs - Standard Care (which may include intravenous Alteplase)
Experimental: Intravenous tenecteplase (TNK) - Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds).
Active Comparator: Intravenous tissue plasminogen activator (tPA) - Patients will receive standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.
Treatment: Drugs: Tenecteplase
Genetically modified tissue plasminogen activator at a dose of 0.25mg/kg given as intravenous bolus over 5-10 seconds
Treatment: Drugs: Standard Care (which may include intravenous Alteplase)
Patients will receive standard care which may include intravenous alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.
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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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Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS
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Assessment method [1]
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Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS (if baseline premorbid mRS =2) at 90 days
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Timepoint [1]
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90 days
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Secondary outcome [1]
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Early clinical improvement
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Assessment method [1]
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Reduction in National Institutes of Health Stroke Scale (NIHSS) score of =8 points at 24 hours or reaching NIHSS 0-1
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Timepoint [1]
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24 hours
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Secondary outcome [2]
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Modified Rankin Scale (mRS) 0-2 (functional independence)
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Assessment method [2]
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Modified Rankin Scale (mRS) 0-2 (functional independence) at 90 days
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Timepoint [2]
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90 days
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Secondary outcome [3]
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Substantial reperfusion at initial angiographic assessment
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Assessment method [3]
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Proportion of patients with >50% reperfusion of the affected vascular territory (mTICI 3b/3) on initial digital subtraction angiography prior to thrombectomy
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Timepoint [3]
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initial angiography within 24 hours of stroke onset
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Secondary outcome [4]
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Symptomatic intracerebral hemorrhage (sICH)
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Assessment method [4]
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sICH defined as parenchymal hematoma type 2 (PH2) - blood clot occupying >30% of the infarcted territory with substantial mass effect
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Timepoint [4]
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24 hours post-randomization
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Secondary outcome [5]
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Death due to any cause
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Assessment method [5]
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Timepoint [5]
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90 days
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Secondary outcome [6]
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Modified Rankin Scale (mRS) 5-6
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Assessment method [6]
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Poor functional outcome of death or requirement for fulltime nursing care
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Timepoint [6]
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90 days
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Secondary outcome [7]
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Successful reperfusion at 24 hours
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Assessment method [7]
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Reperfusion (defined as >90% and >50% reduction in perfusion lesion volume)
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Timepoint [7]
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24 hours
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Secondary outcome [8]
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Infarct growth
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Assessment method [8]
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Increase in the volume of irreversibly injured brain between pre-treatment and 24 hour imaging
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Timepoint [8]
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24 hours
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Secondary outcome [9]
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Recanalization
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Assessment method [9]
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Change in vessel patency between pre-treatment and 24h imaging (CT or MR angiography)
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Timepoint [9]
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24 hours
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Eligibility
Key inclusion criteria
- Patients presenting with acute hemispheric ischemic stroke with onset (or the time
they last known to be well) within 24 hours.
- Patient's age is =18 years.
- Premorbid mRS <3, with a concurrent assessment of whether the patient was able,
immediately prior to the stroke, to: 1) Drive, or (if never drives) perform own
Domestic duties, and 2) Shop for themselves, and 3) Bank/do their own finances (i.e.
Drive/Domestic, Bank, Shop = DBS +ve). Need to be DBS +ve to be study eligible.
- Presence of a vessel occlusion on CTA or MRA. LVO will be defined as 'potentially
retrievable' thrombus at one or more of the following sites: intracranial internal
carotid (ICA), middle cerebral artery (MCA) first segment (M1), proximal middle
cerebral artery second segment (M2) or isolated/tandem occlusion of the extracranial
ICA. Patients with an extracranial ICA stenosis and occlusion are also eligible.
- Presence of 'target mismatch' on automated perfusion CT (CTP) or diffusion-perfusion
MRI software defined as an ischemic core of <70mL, penumbra of >20mL and an ischemic
core to perfusion lesion ratio of >1.8
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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
- Intracranial hemorrhage (ICH) or other diagnosis (e.g. tumor).
- Basilar Artery occlusion.
- Extensive early ischemic change (hypodensity on NCCT or high signal on DWI-MRI) or
early ischemic change outside the perfusion lesion that invalidates mismatch criteria.
- Pre-stroke mRS score of > 2 (indicating significant previous disability) or DBS -ve.
- Any terminal illness such that patient would not be expected to survive more than 1
year
- Any condition that, in the judgment of the investigator could impose hazards to the
patient if study therapy is initiated or affect the participation of the patient in
the study.
- Pregnant women.
- Other standard contraindications to thrombolysis.
- Minor stroke symptoms, or major stroke symptoms rapidly improving
- Clinical presentation suggesting subarachnoid haemorrhage
- Known bleeding diasthesis and/or platelet count <100,000 or taking warfarin with INR >
1.7.
- Patients who have received heparin within 48 hours must have normal aPTT.
- Major surgery or serious trauma within 14 days, serious head trauma within 3 months.
- GI or urinary tract haemorrhage within last 21 days
- Arterial puncture at a non-compressible site or lumbar puncture within 7 days
- Systolic BP > 185, diastolic BP > 110mmHg
- Clinical stroke within 3 months or history of ICH
- Unable to gain consent from patient or person responsible
- Known severe renal impairment (GFR < 15mls/min)
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
Recruiting
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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
1/08/2020
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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
1/12/2025
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Actual
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Sample size
Target
740
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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John Hunter Hospital - Newcastle
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Recruitment hospital [3]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [4]
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Princess Alexandra Hospital - Woolloongabba 4102
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Recruitment hospital [5]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [6]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [7]
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Box Hill Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Liverpool
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Recruitment postcode(s) [2]
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- Newcastle
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Recruitment postcode(s) [3]
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- Randwick
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Recruitment postcode(s) [4]
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4102 - Woolloongabba 4102
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3050 - Melbourne
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Recruitment postcode(s) [7]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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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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Professor Mark Parsons
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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 presenting to the emergency department with an acute ischemic stroke due to a large
vessel occlusion eligible for thrombectomy and target mismatch on computed tomography
perfusion imaging within 24 hours of onset will be assessed determine their eligibility for
randomization into the trial. If the patient gives informed consent they will be randomised
using a central computerised allocation process to either standard of care (no intravenous
thrombolytic treatment or intravenous alteplase 0.9mg/kg) or tenecteplase before undergoing
intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded
endpoint (PROBE) design.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04454788
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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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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 public queries
Name
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Andrew Bivard, PHD
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Address
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Country
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Phone
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+6193424424
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04454788
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