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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/NCT04522102
Registration number
NCT04522102
Ethics application status
Date submitted
18/08/2020
Date registered
21/08/2020
Date last updated
15/06/2023
Titles & IDs
Public title
Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase
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Scientific title
An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Pilot Study of Antiplatelet Therapy in Patients With a History of Stroke Due to Intracerebral Haemorrhage
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Secondary ID [1]
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ASPIRING
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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:
Intracerebral Hemorrhage
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Condition category
Condition code
Stroke
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Haemorrhagic
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Start antiplatelet monotherapy
Experimental: Intervention - Start antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation).
No Intervention: Comparator - Avoid antiplatelet therapy.
Treatment: Drugs: Start antiplatelet monotherapy
Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
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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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regulatory approvals
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Assessment method [1]
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Receipt of regulatory approvals in China,Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC).
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Timepoint [1]
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6 months
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Secondary outcome [1]
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trial database
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Assessment method [1]
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Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Site recruitment
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Assessment method [2]
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Participation of 20 sites in China and 10 sites in Australia and New Zealand
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Timepoint [2]
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12-18 month
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Secondary outcome [3]
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Calculate frequency of clinical data
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Assessment method [3]
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Frequency of ICH survivors who are screened, eligible, approached, consented, and randomised by month and site from activation.
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Timepoint [3]
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3 years
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Secondary outcome [4]
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Barriers to randomisation of eligible patients.
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Assessment method [4]
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Barriers to randomisation of eligible patients.
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Timepoint [4]
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3 years
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Secondary outcome [5]
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Frequency of protocol deviations and violations.
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Assessment method [5]
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Frequency of protocol deviations and violations.
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Timepoint [5]
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3 years
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Secondary outcome [6]
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Adherence to the allocated intervention by investigators and participants
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Assessment method [6]
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Adherence to the allocated intervention by investigators and participants
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Timepoint [6]
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3 years
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Secondary outcome [7]
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Frequency of withdrawal and loss to follow-up
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Assessment method [7]
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Frequency of withdrawal and loss to follow-up
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Timepoint [7]
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3 years
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Secondary outcome [8]
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Completeness of follow-up assessments
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Assessment method [8]
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Completeness of follow-up assessments
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Timepoint [8]
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3 years
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Secondary outcome [9]
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Characteristics of randomised participants compared with eligible patients who were not recruited.
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Assessment method [9]
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Characteristics of randomised participants compared with eligible patients who were not recruited.
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Timepoint [9]
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3 years
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Secondary outcome [10]
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Frequency of the composite of all serious vascular events
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Assessment method [10]
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composite of all serious vascular events (non-fatal stroke, non-fatal myocardial infarction or death from a vascular cause)
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Timepoint [10]
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6 months
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Secondary outcome [11]
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Serious adverse event (SAE)
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Assessment method [11]
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any serious adverse event (SAE)
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Timepoint [11]
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at least 6 months
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Secondary outcome [12]
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Serious adverse reaction (SAR)
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Assessment method [12]
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serious adverse reaction (SAR)
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Timepoint [12]
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at least 6 months
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Secondary outcome [13]
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Suspected Unexpected Serious Adverse Reaction (SUSAR)
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Assessment method [13]
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Suspected Unexpected Serious Adverse Reaction (SUSAR)
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Timepoint [13]
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at least 6 months
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Eligibility
Key inclusion criteria
1. Patient age =18 years.
2. Symptomatic stroke due to spontaneous (non-traumatic) ICH.
3. Patient is at least 24 hours after ICH symptom onset.
4. Patient and their doctor are both uncertain about whether to start or avoid
antiplatelet monotherapy.
5. Consent to randomisation from the patient (or personal / legal / professional
representative if the patient does not have mental capacity).
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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. ICH due to head injury, in the opinion of the investigator.
2. ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the
investigator.
3. Patient is already taking antiplatelet therapy, or full dose anticoagulant therapy,
after ICH.
4. Patient is pregnant, breastfeeding, or of childbearing age and not taking
contraception.
5. Patient and carer unable to understand spoken or written local language.
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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 assessing the outcomes
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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
Active, not 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
3/09/2021
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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
1/10/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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Country [2]
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China
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State/province [2]
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Shanghai
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute for Global Health, China
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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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University of Edinburgh
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Huashan Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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The University of Western Australia
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
ASPIRING is an investigator-led, multicentre, prospective, randomised, open-label, blind
outcome (PROBE), parallel group, clinical trial. The pilot phase will explore the feasibility
of conducting a trial of starting antiplatelet monotherapy versus avoiding antiplatelet
therapy for reducing all serious vascular events for adults surviving symptomatic stroke due
to spontaneous intracerebral haemorrhage (ICH). The pilot phase will involve ~120 patients at
~30 hospitals in China, Australia and New Zealand.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04522102
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Rustam Al-Shahi Salman
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Address
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University of Edinburgh
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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/NCT04522102
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