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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/NCT05982158
Registration number
NCT05982158
Ethics application status
Date submitted
20/07/2023
Date registered
8/08/2023
Date last updated
9/11/2023
Titles & IDs
Public title
Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices
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Scientific title
Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial
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Secondary ID [1]
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GNT2015133
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Universal Trial Number (UTN)
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Trial acronym
AMETHYST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Auditory Hallucination
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Psychotic Disorders
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Schizophrenia and Related Disorders
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Schizophrenia
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Mental Health
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Avatar therapy
Behaviour - Cognitive behavioural therapy (CBT)
Active Comparator: Cognitive Behavioural Therapy (CBT) - The standard therapy arm will be based on a focused cognitive behavioural therapy (CBT) protocol for AVHs. Sessions will involve discussing the characteristics of participant's AVHs, before applying core CBT approaches, adapted to the AVH experience, to conduct a thorough cognitive behavioural assessment with a focus on coping strategy enhancement and cognitive restructuring.
Experimental: Avatar Therapy - The experimental arm will use avatar therapy. Sessions will involve generating an audio-visual avatar as a virtual representation of the primary 'voice' that the participant hears. This will be used to recreate AVHs experientially and allow participants to practice alternative ways of responding to the 'voice'. This innovative approach will be combined with the use of broader CBT methods.
Behaviour: Avatar therapy
Seven 50-minute therapy sessions conducted by videoconferencing.
Behaviour: Cognitive behavioural therapy (CBT)
Seven 50-minute therapy sessions conducted by videoconferencing.
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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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Auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS)
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Assessment method [1]
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Clinician-rated scale providing an index of overall severity based on 11 aspects of hallucinations (frequency, duration, intensity of distress, etc.), rated masked to treatment allocation. Each of the 11-items are scored on a 5-point scale (0 - 4), scores range from 0 to 44, with increased symptom expression indicated by higher scores.
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Timepoint [1]
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Immediately post intervention (3 months), controlling for baseline
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Secondary outcome [1]
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Change in auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) over follow-ups
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Assessment method [1]
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Follow-up timepoints on the clinician rated scale that is used to measure the primary outcome. Includes 11-items that are scored on a 5-point scale (0 - 4), scores range from 0 to 44, with increased symptom expression indicated by higher scores.
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Timepoint [1]
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Baseline, follow-ups (6 and 9 months)
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Secondary outcome [2]
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Change in auditory verbal hallucination-related distress, measured by the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) Distress Score
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Assessment method [2]
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Subscale of the clinician-rated scale that is used to measure the primary outcome. This includes 1-item that is scored on a 5-point scale (0 - 4), score ranges from 0 to 4, with increased symptom expression indicated by a higher score.
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Timepoint [2]
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Baseline, immediately post intervention (3 months), and follow-ups (6 and 9 months)
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Secondary outcome [3]
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Remission of hallucinations, indexed by a score below 3 on the Hallucination scale of the Positive and Negative Syndrome Scales (PANSS)
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Assessment method [3]
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Clinician-rated scale to assess presence and severity of hallucinations. This includes 1-item, scored from 1 to 7, with increased symptom expression indicated by higher scores.
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Timepoint [3]
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Immediately post intervention (3 months), follow-ups (6 and 9 months)
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Secondary outcome [4]
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Change in overall psychosis symptom severity, measured by Positive and Negative Syndrome Scales (PANSS) total and sub scale scores
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Assessment method [4]
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Clinician-rated scale to assess overall psychotic symptom severity on total and sub scale scores (Positive, Negative and General Psychopathology). Includes a total of 30-items that are scored on a 7-point scale (1 - 7). Total score ranges from 30 to 210; Positive and Negative sub scale scores range from 7 to 49; General Psychopathology sub scale scores range from 16 to 112. Higher scores are indicative of increased symptom expression.
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Timepoint [4]
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Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
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Secondary outcome [5]
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Change in depressive symptoms, measured by the Calgary Depression Scale for Schizophrenia (CDSS)
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Assessment method [5]
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Clinician-rated scale to assess depressive symptoms in schizophrenia. Includes a total of 9-items that are scored on a 4-point scale (0 - 3). Total score ranges from 0 to 27, with higher scores indicative of increased symptom expression.
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Timepoint [5]
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Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
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Secondary outcome [6]
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Change in anxiety symptoms, measured by the anxiety scale of the 21-item Depression Anxiety Stress Scale (DASS-21)
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Assessment method [6]
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Self-report measure to assess depression, anxiety, and stress. Includes a total of 21-items that are scored on a 4-point scale (0 - 3). Scoring is made up of three sub scales that each include 7 items (Depression, Anxiety, and Stress). The scores for each of the three sub scales range from 0 to 42, with higher scores indicating increased symptom expression.
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Timepoint [6]
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Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
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Secondary outcome [7]
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Personal recovery (consumer-defined recovery), measured by the Questionnaire for the Process of Recovery (QPR)
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Assessment method [7]
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A self-report measure to assess consumer-defined recovery from psychosis. Includes 15-items that are rated on a 5-point scale, scores range (0-4), scores range from 0-60, with greater recovery indicated by higher scores.
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Timepoint [7]
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Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
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Eligibility
Key inclusion criteria
- Schizophrenia-related disorder or a mood disorder with psychotic symptoms diagnosis
confirmed using the Structured Clinical Interview for DSM (SCID)
- Experiencing current auditory verbal hallucinations as measured by the Positive and
Negative Syndrome Scale (PANSS) item P3 = 4
- Auditory verbal hallucinations present for at least one year
- Auditory verbal hallucinations include significant negative content (PSYRATS item 6 =
2)
- Current treatment with antipsychotic medication at therapeutic levels as per RANZCP
guidelines
- Access to the internet and a computer or other device on which videoconferencing
software can be used
- Sufficient fluency in English for meaningful participation
- Age 18 or over
- Ability to give informed consent
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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
- Auditory verbal hallucinations attributable to a primary substance use disorder or
organic disorder
- Estimated full scale IQ < 70 (using the Test of Premorbid Functioning, TOPF)
- Within the last month or planned at the time of intake: a change of antipsychotic
medication,
- Current or within the past 3 months receipt of individual psychological therapy for
hearing voices, or receipt of electro-convulsive therapy or other brain stimulation
treatment;
- AVHs in a language not spoken by the therapists.
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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 assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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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
1/09/2023
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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
212
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Swinburne University of Technology - Hawthorn
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Recruitment postcode(s) [1]
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3122 - Hawthorn
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Funding & Sponsors
Primary sponsor type
Other
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Name
Swinburne University of Technology
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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 Copenhagen
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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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University of Manchester
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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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University of Melbourne
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Monash University
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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Perth Voices Clinic
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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University of the Sunshine Coast
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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University of Toronto
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Address [7]
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to compare the effects of a new psychological therapy, Avatar
Therapy, to the current standard therapy, Cognitive Behavioural Therapy (CBT), in improving
outcomes in people living with psychotic disorders who have persisting experiences of hearing
voices (auditory verbal hallucinations, AVHs).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05982158
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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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Neil Thomas
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Address
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Swinburne University of Technology
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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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Neil Thomas
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Address
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Phone
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+61 3 92148742
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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/NCT05982158
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