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Trial registered on ANZCTR
Registration number
ACTRN12625000117415p
Ethics application status
Submitted, not yet approved
Date submitted
12/09/2024
Date registered
3/02/2025
Date last updated
3/02/2025
Date data sharing statement initially provided
3/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Pilot Study of a Mental Health Intervention for children and adults with Developmental & Epileptic Encephalopathies (DEEs)
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Scientific title
Pilot Study of a Mental Health Intervention to diagnose and treat psychological and behavioural disorders in children and adults with Developmental & Epileptic Encephalopathies.
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Secondary ID [1]
312939
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MRF2032010
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Universal Trial Number (UTN)
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Trial acronym
MICE-DEE
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Linked study record
This study is related to registration record ISRCTN57823197. This protocol has been modified to treat a more severe population of children and adults with Developmental and Epileptic Encephalopathies. The study coordinators for registration record ISRCTN57823197 are associate investigators for this trial.
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Health condition
Health condition(s) or problem(s) studied:
Developmental and Epileptic Encephalopathy
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behavioural disorders
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psychological disorders
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Condition category
Condition code
Neurological
331607
331607
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0
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Epilepsy
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Mental Health
331608
331608
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Pilot study of a Mental Health Intervention for Children and Adults with DEEs (MICE-DEE).
Our UK collaborators used MATCH-ADTC (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct problems) in children with epilepsy. MATCH-ADTC is based on principles of cognitive behavioural therapy (CBT) for behaviour problems, anxiety, depression, and trauma. Their intervention, MICE (Mental health Intervention for Children with Epilepsy), modified MATCH-ADTC by incorporating additional modules for use with children with epilepsy, including those with mild intellectual disability.
Study design: Children (4+ years) and adults with DEEs and mental health disorders will be randomised to either Assessment-Enhanced Standard Care for 26 weeks, or MICE-DEE, a personalized modular psychological therapy, for 16 (±6, minimum of 10) sessions for 26 weeks.
This intervention will be delivered entirely to caregivers of normal intellect. Individuals with DEEs will often have severe or profound intellectual disability and will not be able, or asked, to engage in telehealth. The caregivers will attend weekly sessions with the MICE-DEE therapist to develop and practice strategies to ameliorate their child’s mental health problem. Caregivers will then practice these strategies at home and complete weekly check-in measures before each session.
The participants will gain access to the MICE-DEE trial via an initial psychological intervention assessment with parents conducted face-to-face where possible. The remaining trial will be delivered by telehealth (zoom or telephone).
The intervention will be provided by therapists trained in the MICE-DEE intervention. The MICE-DEE therapists will come from a range of disciplines, including psychologists, epilepsy nurse specialists, mental health workers, research personnel and clinicians. MICE-DEE therapists will receive regular clinical supervision with clinical psychologists or neuropsychologists.
The MICE-DEE trial involves a weekly consultation using telehealth. Parents/carers will practise intervention strategies at home and complete weekly check-in measures via email before each session with the therapist. MICE-DEE involves an average of 16 sessions (minimum 10, maximum 22 sessions), within 6 months post-randomisation, with two booster sessions permitted between 6 and 12 months.
The time to complete each session is approximately 1 hour, each module involves an average of 16 sessions. Modules included in the MICE-DEE trial include behavioural problems, depression, and anxiety. Each module contains practices: example practices within the ‘behaviour problems’ treatment module include time out, rewards, active ignoring, making a plan, and effective instructions. Each practice is delivered via a 1-hour treatment session that involves psychoeducation and guided practice of therapeutic strategies between the participant and therapist, with homework tasks and additional practice completed outside each session.
Strategies to assess adherence to the intervention are incorporated into the weekly consultation using telehealth and completion of the check-ins prior to the consultation. The weekly questionnaires include a parental self-efficacy scale to assess perceived effectiveness in delivering the intervention. The individualised intervention will be tailored to each patient, taking into account the main mental health problem. This will occur depending on the diagnosis determined following completion of the Developmental Behaviour Checklist (DBC-2) and Development and Wellbeing Assessment (DAWBA) assessments. Patients will then be randomised in the pilot study and the appropriate module assigned depending on the diagnoses.
Changes in the default treatment sequence are accommodated to address treatment difficulties (eg. when outcome measures collected each week show a poor response), or immediate issues arising during treatment (eg. behavioural escalation) to enable real-time adaptation of the treatment protocol to address the key issue, before recommencing the main problem focus. Clinical judgement will be used throughout to determine whether adaptation to the default treatment sequence for the main mental health problem is required.
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Intervention code [1]
329471
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Behaviour
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Intervention code [2]
329470
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Treatment: Other
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Comparator / control treatment
Arm 1: Assessment-Enhanced Standard Care. Participants randomised to this arm will complete the Development and Wellbeing Assessment (DAWBA), and not receive active intervention. The DAWBA diagnosis will be provided to the referring clinician who can use the results to refer the patient for further management if indicated.
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Control group
Active
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Outcomes
Primary outcome [1]
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Rate of recruitment and completion.
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Assessment method [1]
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The intervention will be considered feasible if 80% of the total randomised cohort (N=80), including both intervention and control arms, complete the trial and provide outcome data.
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Timepoint [1]
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Baseline, 6 months, and 12 months post-randomisation.
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Secondary outcome [1]
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To estimate the effect size of the intervention efficacy of the MICE-DEE intervention for children and adults with DEEs and mental health disorders, compared with assessment enhanced standard care.
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Assessment method [1]
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The effect size of the difference in the Developmental Behaviour Checklist (DBC-2) Total problems Score from baseline to 6-months post-randomization amongst those randomised to the MICE-DEE intervention compared to assessment enhanced standard care controls.
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Timepoint [1]
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Baseline, 6 months and 12 months post-randomisation.
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Eligibility
Key inclusion criteria
Age 4 years or older
Diagnosis of a DEE
Scored above pre-specified threshold on the DBC-2 for mental health symptoms
Meeting DSM-5 or ICD-10 diagnostic criteria for a mental health disorder (eg. depression, anxiety, disruptive behaviour or trauma)
Have a parent or regular carer of normal intellect willing to participate in MICE-DEE
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Minimum age
4
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
Insufficient English to access screening measures
Refusing to have therapy sessions audio and/or video recorded
Actively receiving psychological therapy to treat emotional or behavioural problems at time of initial assessment or intervention phase
Presence of active, severe mental health disorder requiring immediate intervention and not suitable for MICE intervention (eg. psychosis, active suicidal ideation).
Unable to complete the measures despite all reasonable efforts being made to assist
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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)
Central randomization by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients meeting all inclusion criteria will be assigned a unique screening number after informed consent is obtained. Then, a sequential randomisation number within the REDCap eCRF will be generated directing patients to either Arm 1 or Arm 2 stratified by age (4-17, >18 years). This will be followed by within stratum use of covariate adaptive randomisation via the minimum sufficient balance method that considers the following parameters: intellectual disability severity based on the results of the Vineland-3 (mild-moderate 36-69; severe-profound 1-35), primary mental health diagnosis (anxiety, depression, disruptive behaviour), and ASD diagnosis (yes/no).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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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
Efficacy
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Statistical methods / analysis
The primary outcome of feasibility of the MICE-DEE intervention will be assessed by recruitment rates, retention rates and time needed per patient for the study. Outcome data will be presented in terms of mean, median, standard deviations, and range. No formal statistical analyses are planned for the assessment of feasibility for the primary outcome analysis.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/02/2025
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Actual
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Date of last participant enrolment
Anticipated
2/02/2027
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Actual
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Date of last data collection
Anticipated
2/02/2028
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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The Royal Childrens Hospital - Parkville
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Recruitment hospital [2]
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Sydney Children's Hospital - Randwick
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Recruitment hospital [3]
27085
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [4]
27089
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Queensland Children's Hospital - South Brisbane
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Recruitment hospital [5]
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The Children's Hospital at Westmead - Westmead
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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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Department of Health and Aged Care: Medical Research Future Fund: 2023 MRFF Clinician Researchers - Applied Research in Health
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
319667
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316103
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The Royal Children’s Hospital Human Research Ethics Committee
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Ethics committee address [1]
316103
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http://www.rch.org.au/ethics
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Ethics committee country [1]
316103
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Australia
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Date submitted for ethics approval [1]
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28/10/2024
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Approval date [1]
316103
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Ethics approval number [1]
316103
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Summary
Brief summary
Developmental and Epileptic Encephalopathies (DEEs) are the most severe group of epilepsies. Patients have intellectual disability and a range of mental health disorders in more than 70% of individuals, including mood disorders, behavioural problems, psychosis, and autism spectrum disorder; which often go undiagnosed and untreated. Current therapies for epilepsy aim to control seizures but do not address the comorbidities in patients with DEEs. As children with DEEs grow, their mental health comorbidities often eclipse seizures as the problem of greatest concern. This study will pilot the first mental health clinical intervention for children and adults with DEEs. A psychological intervention (MICE) successfully pioneered in the UK has been adapted for adults and children with DEEs (MICE-DEE) to test the feasibility in a pilot study of 40 patients with DEEs compared with 40 patients receiving assessment enhanced standard care.
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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
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Prof Ingrid E Scheffer
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Address
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Level 2, Melbourne Brain Centre, 245 Burgundy Street, University of Melbourne, Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 3 9035 7112
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Marie Inder
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Address
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Level 2, Melbourne Brain Centre, 245 Burgundy Street, University of Melbourne, Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 3 9035 7228
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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
Name
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Ingrid E Scheffer
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Address
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Level 2, Melbourne Brain Centre, 245 Burgundy Street, University of Melbourne, Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 3 9035 7112
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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