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Trial registered on ANZCTR
Registration number
ACTRN12616000666426
Ethics application status
Approved
Date submitted
27/04/2016
Date registered
23/05/2016
Date last updated
23/05/2022
Date data sharing statement initially provided
23/05/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Theta Burst Stimulation (TBS) in Treatment Resistant Obsessive Compulsive Disorder.
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Scientific title
Theta Burst Stimulation (TBS) in Treatment Resistant Obsessive Compulsive Disorder.
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Secondary ID [1]
289012
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Nil
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Universal Trial Number (UTN)
U1111-1199-6860
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Trial acronym
TBS for OCD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder
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Condition category
Condition code
Mental Health
298518
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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
It is a parallel group clinical trial where participants will receive bilateral TBS to either the orbital frontal cortex (OFC) or the supplementary motor area (SMA). Each treatment course will involve TBS treatment twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate treatment one month after their initial treatment had ended.
During treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation. TBS will be applied in a single 40 - second train per application. Three pulses per burst will be applied at 50 Hz and the bursts repeated at 5 Hz. The treatment intensity for both rTMS and TBS will be 120% of resting motor threshold which is measured by administering single pulse TMS to the muscle controlling area of the brain.
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Intervention code [1]
294495
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Treatment: Devices
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Comparator / control treatment
Two treatment arms (TBS to SMA and TBS to OFC) are both considered intervention arms, with neither to be allocated as the control.
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Control group
Active
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Outcomes
Primary outcome [1]
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Yale-Brown Obsessive-Compulsive Scale (YBOCS)
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Assessment method [1]
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Timepoint [1]
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The YBOCS will be administered at baseline, at week 2 post start of treatment and at 4 - 6 weeks post treatment completion.
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Secondary outcome [1]
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Beck Depression Inventory (BDI)
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Assessment method [1]
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Timepoint [1]
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The BDI will be administered at baseline, at week 2 post start of treatment and at 4 - 6 weeks post treatment completion.
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Secondary outcome [2]
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Beck Anxiety Inventory (BAI)
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Assessment method [2]
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Timepoint [2]
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The BAI will be administered at baseline, at week 2 post start of treatment and at 4 - 6 weeks post treatment completion.
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Secondary outcome [3]
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The Clinical Global Impression (CGI) scale.
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Assessment method [3]
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Timepoint [3]
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The CGI will be administered at baseline, at week 2 post start of treatment and at 4 - 6 weeks post treatment completion.
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Eligibility
Key inclusion criteria
- Have DSM-5 diagnosis of OCD
- Are treatment resistant
- Have had no changes in medications in 6 weeks prior to screening
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Minimum age
18
Years
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Maximum age
70
Years
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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
- An unstable medical condition, neurological disorder, history of seizure disorder or currently pregnant or lactating
-A current diagnosis of substance abuse or dependence, a personality disorder or other psychiatric disorder, except depression or another anxiety disorder
- Any contraindication to TMS
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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)
The treatment group is determined by a computer program that generates random numbers. The researcher with access to this program and who is not involved in patient selection securely provides the treatment group to a member of the treatment team by email or in a sealed envelope. The staff member in receipt of the treatment group is not involved in assessing a patient's eligibility at the baseline assessment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to one of two treatment conditions will occur via the generation of a single computer number sequence (no stratification).
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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
Crossover
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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 analysis will be conducted on YBOCS scores from baseline to week 2. Student t tests and Chi-squared tests will be used to examine for differences between demographic and clinical characteristics between the groups for continuous and categorical variables following testing for normality of the data. Mixed model analysis of the primary and secondary outcome variables will be computed to look for differences in group scores across the study time points with treatment type as the between-group and time as the within-subject factor. Concurrent medication use will be included in these analyses as a covariate. We will conduct an exploratory analysis to investigate whether the type of OCD symptoms is related to response to treatment at either site.
We aim to recruit 30 patients into each group (total n=60) allowing for a non-completion rate of 5 subjects per group. Twenty five patients per group will provide an 90% chance of detecting a difference of 5.5 points on the Yale–Brown Obsessive–Compulsive Scale (YBOCS) scale with treatment within each treatment group assuming a standard deviation of 8.0 (2-tailed analysis, p<0.05). If there are differences in efficacy between the groups, this will provide an 80% chance of detecting a difference of 7 points on the Yale–Brown Obsessive–Compulsive Scale (YBOCS) scale between the groups (also assuming a standard deviation of 8.0 (2-tailed analysis, p<0.05)). Given a baseline YBOCS level of around 35 this will mean a 20% difference between the groups in final YBOCS score, which is likely to be of clinical significance.
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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Date of first participant enrolment
Anticipated
14/08/2017
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Actual
1/09/2017
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Date of last participant enrolment
Anticipated
17/06/2019
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Actual
20/12/2018
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Date of last data collection
Anticipated
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Actual
11/02/2019
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Sample size
Target
60
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
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Epworth Rehabilitation Camberwell - Camberwell
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Recruitment postcode(s) [1]
16696
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3124 - Camberwell
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Epworth HealthCare
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Address [1]
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Epworth Camberwell
888 Toorak Road
Camberwell
VICTORIA 3124
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Epworth HealthCare
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Address
Epworth Camberwell
888 Toorak Road
Camberwell
VICTORIA 3124
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Country
Australia
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Monash Alfred Psychiatry Research Centre (MAPrc)
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Address [1]
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Level 4 - 607 St Kilda Road
Melbourne VIC 3004
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
294904
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The Melbourne Clinic Research Ethics Comittee
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Ethics committee address [1]
294904
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130 Church Street
Richmond VIC 3121
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
294904
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Approval date [1]
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15/08/2015
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Ethics approval number [1]
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#266
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Ethics committee name [2]
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Epworth HealthCare Human Research Ethics Committee
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Ethics committee address [2]
298261
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Epworth HealthCare
89 Bridge Road
Richmond VIC 3121
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Ethics committee country [2]
298261
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Australia
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Date submitted for ethics approval [2]
298261
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13/02/2017
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Approval date [2]
298261
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Ethics approval number [2]
298261
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EH2017-182
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Summary
Brief summary
This study is assessing the efficacy of Theta Burst Stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), in treating Obsessive Compulsive Disorder (OCD). It is a randomised control trial where participants will receive bilateral TBS to one of two different brain cortical regions. Each treatment course will involve TBS twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate treatment.
During treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation.
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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 Paul Fitzgerald
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Address
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ANU School of Medicine and Psychology, Ground Floor, Florey Building, ANU, 54 Mills Rd, Acton ACT 2601
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Country
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Australia
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Phone
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+61 2 6125 2622
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Fax
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n/a
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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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Prof Paul Fitzgerald
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Address
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ANU School of Medicine and Psychology, Ground Floor, Florey Building, ANU, 54 Mills Rd, Acton ACT 2601
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Country
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Australia
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Phone
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+61 2 6125 2622
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Fax
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n/a
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Email
65199
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[email protected]
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Contact person for scientific queries
Name
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Prof Paul Fitzgerald
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Address
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ANU School of Medicine and Psychology, Ground Floor, Florey Building, ANU, 54 Mills Rd, Acton ACT 2601
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Country
65200
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Australia
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Phone
65200
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+61 2 6125 2622
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Fax
65200
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n/a
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Email
65200
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
There is insufficient data to be of value on open access repositories
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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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