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Trial registered on ANZCTR
Registration number
ACTRN12619000078156
Ethics application status
Approved
Date submitted
29/09/2017
Date registered
21/01/2019
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of psychotherapy on brain activity in patients with borderline personality disorder in comparison with controls: a functional magnetic resonance study.
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Scientific title
Effects of interpersonal psychotherapy on brain functioning in patients with borderline personality disorder (BPD) compared with controls: a functional magnetic resonance (fMRI) study.
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Secondary ID [1]
292654
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None
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Universal Trial Number (UTN)
U1111-1200-6918
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Trial acronym
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Linked study record
This study is a follow- on from the previous investigation: ACTRN12616000149460
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Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder
304387
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Condition category
Condition code
Mental Health
303721
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0
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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
Psychotherapy: interpersonal psychotherapy adapted to borderline personality disorder, revised (IPT-BPD-R), consisting of 40 weeks (1 hour sessions/week). This intervention consists of individual sessions of psychotherapy focused on four main problematic areas: interpersonal contrasts; role transition; grief; and interpersonal deficit. Two phone calls (max 10 minutes) per week are allowed to handle crisis. These sessions are provided at the Psychiatric Clinic of the Hospital by a expert therapist of interpersonal psychotherapy.
If patient skips two consecutive sessions the intervention is stopped (and patient is considered as a drop-out).
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Intervention code [1]
298888
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Treatment: Other
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Comparator / control treatment
Control treatment: waiting list (clinical monitoring with 1 visit/month). After 10 months patients in waiting list will receive psychotherapeutic intervention or combined therapy with psychotherapy and drugs.
Healthy subjects do not receive interventions.
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Control group
Active
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Outcomes
Primary outcome [1]
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As in the previous study registered in ANZCTR, primary outcome was brain functioning changes during the fMRI in the regions of interest (dorsolateral prefrontal cortex, insula, anterior cingulate cortex, and temporal parietal Junction) during the recall of significant life events.These data will be inserted into the Statistical Parametrical Mapping (SPM), a specific program to elaborate fMRI data.
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Assessment method [1]
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Timepoint [1]
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At baseline (T0) and after 40 weeks
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Secondary outcome [1]
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Level of identity integration measured with the Identity disturbance questionnaire (IDQ) score
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Assessment method [1]
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Timepoint [1]
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At baseline (T0) and after 40 weeks
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Secondary outcome [2]
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Specific BPD symptoms assessed with the Borderline Personality Disorder Severity Index (BPDSI) score
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Assessment method [2]
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Timepoint [2]
339187
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At baseline (T0) and after 40 weeks
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Secondary outcome [3]
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Changes in the Barratt Impulsiveness Scale -Version 11 (BIS-11)score
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Assessment method [3]
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Timepoint [3]
339188
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At baseline (T0) and after 40 weeks
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Secondary outcome [4]
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Frequency of self-injuries measured with the Changes in the Self-Harm Inventory (SHI) score
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Assessment method [4]
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Timepoint [4]
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At baseline (T0) and after 40 weeks
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Secondary outcome [5]
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Aggressive Behaviors assessed with the Modified Overt Aggression Scale (MOAS) score
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Assessment method [5]
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Timepoint [5]
339190
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At baseline (T0) and after 40 weeks
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Secondary outcome [6]
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Global symptoms measured with the Clinical Global Impression- Severity (CGI-S) scale.
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Assessment method [6]
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Timepoint [6]
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At baseline (T0) and after 40 weeks
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Eligibility
Key inclusion criteria
Subjects included in the study have all right handed dominance (assessed with the Edinburgh Handedness Inventory. Diagnosis of borderline personality disorder (BPD) is made by an expert clinician and is confirmed with the Structured Clinical Interview for DSM.IV AxisII Disorders. Healthy subjects are recruited among general population, and are matched for age and gender.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria are: diagnoses of dementia, delirium, and other cognitive disorders; neurological diseases; schizophrenia and other psychotic disorders; bipolar disorders; concurrent major depressive episode; substance abuse in the last two months; pharmacological treatments in the last 3 weeks. Female patients of childbearing age were excluded if they were not using adequate birth control methods (according to the judgment of clinicians).
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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 randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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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
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
At least 20 subjects for each groups should be enrolled.
Functional and structural images will be analyzed using Statistical Parametric Mapping 8 (SPM8, Wellcome Department of Cognitive Neurology, London, UK) implemented in Matlab (Mathworks, Cherborn, MA, USA).
Full factorial within-group analysis and full factorial between-groups analysis will be performed, BPD patients who receive IPT-BPD-R, versus BPD patients who receive clinical management, versus healthy controls.
Changes in clinical rating scales scores between baseline and 40 weeks will be analyzed with ANOVA.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
6/06/2016
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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
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Actual
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Sample size
Target
60
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Accrual to date
31
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Final
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Recruitment outside Australia
Country [1]
9245
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Italy
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State/province [1]
9245
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Turin
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Department of Neuroscience, University of Turin
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Address [1]
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Via Cherasco 15, 10126 Turin, Italy
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Country [1]
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Italy
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Primary sponsor type
University
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Name
Department of Neuroscience, University of Turin
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Address
Via Cherasco 15, 10126 Turin, Italy
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Country
Italy
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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]
296670
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Country [1]
296670
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298398
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Comitato Etico Interaziendale A.O.U. Città della Salute e della Scienza di Torino - A.O. Ordine Mauriziano - A.S.L. Città di Torino
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Ethics committee address [1]
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Corso Bramante 88, 10126, Turin (Italy)
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Ethics committee country [1]
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Italy
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Date submitted for ethics approval [1]
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02/07/2015
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Approval date [1]
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30/09/2015
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Ethics approval number [1]
298398
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0094867(b)
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Summary
Brief summary
In our previous study we investigated by fMRI which are the differences of brain activation between BPD patients with a low level of identity integration and healthy controls during a task of autobiographical memory. Based on the recent findings about neural correlates involved in patients with BPD during autobiographical memories we analyze the hemodynamic response in some regions of interest (ROIs). We hypothesized that BPD patients with a deficit in identity integration may present a higher brain activation in dorsolateral prefrontal cortex, insula, anterior cingulate cortex, and temporal parietal junction during the recall of significant life events, both resolved and unresolved, in comparison with controls. In the present study BPD patients who have participated to the previous study are randomly assigned to (1) interpersonal psychotherapy adapted for BPD-R (IPT-BPD-R) or (2) waiting list+clinical management for 40 weeks. All subjects (BPD patients and healthy controls) have fMRI at baseline and will repeat fMRI with the same task after 40 weeks. We will compare the changes in brain functioning in the ROIs (dorsolateral prefrontal cortex, insula, anterior cingulate cortex, and temporal parietal Junction) in the three groups (BPD patients who receive IPT-BPD-R; BPD patients who receive clinical management; and healthy subjects) after 40 weeks. We hypothesize that patients who receive psychotherapy will show a decrease of activity in the regions of interest in comparison with patients in waiting list who receive usual clinical management.
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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 Silvio Bellino
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Address
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Department of Neuroscience, University of Turin, Via Cherasco 11., 10126 Turin, Italy
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Country
76954
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Italy
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Phone
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+39 0116335425
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Fax
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+ 39 0116335425
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Email
76954
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[email protected]
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Contact person for public queries
Name
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Paola Bozzatello
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Address
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Department of Neuroscience, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
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Country
76955
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Italy
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Phone
76955
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+ 39 0116335425
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Fax
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+39 0116335425
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Email
76955
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[email protected]
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Contact person for scientific queries
Name
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Paola Bozzatello
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Address
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Department of Neuroscience, University of Turin, Via Cherasco 11., 10126, Turin, Italy
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Country
76956
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Italy
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Phone
76956
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+ 39 0116335425
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Fax
76956
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+ 39 0116335425
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Email
76956
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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
Our Ethics Committee does not allow.
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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
Source
Title
Year of Publication
DOI
Embase
How Interpersonal Psychotherapy Changes the Brain: A Study of fMRI in Borderline Personality Disorder.
2022
https://dx.doi.org/10.4088/JCP.21m13918
Embase
The Role of Cognitive Deficits in Borderline Personality Disorder with Early Traumas: A Mediation Analysis.
2023
https://dx.doi.org/10.3390/jcm12030787
N.B. These documents automatically identified may not have been verified by the study sponsor.
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