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Trial registered on ANZCTR
Registration number
ACTRN12616000393459
Ethics application status
Approved
Date submitted
26/02/2016
Date registered
24/03/2016
Date last updated
15/06/2021
Date data sharing statement initially provided
15/06/2021
Date results provided
15/06/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of exercise on the relationship between deep muscles asymmetry and lumbopelvic kinematics in healthy women
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Scientific title
Effect of exercise on the relationship between deep muscles asymmetry and lumbopelvic kinematics in healthy women
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Secondary ID [1]
288633
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None
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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:
Muscle asymmetry in the lumbopelvic region
297800
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Condition category
Condition code
Musculoskeletal
297978
297978
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0
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Normal musculoskeletal and cartilage development and function
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Physical Medicine / Rehabilitation
297979
297979
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The women participated in this study will be reported to the laboratory for one visit lasting 2-3 hours. They all will be assessed by one physiotherapist, which will perform standard ortopeadic manual tests and standard physiotherapeutic functional assessment of lumbopelvic complex. Then the quality and symmetry od motion between right and left side will be measured during gait and during functional tascs e.g ascending/descending stairs. Simultaneously with the motion analysis the muscles bioelectrical activity of lumbar, abdominal and lower limbs muscles will be assessed. After it, in supine lying position the pelvic floor muscles activity during Glazer test and deep muscles evaluation by transabdominal ultrasonography will be performed. All subjects will recieve one 20 minutes session of trunk and pelvis muscles exercise, which may stimulate the normalisation of neuromotor control during contraction of muscles in lumbopelvic complex. All exercise will be administrated by one physiotherapists during one-on-one consultation. All measurements will be performed at baseline and immediately after the exercise.
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Intervention code [1]
294041
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Diagnosis / Prognosis
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Intervention code [2]
294042
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Prevention
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Intervention code [3]
294043
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Rehabilitation
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Relationship between deep muscles asymmetry and lumbopelvic kinematics - assessed by surface electromyography (sEMG), motion analisys 3D and ultrasonography.
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Assessment method [1]
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Timepoint [1]
297499
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Baseline and immediately after exercise
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Primary outcome [2]
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Influence of trunk and pelvis muscles exercise on lumbopelvic asymmetry - assessed by surface electromyography (sEMG), motion analisys 3D and ultrasonography
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Assessment method [2]
297500
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Timepoint [2]
297500
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Baseline and immediately after exercise
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Secondary outcome [1]
321231
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Changes in lumbopelvic asymmetry and in functional mobility evaluated by standard ortopeadic manual tests and standard physiotherapeutic functional assessment.
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Assessment method [1]
321231
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Timepoint [1]
321231
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Baseline and immediately after exercise
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Secondary outcome [2]
321232
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Changes in symmetry of muscles bioelectrical activity in lumbopelvic complex during standard functional tests as walking, ascending/descending stairs - assessed by surface electromyography (sEMG)
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Assessment method [2]
321232
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Timepoint [2]
321232
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Baseline and immediately after exercise
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Secondary outcome [3]
321233
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Changes in pelvic floor muscles symmetry - assessed by surface electromyography with vaginal electrode during the Glazer test
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Assessment method [3]
321233
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Timepoint [3]
321233
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Baseline and immediately after exercise
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Secondary outcome [4]
321234
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Changes in the symmetry of movement between body sides evaluated during gait, during spinal motion in sagittal , frontal and transverse planes and during ascending/descending stairs. Assessed by 3D kinematics with motion capture system.
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Assessment method [4]
321234
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Timepoint [4]
321234
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Baseline and immediately after exercise
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Secondary outcome [5]
321235
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Changes in deep muscles symmetry in lumbopelvic complex - assessed by transabdominal ultrasonography (USG)
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Assessment method [5]
321235
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Timepoint [5]
321235
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Baseline and immediately after exercise
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Eligibility
Key inclusion criteria
good health
average level of physical activity
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Minimum age
20
Years
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Maximum age
35
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
professional athleticism
chronic diseases of locomotor system, nervous system and cardiovascular system
sensory disorders
varicoceles of anus and vulva
pregnancy
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised 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
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
8/06/2015
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Date of last participant enrolment
Anticipated
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Actual
31/08/2018
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Date of last data collection
Anticipated
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Actual
30/11/2018
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Sample size
Target
100
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Accrual to date
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Final
107
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Recruitment outside Australia
Country [1]
7624
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Poland
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State/province [1]
7624
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Funding & Sponsors
Funding source category [1]
292991
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Self funded/Unfunded
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Name [1]
292991
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Address [1]
292991
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Country [1]
292991
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Primary sponsor type
Individual
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Name
prof Anna Mika
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Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
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Country
Poland
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Secondary sponsor category [1]
291765
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None
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Name [1]
291765
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Address [1]
291765
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Country [1]
291765
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Other collaborator category [1]
278857
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University
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Name [1]
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Institute of Physiotherapy, Faculty of Medicine, University of Rzeszow, Poland
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Address [1]
278857
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ul. Warszawska 26A
35-205 Rzeszow
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Country [1]
278857
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Poland
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Ethical Committee of University of Rzeszow, Poland
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Ethics committee address [1]
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ul. Warszawska 26A 35-205 Rzeszow
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Ethics committee country [1]
294499
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Poland
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Date submitted for ethics approval [1]
294499
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Approval date [1]
294499
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21/01/2015
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Ethics approval number [1]
294499
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4/01/2015
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Summary
Brief summary
The presence of deep muscles asymmetry at rest and during movement is considered as sign of lumbopelvic region dysfunction. Very often severe asymmetry between right and left side is one of the criteria of the eligibility of the patient for surgery. The asymmetry in muscles work, strength and length is also considered as strong risk factor of musculosceletal injury. Moreover the standard rehabilitation applicated in those patients is not always successful. The reason of this failure may be the misdiagnosis based on traditional interpretation of pelvic floor muscles ultrasonographic evaluation, without consideration of evaluated deep muscles function, and motion in which they are active. Therefore it is important to extend the functional evaluation of deep lumbopelvic muscles by simultaneous assessment of their bioelectrical activity in specific functional tascs, their shape and symmetry at rest and during movement visible in ultrasonography and the influance of deep muscles contraction quality on motion symmetry in lumbopelvic region visible e.g. during gait. The aim of this study is the evaluation of the relationship between deep muscles asymmetry of lumbopelvic region and the quality of motion kinematics in pelvis, spine and lower limbs. We also would like to assess the influence of trunk and pelvis muscles exercise on the quality of movement and on muscles activity in lumbopelvic complex.
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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 Anna Mika
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Address
63938
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University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
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Country
63938
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Poland
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Phone
63938
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+48 12 6831134
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Fax
63938
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+48 12 6831300
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Email
63938
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[email protected]
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Contact person for public queries
Name
63939
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Anna Mika
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Address
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University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
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Country
63939
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Poland
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Phone
63939
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+48 12 6831134
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Fax
63939
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+48 12 6831300
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Email
63939
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[email protected]
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Contact person for scientific queries
Name
63940
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Anna Mika
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Address
63940
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University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
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Country
63940
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Poland
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Phone
63940
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+48 12 6831134
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Fax
63940
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+48 12 6831300
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Email
63940
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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
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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
Dimensions AI
The influence of pelvis reposition exercises on pelvic floor muscles asymmetry
2019
https://doi.org/10.1097/md.0000000000013988
N.B. These documents automatically identified may not have been verified by the study sponsor.
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