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Trial registered on ANZCTR
Registration number
ACTRN12614001278628
Ethics application status
Approved
Date submitted
14/11/2014
Date registered
5/12/2014
Date last updated
16/11/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Therapeutic role of motor imagery at six month following total knee arthroplasty
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Scientific title
Does motor imagery rehabilitation (compared to classical rehabilitation) enhance quadriceps strength, gait performance and daily activities in patients aged from 65 to 75 who underwent total knee arthroplasty?
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Secondary ID [1]
285659
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None
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Universal Trial Number (UTN)
U1111-1164-0700
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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:
total knee arthroplasty
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Condition category
Condition code
Physical Medicine / Rehabilitation
293784
293784
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0
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Physiotherapy
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Musculoskeletal
293932
293932
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All participants will undergo the same physiotherapy treatment with the same physiotherapist. They will receive 12 individual sessions of physiotherapy of 1 hour each, scheduled 3 times per week. Treatment will begin 6 months post-operatively.
In the experimental group, we will add “motor imagery” exercises into classical physiotherapy session during the last 15 minutes of the session. Practically they will practice a sequence of motor imagery exercises (kinesthetic and visual imagery). The control group will be subjected to a period of neutral activities during equivalent time. Accordingly they will spend the last 15 minutes of the session to discuss with the physiotherapist of world news not related to their illness.
the 45 minutes of classical physiotherapy included: quadriceps strengthening exercises, proprioceptive exercises and gait training exercises (maximum knee flexion during swing phase).
Motor imagery is defined as the mental representation of an action without any concomitant movement.
During each motor imagery session, we used visual imagery that requires self-visualization of a movement from a first- (internal visual imagery) or third-person (external visual imagery) perspective and kinesthetic imagery that requires to feel movement and to perceive muscle contractions mentally.Participants performed 2 blocks of each set with a 10-s rest period between rehearsals and 2-min rest period between blocks.
The physiotherapist checked whether the participants did not contract their muscles or move their knees during motor imagery exercises.
All exercises should be showed firstly by the experimenter and secondly the participants should do one trial with the contra lateral limb before starting with the operated limb.
During motor imagery training, the physiotherapist read the same imagery script specific for each exercise to ensure that the participants received similar motor imagery instructions.
An informed consent including the description and the schedule of the rehabilitation program will be signed by all participants. Furthermore all participants will provide a signature at the end of every session.
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Intervention code [1]
290601
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Rehabilitation
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Intervention code [2]
290708
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Treatment: Other
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Comparator / control treatment
Classical physiotherapy protocol includes modalities to enhance quadriceps strength and to improve functional impairments especially walking:
- active resisted exercises for quadriceps muscle
- proprioceptive exercises
- gait training (maximum knee flexion during swing phase)
In the experimental group, we will add “motor imagery” exercises into classical physiotherapy session during the last 15 minutes of the session. Practically they will practice a sequence of motor imagery exercises (kinesthetic and visual imagery). The control group will be subjected to a period of neutral activities during equivalent time. Accordingly they will spend the last 15 minutes of the session to discuss with the physiotherapist of world news not related to their illness.
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Control group
Active
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Outcomes
Primary outcome [1]
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maximum knee flexion during swing phase assessed using electric goniometer
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Assessment method [1]
293583
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Timepoint [1]
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pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
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Secondary outcome [1]
311402
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quadriceps strength assessed using a hand held dynamometer
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Assessment method [1]
311402
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Timepoint [1]
311402
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pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
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Secondary outcome [2]
311631
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"timed up ang go" assessed using a chronometer
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Assessment method [2]
311631
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Timepoint [2]
311631
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pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
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Secondary outcome [3]
311632
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"stairs climbing test" assessed using a chronometer
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Assessment method [3]
311632
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Timepoint [3]
311632
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pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
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Secondary outcome [4]
311633
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"six minutes walk test" assessed using a meter
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Assessment method [4]
311633
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Timepoint [4]
311633
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pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
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Secondary outcome [5]
311634
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"oxford knee score" assessed using oxford knee score questionnaire
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Assessment method [5]
311634
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Timepoint [5]
311634
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pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
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Eligibility
Key inclusion criteria
primary unilateral tricompartmental total knee arthroplasty
cause: arthritis
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Minimum age
65
Years
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Maximum age
75
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
- neurological disorders
- other lower extremity orthopedic problems causing function limitation
- symptomatic osteoarthritis of the contralateral knee
- diabetes
- body mass index> 35kg/m2
- neoplasms
- non cooperative patients
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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)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation methods such as Minimisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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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
20 participants
ANOVA one-way
This is a pilot study that may help us test the existence of a significant statistical effect without a clear assumption on its size and power. Thus, it would help us later on to determine the exact sample size needed in order to have a good statistical power. Regarding the actual difficulties encountered in our clinic to recruit participants, we assume that 10 participants per group is a good beginning for such a pilot study.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
11/11/2014
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Actual
11/11/2014
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Date of last participant enrolment
Anticipated
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Actual
17/06/2015
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
24
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Recruitment outside Australia
Country [1]
6475
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Lebanon
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State/province [1]
6475
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Funding & Sponsors
Funding source category [1]
290246
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Self funded/Unfunded
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Name [1]
290246
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marcel moukarzel
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Address [1]
290246
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ain alak- el metn- lebanon
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Country [1]
290246
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Lebanon
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Primary sponsor type
University
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Name
CRIS-Lyon1 University
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Address
27-29 Boulevard du 11 Novembre 1918
69 622 Villeurbanne Cedex, France
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Country
France
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Secondary sponsor category [1]
288952
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University
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Name [1]
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Holy Spirit University Kaslik (USEK)
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Address [1]
288952
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Jounieh BP 446, 99205 Liban
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Country [1]
288952
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Lebanon
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291948
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Lyon1 University ethic committee.
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Ethics committee address [1]
291948
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27-29 Boulevard de 11 Novembre 1918 69 622 Villeurbanne Cedex, France.
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Ethics committee country [1]
291948
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France
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Date submitted for ethics approval [1]
291948
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03/03/2014
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Approval date [1]
291948
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21/04/2014
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Ethics approval number [1]
291948
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N/A
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Summary
Brief summary
Motor imagery (MI) is the mental representation of a movement without any motor output. The majority of studies on MI practice have been conducted in the field of neurological conditions and after peripheral injuries to decrease pain and facilitate motor and functional recovery. However, there is no study in the literature dealing with the effect of MI training and its integration into physiotherapy program following total knee arthroplasty. quadriceps strength, gait performance and daily activities will be measured before and after a classical intervention (Control Group: classical physiotherapy + neutral activity) or a MI intervention (MI Group: classical physiotherapy + MI exercises). Stronger muscle, better gait performance and better functional outcomes are expected in the MI group.
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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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Mr Marcel Moukarzel
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Address
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Marcel Moukarzel Physiotherapy Center, Antelias, Antonine Building, Bloc B, 2nd floor, Elmetn, Lebanon
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Country
52762
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Lebanon
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Phone
52762
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+961 3 782445
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Fax
52762
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+961 4 414275
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Email
52762
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[email protected]
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Contact person for public queries
Name
52763
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Nady Hoyek
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Address
52763
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Centre de Recherche et d'Innovation sur le Sport-CRIS Laboratoirede la Performance Motrice, Mentale et du Materiel (P3M) Universite Claude Bernard-Lyon1-UFR STAPS 27-29 Boulevard du 11 Novembre 1918 69 622 Villeurbanne Cedex, France
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Country
52763
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France
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Phone
52763
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+33 (0)4 72 43 16 25
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Fax
52763
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+33 (0)4 72 44 80 10
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Email
52763
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[email protected]
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Contact person for scientific queries
Name
52764
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Nady Hoyek
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Address
52764
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Centre de Recherche et d'Innovation sur le Sport-CRIS Laboratoirede la Performance Motrice, Mentale et du Materiel (P3M) Universite Claude Bernard-Lyon1-UFR STAPS 27-29 Boulevard du 11 Novembre 1918 69 622 Villeurbanne Cedex, France
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Country
52764
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France
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Phone
52764
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+33 (0)4 72 43 16 25
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Fax
52764
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+33 (0)4 72 44 80 10
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Email
52764
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[email protected]
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No information has been provided regarding IPD availability
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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