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Trial registered on ANZCTR
Registration number
ACTRN12617000751370
Ethics application status
Approved
Date submitted
26/01/2017
Date registered
22/05/2017
Date last updated
22/05/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparative study of postural changes after global manipulation of the pelvis versus suboccipital inhibition in children aged 4 to 12 years affected by clubfoot: baropodometry and stabilometry
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Scientific title
Comparative study of postural changes after global manipulation of the pelvis versus suboccipital inhibition in children aged 4 to 12 years affected by clubfoot: baropodometry and stabilometry
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Secondary ID [1]
291011
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None
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Universal Trial Number (UTN)
U1111-1192-0805
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Trial acronym
CPMGPVISPZ
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clubfoot
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Postural changes due to changes in the footprint, conditioned by the structural and functional limitations of the clubfoot
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Condition category
Condition code
Physical Medicine / Rehabilitation
301479
301479
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0
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Physiotherapy
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Musculoskeletal
302248
302248
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0
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
302249
302249
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Group 1: Global Manipulation of the pelvis bilaterally: opening the faces of L5 and sacroiliac joint. Patient in lateral decubitus, in lumbar roll possition. Rotation technique with contact in sacroiliac joint. 1 minute for each manipulation, total time for treatment 2 minutes. Patient will be lying in supine decubitus in the stretcher for 3 minutes. Total time included the time for the treatment are 5 minutes. Duration and frequency of treatment: treatment performed on one occasion only for 5 minutes (total time for treatment is 2 minutes, and lying time is 3 minutes)
Group 2: Suboccipital muscle inhibition. Patient lying face up (supine decubitus). therapist sitting with the distal part of the fingers in the suboccipital area, producing a slight ventral and craneal compression. The patient will be 5 minutes in supine decubitus while the treatment will be realized. Frequency and duration: treatment performed on one occasion only for 5 minutes ( total time for treatment and lying time is 5 minutes). In this case the treatment has a duration of 5 minutes, and at the same time, the patient is lying face up.
group 3 : Hands Mobilisation. Patient in supine decubitus, therapist sitting by his side. Articulatiry technique for both hands ( two minutes each one). The patient will be 5 minutes in supine decubitus while the therapist realiza the treatment. Frequency and duration: treatment performed on one occasion only for 5 minutes ( 4 minutes lying and treatment and 1 minute just lying face up)
Stabilometric and baropodometric measurements pre and post intervention.
All the treatment will be administered in a private traumatology clinic, in a room adapted to the physiotherapeutic care of patients, with a stretcher to perform the treatment and a timer to mark the intervention times. The data collection will be performed in a separate room suitable for it.
The treatments will be performed by an osteopath with more than 5 years of clinical experience in the field of pediatric osteopathy.
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Intervention code [1]
296978
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Rehabilitation
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Comparator / control treatment
Group 3 Or Control Group: hands mobilisation.
Patient in supine decubitus.
Therapist sitting by his side.
Articulatiry technique for both hands ( two minutes each one).
The patient will be 5 minutes in supine decubitus ( 4 minutes lying and having treatment, and 1 minute just lying face up).
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Control group
Active
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Outcomes
Primary outcome [1]
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Baropodometric measurements assessed by a pressure platform: podoprint (Namrol) with auto calibration mode.:
1- Surface of right and left forefoot and hindfoot support and load percentage of right and left forefoot and hindfoot.
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Assessment method [1]
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Timepoint [1]
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Before and after the intervention.
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Primary outcome [2]
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Ratio forefoot and hindfoot with respect to the right and left foot. Meassurement with Podoprint (namrol) pressure platform.
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Assessment method [2]
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Timepoint [2]
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before and after the intervention
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Primary outcome [3]
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Total support surface, percentage of total load and total weight of the right and left foot. Meassurement with Podoprint (namrol) pressure platform.
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Assessment method [3]
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Timepoint [3]
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before and after treatment.
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Secondary outcome [1]
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Baropodometry : Measurement with (foot pressure) platform: podoprint (namrol company):
Maximum and mean support pressure, and location of maximum pressure point.
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Assessment method [1]
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Timepoint [1]
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before and after treatment
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Secondary outcome [2]
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X and Y coordinates of oscillation, and X and Y oscillation mean. Meassurement with Podoprint (namrol) pressure platform.
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Assessment method [2]
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Timepoint [2]
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pre and post treatment
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Secondary outcome [3]
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Velocity af anteroposterior and lateral displacement, and mean velocity of lateral displacement.Meassurement with Podoprint (namrol) pressure platform.
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Assessment method [3]
334497
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Timepoint [3]
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pre and post treatment.
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Eligibility
Key inclusion criteria
Uni or bilateral clubfoot treated with Ponseti's method.
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Minimum age
4
Years
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Maximum age
12
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
Syndromic or neurological clubfoot.
Physiotherapic or Osteopathic treatment in the last month.
Traumatologic Pathologies in lower extremities or spine in the last month.
Pathologies that present with balance alterations in the last month.
General Contraindications of the techniques (fractures, severa pathologies, etc...)
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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)
Numbered folders
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be assigned to a folder according to the order of arrival. I.e.: first arrival carpet 1, second arrival carpet 2, third arrival carpet 3. forth arrival carpet 1, fifth arrival carpet 2, etc...
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
69 patients divided 3 grupos of 23
Statistical analysis performed by a statistician external to the study group.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
29/05/2017
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Actual
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Date of last participant enrolment
Anticipated
9/06/2017
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Actual
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Date of last data collection
Anticipated
19/06/2017
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Actual
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Sample size
Target
69
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
8606
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Spain
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State/province [1]
8606
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Barcelona
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Sandra Balaguer
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Address [1]
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Sandra Balaguer Sole
Centro Munoz Balaguer Osteopathy and Phisiotherapy (Osteopatia y Fisioterapia)
c/ Ramon montenegro 32 bajo 1
27002 Lugo
Spain
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Country [1]
295440
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Spain
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Primary sponsor type
Individual
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Name
Sandra Balaguer
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Address
Sandra Balaguer Sole
Centro Munoz Balaguer Osteopathy and Phisiotherapy
c/ Ramon mONTENEGRO 32 BAJO 1
27002 Lugo
Spain
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Country
Spain
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Secondary sponsor category [1]
294259
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None
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Name [1]
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Address [1]
294259
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Country [1]
294259
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296771
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S.E.F.O.: Scientific European Federation Osteopaths
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Ethics committee address [1]
296771
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Ethics committee country [1]
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Spain
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Date submitted for ethics approval [1]
296771
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Approval date [1]
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18/01/2017
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Ethics approval number [1]
296771
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Summary
Brief summary
The clubfoot (PEVAC) is a development patology, in the anatomopathological study of fetus affected with clubfoot it has been shown that the ligamento Deltoideus, scaphoid-talus and the posterior tibial tendón are very thickened and attached to the calcareis scaphoid plantar ligament. The clubfoot is considered a multifactorial inheritance.
The Ponseti method is based on the ability of elongation of collagen fibers present in the pathological ligaments of children with clubfoot, as well as taking into account the biology of the deformity. Dr Ponseti gives special importance to the correction based in the funcional anatomy of the foot
The prevalece of this pathology, the serious functional consequences that causes its absence of treatment or incorrect treatment, and the socio-health cost that the management of this type of patient means, makes that this pathology generates special interest.
Once the corrective treatment of the deformity is completed and the correction is stabilized, it is considered that the child can perform recurrences of the disease until the age of 3-4 years.
Nowadays there is an increasing awareness of the importance of posture in the development of children. In the clubfoot case join the modification of the plantar supports, the load distribution and the size of the affected foot-leg, modifies the position and development of this.
There are previous studies that relate baropodometric and stabilometric modificaciones after the global manipulation of the pelvis in healthy subjects, and changes in the extensibility of hamstrings with the same manipulation. Aswell we have found studies that relate the suboccipital inhibition technicque with postural measurements modification, and changes of the extensibility of hamstrings in persons with shortness hamstrings syndrom.
In this study we want to evaluate the differences in the plantar supports and in the distribution of load after an global manipulation of the pelvis or after an inhibition of sub occipital musculature.
For this we will divide the participants in this study in three groups:
First group: Global manipulation of the pelvis. We will seek to improve the mobility of the pelvis.
Second group: inhibition of sub occipital musculature. In this case the objective will be to relax the musculature in the cranium-cervical joint.
Third group: articular mobilization of the hands. Is the placebo group.
The treatment will be performed on one occasion only for 5 minutes.
Before and after the treatment we will record the stabilometric and baropodometric data.
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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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Ms Sandra Balaguer Sole
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Address
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Sandra Balaguer Sole
Centro Munoz Balaguer osteopathy and phisiotherapy
c/ Ramon Montenegro 32, bajo 1
27002 Lugo
Spain
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Country
72006
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Spain
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Phone
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+34679050735
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Fax
72006
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Email
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[email protected]
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Contact person for public queries
Name
72007
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Ms Sandra Balaguer
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Address
72007
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Sandra Balaguer Sole
Centro Munoz Balaguer Osteopathy and physiotherapy
c/Ramon Montenegro 32 bajo 1
27002 Lugo
Spain
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Country
72007
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Spain
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Phone
72007
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+34679050735
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Fax
72007
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Email
72007
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[email protected]
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Contact person for scientific queries
Name
72008
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Ms sandra balaguer
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Address
72008
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Sandra Balaguer sole
Centro Munoz Balaguer Osteopathy and Phisiotherapy
c/ Ramon Montenegro 32, bajo 1
27002 Lugo
Spain
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Country
72008
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Spain
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Phone
72008
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+34679050735
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Fax
72008
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Email
72008
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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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