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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05196854
Registration number
NCT05196854
Ethics application status
Date submitted
21/12/2021
Date registered
19/01/2022
Date last updated
27/04/2023
Titles & IDs
Public title
Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1
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Scientific title
Feasibility and Comparison Study of Home Blood Pressure Monitoring and Clinical Hypnosis in Children With Neurofibromatosis Type 1
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Secondary ID [1]
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73244
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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:
Hypertension
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Neurofibromatosis 1
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Blood Pressure
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Condition category
Condition code
Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Skin
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Dermatological conditions
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Cancer
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Other cancer types
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Group 1. Standard Home Blood Pressure Measurement
Other interventions - Group 2. Hypnosis script prior to home blood pressure measurement
Other: Group 1: Standard Blood Pressure measurement at home - Standard home blood pressure measurement at home
Experimental: Group 2. Hypnosis script prior to Home Blood Pressure measurement - Participant listens to a pre-recorded hypnosis script (approx 5 mins long) prior to standard home blood pressure measurement.
Other interventions: Group 1. Standard Home Blood Pressure Measurement
Measurement of Blood Pressure using Home blood pressure monitor
Other interventions: Group 2. Hypnosis script prior to home blood pressure measurement
Pre-recorded clinical hypnosis script (approx 5 mins long) used prior to standard home blood pressure measurement. Clinical Hypnosis is used as a non-pharmacological technique for reducing procedural anxiety, distress and discomfort with patients.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Day 1. Clinic-based manual sphygmomanometer blood pressure measurement
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Assessment method [1]
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Three measures of Systolic/diastolic reading (mmHg) using manual sphygmomanometer by trained professional. Following The American Academy Pediatrics guidelines for best practice for blood pressure (BP) measurement to ensure true BP reading.
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Timepoint [1]
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Day 1. Day of recruitment at the clinic appointment
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Primary outcome [2]
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Day 1. Clinic-based automatic oscillometer blood pressure measurement
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Assessment method [2]
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One reading of systolic/diastolic reading (mmHg) using automatic oscillometer BP monitor by trained professional - Following The American Academy Pediatrics guidelines for best practice for blood pressure (BP) measurement to ensure true BP reading.
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Timepoint [2]
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Day 1. Day of recruitment at the clinic appointment
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Primary outcome [3]
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Day 2 Home automatic oscillometer blood pressure measurement
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Assessment method [3]
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Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
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Timepoint [3]
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Day 2 at home
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Primary outcome [4]
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Day 3 Home automatic oscillometer blood pressure measurement
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Assessment method [4]
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Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
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Timepoint [4]
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Day 3 at home
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Primary outcome [5]
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Day 4 Home automatic oscillometer blood pressure measurement
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Assessment method [5]
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Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
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Timepoint [5]
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Day 4 at home
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Secondary outcome [1]
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Day 1. Clinic-based Children's Anxiety Meter Scale (CAM-S)
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Assessment method [1]
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Measurement of participant's reported state of anxiety in clinic when completing BP measurement using Children's Anxiety Meter Scale (CAM-S).
CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale.
0 = calm, not nervous or worried 10 = very very nervous and worried
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Timepoint [1]
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Day1 in clinic
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Secondary outcome [2]
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Day 2,3 and 4 Daily Children's Anxiety Meter Scale (CAM-S) score
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Assessment method [2]
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Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S).
CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale.
0 = calm, not nervous or worried 10 = very very nervous and worried
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Timepoint [2]
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Daily on Day 2, 3 and 4 at home.
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Secondary outcome [3]
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Day 2 Children's Anxiety Meter Scale (CAM-S) score
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Assessment method [3]
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Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S).
CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale.
0 = calm, not nervous or worried 10 = very very nervous and worried
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Timepoint [3]
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Day 2 at home.
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Secondary outcome [4]
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Day 3 Daily Children's Anxiety Meter Scale (CAM-S) score
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Assessment method [4]
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Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S).
CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale.
0 = calm, not nervous or worried 10 = very very nervous and worried
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Timepoint [4]
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Day 3 at home.
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Secondary outcome [5]
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Day 4 Children's Anxiety Meter Scale (CAM-S) score
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Assessment method [5]
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Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S).
CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale.
0 = calm, not nervous or worried 10 = very very nervous and worried
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Timepoint [5]
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Day 4 at home.
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Secondary outcome [6]
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Day 4, Study specific survey of parents/caregivers perceptions
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Assessment method [6]
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Study specific survey. Likert scales used to assess parent/caregiver perception with ease of use of home BP monitor, timeliness to complete measures and interference with family life compared to attending hospital appointment, ease of receiving and returning equipment, and financial cost to attend hospital appointment.
Data will be reported for each item individually, as the proportion of parents/caregivers who responded positively on the Likert scale, where higher scores indicate less favorable responses.
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Timepoint [6]
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Day 4 only
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Eligibility
Key inclusion criteria
- Is between the ages of 5 and 18 years old at enrolment.
- Has a diagnosis of neurofibromatosis type 1(NF1), confirmed by a physician, and
usually attends the NF clinic at The Royal Children's Hospital, Melbourne, Australia
(RCH). Including children with known kidney and cardiac disease.
- Primary residence and residential postal address in Victoria.
- The child can sit quietly for 10-15 minutes at home to complete a blood pressure
assessment.
- Provide a signed and dated participant and/or parent guardian information and consent
form and or has a legally acceptable representative capable of understanding the
informed consent document and providing consent on the participant's behalf.
- For inclusive diverse study group, Parent/caregiver who require an interpreter can be
enrolled in this study. Only inhouse interpreter services able to be included,
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Minimum age
5
Years
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Maximum age
18
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
- Has clinically significant cognitive impairment or attention disorder preventing
ability to sit in a chair for 15 minutes
- Has confirmed hypertension on previous testing
- Parent/caregiver who require an interpreter and cannot upload BP and Heart rate (HR)
values online independently will be excluded from the study.
- Parent/caregiver requiring an interpreter, but the interpreter not present within the
face-to-face appointment eg, phone interpreter services.
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Study design
Purpose of the study
Prevention
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/05/2022
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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
24/04/2023
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Sample size
Target
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Accrual to date
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Final
54
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Murdoch Children's Research Institute - Parkville
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Recruitment postcode(s) [1]
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3050 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study has two primary objectives. The first is to determine if it is feasible and
reliable for children and families with a diagnosis of Neurofibromatosis Type 1 (NF1) to use
of blood pressure (BP) monitor at home.
The second is to determine if there is a difference between a child's measured home BP using
standard instructions or using a clinical hypnosis script. This will be determined by a
randomised control trial design.
Standard and hypnosis Home BP will be compared to the gold standard measurement of BP
measured by a trained health care professional in clinic.
Children who participate will complete a clinic-based BP with a health care professional,
then will be randomised into either the standard home BP measurement or using a hypnosis
script prior to BP measurement.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05196854
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Trial related presentations / publications
Flynn JT, Kaelber DC, Baker-Smith CM, Blowey D, Carroll AE, Daniels SR, de Ferranti SD, Dionne JM, Falkner B, Flinn SK, Gidding SS, Goodwin C, Leu MG, Powers ME, Rea C, Samuels J, Simasek M, Thaker VV, Urbina EM; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017 Sep;140(3):e20171904. doi: 10.1542/peds.2017-1904. Epub 2017 Aug 21. Erratum In: Pediatrics. 2017 Nov 30;: Pediatrics. 2018 Sep;142(3):
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Public notes
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Contacts
Principal investigator
Name
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Gabriel Dabscheck, MBBS FRACP
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Address
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Murdoch Children's Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05196854
Download to PDF