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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/NCT05947292
Registration number
NCT05947292
Ethics application status
Date submitted
14/06/2023
Date registered
17/07/2023
Date last updated
17/07/2023
Titles & IDs
Public title
Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture
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Scientific title
PLEXUS (Pediatric Lower Extremity Ultrasound-Guided Nerve Block) Study: A Prospective, Multi-center, Observational Study Comparing Ultrasound Guided Fascia Iliaca Compartment Nerve Block to Systemic Analgesia for Femur Fractures in the Pediatric Emergency Department
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Secondary ID [1]
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STUDY00000295
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Universal Trial Number (UTN)
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Trial acronym
PLEXUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Femur Fracture
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Ultrasound-Guided Fascia Iliaca Compartment Nerve Block
Nerve Block - Patients with femur fractures who receive a fascia-iliaca compartment nerve block as part of their care in the Emergency Department.
No Nerve Block - Patients with femur fractures who receive only intravenous analgesia in the Emergency Department.
Treatment: Surgery: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block
Patient's who receive this intervention will have an ultrasound-guided fascia iliaca compartment nerve block performed in the Emergency Department.
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Intervention code [1]
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Treatment: Surgery
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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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60 Minute Pain Score
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Assessment method [1]
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Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).
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Timepoint [1]
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60 minutes after enrollment.
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Secondary outcome [1]
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240 Minute Pain Score
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Assessment method [1]
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Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).
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Timepoint [1]
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240 minutes after enrollment.
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Secondary outcome [2]
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Oral Morphine Equivilents
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Assessment method [2]
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Opioid medications received. All opioids will be converted to oral morphine equivilents using the opioid equianalgesic calculator developed the Faculty of Pain Medicine, Australian and New Zealand College of Anesthetists (FPM ANZCA).
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Timepoint [2]
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From admission to the emergency department to hospital discharge, up to 72 hours.
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Secondary outcome [3]
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Parental Satisfaction
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Assessment method [3]
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Participants parents/guardians will be asked to complete a satisfaction survey.
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Timepoint [3]
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From admission to the emergency department to discharge from the emergency department, up to 72 hours.
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Secondary outcome [4]
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Percentage of Patients Experiencing Adverse Events
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Assessment method [4]
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Adverse events and complications will be recorded
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Timepoint [4]
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From admission to the emergency department to hospital discharge, up to 72 hours.
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Eligibility
Key inclusion criteria
- Acute femur fracture (less than 24 hours from initial injury)
- Glasgow Coma Scale of 14 or greater at time of enrollment
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Minimum age
4
Years
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Maximum age
17
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
- Allergy or hypersensitivity to local anesthetic agents
- Pregnant
- Prisoner
- Neurovascular injury to the affected limb
- Bilateral femur fractures
- Confirmed, or significant clinical suspicion for, injury to their head, neck, chest,
abdomen, back or pelvis
- Imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury
- Laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury
- A fracture not limited to the extremities (i.e. vertebral compression fracture)
- A significantly displaced extremity fractures (aside from the primary femur fracture)
- An open fracture (aside from the primary femur fracture)
- An additional fracture to the limb of the primary femur fracture (i.e. tibia fracture
in the same leg as the primary femur fracture).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
1/06/2022
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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
1/06/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Gold Coast Hospital and Health Service - Southport
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Recruitment postcode(s) [1]
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4215 - Southport
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Connecticut
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Michigan
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Country [7]
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United States of America
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State/province [7]
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South Carolina
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Country [8]
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United States of America
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State/province [8]
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Virginia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Zachary Binder
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Address
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Other collaborator category [1]
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Other
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Name [1]
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University of Michigan
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Medical University of South Carolina
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Yale University
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Emory University
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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University of California, San Diego
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Address [5]
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Other collaborator category [6]
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Other
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Name [6]
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University of California, San Francisco
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Address [6]
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Other collaborator category [7]
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Other
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Name [7]
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Denver Health and Hospital Authority
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Address [7]
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Other collaborator category [8]
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Other
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Name [8]
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Children's Hospital of The King's Daughters
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Address [8]
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Other collaborator category [9]
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Other
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Name [9]
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Gold Coast Hospital and Health Service
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Address [9]
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this prospective observational study is to compare pain control strategies in
children with femur fractures. Researchers will compare ultrasound-guided fascia iliaca
compartment nerve block to IV pain control alone. The main questions it aims to answer are:
- Are ultrasound-guided fascia iliaca compartment nerve blocks as effective as IV pain
control in controlling pain?
- Do patients who receive an ultrasound-guided fascia iliaca compartment nerve block
require less opioid pain medication than those that don't?
Participants will be asked to provide pain scores during their Emergency Department stay.
Participants parents will be asked to complete a brief survey at the time their child is
leaving the Emergency Department.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05947292
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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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Zachary W Binder, MD
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Address
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University of Massachusetts, Worcester
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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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Zachary W Binder, MD
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Address
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Country
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Phone
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617-755-7737
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05947292
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