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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03124303
Registration number
NCT03124303
Ethics application status
Date submitted
29/03/2017
Date registered
21/04/2017
Date last updated
27/06/2024
Titles & IDs
Public title
Interventions for Postoperative Delirium: Biomarker-3
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Scientific title
Interventions for Postoperative Delirium: Biomarker-3
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Secondary ID [1]
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A530900
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Secondary ID [2]
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2015-0374
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Universal Trial Number (UTN)
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Trial acronym
IPOD-B3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Delirium
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Mental Health
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Psychosis and personality 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: Drugs - SHR-1316
Treatment: Surgery - High Density-Electroencephalogram
Treatment: Surgery - Magnetic Resonance Imaging
Treatment: Drugs: SHR-1316
PD-L1
Treatment: Surgery: High Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
Treatment: Surgery: Magnetic Resonance Imaging
MRI scan of brain
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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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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Functional Connectivity
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Assessment method [1]
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Change from baseline functional connectivity at immediate postoperative period and association between delirium (CAM) and functional connectivity of the cingulate cortex
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Timepoint [1]
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Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4
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Secondary outcome [1]
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Inflammation
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Assessment method [1]
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Assess the changes from preoperative to postoperative EEG associated with delirium and change in plasma/cerebrospinal fluid (CSF) IL-6 or other biomarkers (e.g. other cytokines or markers of neronal injury)
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Timepoint [1]
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Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4
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Secondary outcome [2]
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Biomarkers
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Assessment method [2]
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Identify biomarkers of delirium and neural damage through changes in circulating plasma proteins and molecules (through mass spectometry)
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Timepoint [2]
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Post-operative day 1 through 4
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Secondary outcome [3]
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Brain measurements
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Assessment method [3]
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Assess the association between preoperative white matter connectivity (DTI) and cortical thickness (derived from MRI) and postoperative delirium
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Timepoint [3]
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Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4
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Secondary outcome [4]
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Long term cognition
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Assessment method [4]
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Examine the incidence of delirium with change in cognition from preoperatively to one-year postoperatively.
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Timepoint [4]
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Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Long term post-operative cognition measured 1 year after surgery.
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Secondary outcome [5]
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Long term cognition
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Assessment method [5]
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Assess the impact of delirium, preoperative and postoperative imaging biomarkers with a change in long term cognition
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Timepoint [5]
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Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery
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Secondary outcome [6]
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Baseline cognition, specific and global.
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Assessment method [6]
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Examine the association between preoperative cognition using a neuropsychological battery, and postoperative delirium incidence.
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Timepoint [6]
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Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4
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Secondary outcome [7]
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Biomarkers and brain measurements
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Assessment method [7]
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Assess the changes in cognition and biomarkers over one year with EEG changes.
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Timepoint [7]
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Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.
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Secondary outcome [8]
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Representativeness of surgical population
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Assessment method [8]
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Identify whether patients who consent to the MRI are reflective of the surgical population.
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Timepoint [8]
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Pre-op MRI: up to 4 weeks prior to surgery.
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Secondary outcome [9]
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Genetics and delirium
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Assessment method [9]
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Identify genetic and epigenetic changes associated with delirium and its pathogenesis.
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Timepoint [9]
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Pre-op blood collected up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Post-operative blood collected on postoperative days 1-4. Long term blood collected 90 days and 1 year after surgery.
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Secondary outcome [10]
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Postoperative amyloid beta deposition and delirium
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Assessment method [10]
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Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography at 90 days after surgery in sub-study IPOD-PET.
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Timepoint [10]
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Post-operative delirium measured on postoperative days 1-4. PET imaging will occur 90 days after surgery.
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Secondary outcome [11]
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Long term changes in amyloid beta deposition and delirium
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Assessment method [11]
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Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography preoperatively and 1 year after surgery in sub-study IPOD-PET2.
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Timepoint [11]
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Pre-operative PET imaging will occur up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Post-operative PET imaging will occur 1 year after surgery.
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Secondary outcome [12]
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Long term cognition
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Assessment method [12]
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Identify predictors of delirium severity and incidence, for change in cognition from preoperatively to two-years postoperatively.
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Timepoint [12]
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Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Long term post-operative cognition measured 2 years after surgery.
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Eligibility
Key inclusion criteria
* Age =65 years
* Anticipated length of hospital stay of at least 2 days after surgery that occurs under general or neuraxial anesthesia
* Written Informed Consent for potential participation prior to surgery
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Contraindication to EEG
* Unable or unwilling to attend the follow-up appointments
* Documented history of dementia
* Deemed incapable of providing consent by surgical team
* Residing in a nursing home
* Undergoing intracranial surgery
* Unable to complete neurocognitive testing due to language, vision or hearing impairment
* Unable to communicate with the research staff due to language barriers
* For optional MRI portion of the study: Contraindication to MRI (e.g., implanted devices not safe for MRI studies, claustrophobia, unable to lie flat or still)
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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
13/02/2017
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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
1/12/2025
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Actual
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Sample size
Target
320
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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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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Wisconsin
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Wisconsin, Madison
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute on Aging (NIA)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The IPOD-B3 study aims to characterize the relationship between premorbid brain activity and postoperative delirium in patients undergoing major surgery. This is a expansion of the NeuroVISION Bolt-On study, NCT01980511.
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Trial website
https://clinicaltrials.gov/study/NCT03124303
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Trial related presentations / publications
Taylor J, Payne T, Casey C, Kunkel D, Parker M, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, McCulloch T, Gaskell A, Sanders RD. Sevoflurane dose and postoperative delirium: a prospective cohort analysis. Br J Anaesth. 2023 Feb;130(2):e289-e297. doi: 10.1016/j.bja.2022.08.022. Epub 2022 Oct 1. Taylor J, Parker M, Casey CP, Tanabe S, Kunkel D, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, Sanders RD. Postoperative delirium and changes in the blood-brain barrier, neuroinflammation, and cerebrospinal fluid lactate: a prospective cohort study. Br J Anaesth. 2022 Aug;129(2):219-230. doi: 10.1016/j.bja.2022.01.005. Epub 2022 Feb 8. Tanabe S, Parker M, Lennertz R, Pearce RA, Banks MI, Sanders RD. Reduced Electroencephalogram Complexity in Postoperative Delirium. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):502-506. doi: 10.1093/gerona/glab352.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Robert Pearce, MD, PhD
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Address
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University of Wisconsin, Madison
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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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David Kunkel, BS
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Address
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Country
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Phone
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608-262-6469
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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
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03124303
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