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Trial registered on ANZCTR
Registration number
ACTRN12614001000695
Ethics application status
Approved
Date submitted
5/09/2014
Date registered
16/09/2014
Date last updated
18/11/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Experiences with a new regional citrate anticoagulation protocol for continuous venovenous hemofiltration using a phosphate containing replacement solution in critically ill patients
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Scientific title
Regional citrate anticoagulation for continuous venovenous hemofiltration using Prismocitrate 18/0 and a phosphate containing replacement solution (Phoxilium) for critically ill patients: Effect on filter life and acid-base changes
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Secondary ID [1]
285294
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Nil
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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:
Acute kidney injury
292962
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Critical illness
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Condition category
Condition code
Renal and Urogenital
293256
293256
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0
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Kidney disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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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
Citrate CVVH was performed using either of the following 2 machines: Prismaflex machine (Gambro-Hospal) with a high-flux hemofilter (HF 1400/ ST 100) or MultiFiltrate (Fresenius Medical Care) with the Ultraflux AV 600S hemofilter. The blood flow rate was maintained at 110ml/min, Prismocitrate 18/0 solution running at a fixed rate of 1250 ml/h as predilution replacement fluid, Phoxilium solution at 1250ml/h as post-dilution replacement fluid. Blood samples for urea/ creatinine/ acid-base/ total calcium/ ionized calcium/ pre-filter ionzied calcium/ post-filter ionized calcium were taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs for monitoring purpose. Additional blood tests were performed as indicated based on clinical indications. Concentrated calcium infusion (10% Calcium chloride) was infused via a separate central line and was titrated to achieve a systemic iCa level of 1–1.2 mmol/L. The fluid withdrawal rate was adjusted to achieve the desired fluid balance. The circuit was run for 72 h unless there was filter clotting, transportation outside ICU, or the patient did not require additional CRRT.
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Intervention code [1]
290195
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Not applicable
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
293108
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Hemofilter life span as determined by time to circuit clotting criteria reached and no more than 72 hours
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Assessment method [1]
293108
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Timepoint [1]
293108
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Circuit clotting criteria: hourly inspections for visible extracorporeal circuit / filter clotting, or transmembrane pressure >450mmHg, up to a maximum of 72 hours
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Secondary outcome [1]
310351
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Serum urea changes
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Assessment method [1]
310351
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Timepoint [1]
310351
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [2]
310443
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Serum creatinine changes
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Assessment method [2]
310443
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Timepoint [2]
310443
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [3]
310444
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Serum acid-base changes
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Assessment method [3]
310444
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Timepoint [3]
310444
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [4]
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Serum sodium changes
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Assessment method [4]
310445
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Timepoint [4]
310445
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [5]
310446
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Serum potassium changes
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Assessment method [5]
310446
0
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Timepoint [5]
310446
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [6]
310447
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Serum magnesium changes
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Assessment method [6]
310447
0
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Timepoint [6]
310447
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [7]
310448
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Serum total calcium changes
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Assessment method [7]
310448
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Timepoint [7]
310448
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [8]
310449
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Serum ionized calcium changes
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Assessment method [8]
310449
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Timepoint [8]
310449
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [9]
310450
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Serum pre-filter ionized calcium changes
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Assessment method [9]
310450
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Timepoint [9]
310450
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Secondary outcome [10]
310451
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Serum post-filter ionized calcium changes
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Assessment method [10]
310451
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Timepoint [10]
310451
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Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
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Eligibility
Key inclusion criteria
All patients who underwent CVVH using Prismocitrate 18/0 and Phoxilium during the study period
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Minimum age
18
Years
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Maximum age
85
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
Insufficient data for analysis
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2014
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Actual
1/11/2014
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Date of last participant enrolment
Anticipated
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Actual
1/12/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment outside Australia
Country [1]
6339
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Hong Kong
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State/province [1]
6339
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Hong Kong
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Queen Elizabeth Hospital
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Address [1]
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30 Gascoigne Road
Kowloon
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Country [1]
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Hong Kong
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Primary sponsor type
Hospital
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Name
Intensive Care Unit, Queen Elizabeth Hospital
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Address
30 Gascoigne Road
Kowloon
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Country
Hong Kong
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Secondary sponsor category [1]
288605
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None
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Name [1]
288605
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Address [1]
288605
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Country [1]
288605
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291633
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Kowloon Central / Kowloon East Cluster Research Ethics Committee
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Ethics committee address [1]
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Room 808, Block S, Queen Elizabeth Hospital 30 Gascoigne Road Kowloon
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Ethics committee country [1]
291633
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Hong Kong
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Date submitted for ethics approval [1]
291633
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10/09/2014
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Approval date [1]
291633
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01/10/2014
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Ethics approval number [1]
291633
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Summary
Brief summary
Acute kidney injury is common in critically ill patients and hence continuous renal replacement therapy (CRRT) is an important treatment modality in intensive care. Clotting of the circuit is a major factor contributed to treatment interruption. Regional citrate anticoagulation (RCA) for CRRT is associated with longer filter-life, less bleeding events and improved mortality. We previously reported the use of the Prismocitate 10/2 with good metabolic control and median circuit filter life range from 50 to 26 hrs. Yet, hypomagnesaemia (41.6%) and hypophosphatemia (17.6%) were two commonly encountered electrolyte anomalies during citrate CRRT. Besides, additional sodium bicarbonate infusion was used in all the patients to provide adequate buffer balance. To circumvent all these problems, another proprietary citrate containing solution (Prismocitrate 18/0, Gambro) and phosphate containing hemofiltration solution (Phoxilim) had been used in combination with success in a number of studies. We would like to assess whether or not the combined used of these solutions can provide a safe and effective alternative for critically ill patients who required CRRT.
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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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Dr Henry Jeffrey Yuen
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Address
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Intensive Care Unit, Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
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Country
51250
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Hong Kong
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Phone
51250
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+85229586363
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Fax
51250
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Email
51250
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[email protected]
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Contact person for public queries
Name
51251
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Henry Jeffrey Yuen
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Address
51251
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Intensive Care Unit, Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
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Country
51251
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Hong Kong
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Phone
51251
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+85229586363
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Fax
51251
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Email
51251
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[email protected]
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Contact person for scientific queries
Name
51252
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Henry Jeffrey Yuen
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Address
51252
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Intensive Care Unit, Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
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Country
51252
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Hong Kong
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Phone
51252
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+85229586363
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Fax
51252
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Email
51252
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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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