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Trial registered on ANZCTR
Registration number
ACTRN12621000850875
Ethics application status
Approved
Date submitted
24/05/2021
Date registered
1/07/2021
Date last updated
1/07/2021
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Sneezing under intravenous sedation during nasal local anaesthetic injection for plastic surgery procedures
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Scientific title
The effect of fentanyl co-administration on sneezing during nasal local anaesthetic injection for adults undergoing plastic surgery under propofol-based intravenous sedation: Randomised-Controlled Blinded Trial
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Secondary ID [1]
304295
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None
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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:
Sneezing
322028
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Intravenous sedation
322029
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Condition category
Condition code
Anaesthesiology
319756
319756
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0
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Anaesthetics
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Surgery
319758
319758
0
0
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Other surgery
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Public Health
319759
319759
0
0
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Other public health
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Respiratory
319760
319760
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0
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Normal development and function of the respiratory system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1. FENTANYL INTRAVENOUS 0.5microg/kg (ideal body weight) once + [Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL] + (Intervention group 1)
AND
2. FENTANYL INTRAVENOUS 1.5microg/kg (ideal body weight) once + [Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL] + (Intervention group 2)
In both groups, the total dose of propofol delivered to the participant will be based on reaching the predefined depth of sedation level using the Modified Ramsay Sedation Scale of 6 to 8. Bispectral Index Monitoring is also attached as another marker to monitor the level of sedation. The depth of sedation therefore is controlled.
Adherence to this intervention is ensured by patient medical records, and recordings made by an independent observer/research assistant present during the case.
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Intervention code [1]
320634
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Treatment: Drugs
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Comparator / control treatment
1. Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL. (Control)
The total dose of propofol delivered to the participant will be based on reaching the predefined depth of sedation level using the Modified Ramsay Sedation Scale of 6 to 8. Bispectral Index Monitoring is also attached as another marker to monitor the level of sedation. The depth of sedation therefore is controlled.
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Control group
Active
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Outcomes
Primary outcome [1]
327620
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Incidence of inducing the sneeze reflex
An independent observer/research assistant will be present in every case to witness, assess and document the incidence of sneezing according to the requirement set out on standardised data collection sheet.
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Assessment method [1]
327620
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Timepoint [1]
327620
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At time of, and shortly after nasal local anaesthetic injection to a maximum of 5 minutes.
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Secondary outcome [1]
395950
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Respiratory depression requiring airway manoeuvres
An independent observer/research assistant will be present in every case to witness, assess and document the incidence of this event according to the requirement set out on standardised data collection sheet.
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Assessment method [1]
395950
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Timepoint [1]
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During surgery
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Secondary outcome [2]
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Haemodynamic parameters including blood pressure, and heart rate.
Each participant will be attached to standard monitoring as set out by the Guideline on sedation and/or analgesia for diagnostic and interventional medical, dental or surgical procedures by The Australian and New Zealand College of Anaesthetists. For these parameters, non-invasive blood pressure measurement and pulse rate as displayed on the anaesthesia machine monitored through pulse oximetry and electrocardiographs are used.
An independent observer/research assistant will be present in every case to witness, assess and document the parameters according to the requirement set out on standardised data collection sheet.
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Assessment method [2]
395951
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Timepoint [2]
395951
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During surgery
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Secondary outcome [3]
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Oxygen saturation level
Each participant will be attached to standard monitoring as set out by the Guideline on sedation and/or analgesia for diagnostic and interventional medical, dental or surgical procedures by The Australian and New Zealand College of Anaesthetists. For this parameter, pulse oximetry is used.
An independent observer/research assistant will be present in every case to witness, assess and document the parameters according to the requirement set out on standardised data collection sheet.
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Assessment method [3]
395952
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Timepoint [3]
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during surgery
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Eligibility
Key inclusion criteria
Participants admitted to the study will be adult surgical patients aged 18 and over who require nasal injections of local anaesthetics under intravenous sedation for plastic surgical procedures on the nose
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Minimum age
18
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?
No
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Key exclusion criteria
Participants will be excluded from the study if they have known allergy to propofol or fentanyl or their refusal to participate.
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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)
Randomisation will be performed by independent research assistant employed for the period of the trial. Patients will be randomised using opaque sealed envelopes with the randomisation sequence determined using computer-generated, block randomisation with variable block sizes. Patients will be assigned in a 1:1:1 ratio to either 0.5microg/kg of intravenous, 1.5microg/kg of intravenous fentanyl or no intravenous fentanyl.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised using opaque sealed envelopes with the randomisation sequence determined using computer-generated, block randomisation with variable block sizes.
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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
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
All data will be assessed for normality. Group comparisons will be performed using chi-square tests for equal proportion (or Fishers exact tests where numbers are small), analysis of variance or student t-tests for normally distributed data and Kruskal Wallis tests or Wilcoxon ranks tests otherwise with results reported as frequency (%), means (standard deviation) and medians (interquartile range) respectively. The primary outcome (proportion of patients that sneezed) will further be analysed using logistic regression with results reported as Odds ratios (95%CI). To ensure any observed finding are not due to baseline imbalance, sensitivity analysis will be performed adjusting for imbalanced baseline variables (p<0.2). All analyses will be performed using SAS version 9.4 (SAS Institute., Inc., Cary, NC) and to account for 3 pairwise group comparisons, a two sided p-value of 0.017 (0.05/3) will be used to indicate statistical significance.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
6/07/2021
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Actual
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Date of last participant enrolment
Anticipated
6/04/2022
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Actual
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Date of last data collection
Anticipated
6/04/2022
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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)
VIC
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Recruitment hospital [1]
19523
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Portland District Health - Portland
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Recruitment postcode(s) [1]
34122
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3305 - Portland
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Funding & Sponsors
Funding source category [1]
308672
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Hospital
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Name [1]
308672
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Portland District Health
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Address [1]
308672
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Portland District Health
141-151 Bentinck Street, Portland, 3305, VIC
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Country [1]
308672
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Australia
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Primary sponsor type
Hospital
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Name
Department of Anaesthesia, Portland District Health
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Address
Department of Anaesthesia
Portland District Health
141-151 Bentinck Street, Portland, 3305, VIC
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Portland District Health
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Address [1]
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Portland District Health
141-151 Bentinck Street, Portland, 3305, VIC
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Country [1]
309548
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Australia
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Secondary sponsor category [2]
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University
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Name [2]
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The University of Queensland
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Address [2]
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The University of Queensland
St Lucia, 4067, QLD
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Country [2]
309550
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308595
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Barwon Health Human Research Ethics Committee
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Ethics committee address [1]
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PO Box 281
Geelong VIC 3220
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Ethics committee country [1]
308595
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Australia
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Date submitted for ethics approval [1]
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12/06/2020
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Approval date [1]
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13/04/2021
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Ethics approval number [1]
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HREC/65803/VICBH-2021-258601(v4)
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Summary
Brief summary
Local anaesthetic injections to the nose may be painful and patients often require intravenous sedation. At the same time, local anaesthetics injections to the nose may lead to sneezing especially when performed in a sedated state. Sneezing during these injections however poses potential patient safety concern, potential infectious spread via aerosol generation and an occupational health hazard.
We hypothesise that administering intravenous fentanyl (a strong opioid) as part of intravenous sedation may lessen the incidence of sneezing in these circumstances. The primary aim of the study therefore is to determine whether administration of intravenous fentanyl as part of propofol-based intravenous sedation given prior to nasal injection of local anaesthetics will reduce the rate of sneezing compared to propofol-only intravenous sedation in adults undergoing plastic surgery to the nose.
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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 Jun Parker
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Address
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Portland District Health
141-151 Bentinck Street, Portland, VIC 3305
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Country
111266
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Australia
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Phone
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+61431711746
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Fax
111266
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Email
111266
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[email protected]
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Contact person for public queries
Name
111267
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Dr Jun Parker
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Address
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Portland District Health
141-151 Bentinck Street, Portland, VIC 3305
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Country
111267
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Australia
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Phone
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+61 3 5521 0333
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Fax
111267
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Jun Parker
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Address
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Portland District Health
141-151 Bentinck Street, Portland, VIC 3305
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Country
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Australia
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Phone
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+61431711746
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Fax
111268
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Email
111268
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
11745
Study protocol
382052-(Uploaded-16-06-2021-14-13-15)-Study-related document.docx
11746
Ethical approval
382052-(Uploaded-24-05-2021-11-41-57)-Study-related document.pdf
11747
Informed consent form
382052-(Uploaded-24-05-2021-11-41-57)-Study-related document.docx
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.
Download to PDF