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Trial registered on ANZCTR
Registration number
ACTRN12624000831583
Ethics application status
Approved
Date submitted
9/06/2024
Date registered
5/07/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The effectiveness of indocyanine green in ureteric identification in Gynaecological Surgery
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Scientific title
Indocyanine green for ureteric identification in complex gynaecology surgery: A single centered, randomised, double-blinded feasibility study in women planned to undergo complex gynaecological laparoscopic surgery
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Secondary ID [1]
312302
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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:
Endometriosis
334039
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Peritoneal fibrosis
334041
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Adenomyosis
334042
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Leiomyoma
334043
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Condition category
Condition code
Surgery
330712
330712
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0
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Surgical techniques
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Reproductive Health and Childbirth
330852
330852
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
25mg of Indocyanine Green (ICG) powder (one vial) will be diluted in 10mls of sterile water and 5mls injected into each ureter.
Patients will be divided into the following groups:
1. Cytoscopic-guided intraurethral ICG solution injected with advanced ureteric catheter at 3cm and remove ureteric catheter straightaway.
2. Cytoscopic-guided intraurethral ICG solution injected into ureter at 3cm with advanced ureteric catheter and insert ureteric catheter up to 17cm.
3. Cytoscopic-guided intraurethral ICG solution injected into ureter with advanced ureteric catheter at 10cm while withdrawing completely and removing it.
4. Cytoscopic-guided intraurethral ICG solution injected into ureter at 10 cm with advanced ureteric catheter while withdrawing then reinsert ureteric catheter at 17cm.
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Intervention code [1]
328772
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Early detection / Screening
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Intervention code [2]
328773
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Prevention
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Intervention code [3]
328774
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Treatment: Surgery
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Comparator / control treatment
2. Cytoscopic-guided intraurethral ICG solution injected into ureter at 3cm with advanced ureteric catheter and insert ureteric catheter up to 17cm.
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Control group
Active
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Outcomes
Primary outcome [1]
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To determine the feasibility of a larger randomized, controlled trial to investigate the effectivity of four methods of administering cystoscopic-guided intraurethral ICG solution for ureteric identification during operative gynecological laparoscopy.
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Assessment method [1]
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Outcome measures will assessed as a composite primary outcome
1. surgeon opinion of cystoscopic- guided intraurethral injection method
- this will be collected in the form of completing a Likert scale
2. recruitment target
- will be determined from study logs and participant recruitment ratio to surgeries booked in a clinical session
3. time to complete recruitment
- calculated in months from time of first recruitment to completion of recruitment
4. study procedure process complications
- study logs of equipment set up and ease of use
5. participant acceptability of study
- any complaints or concerns from partipants will be logged
6. costing
- the cost of ICG vials to the health department or any unforeseen additional costs that arise
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Timepoint [1]
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1. surgeon opinion of cystoscopic- guided intraurethral injection method during and at the end of the surgery
2. recruitment target after baseline
3. time to complete recruitment
4. study procedure process complications during surgery and during hospital admission
5. participant acceptability of study during recruitment and end of the study
6. costing throughout the study
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Secondary outcome [1]
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To determine the effectiveness of the four administration methods in visualising the ureters intra-operatively
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Assessment method [1]
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Likert scale
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Timepoint [1]
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During surgery
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Secondary outcome [2]
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To determine if ureteric ICG alters surgical time
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Assessment method [2]
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Surgical time in minutes will be analysed from time of cystoscopy
- this will be collected from surgical database utilise in hospital as 'surgical start time'
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Timepoint [2]
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During surgery
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Secondary outcome [3]
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To determine change in the number of additional procedures such as repeat cystoscopy or imaging
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Assessment method [3]
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Any additional procedures will be documented
- this will be obtained from the operative record, patient hospital records
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Timepoint [3]
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During surgery and post-procedure during hospital admission
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Secondary outcome [4]
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To determine if intraurethral ICG results in a change ureteric injury rates.
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Assessment method [4]
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Ureteric injury will be documented.
- this will be collected from operative record or patient hospital record
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Timepoint [4]
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Intra-operative and post-operative up to 6 weeks to allow late diagnosis of potential ureteric injury
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Secondary outcome [5]
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To determine if intraurethral ICG results in acute kidney injury (AKI)
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Assessment method [5]
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Post-operative Day 1 creatinine levels will be observed.
- this will be obtained via serum urine and electrolyte
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Timepoint [5]
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Post-operatively Day 1
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Eligibility
Key inclusion criteria
All participants older or equal to 18 years of age planned to undergo gynecological laparoscopic surgery on the complex gynecology list at Fiona Stanley Hospital, Western Australia.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Known allergy to iodides.
Any of the following contraindications: lactating women, impaired renal or liver function.
Non-English-speaking patients (due to the patient information only being available in English).
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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)
Sequentially numbered, opaque, sealed envelope (SNOSE) technique will be utilised. The randomisation group will be written on a paper and kept in an opaque sealed envelope. The primary investigator will open the sealed envelope once the patient has consented to participate and then assigns the treatment group accordingly.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised into equal allocation of 5 patients per group using a computer-generated random allocation key sequence.
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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 assessing the outcomes
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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
Efficacy
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Statistical methods / analysis
Data will be analysed with the intent-to-treat principle and per protocol analysis. As this is a feasibility study, no statistical analysis will occur between the intervention groups. The mean scores on the Likert scale will be presented, as will the mean surgical time. Complications will be presented descriptively.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
31/03/2025
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Actual
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Date of last data collection
Anticipated
31/03/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
42789
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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South Metropolitan Health Services
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Address [1]
316694
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Country [1]
316694
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Australia
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Primary sponsor type
Government body
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Name
South Metropolitan Health Services
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318894
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Country [1]
318894
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
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https://smhs.health.wa.gov.au/Our-research/For-researchers
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/12/2023
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Approval date [1]
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17/04/2024
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Ethics approval number [1]
315473
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RGS0000006458
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Summary
Brief summary
Rationale: Ureteric injury is a known risk associated with complex gynecological surgery given its variable anatomical course through the pelvis. Ureteric injury is associated with significant morbidity thus methods to reduce surgical complications are important. Objectives: The primary objective is to determine the feasibility of undertaking a four-arm randomized trial to determine the most effective method of introducing cystoscopic-guided intraurethral indocyanine green (ICG) solution for ureteric identification during laparoscopic gynecological surgery. The intended primary outcome of the final study will be surgeon opinion of ease of ureteric identification laparoscopically. Secondary objectives include assessing if improved ureteric visualisation reduces surgical time, reduces additional procedures such as repeat cystoscopy or additional radiological investigations such as CT-IVP and reduces ureteric injury.
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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 Vinita Rajadurai
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Address
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Obstetrics and Gynaecology Department, Fiona Stanley Hospital, 11 Warren Drive, Murdoch 6150 Western Australia
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Country
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Australia
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Phone
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+61452486774
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Vinita Rajadurai
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Address
134803
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Obstetrics and Gynaecology Department, Fiona Stanley Hospital, 11 Warren Drive, Murdoch 6150 Western Australia
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Country
134803
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Australia
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Phone
134803
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+61452486774
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Fax
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Email
134803
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[email protected]
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Contact person for scientific queries
Name
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Vinita Rajadurai
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Address
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Obstetrics and Gynaecology Department, Fiona Stanley Hospital, 11 Warren Drive, Murdoch 6150 Western Australia
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Country
134804
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Australia
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Phone
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+61 861522222
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Fax
134804
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Email
134804
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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
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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