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Trial registered on ANZCTR
Registration number
ACTRN12622000535774
Ethics application status
Approved
Date submitted
13/03/2022
Date registered
5/04/2022
Date last updated
7/03/2023
Date data sharing statement initially provided
5/04/2022
Date results information initially provided
7/03/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
High fermentable fibre bread consumption and the bowel health of Australian parents and caregivers of children.
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Scientific title
Effect of highly fermentable fibre bread consumption on faecal short chain fatty acid producing bacteria in Australian parents and caregivers of children.
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Secondary ID [1]
306676
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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:
Poor gut health
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Low fibre consumption
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Condition category
Condition code
Diet and Nutrition
322972
322972
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0
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Other diet and nutrition disorders
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Oral and Gastrointestinal
323210
323210
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will consume 3 slices of bread high in fermentable fibre containing a blend of high fibre grains that include BARLEYmax (providing a total of ~17 g fibre) daily, for 2 weeks. The bread will be delivered to the participant’s home. Participants will complete a daily log via a mobile app or paper-based diary to assess protocol compliance, adverse events and use of concomitant medications. Participants will have a 4 week washout period between intervention/control where they will be advised to continue their regular diet.
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Intervention code [1]
323116
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Treatment: Other
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Comparator / control treatment
Participants will consume 3 slices of white bread daily for 2 weeks. The Control bread is low in fibre, providing a total daily dose of ~3 g of dietary fibre..
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Control group
Active
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Outcomes
Primary outcome [1]
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short chain fatty acid producing bacteria (%relative abundance) assessed using a stool sample
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Assessment method [1]
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Timepoint [1]
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Baseline, 2 weeks post-intervention commencement
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Secondary outcome [1]
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Stool consistency assessed using the Bristol stool rating chart (no units)
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Assessment method [1]
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Timepoint [1]
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Baseline, 2 weeks post-intervention commencement
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Secondary outcome [2]
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Gut comfort assessed using the Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire (no units)
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Assessment method [2]
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Timepoint [2]
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Baseline, 2 weeks post-intervention commencement
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Secondary outcome [3]
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Firmicutes/Bacteroidetes ratio assessed in stool samples
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Assessment method [3]
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Timepoint [3]
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Baseline, 2 weeks post-intervention commencement
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Secondary outcome [4]
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Microbial diversity assessed in stool samples
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Assessment method [4]
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Timepoint [4]
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Baseline, 2 weeks post-intervention commencement
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Eligibility
Key inclusion criteria
1. Male or Female individuals
2. Aged 22 to 55 years of age at clinic screen
3. Be a parent or carer for at least one, primary school aged child aged 5 to 12 years
4. BMI 18.5 to 29.9 at time of clinic screening
5. Willing to maintain body weight for the duration of the study (i.e. no more than 3 kg weight loss/gain).
6. Located within 15km of Ashwood, Melbourne.
7. Access to a smartphone and willing to download and use free applications from the app store
8. Access to a personal email inbox
9. Willing and able to provide Informed Consent
10. Understand the study requirements, including faecal sampling and willing to adhere closely to prescribed food consumption as per the research protocol.
11. Willing to maintain regular dietary pattern and level of physical activity
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Minimum age
22
Years
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Maximum age
55
Years
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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
1. Use of any of the following types of supplements within 28 days of clinic screening and not prepared to abstain from use for the study duration: laxatives, fibre supplements
2. Aversion and/or intolerance/allergy to any of the following: gluten, spelt, egg, tree nuts, lupin or FODMAPs.
3. Have a significant acute or chronic illness (i.e., psychiatric, gastrointestinal, cardiovascular [except uncontrolled hypertension], endocrine or immunological) or any condition that in the opinion of the Principal Investigator (PI) or Designee may affect the applicant’s ability to participate in the study or the study results
4. Have experienced a cardiovascular event such as congestive heart failure, heart attack, stroke, or angina (chest pain) in the past 84 days from screening
5. Currently have, or have a history of, inflammatory bowel disease (e.g., ulcerative colitis, Chron’s disease), coeliac disease, irritable bowel syndrome, chronic constipation or regular bouts of diarrhea
6. History of Chemotherapy or Radiotherapy treatment within preceding two years of screening
7. Current smoker/vaper (or history of smoking/vaping including within last 6 months from screening)
8. Women of childbearing potential (WOCBP) who are self reported as currently pregnant or lactating
9. Currently hospitalised or any planned hospitalisations during the study that may affect the participant’s ability to comply with the study in the opinion of the PI or Designee
10. Self-reported alcohol intake exceeding 10 standard drinks per week on average over the four weeks preceding screening
11. Currently a night shift worker
12. Are currently, or in the past 30 days have been, enrolled in another investigational device or drug study(s), or are currently receiving other investigational agent(s) that in the opinion of the PI or Designee may affect the applicant’s ability to participate in the study or the study results
13. Have changed their usual dietary intake/pattern, within the past 28 days from screening
14. Are currently on a weight loss dietary pattern
15. Have self-reported body weight fluctuations of more than 5 kg within the last 3 months from screening.
16. Require concomitant treatment during screening/baseline period with any medication that could influence the gastrointestinal tract e.g. Loperamide
17. Have used probiotics or antibiotics in the last 28 days since screening
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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)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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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
Primary analyses, comparing changes in gut health endpoints including fecal short chain fatty acid producing bacteria between high fibre and white bread will be performed using linear mixed models for repeated measures including treatment and time as fixed factors and treatment*time as interaction term. To assess whether the order in which participants received the study products affected responses, an interaction term for treatment*time*allocation order will be included in the model; if no significant treatment*time*allocation order interaction is observed, the interaction term will be removed from the model. A first-order autoregressive (AR(1)) repeated covariance type will be used and a random intercept per participant included. Assumptions underpinning mixed linear statistical analyses, namely normal distribution and homoscedasticity of residuals, will be assessed. The threshold for significance will be set at 0.05 (two-sided). Statistical analyses will be performed using SPSS software (IBM Corporation, New York, USA).
Using clinical trial data from a dietary intervention study by Akagawa et al (2021) it is estimated that a sample size of 21 would provide 80% power to detect a 3% increase in faecal butyric acid producing bacteria. To allow for a potential dropout rate of up to 20% (n=5), we will recruit 26 participants into the study.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
18/04/2022
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Actual
26/05/2022
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Date of last participant enrolment
Anticipated
27/05/2022
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Actual
15/07/2022
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Date of last data collection
Anticipated
23/09/2022
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Actual
22/08/2022
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Sample size
Target
26
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Accrual to date
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Final
26
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Bakers Delight
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Address [1]
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Level 1, 293 Camberwell Rd, Camberwell VIC 3124 Australia
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
CSIRO
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Address
POBOX 10041, Adelaide BC, 5000, South Australia, Australia
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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]
312319
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Country [1]
312319
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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CSIRO Health and Medical Human Ethics Committee
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Ethics committee address [1]
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Ecosciences Precinct, Dutton Park, Qld, 4102
GPO BOX 2583
Brisbane, QLD, 4001 Australia
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Ethics committee country [1]
310557
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Australia
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Date submitted for ethics approval [1]
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08/02/2022
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Approval date [1]
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25/05/2022
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Ethics approval number [1]
310557
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Summary
Brief summary
While the role of dietary fibre for the maintenance of gut health is well recognised, typical dietary consumption in Australian adults remains below recommendations. Further, there are many types of dietary fibre, each with different health benefits. In particular, fermentable fibres such as beta glucan and fructans that can impact gut microbe activity, are less likely to be consumed than standard stool bulking agent fibres such as cellulose.
This study uses bread as the test product, a common source of dietary fibre for Australians, to pose the question of whether the simple replacement of white fibre bread with a highly fermentable fibre (barleyMAX) bread is achievable and effective in increasing the fibre intake and gut health of Australian parents/caregivers, a group whose busy lifestyle often can result in less favourable dietary patterns, and who can be tested as ideal role models for increasing dietary fibre consumption for the whole family unit.
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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 Damien Belobrajdic
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Address
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POBOX 10041, Adelaide BC, 5000, South Australia, Australia
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Country
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Australia
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Phone
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+61 8 83038815
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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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Dr Damien Belobrajdic
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Address
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POBOX 10041, Adelaide BC, 5000, South Australia,,Australia
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Country
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Australia
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Phone
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+61 8 83038815
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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
Name
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Dr Damien Belobrajdic
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Address
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POBOX 10041, Adelaide BC, 5000, South Australia,,Australia
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Country
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Australia
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Phone
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+61 8 83038815
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Fax
118076
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Email
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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)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results only.
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When will data be available (start and end dates)?
Immediately following publication, no end date determined.
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Available to whom?
On a case-by-case basis at the discretion of Primary Sponsor.
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Available for what types of analyses?
Only to achieve the aims in approved proposal, e.g. for IPD meta-analyses
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How or where can data be obtained?
The Principal Investigator will provide the data by email;
[email protected]
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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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