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Trial registered on ANZCTR
Registration number
ACTRN12624000120572
Ethics application status
Approved
Date submitted
11/01/2024
Date registered
9/02/2024
Date last updated
9/02/2024
Date data sharing statement initially provided
9/02/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A Study of the Efficacy and Safety of Faecal Microbiota Transplant for the Treatment of Immune Checkpoint Inhibitor Colitis
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Scientific title
A Pilot Study of the Efficacy and Safety of Faecal Microbiota Transplant for the Treatment of Immune Checkpoint Inhibitor Colitis
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Secondary ID [1]
311245
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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:
Immune Checkpoint Inhibitor Colitis
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Condition category
Condition code
Inflammatory and Immune System
329161
329161
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
329162
329162
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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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Cancer
329414
329414
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This will be an open-label study, all potential participants will be offered the intervention.
Faecal Microbiota Transplant (FMT) - provided by The Australian Red Cross Lifeblood
A suspension of faecal microbiota derived from 50g of human stool from an individual screened donor in a mixture of Glycerolyte-57 and normal saline, to achieve an equivalent concentration of 10% glycerol as a cryoprotectant. The suspension is filtered to remove particles >1mm.
Faecal Microbiota for Transplant (Faecal microbiota cryopreserved in glycerol) – is designed for administration to the patient’s caecum via colonoscopy as a single 150g dose.
The procedure including both colonoscopy and faecal transplant will be performed by a consultant gastroenterologist and will take approximately 30 minutes.
This will be administered once only on Day 0 of the study.
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Intervention code [1]
327703
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Treatment: Other
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Comparator / control treatment
Patients who do not wish to have an FMT will be enrolled on to the control arm of the study and be managed as per standard of care for immune checkpoint inhibitor colitis with steroid therapy only. As per standard of care, patients who fail to respond to steroid therapy may receive biologic therapy including infliximab or vedolizumab.
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Control group
Active
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Outcomes
Primary outcome [1]
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Commencement of steroid therapy
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Assessment method [1]
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Clinical review conducted by the treating physician and study investigators to assess change in symptoms such as stool frequency, abdominal pain and rectal bleeding.
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Timepoint [1]
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Patients in the FMT intervention arm will be assessed up to day 7 post-transplant. Patients in the control group will be assessed up to day 7 post commencement of steroid therapy.
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Secondary outcome [1]
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Change in endoscopic grading of colitis
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Assessment method [1]
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Colonoscopy
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Timepoint [1]
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Patients in the FMT intervention arm and control group will be assessed at week 8 post the initial colonoscopy
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Secondary outcome [2]
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Change in histologic grading of colitis
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Assessment method [2]
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Tissue biopsy
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Timepoint [2]
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Patients in the FMT intervention arm and control group will be assessed at week 8 post the initial colonoscopy
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Secondary outcome [3]
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Rate of less than or equal to Grade 1 diarrhoea and/or colitis
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Assessment method [3]
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Clinical symptoms as per CTCAE for diarrhoe and/or colitis
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Timepoint [3]
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Patients in the FMT intervention arm and control group will be assessed at week 8 post the initial colonoscopy
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Secondary outcome [4]
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Safety of FMT. Possible adverse events include worsening of clinical symptoms including diarrhoea, abdominal pain, rectal bleeding and bloating.
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Assessment method [4]
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Clinical review of patient by treating physician and study investigators to assess the presence of new or worsening clinical symptoms such as diarrhoea, abdominal pain, rectal bleeding, bloating, nausea and vomiting.
Blood tests to assess full blood count, renal function, liver function and markers of inflammation such as c-reactive protein
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Timepoint [4]
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Patients in the FMT intervention arm and control group will be assessed at week 8 post the initial colonoscopy
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Eligibility
Key inclusion criteria
- 18 years of age or older.
- Able to provide informed consent.
- Receipt of an immune checkpoint inhibitor agent (e.g. anti-CTLA-4, anti-PD-(L)1) as part of a treatment regimen for a solid cancer within 6 months of the onset of colitis symptoms. The ICI may be used as a single agent, or in combination with other ICIs, or with chemotherapy.
- Current diagnosis of immune-related diarrhoea and/or colitis characterized by grade 2 diarrhea as per CTCAE v5.0.
- Treatment including corticosteroid and biologic naive
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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
- Patients who have received either corticosteroid or immunosuppressive treatment for the current episode of ICI colitis
- Life-threatening food allergies, e.g. nut allergy
- Patients unable to provide informed consent
- Patients with a known diagnosis of inflammatory bowel disease
- Patients with a previous total colectomy
- Patients with an –ostomy (i.e. ileostomy or colostomy)
- Diagnosis of a thromboembolic event (deep vein thrombosis, pulmonary embolism, embolic stroke, myocardial infarction, or peripheral arterial insufficiency) within 3 months of enrollment.
- Diagnosis of concomitant infectious colitis (e.g. C. difficile or other bacterial source), unless the patient has finished an appropriate length of treatment with antibiotics as indicated for each diagnosis at the time of enrollment.
- Active pregnancy or breastfeeding.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/02/2024
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Actual
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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
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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)
VIC
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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Gastroenterological Society of Australia Research Grant
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Address [1]
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1/517 Flinders Lane, Melbourne Victoria 3000
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
21 Chancellor's Walk, Monash University, Clayton VIC 3800
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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]
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Country [1]
317580
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Other collaborator category [1]
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Hospital
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Name [1]
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Alfred Health
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Address [1]
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55 Commercial Road, Melbourne Victoria 3004
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Health Ethics and Research Committee
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Ethics committee address [1]
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55 Commercial Rd, Melbourne VIC 3004
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Ethics committee country [1]
314405
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Australia
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Date submitted for ethics approval [1]
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14/09/2023
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Approval date [1]
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06/12/2023
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Ethics approval number [1]
314405
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Summary
Brief summary
The immune checkpoint inhibitors (ICI) are a form of cancer treatment that have resulted in significant improvement in the outcomes of the management of a number of malignancies. They work by activating the immune system and thereby promoting the destruction of cancer cells. The use of ICIs is limited by a group of side-effects known as immune related adverse events (irAEs). One of the more common irAEs is the development of inflammation of the large intestine known as ICI colitis. The treatment of ICI colitis is mostly aimed at suppressing the immune system and ‘switching off’ the overactive immune cells that are causing the inflammation. The use of treatments that suppress the Immune system may themselves result in significant side-effects by increasing the risk of infection. Immune suppression may have a detrimental impact on the outcome of the cancer being treated, by reducing the ability of the patient’s immune system to control the cancer.
Who is it for?
You may be eligible for this study if you are an adult who is receiving treatment for a solid cancer, who has experienced onset of colitis symptoms within 6 months of treatment commencement.
Study details
Participants in this study will be able to choose if they wish to receive the intervention or are considered part of the 'control' group. Participants who choose to receive the intervention will undergo a colonoscopy where they will receive a faecal transplant.
If a participant chooses not to receive the intervention, they will continue with standard treatment as determined by their doctor.
All participants will then be followed up for 8 weeks and asked to complete questionnaires and provide additional blood and stool samples.
It is hoped that this study will help assess the efficacy and safety of Faecal Microbiota Transplant as first-line therapy in the treatment of ICI colitis.
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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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Prof Alex Boussioutas
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Address
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Alfred Hospital. 55 Commercial Road. Melbourne. 3004
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Country
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Australia
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Phone
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+61 3 9903 8942
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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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Prof Alex Boussioutas
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Address
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Alfred Hospital. 55 Commercial Road. Melbourne. 3004
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Country
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Australia
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Phone
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+61 3 9903 8942
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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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Prof Alex Boussioutas
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Address
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Alfred Hospital 55 Commercial Road. Melbourne. 3004
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Country
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Australia
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Phone
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+61 3 9903 8942
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Fax
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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)?
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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