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Trial registered on ANZCTR
Registration number
ACTRN12625000555459
Ethics application status
Approved
Date submitted
14/05/2025
Date registered
30/05/2025
Date last updated
30/05/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy, Safety, and Tolerability of BRP-185 (Bupropion immediate-release (IR) and sustained-release (SR)) in Adults with Idiopathic Hypersomnia
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Scientific title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BRP-185 (Bupropion IR/SR) in Adults with Idiopathic Hypersomnia
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Secondary ID [1]
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BRP-185-IH-2024-001
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Secondary ID [2]
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CT-2025-CTN-01901-1
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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:
Idiopathic Hypersomnia
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Condition category
Condition code
Mental Health
334002
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0
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Other mental health disorders
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Neurological
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicentre trial evaluating two dose levels of BRP-185 against placebo in adult patients diagnosed with idiopathic hypersomnia. BRP-185 is a combination of Bupropion immediate-release (IR) and sustained-release (SR) formulations. There are 2 treatment groups:
1. High-dose BRP-185 group (225 mg - 75 mg Bupropion IR + 150 mg Bupropion SR) – oral capsule once daily in the morning
2. Low-dose BRP-185 group (150 mg - 75 mg Bupropion IR + 75 mg Bupropion SR) – oral capsule once daily in the morning
The study is structured into three distinct phases: the screening phase, the treatment phase, and the follow-up phase, each designed to ensure accurate diagnosis, appropriate treatment administration, and comprehensive safety monitoring.
The screening phase lasts up to 28 days and serves to confirm eligibility based on the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Idiopathic Hypersomnia (IH). Participants undergo comprehensive medical evaluations, including a detailed clinical history, physical examination, and objective sleep assessments. Baseline sleep data is obtained using actigraphy and sleep logs, with polysomnography (PSG) performed if necessary to rule out other sleep disorders. If participants have been using wake-promoting agents before enrollment, they are required to undergo a washout period to eliminate residual pharmacological effects that may confound baseline assessments. Once eligibility is confirmed, participants proceed to randomization.
The treatment phase spans 12 weeks, during which participants receive once-daily morning doses of their assigned treatment. Throughout this period, participants attend scheduled clinic visits at Weeks 2, 4, 8, and 12, during which assessments such as the Epworth Sleepiness Scale (ESS), sleep inertia severity, and functional tests are performed. Cognitive neuropsychological tests, and sleep patterns are assessed through actigraphy and sleep diaries. Safety monitoring is conducted at all study visits, with adverse event tracking, laboratory tests, electrocardiograms (ECG), and vital sign assessments. Participants also complete patient-reported outcome measures, including the Patient Global Impression of Change (PGIC) scale.
The follow-up phase lasts for two weeks following the completion of the treatment phase. Participants return for a final clinical assessment, during which vital signs, laboratory parameters, and ECG findings are reviewed.
Adherence strategies to assess compliance include study drug compliance monitoring via the study app, return of unused Investigational Product (IP) during clinic visits for reconciliation.
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Intervention code [1]
331071
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Treatment: Drugs
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Comparator / control treatment
The placebo product is an oral capsule containing Microcrystalline cellulose. The placebo has the same appearance and capsule size as the BRP-185 finished product.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To evaluate the efficacy of BRP-185 in changing excessive daytime sleepiness (EDS) in adults with idiopathic hypersomnia
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Assessment method [1]
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Epworth Sleepiness Scale (ESS)
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Timepoint [1]
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Week 12 from Baseline
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Secondary outcome [1]
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Assess the impact of BRP-185 on cognitive impairment
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Assessment method [1]
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Both Idiopathic Hypersomnia Severity Scale (IHSS) and PROMIS Cognitive Function Short Form used to assess outcome
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Timepoint [1]
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Baseline and Week 12 post-commencement of intervention
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Secondary outcome [2]
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Assess the impact of BRP-185 on functional impairment
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Assessment method [2]
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Both Idiopathic Hypersomnia Severity Scale (IHSS) and PROMIS Cognitive Function Short Form used to assess outcome
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Timepoint [2]
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Baseline and Week 12 post-commencement of intervention
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Secondary outcome [3]
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Evaluate the safety and tolerability of BRP-185 compared to placebo (composite outcome)
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Assessment method [3]
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Incidence of treatment-emergent adverse events (TEAEs) specifically monitoring for common side effects, such as headache, nausea, anxiety, insomnia, and cardiovascular effects (e.g., increased heart rate, blood pressure changes) through self reported diaries and questionnaires on the study app and clinical examination during in patient visits.
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Timepoint [3]
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Baseline, Week 2, Week 4, Week 12 post-commencement of intervention
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Secondary outcome [4]
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Evaluate change in total sleep time (TST) and sleep consolidation (composite outcome)
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Assessment method [4]
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actigraphy and polysomnography
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Timepoint [4]
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Baseline and Week 12 post-commencement of intervention
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Secondary outcome [5]
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Assess the effect of BRP-185 on sleep inertia severity and duration (composite outcome)
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Assessment method [5]
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Patient reported diaries
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Timepoint [5]
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Baseline and Week 12 post-commencement of intervention
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Eligibility
Key inclusion criteria
• Adults aged 18-65 years.
• Diagnosis of Idiopathic Hypersomnia (IH) according to ICSD-3 criteria.
• Epworth Sleepiness Scale (ESS) score more than or equal to 10 at baseline.
• Total sleep time (TST) more than or equal to 11 hours per 24 hours based on sleep logs or actigraphy.
• Persistent sleep inertia symptoms causing daily functional impairment.
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Minimum age
18
Years
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Maximum age
65
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
• History of narcolepsy (Type 1 or Type 2) based on MSLT and hypocretin levels.
• Untreated obstructive sleep apnoea (OSA) (AHI > 15).
• Use of stimulants or wake-promoting agents within 14 days prior to randomization.
• History of seizure disorders or conditions that lower the seizure threshold.
• Use of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomization.
• Uncontrolled cardiovascular disease or hypertension.
• Pregnant or lactating women.
• Active substance use disorder within the last 6 months.
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Study design
Purpose of the study
Treatment
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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 central randomisation by computer that is stratified by country to ensure equal number of active and placebo in all countries where trial is happening
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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
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Phase 2
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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
2/06/2025
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Actual
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Date of last participant enrolment
Anticipated
31/05/2028
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Actual
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Date of last data collection
Anticipated
1/10/2028
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,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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Bioron Pharma
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Bioron Pharma
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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]
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Country [1]
321453
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee K
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Ethics committee address [1]
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https://bellberry.com.au/
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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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04/03/2025
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Approval date [1]
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11/04/2025
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Ethics approval number [1]
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2025-03-340
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Summary
Brief summary
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicentre trial evaluating two dose levels of BRP-185 against placebo in adult patients diagnosed with idiopathic hypersomnia. Participants will be randomly assigned in a 1:1:1 ratio to one of the following arms: 1. High-dose BRP-185 group (225 mg) – orally once daily in the morning 2. Low-dose BRP-185 group (150 mg) – orally once daily in the morning 3. Placebo group – orally once daily in the morning This trial aims to provide critical data on BRP-185's ability to improve wakefulness and reduce hypersomnolence symptoms, addressing an unmet need in the treatment of idiopathic hypersomnia.
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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 Arul Sivanesan
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Address
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Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
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Country
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Australia
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Phone
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+610422156206
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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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Arul Sivanesan
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Address
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Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
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Country
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Australia
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Phone
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+610422156206
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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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Arul Sivanesan
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Address
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Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
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Country
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Australia
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Phone
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+610422156206
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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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