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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02685709
Registration number
NCT02685709
Ethics application status
Date submitted
28/01/2016
Date registered
19/02/2016
Date last updated
22/04/2022
Titles & IDs
Public title
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
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Scientific title
A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands
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Secondary ID [1]
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2015-002854-11
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Secondary ID [2]
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OOC-ACM-302
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Universal Trial Number (UTN)
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Trial acronym
MPOWERED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acromegaly
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Condition category
Condition code
Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Octreotide capsules
Experimental: Run-in phase - Oral octreotide capsules
Experimental: RCT phase - Oral - Oral octreotide capsules
Active Comparator: RCT phase - Injectables - Injectable somatostatin analogs (octreotide or lanreotide)
Experimental: Combination phase (sub-study) - Octreotide capsules plus cabergoline
Treatment: Drugs: Octreotide capsules
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase
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Assessment method [1]
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Proportion of patients who are biochemically controlled throughout the RCT phase. A patient was considered biochemically controlled if IGF-1 Time Weighted Average (TWA) during the RCT phase is <1.3 ULN
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Timepoint [1]
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62 weeks
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Secondary outcome [1]
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Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase
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Assessment method [1]
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Proportion of patients with clinical and biochemical control at the end of the RCT phase. Patients were considered biochemically and clinically controlled if they met both of the following criteria:
Their IGF-1 TWA during the RCT phase was <1.3 times ULN
Their AIS score at week 62/EOT was maintained or reduced compared to week 26 (start of RCT phase)
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Timepoint [1]
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Week 62/ End of treatment; EOT
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Secondary outcome [2]
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Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase
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Assessment method [2]
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Proportion of patients who maintain or reduce the overall number of active acromegaly symptoms at the end of the RCT phase (week 62/ EOT) , compared to week 26 (start of the RCT phase
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Timepoint [2]
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62 weeks
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Secondary outcome [3]
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Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase
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Assessment method [3]
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Proportion of patients who maintain or improve their overall Acromegaly index of severity (AIS) score at the end of the RCT phase (improvement defined as a reduction of at least one point in the AIS score), compared to week 26 (start of the RCT phase)
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Timepoint [3]
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62 weeks
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Secondary outcome [4]
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Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase
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Assessment method [4]
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Proportion of patients of those completing the RCT phase (at a time octreotide capsules were not commercially available at the specific country), who entered the Study Extension phase, overall and by treatment group
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Timepoint [4]
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62 weeks
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Secondary outcome [5]
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Change in IGF-1 Levels in the RCT Phase
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Assessment method [5]
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Change in IGF-1 levels from the start of the randomized phase to the end of RCT phase.
Complete Responder (CR) is defined as IGF-1 = 1 x ULN; Partial Responder (PR) is defined as 1 x ULN < IGF-1 < 1.3 x ULN, and Non-Responder (NR): IGF-1 = 1.3 x ULN
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Timepoint [5]
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Change from Week 26 to week 62
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Secondary outcome [6]
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Change in GH Levels in the RCT Phase
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Assessment method [6]
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Change in GH levels from the start of the randomized phase through the end of RCT phase.
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Timepoint [6]
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Change from Week 26 to week 62
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Eligibility
Key inclusion criteria
- Confirmed diagnosis of acromegaly
- Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least
6 months
- Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL)
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Minimum age
18
Years
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Maximum age
75
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
- Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks.
- Pituitary radiotherapy within 5 years
- Pituitary surgery within six months
- Patients who previously participated in CH-ACM-01 study
- Any clinically significant uncontrolled concomitant disease
- Symptomatic cholelithiasis
- Previous treatment with:
- Pegvisomant, within 12 weeks
- Dopamine agonists, within 6 weeks
- Pasireotide, within 12 weeks
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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)
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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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2016
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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
1/08/2021
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Sample size
Target
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Accrual to date
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Final
146
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Georgia
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Illinois
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Massachusetts
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Ohio
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Texas
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Austria
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Graz
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Austria
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Wien
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France
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Bron
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France
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Le Kremlin-Bicêtre
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Germany
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Oldenburg
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Hungary
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Budapest
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Hungary
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Hungary
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Szeged
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Italy
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Monserrato
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Italy
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Pisa
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Italy
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Rome
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Vilnius
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Gdansk
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Romania
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Russian Federation
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Barnaul
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Kazan
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Russian Federation
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Samara
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Serbia
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Belgrade
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Spain
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Alzira
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Birmingham
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Manchester
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Newcastle upon Tyne
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Chiasma, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Octreotide capsule is a novel, orally-administered formulation of the commercially-available
injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide
capsules demonstrated sustained biochemical response up to 13 months in patients with
acromegaly previously managed with somatostatin analog injections (ref).
The objective of this study was to compare the efficacy, safety, and patient reported
outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands
(SRLs).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02685709
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Trial related presentations / publications
Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M, Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9. Erratum In: J Clin Endocrinol Metab. 2016 Oct;101(10 ):3863. J Clin Endocrinol Metab. 2020 Dec 1;105(12):
Melmed S. New therapeutic agents for acromegaly. Nat Rev Endocrinol. 2016 Feb;12(2):90-8. doi: 10.1038/nrendo.2015.196. Epub 2015 Nov 27.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Maria Fleseriu, M.D., FACE
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Address
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Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02685709
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