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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02854436
Registration number
NCT02854436
Ethics application status
Date submitted
1/08/2016
Date registered
3/08/2016
Date last updated
13/11/2023
Titles & IDs
Public title
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
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Scientific title
A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
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Secondary ID [1]
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0
64091742PCR2001
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Secondary ID [2]
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CR108208
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Universal Trial Number (UTN)
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Trial acronym
Galahad
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
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0
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Condition category
Condition code
Cancer
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0
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Niraparib
Experimental: Niraparib - Participants will receive 300 milligram (mg) niraparib (3 capsules\*100 mg) orally once daily.
Treatment: Drugs: Niraparib
Participants will receive 300 mg niraparib (3 capsules\*100 mg) orally once daily.
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Intervention code [1]
0
0
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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Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation
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Assessment method [1]
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ORR defined as percentage of participants with BRCA DNA-repair anomalies and measurable disease whose best response is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and with no evidence of bone progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
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Timepoint [1]
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Up to 52 months
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Secondary outcome [1]
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Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation
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Assessment method [1]
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ORR defined as percentage of participants with BRCA deoxyribonucleic acid (DNA)-repair anomalies and measurable disease whose best response is either CR or PR per RECIST 1.1 and with no evidence of bone progression per PCWG3 criteria.
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Timepoint [1]
0
0
Up to 52 months
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Secondary outcome [2]
0
0
Circulating Tumor Cells (CTC) Response Rate
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Assessment method [2]
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CTC response rate was defined as the percentage of participants with CTC equals to (=) 0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (\>) 0.
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Timepoint [2]
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0
At 8 weeks post-baseline
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS is defined as time from enrollment to death from any cause.
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Timepoint [3]
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Up to 52 months
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Secondary outcome [4]
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Radiographic Progression-Free Survival (rPFS)
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Assessment method [4]
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rPFS was defined as time from enrollment to radiographic progression or death from any cause, whichever occurred first. Radiographic progression was evaluated per RECIST 1.1 criteria for soft tissue disease and per PCWG3 criteria for bone disease.
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Timepoint [4]
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Up to 52 months
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Secondary outcome [5]
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Time to Radiographic Progression
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Assessment method [5]
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Time to radiographic progression is defined as time from enrollment to radiographic progression or death due to disease progression, whichever occurs first. Disease progression is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
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Timepoint [5]
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Up to 52 months
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Secondary outcome [6]
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Time to Prostate-Specific Antigen (PSA) Progression
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Assessment method [6]
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Time to PSA progression was defined as time from enrollment to the first date of documented PSA progression based on PCWG3 criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanograms per milliliter (ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks.
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Timepoint [6]
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Up to 52 months
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Secondary outcome [7]
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Time to Symptomatic Skeletal Event (SSE)
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Assessment method [7]
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Time to SSE was defined as the time from enrollment to first occurrence of one of the following symptomatic skeletal events: tumor-related spinal cord compression, radiation to bone to relieve skeletal symptoms, surgery to bone or need for tumor-related orthopedic surgical intervention, symptomatic or pathologic fracture.
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Timepoint [7]
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Up to 52 months
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Secondary outcome [8]
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Duration of Objective Response
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Assessment method [8]
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Duration of objective response is defined as time from CR or PR to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first. Unequivocal clinical progression defined as one or more of following: 1) deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) to Grade 3 or higher; 2) need to initiate any of following because of tumor progression (even in absence of radiographic evidence of disease): alternative anticancer therapy for prostate cancer, radiation therapy, surgical interventions for complications due to tumor progression.
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Timepoint [8]
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Up to 52 months
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Secondary outcome [9]
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Number of Participants With Adverse Events (AEs)
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Assessment method [9]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
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Timepoint [9]
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Up to 52 months
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Secondary outcome [10]
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Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
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Assessment method [10]
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Number of participants with worst toxicity grades for clinical laboratory tests (chemistry and hematology) based on NCI-CTCAE were reported. The chemistry laboratory parameters were: alanine aminotransferase (ALT) increased, alkaline phosphatase increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine increased, gamma glutamyl transferase (GGT) increased and the hematology parameters were: hemoglobin increased, lymphocyte count increased. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).
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Timepoint [10]
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Up to 52 months
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Eligibility
Key inclusion criteria
* Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is excluded)
* Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event
* Received a second-generation or later androgen receptor (AR)-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis
* Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing)
* Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
* Prior platinum-based chemotherapy for the treatment of prostate cancer
* Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Symptomatic or impending cord compression
* Symptomatic brain metastases
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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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
Single group
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Other design features
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Phase
Phase 2
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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
31/08/2016
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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
16/08/2023
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Sample size
Target
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Accrual to date
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Final
289
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Camperdown
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- Darlinghurst
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- East Albury
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- Kurralta Park
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- Macquarie University
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- Melbourne
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- Murdoch
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- Port Macquarie
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- Randwick
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- Wahroonga
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- Camperdown
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- Darlinghurst
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- East Albury
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- Kurralta Park
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- Macquarie University
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- Randwick
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- Wahroonga
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Recruitment outside Australia
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Preston
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
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Trial website
https://clinicaltrials.gov/study/NCT02854436
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Trial related presentations / publications
Smith MR, Scher HI, Sandhu S, Efstathiou E, Lara PN Jr, Yu EY, George DJ, Chi KN, Saad F, Stahl O, Olmos D, Danila DC, Mason GE, Espina BM, Zhao X, Urtishak KA, Francis P, Lopez-Gitlitz A, Fizazi K; GALAHAD investigators. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):362-373. doi: 10.1016/S1470-2045(21)00757-9. Epub 2022 Feb 4.
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/36/NCT02854436/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/36/NCT02854436/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02854436
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