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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00856284
Registration number
NCT00856284
Ethics application status
Date submitted
4/03/2009
Date registered
5/03/2009
Date last updated
3/12/2013
Titles & IDs
Public title
Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
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Scientific title
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes
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Secondary ID [1]
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2008-007444-34
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Secondary ID [2]
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SYR-322_305
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Universal Trial Number (UTN)
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Trial acronym
ENDURE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Alogliptin
Treatment: Drugs - Metformin
Treatment: Drugs - Glipizide
Experimental: Metformin + Alogliptin 12.5 mg - Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
Experimental: Metformin + Alogliptin 25 mg - Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
Active comparator: Metformin + Glipizide - Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose =250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
Treatment: Drugs: Alogliptin
Alogliptin tablets
Treatment: Drugs: Metformin
Metformin tablets
Treatment: Drugs: Glipizide
Glipizide tablets
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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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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
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Assessment method [1]
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The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
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Timepoint [1]
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Baseline and Week 52
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Primary outcome [2]
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104
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Assessment method [2]
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The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
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Timepoint [2]
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Baseline and Week 104
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Secondary outcome [1]
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Change From Baseline in Glycosylated Hemoglobin at Other Time Points
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Assessment method [1]
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The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
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Timepoint [1]
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Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.
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Secondary outcome [2]
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Change From Baseline in Fasting Plasma Glucose Over Time
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Assessment method [2]
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The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.
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Timepoint [2]
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Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.
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Secondary outcome [3]
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Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%
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Assessment method [3]
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The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.
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Timepoint [3]
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Weeks 26, 52, 78, and 104.
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Secondary outcome [4]
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Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%
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Assessment method [4]
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Percentage of participants with HbA1c = 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.
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Timepoint [4]
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Weeks 26, 52, 78, and 104.
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Secondary outcome [5]
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Change From Baseline in Body Weight Over Time
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Assessment method [5]
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LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.
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Timepoint [5]
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Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.
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Eligibility
Key inclusion criteria
* Has a diagnosis of type 2 diabetes mellitus.
* Must meet one of the following:
* Has been inadequately controlled on a stable daily dose of =1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening.
* Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 - 10%, inclusive) on metformin <1500 mg without documented maximum tolerated dose.
* No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B).
* Has body mass index within 23 kg/m^2 and 45 kg/m^2 unless the patient is Asian or of Asian descent, for whom the allowable body mass index will be = 20 kg/m^2 and = 35 kg/m^2, inclusive.
* Has fasting C-peptide concentration at least 0.8 ng.
* If regularly using non-excluded medications, must be on a stable dose at least 4 weeks prior to Screening/Pre-screening.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant, lactating or intends to donate ova from Screening throughout the duration of the study.
* Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments.
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Minimum age
18
Years
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Maximum age
80
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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
* Systolic blood pressure greater than or equal to 150 mmHg and/or diastolic pressure greater than or equal to 90.
* Hemoglobin less than or equal to 12 g/dL for males and less than or equal to 10 g/dL for females at Screening Visit.
* Alanine aminotransferase greater than or equal to 2.5 times the upper limit of normal at Screening Visit.
* Serum creatinine greater than or equal to 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance less than 60 L/min.
* Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study.
* A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 years.
* A history of laser treatment for diabetic retinopathy within 6 months of screening.
* Treated for diabetic gastric paresis, gastric banding, or gastric bypass.
* New York Heart Association Class III or IV heart failure.
* History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening.
* Known history of human immunodeficiency virus, hepatitis B or C.
* Alcohol or substance abuse within 2 years prior to screening.
* Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
* Any investigational drug within 30 days
* Any investigational diabetic drug within 3 months
* Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin
* Prior treatment with alogliptin.
* Weight-loss drugs
* Oral or systemically injected glucocorticoids
* A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide.
* Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
1/03/2009
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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
1/10/2012
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Sample size
Target
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Accrual to date
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Final
2639
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,WA
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Recruitment hospital [1]
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- Garran
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- Wollongong
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- Herston
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- Nedlands
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- Garran
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- Wollongong
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- Herston
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- Nedlands
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Recruitment outside Australia
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Edo de Mexico
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Mexico
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Mexico
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Nuevo Leon
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Mexico
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Huixquilucan Edo. de Mexico
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Mexico
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Auckland
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Sibiu
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Russian Federation
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St Petersburg
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Russian Federation
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Alicante
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Bangkok
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Zaporizhye
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Ukraine
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Aintree-Liverpool
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Bath
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Bournemouth
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.
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Trial website
https://clinicaltrials.gov/study/NCT00856284
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Trial related presentations / publications
Gordon J, McEwan P, Hurst M, Puelles J. The Cost-Effectiveness of Alogliptin Versus Sulfonylurea as Add-on Therapy to Metformin in Patients with Uncontrolled Type 2 Diabetes Mellitus. Diabetes Ther. 2016 Dec;7(4):825-845. doi: 10.1007/s13300-016-0206-7. Epub 2016 Oct 27.
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Public notes
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Contacts
Principal investigator
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Medical Director, Clinical Science
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Address
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Takeda
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00856284
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