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    Summary
    EudraCT Number:2020-000065-16
    Sponsor's Protocol Code Number:DS102A-07-CV1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2020-000065-16
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Dose Finding Phase IIb Study to Assess the Efficacy and Safety of Orally Administered Epeleuton in Patients with Hypertriglyceridemia and Type 2 Diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate whether Epeleuton capsules are effective as a treatment for high levels of triglycerides in the blood and type 2 diabetes, whether this medicine is safe and what is the best dose.
    A.3.2Name or abbreviated title of the trial where available
    TRIglyceride And Glucose control with Epeleuton in Metabolic Syndrome Patients (TRIAGE)
    A.4.1Sponsor's protocol code numberDS102A-07-CV1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAfimmune Ltd.
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAfimmune Ltd.
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAfimmune Ltd.
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressTrintech Building, South County Business Park
    B.5.3.2Town/ cityLeopardstown, Dublin 18
    B.5.3.3Post codeD18 H5H9
    B.5.3.4CountryIreland
    B.5.4Telephone number+35312946380
    B.5.5Fax number+35312176117
    B.5.6E-mailafimmune.regulatory@afimmune.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDS102 Capsule
    D.3.2Product code DS102
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepeleuton
    D.3.9.1CAS number 1667760-39-5
    D.3.9.2Current sponsor codeDS102
    D.3.9.3Other descriptive name15(S)-HYDROXY-EICOSAPENTAENOIC ACID ETHYL ESTER
    D.3.9.4EV Substance CodeSUB193616
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertriglyceridemia and Type 2 Diabetes
    E.1.1.1Medical condition in easily understood language
    High triglyceride levels in blood and type 2 diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020870
    E.1.2Term Hypertriglyceridemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy Objective:
    • To assess the efficacy of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes.

    Safety Objective:
    • To assess the safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients diagnosed with type 2 diabetes mellitus at least 90 days prior to the first screening visit.
    2. Patients with a HbA1C (glycosylated haemoglobin) between 7.0 - 10.0% (53-86 mmol/mol) (both inclusive)
    3. Patients with a fasting triglyceride level ≥200 mg/dL (2.26 mmol/L) and <750mg/dL (8.46 mmol/L) at both screening visits.
    Note: If the triglyceride level is outside the required range at the second screening visit, an additional measurement can be obtained 1 week later, to confirm eligibility.
    Note: If a large difference in triglyceride level (>15%) is observed between screening 1 and screening 2, an additional measurement may be requested or patient may be deemed not eligible.
    4. Patients who have been educated regarding diet and exercise at or before visit 1 (screening 1) and are willing to maintain and not alter a stable diet and activity routine throughout the study.
    5. Patients who have been on a stable statin therapy at doses that are likely to achieve optimal LDL cholesterol and who are willing to continue this treatment throughout the study.
    Note: Stable statin therapy may consist of a statin with or without ezetimibe.
    6. Patients with an LDL cholesterol level <130mg/dL (3.34 mmol/L) at both screening visits.
    7. Patients who have a body mass index (BMI) ≥ 25kg/m2 and <50kg/m2.
    8. Patients who have been on a stable daily dose of metformin (at least 1500mg or maximum tolerated dose for metformin monotherapy as documented in the subject medical record) and/or a sulfonylurea and/or a dipeptidyl peptidase-4 (DPP-4) inhibitor and/or a sodium-glucose transport protein 2 inhibitor (SGLT2i) and/or a GLP1-RA and/or basal insulin for at least 90 days prior to the day of first screening visit.
    Note: Dose of GLP1-RA must be stable for 6 months prior to baseline with no weight change >2kg for 3 months prior to baseline.
    Note: Dose of basal insulin must be stable for 4 months prior to baseline. All types of basal insulin are permitted, including insulin glargine, insulin degludec, insulin detemir, NPH insulin and pre-mixed insulin.
    9. Female patients and male patients with female partners of childbearing potential must use highly effective contraceptive methods or have a sterilised partner for the duration of the study. Highly effective contraceptive methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include hormonal contraception, intrauterine device or sexual abstinence.
    Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
    Note: Hormonal contraceptives must be on a stable dose for at least one month before baseline.
    Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
    10. Patients whose pre-study or screening clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator, and do not violate any inclusion or exclusion criteria
    11. Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
    12. Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent prior to initiation of any study specific activities or procedures.
    E.4Principal exclusion criteria
    1. Patients who have a history of intolerance or hypersensitivity to any substance in epeleuton capsules, placebo capsules or statins.
    2. Patients with uncontrolled hypertension defined as a systolic blood pressure ≥160 mmHg or a diastolic blood pressure ≥100mmHg.
    3. Patients who have a body mass index (BMI) <25kg/m2 or ≥ 50kg/m2.
    4. Patients who have a weight change >2kg from the first screening visit to the baseline visit.
    5. Patients who have type 1 diabetes mellitus.
    6. Patients who have thyroid stimulating hormone (TSH) levels >1.5 times the upper limit of normal.
    7. Patients with known familial lipoprotein lipase deficiency (Fredriksen type I), apolipoprotein C-II deficiency or familial dysbetaliproteinemia (Fredriksen type III).
    8. Patients with significant liver disease or liver function impairment defined as any of the following; cirrhosis, hepatitis, biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and aspartate aminotransferase (AST) or alanine aminotransferase levels (ALT) >3 times the upper limit of normal.
    9. Patients with renal impairment defined as an estimated glomerular filtration rate <50mL/min/1.73m2 as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
    10. Patients with a history of malignancies within the past 5 years other than curatively treated non-melanoma skin cancer (basal cell or squamous cell carcinomas).
    11. Patients who have been treated with any investigational product within 60 days prior to visit 1 (Screening 1), or 5 half-lives (whichever is longer). Patients cannot participate in any other investigational medication or medical device trial while participating in this study.
    12. Patients who have used dietary supplements or prescription products rich in omega-3 or omega-6 fatty acids in the four weeks prior to baseline.
    13. Patients who have been treated with any medication for diabetes or obesity in the four weeks before the baseline visit, except for metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, basal insulin, GLP1-RAs (must be on a stable dose for at least 6 months) and short-term insulin treatment for acute illness for a total of below or equal to 14 days.
    14. Patients who have been treated with fibrates, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, bile acid sequestrants, niacin, niacin analogues or dietary supplements for the purpose of lowering triglycerides or cholesterol in the six weeks prior to baseline.
    15. Patients who have a family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomas.
    16. Patients who have a history of acute or chronic pancreatitis.
    17. Patients who have a history of major surgical procedures involving the stomach potentially affecting absorption of investigational medicinal product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
    18. Patients who have planned major surgical procedures, coronary intervention (such as stent placement or heart bypass), carotid or peripheral revascularisation.
    19. Patients who have a history of myocardial infarction, stroke, coronary revascularisation or hospitalisation for unstable angina in the 3 months prior to screening.
    20. Patients with creatine kinase concentrations > 10 times the upper limit of normal or creatine kinase elevation due to known muscle disease at visit 1 (screening 1)
    21. Patients who are classified as being in New York Heart Association (NYHA) Class IV heart failure.
    22. Patients who have a history of diabetic ketoacidosis.
    23. Patients with known proliferative retinopathy or maculopathy requiring acute treatment.
    24. Patients with significant systemic or major illnesses that, in the opinion of the Investigator, would preclude or interfere with treatment with Epeleuton, adequate follow up and/or compliance with the protocol.
    25. Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception (as specified in Inclusion Criterion 9) during the trial.
    26. Patients with active infectious diseases or chronic infectious disease (e.g. human immunodeficiency virus or tuberculosis).
    27. Patients who have recently received a vaccination or for whom a vaccination is planned (apart from flu, SARS-COV2 and pneumococcal vaccines which are permitted at any time).
    28. Patients who have previously entered into the study.
    29. Patients, in the opinion of the Investigator, not suitable to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    • Percent change in triglycerides from baseline to week 16.
    • Change in HbA1c from baseline to week 26.

    Note:
    • Each of the independent primary endpoints will be analysed separately.
    • The primary endpoints will be analysed in a hierarchical testing sequence in the following order:
    1. Percent change in triglycerides – Epeleuton 4g/day vs Placebo
    2. Percent change in triglycerides – Epeleuton 2g/day vs Placebo
    3. Change in HbA1c – Epeleuton 4g/day vs Placebo
    4. Change in HbA1c – Epeleuton 2g/day vs Placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, week 16 and week 26
    E.5.2Secondary end point(s)
    Secondary Endpoints
    • Percent change in triglycerides from baseline to weeks 4, 8, 12, 20 and 26.
    • Change in HbA1c from baseline to weeks 4, 8, 12, 16 and 20.
    • Proportion of patients achieving a HbA1c below 7.0% at weeks 4, 8, 12, 16, 20 and 26.
    • Percent change in very low-density lipoprotein cholesterol (VLDL-C) from baseline to weeks 4, 8, 12, 16, 20 and 26.
    • Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to weeks 4, 8, 12, 16, 20 and 26.
    • Percent change in total cholesterol from baseline to weeks 4, 8, 12, 16, 20 and 26.
    • Change in fasting plasma glucose from baseline to weeks 4, 8, 12, 16, 20 and 26.
    • Proportion of patients achieving a HbA1c below 6.5% at weeks 4, 8, 12, 16, 20 and 26.
    • Percent change in apolipoprotein B (ApoB) from baseline to weeks 16 and 26.
    • Percent change in remnant lipoprotein cholesterol (RLP-C) from baseline to weeks 8, 16 and 26.
    • Percent change in high-density lipoprotein cholesterol (HDL-C) from baseline to weeks 4, 8, 12, 16, 20 and 26.
    • Percent change in low-density lipoprotein cholesterol (LDL-C) (preparative ultracentrifugation) from baseline to weeks 16 and 26.
    • Change in body weight (kg) from baseline to weeks 4, 8, 12, 16, 20 and 26.
    • Change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 8, 16 and 26.
    • Change in systolic blood pressure from baseline to weeks 4, 8, 12, 16, 20 and 26.
    • Change in diastolic blood pressure from baseline to weeks 4, 8, 12, 16, 20 and 26.
    • Change in urinary albumin-to-creatinine ratio (UACR) from baseline to week 26 in the subgroup of patients with microalbuminuria at baseline.

    Exploratory Endpoints
    • Change in waist circumference from baseline to weeks 8, 16 and 26.
    • Percent change in apolipoprotein CIII (ApoCIII) from baseline to weeks 16 and 26.
    • Percent change in apolipoprotein A1 (ApoA1) from baseline to weeks 16 and 26.
    • Percent change in lipoprotein (a) (Lp(a)) from baseline to weeks 16 and 26.
    • Percent change in high-density lipoprotein particle concentration (HDL-P) from baseline to weeks 16 and 26.
    • Percent change in small low-density lipoprotein particle concentration (Small LDL-P) from baseline to weeks 16 and 26.
    • Percent change in large low-density lipoprotein particle concentration (Large LDL-P) from baseline to weeks 16 and 26.
    • Percent change in low-density lipoprotein size (LDL size) from baseline to weeks 16 and 26.
    • Percent change in very low-density lipoprotein size (VLDL size) from baseline to weeks 16 and 26.
    • Percent change in high-density lipoprotein size (HDL size) from baseline to weeks 16 and 26.
    • Change in fasting plasma insulin from baseline to weeks 16 and 26.
    • Change in Homeostatic model assessment insulin resistance (HOMA-IR) from baseline to weeks 16 and 26.
    • Change in Homeostatic model assessment β-cell function (HOMA-β) from baseline to weeks 16 and 26.
    • Change in interleukin 6 (IL-6) from baseline to week 26. • Change in interleukin 1β (IL-1β) from baseline to week 26.
    • Change in plasminogen activator inhibitor 1 (PAI-1) from baseline to week 26.
    • Change in vascular cell adhesion molecule 1 (VCAM-1) from baseline to week 26.
    • Change in intercellular adhesion molecule 1 (ICAM-1) from baseline to week 26.
    • Change in monocyte chemoattractant protein 1 (MCP-1) from baseline to week 26.
    • Change in red cell distribution width (RDW) from baseline to weeks 16 and 26.
    • Change in haemoglobin from baseline to weeks 16 and 26.
    • Change in reticulocyte count from baseline to weeks 16 and 26.
    • Change in erythrocyte (red blood cell) count from baseline to weeks 16 and 26.
    • Trough plasma concentrations of total and unesterified 15-hydroxy eicosapentaenoic acid (15(S)-HEPE) in treated population compared to placebo population at Baseline/Day 0, Week 4, Week 8, Week 16 and Week 26.
    • Trough plasma concentrations of EPA in treated population compared to placebo population at Baseline/Day 0, Week 4, Week 8, Week 16 and Week 26.
    • Determination of exploratory serum biomarkers in treated population compared to placebo population at Baseline and Week 26.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, weeks 4, 8, 12, 16, 20, 26.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Georgia
    Israel
    United States
    Germany
    Latvia
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is defined as ‘last patient last visit (LPLV)’. LPLV is defined as the date the Investigator reviews the last patient’s safety data and determines that no further evaluation is required for the patient to complete the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 240
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not different from expected normal treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-03
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