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    Summary
    EudraCT Number:2013-001521-43
    Sponsor's Protocol Code Number:009246QM
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-16
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2013-001521-43
    A.3Full title of the trial
    A Phase II, double blind, randomised, placebo-controlled study of the AKT inhibitor AZD5363 in combination with paclitaxel in triple-negative advanced or metastatic breast cancer
    Étude de phase II randomisée, en double aveugle, contrôlée par placebo, étudiant l’association de l'AZD5363, un inhibiteur de l'AKT, et du paclitaxel pour traiter le cancer du sein triple négatif, avancé ou métastatique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, double blind, randomised, placebo-controlled study of the AKT inhibitor AZD5363 in combination with paclitaxel in triple-negative advanced or metastatic breast cancer
    Étude de phase II randomisée, en double aveugle, contrôlée par placebo, étudiant l’association de l'AZD5363, un inhibiteur de l'AKT, et du paclitaxel pour traiter le cancer du sein triple négatif, avancé ou métastatique
    A.3.2Name or abbreviated title of the trial where available
    PAKT
    A.4.1Sponsor's protocol code number009246QM
    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 SponsorQueen Mary, University of London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheorem Clinical Research Ltd
    B.5.2Functional name of contact pointCharl Marais
    B.5.3 Address:
    B.5.3.1Street AddressB2 Methuen South, Methuen Park
    B.5.3.2Town/ cityChippenham, Wiltshire
    B.5.3.3Post codeSN14 0GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628604383
    B.5.5Fax number+441249444189
    B.5.6E-mailcharl.marais@theoremclinical.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 nameAZD5363
    D.3.2Product code AZD5363
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAZD5363
    D.3.9.2Current sponsor codeAZD5363
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.IMP: 2
    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 nameAZD5363
    D.3.2Product code AZD5363
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAZD5363
    D.3.9.2Current sponsor codeAZD5363
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    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
    Triple negative (ER-negative, PR-negative/unknown, HER2-negative) advanced or metastatic breast cancer
    Cancer du sein triple négatif (ER négatif, PR négatif/non connu et HER-2 négatif) avancé ou métastatique
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Cancer du sein
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate the clinical benefit of paclitaxel + AZD5363 relative to paclitaxel + placebo, as measured by investigator-assessed progression-free survival (PFS) in all treated patients
    E.2.2Secondary objectives of the trial
    • Clinical benefit of paclitaxel + AZD5363 relative to paclitaxel + placebo, measured by investigator-assessed PFS in patients with and without aberrant activation of the PI3K/AKT pathway
    • Clinical activity, measured by response rate (RECIST 1.1), change in tumour size, clinical benefit rate, and duration of response of paclitaxel + AZD5363 relative to paclitaxel + placebo in all treated patients and in patients with and without aberrant activation of the PI3K/AKT pathway
    • Overall survival benefit of paclitaxel + AZD5363 relative to paclitaxel + placebo in all treated patients and in patients with and without aberrant activation of the PI3K/AKT pathway
    • Clinical benefit of paclitaxel + AZD5363 relative to paclitaxel + placebo, measured by investigator-assessed PFS rate at 8 and 24 wk visit
    • Compare the differences in health-related quality of life (HRQL) and symptoms for patients by treatment arm
    • Safety and tolerability of paclitaxel + AZD5363 versus paclitaxel + placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all of the following inclusion criteria to be enrolled in the study:
    1. Written informed consent prior to admission to this study
    2. Women, age ≥ 18 years
    3. Histologically confirmed breast cancer
    4. Metastatic or locally recurrent disease; locally recurrent disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
    5. Patients must have
    • at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements, or
    • lytic or mixed (lytic + sclerotic) bone lesions in the absence of measurable disease as defined above; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible
    6. Radiological or clinical evidence of recurrence or progression
    7. Triple-negative disease, defined as tumour cells being:
    • negative for ER with <1% of tumour cells positive for ER on IHC or IHC score (Allred) of ≤2
    • negative for PR with <1% of tumour cells positive for PR on IHC or IHC score (Allred) of ≤2 or PR unknown, and
    • negative for HER2 with 0,1+ or 2+ intensity on IHC and no evidence of amplification on ISH
    8. Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing
    9. Patients must be able to swallow and retain oral medication
    10. Haematologic and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to randomisation
    • ANC >= 1.5x 109/L, and platelet count >= 100 x 109/L
    • Serum creatinine < 1.5 times the upper limit of normal (ULN)
    • Bilirubin level < 1.5 x ULN
    • AST or ALT <2.5 x ULN or <5 x ULN in the presence of liver metastases
    11. ECOG performance status 0-2
    12. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, bilateral oopheroctemy, bilateral tubular ligation or is post-menopausal (total cessation of menses for ≥ 1 year; if the patient is of childbearing potential, she must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception (for example, intrauterine device [IUD], birth control pills unless clinically contraindicated, or barrier device) beginning 2 weeks before the first dose of investigational product and for for at least 1 month after AZD5363/placebo treatment discontinuation or for at least 6 months after paclitaxel treatment discontinuation, whichever is longer.
    13. Willing and able to provide written informed consent
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
    1. Patients with confirmed brain metastases or a history of primary central nervous system tumours or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. Patients with treated brain metastases that are asymptomatic and have been clinically stable for 3 months will be eligible for protocol participation
    2. Prior chemotherapy for metastatic breast cancer
    3. Radiotherapy with a wide field of radiation (greater than or equal to 30% marrow or whole pelvis or spine) within 4 weeks before the first dose of study medication (AZD5363/placebo)
    4. Prior treatment with PI3K inhibitors, AKT inhibitors or mTOR inhibitors
    5. Prior treatment with paclitaxel or docetaxel in the (neo)adjuvant setting within 12 months from inclusion into this study
    6. Preexisting sensory or motor polyneuropathy >= Grade 2 according to NCI CTCAE (Version 4.0.3)
    7. Malabsorption syndrome or other condition that would interfere with enteral absorption
    8. Clinically significant pulmonary dysfunction
    9. prolongation defined as a QTc interval >470 msecs or other significant abnormalities in rhythm, conduction or morphology of resting ECG including 2nd degree (type II) or 3rd degree AV block or bradycardia (ventricular rate <50 beats/min)
    10. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
    11. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade ≥2, or Cardiac ejection fraction outside institutional range of normal or <50%
    12. Clinically significant abnormalities of glucose metabolism as defined by any of the following:
    • Diagnosis of diabetes mellitus type I or II (irrespective of management)
    • Glycosylated haemoglobin (HbA1C) ≥8.0% at screening (64 mmol/mol) (conversion equation for HbA1C [IFCC-HbA1C (mmol/mol) = [DCCT-HbA1C (%) – 2.15] x 10.929)
    • Fasting Plasma Glucose ≥ 7.0mmol/L (126 mg/dL) at screening. Fasting is defined as no caloric intake for at least 8 hours
    13. Patients with proteinuria (3+ on dipstick analysis or > 500mg/24 hours) or creatinine > 1.5 x ULN concurrent with creatinine clearance <50 mL/min
    14. Exposure to potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort) (for details please refer to Appendix 2)
    15. Exposure to potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort) (for details please refer to Appendix 2)
    16. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
    17. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent
    18. Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol
    19. Detained persons or prisoners
    20. Pregnant or nursing women
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this study is progression-free survival.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression free survival is defined as the time from the date of randomisation to the date of first documented tumour progression based on investigator assessment (using RECIST 1.1) or death from any cause, whichever occurs first.

    Tumour assessments of progression will be performed at screening, weeks 8, 16 and 24, and every 12 weeks thereafter, at the end of treatment and at follow-up.
    E.5.2Secondary end point(s)
    Efficacy
    The secondary outcome measures in all treated patients and in patients with and without aberrant activation of the PI3K/AKT pathway are:
    1. Objective response, defined as a complete or partial response (as assessed by the site radiologist and/or investigator, using RECIST 1.1)
    2. Average change (%) in tumour size at 8 weeks compared to baseline, as assessed by RECIST 1.1); tumour size is defined as the sum of the longest diameters of the target (i.e. measurable tumour) lesions
    3. Clinical Benefit (CB), defined as number of patients with complete or partial response or stable disease maintained ≥24 weeks (as assessed by the site radiologist and/or investigator, using RECIST 1.1).
    4. Overall survival, defined as the time from date of randomisation to the date of death due to any cause
    5. Duration of response, defined as the time from first documentation of complete or partial response to disease progression (as assessed by the site radiologist and/or investigator, using RECIST 1.1)
    6. Duration of clinical benefit, defined as the time from randomisation to disease progression (as assessed by the site radiologist and/or investigator, using RECIST1.1) in patients with CB
    7. 8-week progression-free survival and 24-week progression-free survival, respectively, defined as the percentage of patients with an 8 or 24 week visit response of CR, PR or SD (as defined by RECIST 1.1) with no evidence of previous progression.
    8. Patient reported outcomes, as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, the Functional Assessment of Cancer Therapy-Diarrhoea (FACT-D) subscale, the Functional Assessment of Cancer Therapy – EGFRI (FACT-EGFRI) subscale, and the Euro-QOL 5D (EQ-5D)

    Safety Outcome Measures
    The safety outcome measures for this study are as follows:
    • Incidence of serious adverse events
    • Incidence of grade 3 and 4 adverse events (CTCAE, version 4.03)
    • Incidence of all adverse events of all grades
    • Incidence of the following selected adverse events - any grade (Hyperglycaemia, Diarrhoea, Rash, Interstitial pneumonitis)
    • Adverse events leading to discontinuation of the study medication
    • Changes in vital signs and clinical laboratory results during and following study drug administration
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy
    1. Assessed at the end of the study by an independent review facility (IRF).
    2. Assessed at the end of patient treatment (Investigator) and at the end of the study (IRF).
    3. Assessed at ≥24 weeks and at the end of the trial.
    4. Assessed at ≥24 weeks (investigator) and at the end of the study (IRF).
    5&6. Assessed at disease progression (investigator) and at the end of the study (IRF).
    7. Assessed at disease progression (investigator) and at the end of the study (IRF).
    8. Assessed when the last patient has submitted their last FACT questionnaire.

    Safety
    Assessed at all study visits and analysed at the end of the study.

    Exploratory
    When final patients submits last sample.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 No
    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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    France
    Georgia
    Hungary
    Korea, Democratic People's Republic of
    Romania
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    For the purposes of Clinical Trial Authorisation (CTA) under the European Union Directive 2001/20/EC, the study is deemed to have ended 30 days after the last patient receives the last dose of the investigational medicinal product (IMP). For all other purposes, the study end date is deemed to be the date of last data capture.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 140
    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)
    Patients will be treated until disease progression, treatment-limiting toxicity, elective withdrawal, study completion or termination, or death. After that, alternative treatments will be considered at the clinician's discretion.

    There will be no crossover. The Sponsor will not provide the study drug or any other study treatments after participants leave the study. The investigator will discuss treatment options with participants to ensure their ongoing care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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