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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43716   clinical trials with a EudraCT protocol, of which   7255   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2014-003233-26
    Sponsor's Protocol Code Number:CD-ON-CAT-8015-1053
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-003233-26
    A.3Full title of the trial
    A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
    Ensayo pivotal multicéntrico de moxetumomab pasudotox en la leucemia de células pilosas recidivante/resistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial of Investigational Agent (Moxetumomab Pasudotox) in
    Patients with Relapsed/ Refractory Hairy Cell Leukemia
    Un ensayo clinico de un producto en investigación (Moxetumomab Pasudotox) en pacientes con leucemia de células pilosas recidivante / resistente.
    A.4.1Sponsor's protocol code numberCD-ON-CAT-8015-1053
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01829711
    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 SponsorMedImmune, LLC, a wholly owned subsidiary of AstraZeneca
    B.1.3.4CountryUnited States
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountryUnited States
    B.5.4Telephone number900 811 335
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/592
    D.3 Description of the IMP
    D.3.1Product nameMoxetumomab Pasudotox
    D.3.2Product code CAT-8015
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMoxetumomab Pasudotox
    D.3.9.1CAS number 1020748-57-5
    D.3.9.2Current sponsor codeCAT-8015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.90 to 1.10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hairy Cell Leukemia
    Leucemia de células pilosas
    E.1.1.1Medical condition in easily understood language
    A specific type of cancer of the blood
    Un tipo concreto de cáncer de la sangre
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10019055
    E.1.2Term Hairy cell leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10019056
    E.1.2Term Hairy cell leukemia variant
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the rate of durable complete response (CR) in multiply relapsed HCL with moxetumomab pasudotox.
    Determinar la tasa de respuesta completa (RC) duradera con moxetumomab pasudotox en la LCP con múltiples recidivas
    E.2.2Secondary objectives of the trial
    -Determine the overall response rate (ORR), progression-free survival (PFS), time to treatment failure (TTF), and duration of responses (CR and partial response [PR]).
    -Confirm the tolerability and safety of moxetumomab pasudotox in patients with HCL.
    -Evaluate immunogenicity and pharmacokinetics (PK) of moxetumomab pasudotox.
    -Determinar la tasa de respuesta global (TRG), la supervivencia libre de progresión (SLP), el tiempo hasta el fracaso del tratamiento (TFT), la duración de las respuestas (RC y respuesta parcial [RP])
    -Confirmar la tolerabilidad y seguridad de moxetumobab pasudotox en pacientes con LCP.
    -Evaluar la inmunogenicidad y la farmacocinética de moxetumomab pasudotox.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must have histologically confirmed hairy cell leukemia or hairy cell leukemia variant .with a need for therapy based on at least one of the following criteria:
    neutrophils less than 1000/mm(3)

    platelets less than 100,000/mm(3)

    hemoglobin less than 10 g/dL)

    symptomatic splenomegaly.

    Patients must be Pseudomonas-immunotoxin naive
    Patients must have had at least 2 prior purine analogs, or at least 1 course of purine analog and 1 of either rituximub or BRAF inhibitor.
    Men or women age greater than or equal to 18 years. Because this disease does not generally occur in children, children are excluded from this study, but will be eligible for future pediatric trials in other indications.
    ECOG performance status less than or equal to 2.
    The effects of moxetumomab pasudotox on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and 4 months after completion of moxetumomab pasudotox administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
    Patients must have adequate organ function as defined below:
    total bilirubin less than or equal to 1.5 mg/dL, unless consistent with Gilbert s (ratio between total and direct bilirubin greater than 5)
    AST and ALT less than or equal to 3 times upper limit of normal (ULN)
    alkaline phosphatase less than or equal to 2.5 ULN
    serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 mL/min as estimated by the Cockcroft-Gault equation
    Prothrombin time/INR or partial thromboplastin time less 2.5 ULN, fibrinogen greater than or equal to 0.5 LLN; if on warfarin, INR less than 3.5, if on any other anticoagulation, PT less than 2.5 times baseline
    Ability to understand and the willingness to sign a written informed consent document.
    Life expectancy greater than or equal to 6 months
    1. Los pacientes deben tener leucemia de células pilosas con confirmación histológica, o variante de la leucemia de células pilosas con necesidad de tratamiento basándose en al menos uno de los siguientes criterios:
    a. neutrófilos < 1,0 x 109/l
    b. trombocitos < 100 x 109/l
    c. hemoglobina < 10 g/dl
    d. esplenomegalia sintomática
    2. Los pacientes no deben haber recibido tratamiento previo con inmunotoxinas de Pseudomonas.
    3. Los pacientes deben haber recibido al menos 2 tratamientos sistémicos previos, incluidos 2 tratamientos con un ANP, o 1 tratamiento con rituximab o un inhibidor de BRAF tras un único tratamiento previo con un ANP.
    4. Hombres o mujeres > 18 años. Puesto que esta enfermedad no ocurre generalmente en niños, se han excluido de este estudio.
    5. Estado funcional ECOG (Eastern Cooperative Oncology Group) ? 2 (véase el 0).
    6. Los pacientes deben tener una función orgánica adecuada, tal y como se define a continuación:
    a. Bilirrubina total ? 1,5 mg/dl, a menos que concuerde con síndrome de Gilbert (cociente entre bilirrubina total y directa > 5).
    b. ALT y AST ? 3 veces el límite superior de la normalidad (LSN).
    c. Fosfatasa alcalina < 2,5 x LSN.
    d. Creatinina sérica ? 1,5 mg/dl o aclaramiento de creatinina ? 60 ml/min estimado mediante la ecuación de Cockcroft-Gault (0).
    7. Tiempo de protrombina (TP)/índice internacional normalizado (INR) o tiempo de tromboplastina parcial (TTP) < 2,5 x LSN, fibrinógeno ? 0,5 x límite inferior de la normalidad; si recibe warfarina, INR < 3,5, si recibe algún otro anticoagulante, TP < 2,5 x valor basal.
    8. Con capacidad de entender y voluntad de firmar el documento de consentimiento informado.
    9. Esperanza de vida ? 6 meses.
    10. Las mujeres fértiles y sexualmente activas con una pareja masculina no esterilizada deben utilizar un método anticonceptivo muy eficaz antes de incorporarse al estudio y durante la participación, y acceder a seguir utilizándolo durante 4 meses tras el fin de la administración de moxetumomab pasudotox; el cese de la anticoncepción después de este momento se debe consultar con un médico responsable. La abstinencia periódica, el método del ritmo y el coito interrumpido no son métodos anticonceptivos aceptables.
    ? Las mujeres fértiles se definen como las que no están esterilizadas quirúrgicamente (es decir, ligadura de trompas bilateral, ovariectomía bilateral o histerectomía completa) o las que son premenárquicas o posmenopáusicas (12 meses sin menstruación sin una causa médica alternativa).
    ? Un método anticonceptivo muy eficaz es aquel con una reducida tasa de fallos (es decir, menos del 1 % al año) cuando se usa de forma sistemática y correcta. Los métodos anticonceptivos aceptables se describen en la Tabla 3.1.1-1.
    ? Si una mujer se queda embarazada o sospecha que está embarazada mientras ella o su pareja está participando en este estudio, debe informar a su médico de inmediato.
    11. Los hombres no esterilizados y sexualmente activos que tengan una pareja femenina en edad fértil deben utilizar un método anticonceptivo muy eficaz (véase la Tabla 3.1.1-1) desde el día 1 hasta 60 días después de recibir la última dosis del fármaco en investigación.
    E.4Principal exclusion criteria
    Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to entering the study.
    Patients who are receiving any other investigational agents.
    Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
    Patients with clinically significant ophthalmologic findings during screening
    Pregnant or breastfeeding females. The effects of moxetumomab pasudotox on the developing fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with moxetumomab pasudotox breastfeeding should be discontinued if the mother is treated with moxetumomab pasudotox
    Positive for Hepatitis B surface antigen unless the patient is on Lamivudine or Entecavir and Hepatitis B Viral DNA load is less than 2000 IU/mL.
    Lymph nodes greater than 4cm or prior splenectomy
    Active second malignancy requiring treatment other than minor resection of indolent cancers like basal cell and squamous skin cancers
    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, malaria infection or psychiatric illness/social situations that would limit compliance with study requirements.
    HIV-positive patients unless taking appropriate anti-HIV medications with a CD4 count of greater than 200. Otherwise, there may be increased risk of lethal infections when temporarily suppressing normal B-cells.
    History of allogeneic bone marrow transplant.
    Patients with history of both thromboembolism and known congenital hypercoagulable conditions.
    Uncontrolled pulmonary infection, pulmonary edema.
    Oxygen saturation at rest less than 88% measured by pulse oximetry or PaO (2) less than or equal to 55 mm Hg.
    Serum albumin less than 2 g/dL.
    Radioimmunotherapy within 2 years prior to enrollment in study.
    ANC less than 1000/mm(3), or platelet count less than 50,000/mm(3), if these cytopenias are not judged by the investigator to be due to underlying disease (ie, potentially reversible with antineoplastic therapy). A patient will not be excluded because of pancytopenia greater than or equal to Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies.
    Patients with less than 50% of predicted forced expiratory volume (FEV1) or less than 50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed after bronchodilator therapy.
    Patients with history of thrombotic microangiopathy or TTP-HUS.
    Patients with QTc elevation > grade 1
    Patient on high dose estrogen (defined as > 0.625 mg/day of an estrogen compound.
    Patients with clinical evidence of disseminated intravascular coagulation (grade 3-4)
    1. Pacientes que han recibido quimioterapia, inmunoterapia o radioterapia en las 4 semanas previas a la incorporación al estudio.
    2. Pacientes que estén recibiendo algún otro fármaco en investigación.
    3. Los pacientes con metástasis cerebrales conocidas deben ser excluidos de este ensayo clínico debido a su pronóstico desfavorable y a que a menudo padecen disfunción neurológica progresiva, que confundiría la evaluación de los efectos adversos neurológicos y otros acontecimientos adversos (AA).
    4. Pacientes con desprendimiento de retina o coroideo identificado durante la evaluación oftalmológica de la selección.
    5. Mujeres embarazadas o en período de lactancia. Se desconocen los efectos de moxetumomab pasudotox sobre el feto en desarrollo. Dado que existe un riesgo desconocido pero posible de AA en los lactantes a consecuencia del tratamiento de la madre con moxetumomab pasudotox, debe suspenderse la lactancia si la madre recibe moxetumomab pasudotox.
    6. Resultado positivo en la detección del antígeno de superficie del virus de la hepatitis B o de anticuerpos contra el antígeno nuclear, a menos que el paciente esté recibiendo lamivudina o entecavir y la cantidad de ADN del virus de la hepatitis B sea < 2000 UI/ml.
    7. Ganglios linfáticos > 4 cm o esplenectomía previa.
    8. Segunda neoplasia maligna activa que requiere otro tratamiento distinto de la resección menor de tumores poco activos, como el carcinoma basocelular o espinocelular.
    9. Enfermedad intercurrente no controlada, entre otras, infección en curso o activa, insuficiencia cardíaca congestiva sintomática, angina de pecho inestable, hipertensión no controlada, arritmia cardíaca, paludismo o trastorno psiquiátrico/situaciones sociales que limiten el cumplimiento de los requisitos del estudio.
    10. Pacientes con infección conocida por el virus de la inmunodeficiencia humana (VIH), a menos que tomen los medicamentos apropiados contra el VIH y tengan un recuento de CD4 > 200. De lo contrario, puede haber un mayor riesgo de infecciones letales al suprimir temporalmente los linfocitos B normales.
    11. Antecedentes de trasplante alogénico de médula ósea.
    12. Pacientes con antecedentes de tromboembolia y estados de hipercoagulabilidad congénitos conocidos.
    13. Infección pulmonar no controlada, edema pulmonar.
    14. Saturación de oxígeno en reposo < 88 % determinada mediante pulsioximetría o PaO2 ? 55 mm Hg.
    15. Albúmina sérica < 2 mg/dl.
    16. Radioinmunoterapia en los 2 años anteriores a la inscripción en el estudio.
    17. Recuento absoluto de neutrófilos (RAN) < 1,0 x 109/l, o recuento de trombocitos < 50 x 109/l, a menos que el investigador considere que se debe a una enfermedad subyacente (es decir, posiblemente reversible con un tratamiento antineoplásico). Un paciente no será excluido a causa de una pancitopenia de grado ? 3, o dependencia de eritropoyetina, si se debe a una enfermedad, según los estudios de la médula ósea.
    18. Pacientes con < 50 % del volumen espiratorio máximo (FEV1) previsto o < 50 % de la capacidad de difusión del monóxido de carbono prevista, corregida en función de la concentración de hemoglobina y el volumen alveolar (DLCO). Nota: No se requieren pruebas funcionales pulmonares (PFP) para los pacientes sin antecedentes de enfermedades pulmonares. El volumen espiratorio máximo se evaluará tras el tratamiento broncodilatador.
    19. Pacientes con antecedentes de microangiopatía trombótica o microangiopatía trombótica/SUH.
    20. Pacientes con una elevación del intervalo QT corregido (Fridericia) > 500 ms (lectura e interpretación no automatizada del ECG por una persona médicamente cualificada) en función de, al menos, dos ECG de 12 derivaciones separados.
    21. Pacientes que reciben dosis altas de estrógenos (> 0,625 mg/día de un compuesto estrogénico).
    22. Pacientes con signos clínicos de coagulación intravascular diseminada (grado 3-4).
    E.5 End points
    E.5.1Primary end point(s)
    Durable Complete response
    Respuesta completa duradera.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 12 months from the start of treatment
    Aproximadamente 12 meses tras el inicio del tratamiento.
    E.5.2Secondary end point(s)
    Overall Response Rate (ORR), progression free survival (PFS), time to treatment failute, duration fo response (CR and PR), Safety, Immunogenicty, and Pharmokokinetics
    Tasa de respuesta global (TRG), la supervivencia libre de progresión (SLP), el tiempo hasta el fracaso del tratamiento (TFT), la duración de las respuestas (RC y respuesta parcial [RP]), seguridad, inmunogenicidad y farmacocinética .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of study
    Duración del ensayo.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Czech Republic
    United Kingdom
    United States
    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
    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 years4
    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.1.1.1In 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 Yes
    F. of other specific vulnerable populations
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 77
    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)
    Standard of Care
    Tratamiento habitual
    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 Decision2015-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-29
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