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    Summary
    EudraCT Number:2017-001861-25
    Sponsor's Protocol Code Number:DIAGNODE-2(D/P2/17/6)
    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:2017-07-06
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-001861-25
    A.3Full title of the trial
    A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetes
    Estudio Fase IIb, 2-brazos, aleatorizado, Doble-ciego, Placebo-Controlado, Multicéntrico para Optimizar la terapia de Diamyd® Administrada dentro de los ganglios linfáticos combinados con la vitamina D oral para investigar el impacto en la progresión de la diabetes tipo 1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIb, Placebo-Controlled, Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Vitamin D oral drops to Investigate the Impact on the Progression of Type 1 diabetes
    Ensayo fase IIb, controlado con placebo, para optimizar la terapia Diamyd® administrada en ganglios linfáticos combinada con gotas orales de vitamina D para investigar el impacto en la progresión de la diabetes tipo 1
    A.4.1Sponsor's protocol code numberDIAGNODE-2(D/P2/17/6)
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDiamyd Medical AB
    B.1.3.4CountrySweden
    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 supportDiamyd Medical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTFS Trial Form Support International AB
    B.5.2Functional name of contact pointProject Leader - Clinical Trial
    B.5.3 Address:
    B.5.3.1Street AddressBox 165
    B.5.3.2Town/ cityLund
    B.5.3.3Post code221 00
    B.5.3.4CountrySweden
    B.5.4Telephone number+4646280 18 00
    B.5.6E-mailanna.westerdahl@tfscro.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 nameDiamyd
    D.3.2Product code rhGAD65 formulated in alum (GAD-alum)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrecombinant human GAD65
    D.3.9.2Current sponsor codeRHGAD65
    D.3.9.3Other descriptive nameDiamyd
    D.3.9.4EV Substance CodeSUB32062
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 4.5
    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.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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntralymphatic use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes
    Diabetes tipo 1
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes
    Diabetes tipo 1
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term 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
    The primary objective is to evaluate the efficacy of Diamyd, administered into lymph nodes in combination with an oral vitamin D regimen, compared to placebo in terms of preserving endogenous insulin secretion as measured by C-peptide.
    El objetivo primario es evaluar la eficacia de Diamyd, administrado en los ganglios linfáticos en combinación con un régimen oral de vitamina D, comparado con placebo en términos de preservar la secreción de insulina endógena, medida por el péptido C.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare Diamyd, administered into lymph nodes in combination with an oral vitamin D regimen and placebo treatment with respect to the effects on the diabetes status, treatment safety, immune system and quality of life (QoL) of the patients.
    Los objetivos secundarios son comparar Diamyd, administrado en los ganglios linfáticos en combinación con un régimen oral de vitamina D, y tratamiento con placebo con respecto a los efectos sobre el estado de la diabetes, la seguridad del tratamiento, el sistema inmunológico y la calidad de vida (QoL) de los pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent given by patients and/or patient’s parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
    2. T1D according to the ADA classification diagnosed ≤6 months at the time of screening
    3. Age: ≥12 and <25 years old
    4. Fasting C-peptide ≥0.12 nmol/L on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)
    5. Positive for GAD65A but < 50 000 random units
    6. Females must agree to avoid pregnancy and have a negative urine pregnancy test.
    Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of Diamyd. Adequate contraception is as follows:
    For females of childbearing potential:
    a. oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
    b. intrauterine device
    c. intrauterine system (for example, progestin‐releasing coil)
    d. vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
    For males of childbearing potential:
    e. condom (male)
    1. Consentimiento informado obtenido de los pacientes y / o los padres de los pacientes o representantes legales (tutor (es)) de acuerdo con las regulaciones nacionales
    2. Diabetes tipo 1 según la clasificación ADA diagnosticada ≤6 meses en el momento de la selección
    3. Edad: ≥12 y <25
    4. Péptido-C en ayunas ≥0,12 nmol / L en al menos una ocasión (máximo 2 pruebas en días diferentes en un período de 2 semanas)
    5. Positivo para GAD65A pero <50 000 unidades random
    6. Las mujeres deben aceptar evitar el embarazo y tener una prueba de embarazo negativa en la orina.
    Los pacientes en edad fértil deben acordar el uso de métodos anticonceptivos adecuados, hasta un (1) año después de la última administración de Diamyd. La contracepción adecuada es la siguiente:
    Para las mujeres en edad fértil:
    a. Oral (excepto gestagen de dosis baja (lynestrenol y norestisteron)), anticonceptivos hormonales inyectables o implantados
    b. dispositivo intrauterino
    c. Sistema Intrauterino (por ejemplo, bobina de liberación de progestina)
    d. Varón vasectomizado (con la documentación apropiada de la vasectomía de la ausencia de esperma en el eyaculado)
    Para los varones en edad fértil:
    e. Condón (masculino)
    E.4Principal exclusion criteria
    1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
    2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
    3. Treatment with any oral or injected anti-diabetic medications other than insulin
    4. A history of anemia or significantly abnormal hematology results at screening
    5. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
    6. Clinically significant history of acute reaction to vaccines or other drugs in the past
    7. Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug.
    8. Participation in other clinical trials with a new chemical entity within the previous 3 months
    9. Inability or unwillingness to comply with the provisions of this protocol
    10. A history of alcohol or drug abuse
    11. A significant illness other than diabetes within 2 weeks prior to first dosing
    12. Known HIV or hepatitis
    13. Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the Diamyd/placebo treatment)
    14. Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
    15. Deemed by the investigator not being able to follow instructions and/or follow the study protocol
    1. Tratamiento anterior o actual con terapia inmunosupresora (aunque se aceptan esteroides tópicos o inhalados)
    2. Tratamiento continuo con fármacos anti-inflamatorios (se aceptará un tratamiento esporádico de unos días por ejemplo debido a un dolor de cabeza o en relación con fiebre)
    3. Tratamiento con cualquier medicación oral o inyectada antidiabética que no sea insulina
    4. Antecedentes de anemia o resultados hematológicos significativamente anormales en la selección
    5. Antecedentes de epilepsia, traumatismo craneal o accidente cerebrovascular, o características clínicas de la actividad de la unidad motora continua en los músculos proximales
    6. Antecedentes clínicamente significativos de reacción aguda a vacunas u otros fármacos en el pasado
    7. Tratamiento con cualquier vacuna, incluida la vacuna contra la gripe, dentro de los 4 meses anteriores a la primera dosis de fármaco del estudio o tratamiento previsto con cualquier vacuna hasta 4 meses después de la última inyección con el fármaco del estudio.
    8. Participación en otros ensayos clínicos con una nueva entidad química en los 3 meses anteriores
    9. Incapacidad o falta de voluntad para cumplir con las disposiciones de este protocolo
    10. Historia de abuso de alcohol o drogas
    11. Una enfermedad significativa distinta de la diabetes dentro de 2 semanas antes de la primera dosis
    12. VIH o Hepatitis conocida
    13. Mujeres en periodo de lactancia o embarazadas (la posibilidad de embarazo debe ser excluida en el centro dentro de las 24 horas previas al tratamiento con Diamyd / placebo mediante βHCG en orina)
    14. Presencia de enfermedad o afección grave asociada, incluidas las infecciones cutáneas activas que excluyen la inyección intralinfática, que, a juicio del investigador, hagan que el paciente no sea elegible para el estudio
    15. Considerado por el investigador incapaz de seguir las instrucciones y / o seguir el protocolo del estudio
    E.5 End points
    E.5.1Primary end point(s)
    • Change in C-peptide (Area Under the Curve [AUC]mean 0-120 min-) during a Mixed Meal Tolerance Test (MMTT) between baseline to 15 months.
    • Cambio en el péptido C (área bajo la curva [AUC] media 0-120 min) durante una Prueba de Tolerancia de Comidas Mixtas (Mixed Meal Tolerance Test; MMTT) entre el inicio y los 15 meses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    between baseline to 15 months
    Entre el inicio y los 15 meses
    E.5.2Secondary end point(s)
    The secondary endpoints to evaluate diabetic status are:
    • Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months.
    • Proportion of patients with a stimulated 90min C-peptide level above 0.2 nmol/L at 15 months.
    • Change in maximum C-peptide during MMTT between baseline and 15 months.
    • C-peptide measured at 30, 60, 90, and 120 minutes during MMTT at 15 months.
    • Change in Fasting C-peptide between baseline and 15 months.
    • Change in HbA1c between baseline and 15 months.
    • Change in daily exogenous insulin consumption between baseline and 15 months.
    • Change in insulin-dose-adjusted HbA1c (IDAA1c) between baseline and 15 months.
    • Proportion of patients with by IDAA1c ≤ 9 at 15 months.
    • Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) between baseline and 15 months.
    • Change in Rate of hypoglycemic events between baseline and 15 months.
    • Number of patients having at least 1 severe hypoglycemic event between baseline and 15 months.
    • Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, Flash Glucose Monitoring [FGM]) over 14 day period between Screening and 15 months.

    The secondary endpoints to evaluate safety are:
    • Injection site reactions
    • Occurrence of AEs
    • Laboratory measurements (hematology and clinical chemistry)
    • Urine analysis (microalbuminuria, creatinine)
    • Physical examinations, including neurological assessments
    • GAD65A titer
    • Vital signs (blood pressure)

    The secondary endpoints to evaluate the influence on the immune system are:
    • Concentrations of serum autoantibodies towards GAD65 and IA 2.
    • Concentrations of serum autoantibody isotypes towards GAD65.
    • Total serum Immunoglobulin E (IgE).
    • Secretion of cytokines interleukin (IL)-1, IL-2, IL-5, IL-13, IL-10, IL-17, interferon (IFN)γ, and tumour necrosis factor (TNF)α by peripheral blood mononuclear cells (PBMCs) upon stimulation with GAD65.
    • Number of PBMCs secreting IL-10, IL-4 and/or IFNγ upon stimulation with GAD65 measured by enzyme linked immunosorbent spot forming cell assay (ELISPOT)
    • Proliferation of PBMCs upon stimulation with GAD65.
    • Flow cytometric analysis of PBMC subsets.
    • Further exploratory immunological characterization.

    The secondary endpoints of Quality of Life are:
    • Change in QoL as measured by questionnaire EQ-5D-5L between baseline and Month 15.
    • Quality adjusted life years (QALYs) based on the EQ-5D-5L questionnaire.
    Las variables secundarias para evaluar el estado de la diabetes son:
    • Proporción de pacientes con un nivel de péptido C máximo estimulado por encima de 0,2 nmol / L a los 15 meses
    • Proporción de pacientes con un nivel estimulado de péptido C de 90 minutos por encima de 0,2 nmol / L a los 15 meses.
    • Cambio en el máximo del péptido C durante el MMTT entre el inicio y los 15 meses.
    • Péptido-C medido a los 30, 60, 90 y 120 minutos durante la MMTT a los 15 meses.
    • Cambio en el péptido-C en ayunas entre el inicio y los 15 meses
    • Cambio en HbA1c entre el inicio y los 15 meses
    • Cambio en el consumo diario de insulina exógena entre el inicio y los 15 meses.
    • Cambio en HbA1c ajustado a la dosis de insulina (IDAA1c) entre el inicio y los 15 meses.
    • Proporción de pacientes con IDAA1c ≤ 9 a los 15 meses.
    • Número de episodios de hipoglucemia grave autoevaluada (hipoglucemia severa definida como necesidad de ayuda de otros y / o convulsiones y / o inconsciente) entre el inicio y los 15 meses.
    • Cambio en la tasa de eventos hipoglucémicos entre el inicio y los 15 meses.
    • Número de pacientes con al menos 1 episodio de hipoglucemia grave entre el inicio y los 15 meses.
    • Cambios en la variabilidad / fluctuación de la glucemia (evaluados a partir de los datos de la monitorización continua de glucosa FreeStyle LibrePro, Monitorización de Glucosa Flash [FGM]) durante un período de 14 días entre la selección y los 15 meses.

    Las variables secundarias para evaluar la seguridad son:
    • Reacciones en el sitio de inyección
    • Ocurrencia de AEs
    • Mediciones de laboratorio (hematología y química clínica)
    • Análisis de orina (microalbuminuria, creatinina)
    • Exámenes físicos, incluyendo evaluaciones neurológicas
    • Título de GAD65A
    • Signos vitales (presión arterial)

    Las variables secundarias para evaluar la influencia en el sistema inmunológico son:
    • Concentraciones de autoanticuerpos séricos para GAD65 e IA-2.
    • Concentraciones de isotipos de autoanticuerpos séricos para GAD65.
    • Inmunoglobulina E (IgE) en suero total.
    • Secreción de citocinas interleucina (IL) -1, IL-2, IL-5, IL-13, IL-10, IL-17, interferón (IFN)γ, y factor de necrosis tumoral (TNF)α por células mononucleares de sangre periférica (PBMCs) tras la estimulación con GAD65.
    • Número de PBMCs que secretan IL-10, IL-4 y / o IFNγ tras la estimulación con GAD65 medido por ensayo de células de formación de puntos inmunosorbentes unidos a enzimas (ELISPOT)
    • Proliferación de PBMCs mediante estimulación con GAD65.
    • Análisis de citometría de flujo de subconjuntos de PBMC.
    • Caracterización inmunológica exploratoria adicional.

    Las variables secundarias de calidad de vida son:
    • Cambio en la calidad de vida tal como se mide mediante el cuestionario EQ-5D-5L entre el inicio y el mes 15.
    • Años de calidad de vida ajustados (QALYs) basados en el cuestionario EQ-5D-5L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    between baseline to 15 months
    Entre el inicio y los 15 meses
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Calidad de vida
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    Última visita último paciente
    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 months2
    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 months3
    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 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 care.
    Tratamiento/cuidados médicos por práctica clínica 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 Decision2017-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-27
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