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    Summary
    EudraCT Number:2015-002356-27
    Sponsor's Protocol Code Number:XCGD_MOBI1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-29
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002356-27
    A.3Full title of the trial
    A multicentric, exploratory, non-randomised, non-controlled, prospective, open-label phase II, study evaluating safety and efficacy of IBU, G-CSF and Plerixafor as a stem cell mobilization regimen in patients affected by X-CGD.
    Studio multicentrico, esplorativo, non randomizzato, non controllato, prospettico, in aperto, atto a valutare la sicurezza e l'efficacia di Ibuprofene (IBU), G-CSF e Plerixafor come regime di mobilizzazione di cellule staminali in pazienti affetti da XCGD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of safety and efficacy of the combination of Ibuprofen (IBU), G-CSF and Plerixafor as a stem cell mobilization regimen in patients affected by XCGD
    Valutazione della sicurezza e dell’effetto di Ibuprofene (IBU), G-CSF e Plerixafor come regime di mobilizzazione di cellule staminali in pazienti affetti da XCGD
    A.4.1Sponsor's protocol code numberXCGD_MOBI1
    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 SponsorOspedale San Raffaele
    B.1.3.4CountryItaly
    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 supportFondazione Telethon
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointTIGET Clinical Trial Office (TCTO)
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number00390226434875
    B.5.5Fax number00390226436545
    B.5.6E-mailtcto@hsr.postecert.it
    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 Yes
    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 nameIbuprofen
    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 INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB08098MIG
    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.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 Yes
    D.2.1.1.1Trade name MYELOSTIM 34 milions UI/ml, powder and solvent for solution for injection or infusion
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMYELOSTIM 34 milions UI/ml - powder and solvent for solution for injection/infusion
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENOGRASTIM
    D.3.9.1CAS number 135968-09-1
    D.3.9.4EV Substance CodeSUB02888MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number34
    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) 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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Mozobil 20mg/mL vial (injectable solution for subcutaneous use)
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMozobil 20mg/mL vial (injectable solution, subcutaneous use)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlerixafor
    D.3.9.1CAS number 110078-46-1
    D.3.9.3Other descriptive namePlerixafor
    D.3.9.4EV Substance CodeSUB28849
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.3.11.13.1Other medicinal product typeMozobil is a selective reversible antagonist of the CXCR4 chemokine receptor.
    D.IMP: 4
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePantoprazolo 20 mg gastro-resistant tablets
    D.3.4Pharmaceutical form Gastro-resistant 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 INNPantoprazole
    D.3.9.1CAS number 102625-70-7
    D.3.9.3Other descriptive namePANTOPRAZOLE
    D.3.9.4EV Substance CodeSUB09608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    X-linked chronic granulomatous disease
    Malattia granulomatosa cronica X-linked (X-CGD)
    E.1.1.1Medical condition in easily understood language
    Chronic granulomatous disease
    Malattia granulomatosa cronica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10008906
    E.1.2Term Chronic granulomatous disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To explore the safety of IBU, G-CSF and Plerixafor when administered as a stem cell mobilization regimen in patients affected by X-CGD.
    2. To explore the effect of IBU, G-CSF and Plerixafor in mobilizing CD34+ cells thus allowing the collection of a number of HSPC deemed sufficient for ex vivo gene therapy in patients affected by X-CGD.
    1. Esplorare la sicurezza di Ibuprofene, G-CSF e Plerixafor, somministrati come regime mobilizzante in pazienti affetti da X-CGD.
    2. Esplorare l’effetto di Ibuprofene, G-CSF e Plerixafor nella mobilizzazione delle cellule CD34+, permettendo una raccolta di cellule ematopoietiche staminali progenitrici che possa essere ritenuta adeguata per terapia genica ex vivo in pazienti affetti da X-CGD.
    E.2.2Secondary objectives of the trial
    1. To explore the effect of Ibuprofen in mobilizing CD34+ cells in the PB.
    2. To explore the in vitro efficacy of a lentiviral vector encoding for a corrective cDNA of the human gp91phox gene in transducing CD34+ cells obtained by the XCGD-MOBI protocol and correcting the func-tional defects in the differentiated myeloid progeny.
    3. To functionally characterize the properties of IBU, G-CSF and Plerixafor mobilized CD34+ cells from X-CGD patients
    1. Esplorare l’effetto della mobilizzazione delle cellule CD34+ in sangue periferico con Ibuprofene.
    2. Esplorare l'efficacia in vitro di trasduzione tramite un vettore lentivirale contente il gene della gp91phox umana nelle cellule CD34+ ottenute da questo regime di mobilizzazione e correggere i difetti funzionali nella progenie mieloide differenziata.
    3. Caratterizzare funzionalmente le proprietà delle cellule CD34+ mobilizzate con IBU, G-CSF e Plerixafor da pazienti X-CGD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Genetic diagnosis of X-CGD
    •18-45 years of age
    •Karnofsky Index > 80 %
    •Adequate cardiac, renal, hepatic and pulmonary function.
    •Negative thrombophilic screen and negative history for previous thrombotic events
    •Written informed consent.
    •Diagnosi genetica di X-CGD
    •18-45 anni di età
    •Indice di Karnofsky> 80%
    •Adeguata funzionalità cardiaca, renale, epatica e polmonare.
    •Screening trombofilico negativo e anamnesi negativa per precedenti eventi trombotici
    •Firma del consenso informato
    E.4Principal exclusion criteria
    •Previous Bone Marrow Transplantation or previous Gene Therapy.
    •Use of other investigational agents within 4 weeks prior to study en-rolment (within 6 weeks if use of long-acting agents).
    •Ongoing IFN-γ treatment (within 4 weeks).
    •Symptomatic inflammatory bowel disease.
    •Symptomatic viral, bacterial, or fungal infection within 6 weeks of eli-gibility evaluation or active infection (including fever of unknown origin)
    •Neoplasia (except local skin cancer) or history of “familial” cancer.
    •Myelodysplasia or other serious hematological disorder
    •History of uncontrolled seizures and deep venous thrombosis
    •Other systemic disease judged as incompatible with the procedure
    •Positivity for HIV and/or HCV RNA and/or HbsAg and/or HBV DNA
    •Active alcohol or substance abuse within 6 months of the study.
    •Contraindications to IBU, G-CSF, Plerixafor or Pantoprazole administration
    •L'uso di altri farmaci sperimentali nelle 4 settimane prima dell'arruolamento nello studio (entro 6 settimane se sono stati utilizzati farmaci a lunga durata d'azione).
    •Precedente trapianto di midollo osseo o terapia genica.
    •Malattia infiammatoria intestinale sintomatica.
    •Trattamento con IFN-γ in corso (entro 4 settimane).
    •Infezione virale, batterica o fungina sintomatica entro 6 settimane dalla valutazione di ammissibilità o infezione attiva (compresa la febbre di origine sconosciuta).
    •Neoplasia (eccetto tumori cutanei localizzati) o storia di cancro "familiare".
    •Mielodisplasia o altri gravi disturbi ematologici
    •Storia di convulsioni non controllate e trombosi venosa profonda
    •Altre malattie sistemiche giudicate incompatibili con la procedura
    •Positività per l'HIV e / o HCV RNA e / o HBsAg e / o HBV DNA
    •Controindicazioni alla somministrazione di Ibuprofene, G-CSF, Plerixafor o Pantoprazolo.
    E.5 End points
    E.5.1Primary end point(s)
    1) Safety
    Incidence and severity of adverse events following IBU, G-CSF and Plerixafor administration (any grade) occurring between day 0 and 30 days after the last LP.
    2) Efficacy - Harvest of >= 8X10^6 CD34+/Kg in one or more collections
    1) Sicurezza - incidenza e gravità degli eventi avversi conseguenti alla somministrazione di Ibuprofene, G-CSF e Plerixafor (qualsiasi grado) che si verificano
    2) Efficacia - Raccolta di ≥ 8 x10 ^ 6 cellule CD34 + / kg in una o più raccolte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) From Day 0 to 30 days after the last LP
    2) from the first to the last LP
    1) tra il giorno 0 e 30 giorni dopo l'ultima leucoaferesi (LP).
    2) dalla prima all’ultima Leucaferesi.
    E.5.2Secondary end point(s)
    1.Increase in PB CD34+ cell count after administration of Ibuprofen.
    2.Efficient transduction of mobilized HSPC and oxidase activity restoration in their myeloid progeny following gene transfer with a lentiviral vector encoding for human gp91phox.
    3.Maintenance of repopulating activity of transduced HSPC in immunodeficient mice
    1) Aumento delle cellule CD34+ dosate nel sangue periferico dopo somministrazione di Ibuprofene.
    2) Efficienza di trasduzione e ripristino dell’attività ossidasica nella progenie mielodie dopo trasduzione con vettore lentivirale codificante per la proteina gp91 phox umana.
    3) Mantenimento dell’attività di ripopolamento delle cellule CD34+ mobilizzate trasdotte in topi immunodeficienti.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 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
    End of laboratory experiments
    Fine degli esperimenti di laboratorio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months23
    E.8.9.1In the Member State concerned 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: 3
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3
    F.4.2.2In the whole clinical trial 3
    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)
    At the end of the therapeutic phase a follow-up is forseen for 30 days after the last leukapheresis.
    No other follow-up is planned. Patients will be followed in their reference center for their disease.
    Al termine della fase terapeutica è previsto un follow-up ad una settimana e a 30 giorni dall’ultima leucoaferesi.
    Trascorsi questi 30 giorni non sono necessari altri follow-up futuri. I pazienti proseguiranno il follow-up previsto dalla patologia di base nel centro di riferimento.
    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 Decision2015-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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