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    The EU Clinical Trials Register currently displays   43887   clinical trials with a EudraCT protocol, of which   7297   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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    Summary
    EudraCT Number:2009-018077-31
    Sponsor's Protocol Code Number:012010
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-05-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-018077-31
    A.3Full title of the trial
    A phase I/II dose schedule finding study of ch14.18/CHO continuous infusion combined with subcutaneous Aldesleukin (IL-2) in patients with primary refractory or relapsed Neuroblastoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose schedule finding study of ch14.18/CHO & Aldesleukin in patients with high-risk neuroblastoma
    A.3.2Name or abbreviated title of the trial where available
    Long term continuous infusion ch14.18/CHO plus s.c. aldesleukin (IL-2)
    A.4.1Sponsor's protocol code number012010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01701479
    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 SponsorSt. Anna Kinderkrebsforschung
    B.1.3.4CountryAustria
    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 supportCRUK (CTAAC)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham, Cancer Research UK Clinical Trials Unit
    B.5.2Functional name of contact pointUK Coordinating Centre
    B.5.3 Address:
    B.5.3.1Street AddressVincent Drive
    B.5.3.2Town/ cityEdbgaston, Birmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214143799
    B.5.5Fax number01214143700
    B.5.6E-mailGD2@trials.bham.ac.uk
    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 nameCh14.18/CHO
    D.3.2Product code Ch14.18/CHO
    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 INNCh14.18/CHO
    D.3.9.2Current sponsor code012010
    D.3.9.3Other descriptive nameChimeric 14.18 monoclonal Antibody produced in Chinese Hamster Ovary cells
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4-5
    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) 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: 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 Proleukin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAldesleukin
    D.3.4Pharmaceutical form Powder 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 INNAldesleukin
    D.3.9.3Other descriptive nameIL-2
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22 x 10^6 in vial
    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.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 Isotretinoin
    D.2.1.1.2Name of the Marketing Authorisation holderBeacon Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameIsotretinoin
    D.3.2Product code 13-cis-Retinoic Acid
    D.3.4Pharmaceutical form Capsule, soft
    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 INNIsotretinoin
    D.3.9.1CAS number 4759-48-2
    D.3.9.2Current sponsor code012010
    D.3.9.3Other descriptive name13-cis-Retinoic Acid
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neuroblastoma
    E.1.1.1Medical condition in easily understood language
    Neuroblastoma is a malignant (cancerous) tumour that develops from precursor cells in adrenal or autonomic nervous system tissues.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find a tolerable treatment schedule of ch14.18/CHO antibody given as a continuous intravenous (through a vein) infusion combined with subcutaneous aldesleukin (IL-2) (given as a needle under the skin) and 13-cis-retinoic acid (isotretinoin), where pain is reduced whilst maintaining immunomodulatory efficacy (ability to successfuly alter or regulate immune functions).

    To characterise dose limiting toxicities (side effects that could limit the dose a patient can withstand) and to determine a recommended Phase III dose for further studies in children and adolescents with high risk neuroblastoma.
    E.2.2Secondary objectives of the trial
    To assess pain intensity and pain relief by appropriate medication with a validated self-report tool to be completed by the patient and/or their parent/guardian.

    To validate during the first course, the correlation between activated natural killer (NK) cells and ch14.18/CHO level with antibody-dependent cell-mediated cytotoxicity (ADCC) by using mononuclear cells (MNC) and serum from patients on day 15.

    To determine ability to successfully alter or regulate immune functions resulting from the combined treatment of ch14.18/CHO and s.c. aldesleukin (IL-2) by repeated analysis of NK cell activation, soluble IL-2 receptor, ADCC, complement-dependent cytotoxicity (CDC) and anti-idiotype response (the human antiglobulin antibodies HAMA and HACA).

    To determine the pharmacokinetics of ch14.18/CHO.

    To evaluate anti-tumour responses resulting from this treatment regimen through clinical assessments in patients with measurable disease.

    To confirm the results of the chosen ch14.18/C
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) At study entry patients must be > 1 year but <= 21 years of age.

    NOTE: Patients >21 years but <=45 years of age, fulfilling the remaining criteria, may be enrolled in the study. These patients will be analysed separately and will not be included in the dose finding schedule algorithm. The purpose for inclusion of the older patients is to enable the collection of tolerability data.

    b) Patients must be diagnosed with neuroblastoma according to the INSS criteria.

    c) Must have received at least one previous high dose treatment followed by stem cell rescue after conventional therapy.

    d) Must fulfil one of the following criteria:
    • Patients with stage 4 neuroblastoma either:
    o on the current high-risk SIOPEN trial (HR-NBL-1/SIOPEN) either with primary refractory disease having had two or more front-line treatments or patients ineligible for the R2 randomisation due to major delays after completed high-dose treatments or
    o Standard high-risk front-line treatment (other than HR-NBL (1.5)/SIOPEN) consisting of intensive induction, followed by high-dose treatment with stem cell rescue.
    • Treated and responding relapse after primary stage 4 disease, without signs of progression at study entry
    • Treated and responding disseminated neuroblastoma relapse after having received ASCT without signs of progression at study entry.

    e) Patients must have a performance status greater or equal 70% (Lansky Score or Karnofsky)

    f) Patients must have an estimated life expectancy of at least 12 weeks.

    g) Patients must consent to the placement of a central venous line, if one has not already been placed.

    h) Patients must be off any standard or experimental treatments for at least two weeks prior to study entry and be fully recovered from the short term major toxic effects.

    i) Patients must have no immediate requirements for palliative chemotherapy, radiotherapy or surgery.

    j) At least 4 weeks after major surgery (e.g. laporotomy or thoracotomy) and fully recovered from any post-surgical complications.

    k) HIV and Hepatitis B negative.

    l) Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment onto the study. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.

    m) Patients may have had prior CNS metastasis providing the following criteria are all met:
    a. the patient’s CNS disease has been previously treated,
    b. the patient’s CNS disease has been clinically stable for four weeks prior to starting this study (assessment must be made clinically and by CT or MRI scan),
    c. the patient is off steroids for CNS disease for four weeks prior to starting on study and during the course of the study.

    n) Patients with seizure disorders may be enrolled if on anticonvulsants and are well controlled.

    o) All patients and/or their parents or legal guardians must sign a written informed consent.

    p) All institutional and national requirements for human studies must be met.

    q) Laboratory Testing
    • Patients should have a shortening fraction of >=30 % by Echocardiogram.
    • Patients should have FEV1 and FVC >60% of the predicted by pulmonary function tests. Children unable to do PFTs should have no dyspnoea at rest and a pulse oximetry >94% on room air. All patients must have adequate bone marrow function as defined by ANC >1 10^9/L, platelets >=50 10^9/L and haemoglobin > 9.0 g/dL.Patients must have adequate liver function, as defined by an ALT or AST < 5 x normal and a total bilirubin < 1.0 mg/dL.
    • Patients must have adequate renal function, as defined by a serum creatinine <1.5 mg/dL or a creatinine clearance or radioisotope GFR of > 60 mL/minute/1.73m2
    E.4Principal exclusion criteria
    a) Patients with progressive disease.

    b) Patients who have previously received treatment with ch14.18/SP2/0 and/or
    ch14.18/CHO.

    c) Platelet transfusion dependent.

    d) Patients with significant intercurrent illnesses and/or any of the following:
    - Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance.
    - Patients with significant psychiatric disabilities or uncontrolled seizure disorders.
    - Patients with active infections.
    - Patients with a clinically significant neurologic deficit or objective peripheral neuropathy (Grade >2) are ineligible.
    - Patients with clinically significant, symptomatic, pleural or pericardial effusions or ascites.
    e) Patients who require, or are likely to require, corticosteroid or other immunosuppressive drugs.
    f) Concurrent treatment with any non-trial anticancer therapies.
    E.5 End points
    E.5.1Primary end point(s)
    For the evaluation of the primary endpoints only the first course will be taken into account for the dose schedule finding algorithm.
    A) Pain-toxicity endpoint: i.v. morphine free ch14.18/CHO infusion schedule after the first 5 days during the first cycle in ≥ 80% of patients.
    B) Efficacy endpoint: On day 15 of the first cycle in ≥ 80% of patients:
    - an increase of 500% and/or an absolute minimum increase to ≥100 cells/mcL of the CD16/CD56 positive activated NK cells, AND
    - a measurable ch14.18/CHO level of at least 1 µg/ml.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the primary endpoints is carried out after patients have received their first cycle. A cohort of 10 patients will be evaluated at each dose level until acceptable efficacy and toxicity is found, thereby indicating a suitable dose schedule.
    E.5.2Secondary end point(s)
    • ADCC and activated NK cell concentrations above baseline levels in ≥ 80% of patients.
    • Appearance of soluble IL-2 receptor and CDC.
    • Detection of anti-idiotype response by appearance of HAMA and HACA.
    • Increase of absolute lymphocyte counts by 50% over baseline.
    • Increase of absolute NK cell numbers >1000 cells/mcL in ≥80% of patients.
    • Ch14.18/CHO concentrations.
    • Anti-tumour response in patients with measureable disease (bone marrow, skeletal lesions, soft tissue lesions, lymph nodes and/or primary tumour site) as measured by immunocytology, MIBG, CT and/or MRI.
    • Confirmation of the primary and secondary endpoints in the expansion cohort .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each treatment level will have a cohort of 10 patients. The secondary endpoints will be assessed after each cohort to provide additional information as to the best dose schedule. Confirmation of these end points in the expansion cohort will be done after an additional 20 patients have been recruited to the proposed best dose schedule.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose/infusion finding
    E.7.2Therapeutic exploratory (Phase II) No
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Australia
    Austria
    France
    Germany
    Ireland
    Israel
    Italy
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days28
    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: 20
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 12
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients between aged 1 and 15 years will be subjects in this study. Such patients are not legally able to consent for their own participation in clinical research.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    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)
    Following completion of protocol therapy, if a patients toxicities have resolved to CTCAE Grade 1 or less, their disease has stabilised or regressed and the patient/family and responsible physician desire, they will be eligible to receive up to a further 5 cycles of treatment.

    Thereafter, patients will return to their treating physican for future care and treatment.
    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 Decision2012-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-03
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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