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    Summary
    EudraCT Number:2015-003186-28
    Sponsor's Protocol Code Number:BPC01_002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-003186-28
    A.3Full title of the trial
    BIOSKILL: Studying Vacc-4x, an HIV therapeutic vaccine, an assessment of immune-mediated anti-viral effects, when administered with adjuvant GM-CSF prior to HIV latent reservoir activation by the HDAC inhibitor, romidepsin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BIOSKILL: Studying Vacc-4x, an HIV therapeutic vaccine, an as-sessment of immune-mediated anti-viral effects, when administered with adjuvant GM-CSF prior to HIV latent reservoir activation by the HDAC inhibitor, romidepsin
    A.3.2Name or abbreviated title of the trial where available
    BIOSKILL
    A.4.1Sponsor's protocol code numberBPC01_002
    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 SponsorBionor Pharma ASA
    B.1.3.4CountryNorway
    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 supportBionor Pharma ASA
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlifo A/S
    B.5.2Functional name of contact pointJoris Wilms
    B.5.3 Address:
    B.5.3.1Street AddressSmedeland 36
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number4544222921
    B.5.5Fax number4539209045
    B.5.6E-mailjoris.wilms@klifo.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 nameVacc-4x
    D.3.2Product code Vacc-4x
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacc-10
    D.3.9.2Current sponsor codeVacc-10
    D.3.9.3Other descriptive nameVacc-10
    D.3.9.4EV Substance CodeSUB96362
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacc-11
    D.3.9.2Current sponsor codeVacc-11
    D.3.9.3Other descriptive nameVacc-11
    D.3.9.4EV Substance CodeSUB96362
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacc-12
    D.3.9.2Current sponsor codeVacc-12
    D.3.9.3Other descriptive nameVACC-4X
    D.3.9.4EV Substance CodeSUB96362
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacc-13
    D.3.9.2Current sponsor codeVacc-13
    D.3.9.3Other descriptive nameVacc-13
    D.3.9.4EV Substance CodeSUB96362
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 Leukine
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis U.S. LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLeukine
    D.3.2Product code -
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARGRAMOSTIM
    D.3.9.1CAS number 123774-72-1
    D.3.9.2Current sponsor codeGM-CSF
    D.3.9.3Other descriptive nameGM-CSF
    D.3.9.4EV Substance CodeSUB10450MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Istodax
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIstodax
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    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 INNROMIDEPSIN
    D.3.9.2Current sponsor coderomidepsin
    D.3.9.3Other descriptive nameromidepsin
    D.3.9.4EV Substance CodeSUB26362
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntradermal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV infection
    E.1.1.1Medical condition in easily understood language
    HIV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 assess the immune-mediated effect on plasma VL (HIV-1 RNA) of the HIV therapeutic vaccine Vacc-4x with GM-CSF adjuvant when administered prior to HIV latent reservoir activation by the HDACi romidepsin in HIV patients on ART.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of Vacc-4x when administered prior to the HDACi romidepsin in HIV patients on ART.
    To explore the effect of Vacc-4x on HIV viral reservoir size in CD4 T cells when ad-ministered prior to the HDACi romidepsin in HIV patients on ART.
    To explore virus production induced by romidepsin
    To assess the potential additive antiviral effect of two additional booster injections of Vacc-4x when administered prior to the HDACi romidepsin in HIV patients on ART.
    To explore the effects of Vacc-4x on immune responses to HIV when Vacc-4x is admin-istered prior to the HDACi romidepsin in HIV patients on ART.
    To explore the effects of Vacc-4x on selected markers of inflammation when adminis-tered prior to the HDACi romidepsin in HIV patients on ART.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects.
    2. Age ≥18 to ≤ 55 years.
    3. All subjects must have a serologically documented HIV diagnosis.
    4. Subjects receiving ART according to the national and/or International guidelines and recommendations observed by the trial centers.
    5. ART maintained without interruption for at least 3 years prior to randomization.
    6. Plasma HIV RNA maintained <20 copies/mm3. Should the subject have a record of a viral blip, the blip should have been documented by record of a negative HIV RNA test before the observed blip and a re-controlled negative HIV RNA after the observed blip.
    7. CD4 count ≥500 cells/mm3 at screening.
    8. Documented CD4 nadir of ≥250 cells/mm3.
    9. Capability and availability to comply with trial constraints and requirements; evaluation by the investigators, acceptance and signature of the ICF.
    10. If available, preART viral load levels and CD4 levels values must be taken within 6 months of ART initiation.
    a. Note: Patient are still eligible if these data are not available.
    11. Subjects who have never received Vacc-4x.
    E.4Principal exclusion criteria
    1. Subjects with contraindications (hypersensitivity included) to Leukine®, see Appendix 1.
    2. Subjects with contraindications to the practice of i.d. injections.
    3. Subjects who have received a HIV experimental therapeutic or preventive vaccination or immune-modulatory or interleukin-based treatment within 3 years of randomization.
    4. Subjects with a history of treatment with chemotherapeutic agents within 2 years of ran-domization.
    5. Subjects on a Protease Inhibitor-based regimen during three months preceding randomization.
    6. History of any latency activating agent, notably HDACi use within 24 months preceding randomization.
    7. Any vaccinations within 4 weeks of randomization, excluding influenza vaccinations.
    8. Any acute and clinically significant infection within the last 4 weeks of randomization.
    9. Subjects with a history of AIDS defining condition.
    10. Clinical abnormalities, as determined by physical examination alone, indicative of chronic active disease states. Subjects with acute or chronic conditions which are either non-stabilized or not in remission as per the investigator's opinion.
    11. Subjects with a history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncope episodes, or additional risk factors for Torsades de Pointes (e.g. heart failure, congenital long QT syndrome).
    12. Subjects receiving concomitant medication according to Appendix 5.
    13. Subjects with a history of current or past:
    a. HBV infection.
    b. HBV/HDV infection.
    c. HCV infection.
    14. Subjects with recurrent Herpes Zoster.
    15. Subjects with recurrent herpes infection (HSV-1 or HSV-2 reactivation) that cannot be controlled with valaciclovir.
    16. Subjects with clinically significant laboratory abnormalities:
    a. Hemoglobin ≤12 g/dL
    b. Platelet count ≤150 x109/L
    c. Absolute neutrophil count ≤2.0x109/L
    d. Hepatic transaminases (AST or ALT) ≥1.5 x ULN
    e. Serum total bilirubin ≥1.5 x ULN
    f. Specific or standard (CRP and CBC) ≥1.5 x ULN
    g. eGFR ≤60 mL/min (based on serum creatinine or other appropriate validated markers)
    h. Serum potassium, magnesium, phosphorus outside ≥1.5 x ULN/LLN
    17. Subjects with acute or chronic major psychiatric conditions (i.e. schizophrenia, major depression or bipolar disease) which are either non-stabilized or not in remission as per the investigator's clinical assessment, or are in need of continual psycho-active medications.
    18. Subjects with a history of multiple sclerosis including subjects in remission.
    19. Subjects with a history of substance and/or alcohol abuse/dependency within the last 24 months prior to randomization.
    20. Males who are unwilling to use barrier contraception during the entire course of the present trial.
    21. ECG at screening that shows QTc >450 msec for males and >470 msec for women when calculated using the Fridericia formula from either lead V3 or V4.
    22. Subjects who have switched ART regimens more than once due to resistance or intolerance.
    23. Females of childbearing potential*).
    *) Females of non-childbearing potential are defined as:
    - Women who have not reached menarche or
    - Women who have not had menses within the past 12 months and who do have an FSH ≥40 IU/L or
    - Women who have not had menses within the past 24 consecutive months if an FSH measurement is not available
    - Women who have undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral salpingectomy).
    Confirmation of the lack of childbearing potential is required.
    Written documentation or oral communication from a clinician or clinician’s personnel documented in source documents of one of the following must be provided: Physician report/letter, operative report or other source documentation in the patient record, dis-charge summary, FSH measurement elevated into the menopausal range (as established by the reporting laboratory).
    E.5 End points
    E.5.1Primary end point(s)
    Plasma HIV RNA levels below 20 copies/mL 72 h after each of the three romidepsin infusions.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of trial
    E.5.2Secondary end point(s)
    Virological Endpoints
    - Change from baseline in CA US HIV RNA at visits 6, 9, 12-25.
    - Change from baseline in proviral DNA at visits 6, 9, 12, 13, 24 and 25.
    - Change from baseline in plasma HIV-1 RNA (single-copy assay) at 2 h, 24 h and 72 h after each of the three romidepsin infusions.
    Immunological and Inflammatory Endpoints
    - Change from baseline in CD4 and CD8 counts at visits 13, 24 and 25.
    - Change from baseline in CD4/CD8 ratio at visits 13, 24 and 25.
    - Change from baseline in T cell proliferation to visits 6, 9, 12, 13, 21, 22, and 23.
    - Change from baseline in intracellular cytokines to visits 6, 9, 12, 13, 21, 22, and 23.
    - Change from baseline in hs-CRP to visits 13 and 25.
    - Change from baseline in IP-10 to visits 13 and 25.
    - Change from baseline in D-dimer to visits 13 and 25
    - Change from baseline in sTNF1 and sTNF2 to visits 13 and 25.
    Pharmacodynamic Endpoint
    - Histone H3 acetylation to visits 13-21 and 24.
    Safety Endpoints
    - Number of AEs
    - Number of ARs
    - Number of SAEs
    - Number of SARs
    - Number of SUSARs
    - Laboratory safety parameters.
    - Plasma concentrations of romidepsin prior to romidepsin administration, close to the end of the infusion (3:45-4:00 h after infusion start) and at visits 14, 15, 17, 18, 20 and 21.
    Serological Endpoint
    - Change from baseline in Anti-Vacc C5 Ab levels to visit 13 and visit 25 (or EOT).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of trial
    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 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.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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    European Union
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days7
    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: 192
    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 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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 158
    F.4.2.2In the whole clinical trial 192
    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)
    The Investigator, in consultation with the subject, will decide upon future treatment.
    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 Decision2016-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-31
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