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    Summary
    EudraCT Number:2021-003875-32
    Sponsor's Protocol Code Number:P288ALS
    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:2021-12-29
    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 number2021-003875-32
    A.3Full title of the trial
    A double-blind, placebo-controlled, exploratory randomised clinical trial
    to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs
    placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic
    lateral sclerosis (Study TRIALS)
    Studio clinico esplorativo, randomizzato, in doppio cieco, controllato, per valutare la sicurezza e l’efficacia di IFB-088 più riluzolo 100 mg rispetto al placebo più riluzolo 100 mg in pazienti con sclerosi laterale amiotrofica a esordio bulbare (studio TRIALS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100
    mg vs placebo plus riluzole 100 mg in patients with bulbar-onset
    amyotrophic lateral sclerosis
    Studio clinico per valutare la sicurezza e l'efficacia di IFB-088 più riluzolo 100
    mg vs placebo più riluzolo 100 mg in pazienti con esordio bulbare
    sclerosi laterale amiotrofica
    A.3.2Name or abbreviated title of the trial where available
    TRIALS
    TRIALS
    A.4.1Sponsor's protocol code numberP288ALS
    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 SponsorInFlectis BioScience
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInFlectis BioScience
    B.5.2Functional name of contact pointAnne Visbecq
    B.5.3 Address:
    B.5.3.1Street Address21 Rue La Noue Bras de Fer
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44200
    B.5.3.4CountryFrance
    B.5.4Telephone number33630632020
    B.5.6E-mailannevisbecq@inflectisbioscience.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 nameIcerguastat
    D.3.2Product code [IFB-088]
    D.3.4Pharmaceutical form 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.3.9.1CAS number 469866-31-7
    D.3.9.2Current sponsor codeIFB-088
    D.3.9.4EV Substance CodeSUB192704
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic lateral sclerosis (bulbar-onset)
    Sclerosi laterale amiotrofica (esordio bulbare)
    E.1.1.1Medical condition in easily understood language
    Amyotrophic lateral sclerosis
    Sclerosi laterale amiotrofica
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of IFB-088 50 mg/day in patients with bulbar-onset ALS.
    Valutare la sicurezza di IFB-088 50 mg/die in pazienti con SLA a esordio bulbare.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of IFB-088 50 mg/day plus riluzole 100 mg/day
    versus placebo plus riluzole 100 mg/day over a 6-month period in
    patients
    with bulbar-onset ALS,
    • To determine pharmacokinetics (PK) parameters of IFB-088,
    • To investigate the effects of IFB-088 on ALS potential biomarkers,
    • To investigate quality of life (QoL).
    - Valutare l’efficacia di IFB-088 50 mg/die più riluzolo 100 mg/die rispetto a
    placebo più riluzolo 100 mg/die in un periodo di 6 mesi in pazienti con SLA
    a esordio bulbare.
    - Determinare i parametri farmacocinetici (Pharmacokinetics, PK) di IFB-088.
    - Studiare gli effetti di IFB-088 sui potenziali biomarcatori della SLA.
    - Esaminare la qualità della vita (Quality of Life, QoL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of probable or definite ALS according to the revised El Escorial
    criteria, with bulbar onset of disease, familial or sporadic form,
    2. Onset of symptoms = 18 months prior to screening, as reported by the patient,
    3. Adult males or females, aged at least 18 years old,
    4. SVC > 60% of predicted value for age and sex,
    5. ALSFRS-R score = 36, with score 3 or 4 for item 3 (swallowing),
    6. Treatment with riluzole 100 mg/day, at stable dose since at least one month
    and well tolerated,
    7. Male or female patient of childbearing potential who agrees to use highly
    effective mechanical contraception methods (condom, sexual abstinence,
    intrauterine device, bilateral tubal occlusion, vasectomised partner)
    throughout the study, and for 3 months after the end of the treatment,
    8. Patient who read, understood and signed the informed consent form (ICF),
    9. Patient who is willing to adhere to the study visit schedule and is capable to
    understand and comply with protocol requirements.
    1. Diagnosi di SLA probabile o certa secondo i criteri El Escorial rivisti, con
    insorgenza bulbare di malattia, forma familiare o sporadica.
    2. Insorgenza dei sintomi =18 mesi prima dello screening, come riferito dal
    paziente.
    3. Soggetti adulti di sesso maschile o femminile, di almeno 18 anni di età.
    4. SVC >60% del valore previsto per età e sesso.
    5. Punteggio ALSFRS-R =36, con punteggio di 3 o 4 per la voce 3
    (deglutizione).
    6. Trattamento con riluzolo 100 mg/die, a dose stabile da almeno un mese e ben
    tollerato.
    7. Pazienti di sesso maschile o femminile in età fertile che accettano di
    utilizzare metodi contraccettivi meccanici altamente efficaci (preservativo,
    astinenza sessuale, dispositivo intrauterino, occlusione tubarica bilaterale,
    partner vasectomizzato) per tutta la durata dello studio e per 3 mesi dopo la
    fine del trattamento.
    8. Pazienti che hanno letto, compreso e firmato il modulo di consenso informato
    (Informed Consent Form, ICF).
    9. Pazienti disposti ad aderire al programma delle visite dello studio ed in grado
    di comprendere e rispettare i requisiti del protocollo.
    E.4Principal exclusion criteria
    1. Known other significant neurological disease(s),
    2. Serious illness(es) or medical condition(s) (e.g. unstable cardiac disease,
    cancer, hematologic disease, hepatitis or liver failure, renal failure) that is not
    stabilised or that could require hospitalisation and may jeopardise the
    participation in the study,
    3. Other causes of neuromuscular weakness,
    4. Non progressive or very rapidly progressing ALS (ALSFRS-R decline from
    disease onset to randomisation = 0.1 / month or = 1.2 / month)1,
    5. Percutaneous endoscopic gastrostomy or parenteral nutrition,
    6. Non-invasive ventilation,
    7. Tracheotomy,
    8. Weight loss = 10% compared to weight at symptoms onset as declared by the
    patient or BMI <18 kg/m2 at screening,
    9. Dementia or other severe active psychiatric illness,
    10. Patient with a significant pulmonary disorder not attributed to ALS or who
    require treatments that might complicate the evaluation of the effect of ALS
    on respiratory function,
    11. Patient using unauthorised concomitant treatments, namely moderate or
    strong inhibitors or inducers of cytochrome P450 family 1 subfamily A
    member 2 (CYP1A2). Combined oral contraceptives containing
    ethinylestradiol are forbidden concomitant medications,
    12. Smoker of > 10 cigarettes per day (e-cigarettes and nicotine patches are
    permitted),
    13. Known hypersensitivity to any of the ingredients or excipients of the
    investigational medicinal products (IMPs),
    14. Pregnant, lactating women,
    15. Patient who participated in another trial of investigational drug(s) within 30
    days prior to randomisation,
    16. Patient who has forfeited their freedom by administrative or legal award, or
    who is under guardianship or under limited judicial protection.
    1. Altra o altre malattie neurologiche note significative.
    2. Una o più malattie gravi o condizioni mediche (per es., cardiopatia instabile,
    tumori, malattia ematologica, epatite o insufficienza epatica, insufficienza
    renale) che non siano stabilizzate o che potrebbero richiedere il ricovero in
    ospedale e potrebbero mettere a rischio la partecipazione allo studio.
    3. Altre cause di debolezza neuromuscolare.
    4. SLA non progressiva o in rapida progressione (declino nella scala ALSFRS-R dall’esordio della malattia alla randomizzazione =0,1/mese o =1,2/mese)1,
    5. Gastrostomia endoscopica percutanea o nutrizione parenterale.
    6. Ventilazione non invasiva.
    7. Tracheotomia.
    8. Perdita di peso =10% rispetto al peso all’insorgenza dei sintomi come
    dichiarato dal paziente o IMC <18 kg/m2
    allo screening.
    9. Demenza o altra grave malattia psichiatrica attiva.
    10. Patologia polmonare significativa non attribuita alla SLA o che necessita di
    trattamenti che potrebbero complicare la valutazione dell’effetto della SLA
    sulla funzionalità respiratoria.
    11. Utilizzo di trattamenti concomitanti non autorizzati, vale a dire inibitori o
    induttori moderati o forti del citocromo P450 famiglia 1 sottofamiglia A
    membro 2 (CYP1A2). I contraccettivi orali combinati contenenti
    etinilestradiolo sono farmaci concomitanti vietati.
    12. Fumare >10 sigarette al giorno (sono consentite sigarette elettroniche e
    cerotti di nicotina).
    13. Ipersensibilità nota a uno qualsiasi degli ingredienti o eccipienti dei prodotti
    medicinali sperimentali (Investigational Medicinal Product, IMP).
    14. Donne in gravidanza o in allattamento.
    15. Partecipazione a un’altra sperimentazione su uno o più farmaci sperimentali
    nei 30 giorni precedenti la randomizzazione.
    16. Perdita della libertà per sentenza amministrativa o legale, o essere sotto tutela
    o sotto protezione giudiziaria limitata.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints include:
    • Incidence, grade and relationship to IFB-088 for treatment emergent AEs,
    SAEs, and AESIs,
    • AEs leading to dose interruption or premature discontinuation
    Gli endpoint di sicurezza includono:
    - Incidenza, grado e relazione con IFB-088 per EA emergenti dal trattamento,
    SAE (Serious Adverse Event [evento avverso serio]) e AESI (Adverse Event
    of Special Interest [evento avverso di particolare interesse]),
    - EA che portano all’interruzione della dose o all’interruzione prematura.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety assessments will be performed in a continuous manner during the
    6 months treatment period, and at the follow-up visit.
    Le valutazioni di sicurezza saranno eseguite in modo continuativo durante il
    Periodo di trattamento di 6 mesi e alla visita di follow-up.
    E.5.2Secondary end point(s)
    Efficacy:
    • Change in Revised ALS functional rating scale (ALSFRS-R) score from
    baseline to month 3 and to month 6,
    • Worsening according to ALS-Milano-Torino staging system (MITOS) score,
    i.e. progression to a higher stage at 3 and at 6 months compared to the
    baseline,
    • Change in King’s College score from baseline to month 3 and to month 6,
    • Assessment of respiratory function (slow vital capacity [SVC], sniff test
    [optional], arterial blood gases [ABG]): exploratory endpoint.
    PK parameters:
    • Plasma concentration of IFB-088 and IFB-139,
    • AUC of IFB-088 and IFB-139,
    • Maximum observed plasma concentration (Cmax), with associated Tmax,
    • Terminal or apparent terminal half-life (t1/2),
    • Apparent systemic clearance, apparent volume of distribution.
    Biomarkers:
    • Change in TDP-43 plasmatic concentration from baseline to 6 months,
    compared to placebo,
    • Change in neurofilament (NfL) light chain plasmatic concentration from
    baseline to 6 months, compared to placebo,
    • Change in plasmatic (neuro)inflammatory biomarkers from baseline to 3
    months, and from baseline to 6 months, compared to placebo,
    • Change in plasmatic oxidative stress biomarkers from baseline to 3 months
    and from baseline to 6 months, compared to placebo.
    QoL:
    • Change in ALS assessment questionnaire (ALSAQ-40) from baseline to 6
    months.
    Efficacia:
    - Variazione nel punteggio della scala di valutazione funzionale della SLA
    rivista (ALS Functional Rating Scale-Revised, ALSFRS-R) dal basale al
    mese 3 e al mese 6.
    - Peggioramento secondo il punteggio del sistema di stadiazione dell’ASL
    Milano-Torino (Milano-Torino Staging, MITOS), ovvero progressione a uno
    stadio più alto a 3 mesi e a 6 mesi rispetto al basale.
    - Variazione nel punteggio del King’s College dal basale al mese 3 e al mese
    6.
    - Valutazione della funzionalità respiratoria (capacità vitale lenta [Slow Vital
    Capacity, SVC], sniff test [facoltativo], emogas arterioso [Arterial Blood
    Gases, ABG]): endpoint esplorativo.
    Parametri PK:
    - Concentrazione plasmatica di IFB-088 e IFB-139.
    - Area sotto la curva (Area Under the Curve, AUC) di IFB-088 e IFB-139.
    - Concentrazione plasmatica massima osservata (Cmax), con Tmax associato.
    - Emivita terminale o terminale apparente (t1/2).
    - Clearance sistemica apparente, volume di distribuzione apparente.
    Biomarcatori:
    - Variazione della concentrazione plasmatica della proteina 43 legante il DNA
    TAR (TAR DNA-binding Protein 43, TDP-43) dal basale a 6 mesi, rispetto
    al placebo.
    - Variazione della concentrazione plasmatica del neurofilamento (NfL) a
    catena leggera dal basale a 6 mesi, rispetto al placebo.
    - Variazione dei biomarcatori (neuro)infiammatori plasmatici dal basale a 3
    mesi e dal basale a 6 mesi, rispetto al placebo.
    - Variazione dei biomarcatori dello stress ossidativo plasmatico dal basale a 3
    mesi e dal basale a 6 mesi, rispetto al placebo.
    QoL:
    - Variazione nel questionario di valutazione della SLA (ALS Assessment
    Questionnaire, ALSAQ-40) dal basale a 6 mesi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    •Change in Revised ALS functional rating scale (ALSFRS-R) score from
    baseline to month 3 and to month 6,
    •Worsening according to ALS-Milano-Torino staging system (MITOS)
    score, i.e. progression to a higher stage at 3 and at 6 months compared
    to the baseline,
    •Change in King's College score from baseline to month 3 and to month
    6,
    •Assessment of respiratory function (slow vital capacity [SVC], sniff test
    [optional], arterial blood gases [ABG]). At screening, V2 and V3.
    PK parameters at V1.
    Biomarkers changes from baseline to 3 and/or 6 months compared to
    placebo.
    QoL change in ALS assessment questionnaire (ALSAQ-40) from baseline
    to 6 months.
    Efficacia:
    •Modifica del punteggio della scala di valutazione funzionale ALS rivista (ALSFRS-R) da
    linea di base al mese 3 e al mese 6,
    • Peggioramento secondo sistema di stadiazione ALS-Milano-Torino (MITOS)
    punteggio, cioè progressione a uno stadio più alto a 3 e a 6 mesi rispetto
    alla linea di base,
    •Cambiamento nel punteggio del King's College dalla linea di base al mese 3 e al mese
    6,
    •Valutazione della funzione respiratoria (capacità vitale lenta [SVC], sniff test
    [opzionale], emogasanalisi). Allo screening, V2 e V3.
    Parametri PK a V1.
    I biomarcatori cambiano dal basale a 3 e/o 6 mesi rispetto a
    placebo.
    Modifica della qualità di vita nel questionario di valutazione della SLA (ALSAQ-40) rispetto al basale
    a 6 mesi.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    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
    LVLS
    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 months6
    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 months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-12-29. Yes
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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 medication management of the patients will be re-evaluated by the
    doctor who follows them.
    La gestione dei farmaci dei pazienti sarà rivalutata dal
    medico che li segue.
    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 Decision2022-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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