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    Summary
    EudraCT Number:2017-000421-13
    Sponsor's Protocol Code Number:NL60229.078.17
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-06
    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 number2017-000421-13
    A.3Full title of the trial
    Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial
    Neonati con Ernia Diaframmatica Congenita: Ossido di Azoto per via inalatoria versus Sildenafil endovena: studio internazionale randomizzato controllato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Newborns with Congenital diaphragmatic hernia; iNO versus sildenafil
    Neonati con Ernia Diaframmatica Congenita: Ossido di Azoto versus Sildenafil endovena
    A.3.2Name or abbreviated title of the trial where available
    CoDiNOS Trial
    CoDiNOS Trial
    A.4.1Sponsor's protocol code numberNL60229.078.17
    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 SponsorERASMUS MEDICAL CENTER
    B.1.3.4CountryNetherlands
    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 supportCDH UK Sparks
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointproject leader
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CN
    B.5.3.4CountryNetherlands
    B.5.4Telephone number7030117
    B.5.5Fax number7036288
    B.5.6E-mails.denotter@erasmusmc.nl
    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.2.1.1.1Trade name REVATIO - 0.8 MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 1 FLACONCINO DA 20 ML
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LIMITED
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/815
    D.3 Description of the IMP
    D.3.1Product nameSildenafil
    D.3.2Product code [na]
    D.3.4Pharmaceutical form 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 INNSildenafil
    D.3.9.2Current sponsor codena
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 INALOSSIN - 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO BOMBOLA IN ALLUMINIO CON VALVOLA VI DA 20 LITRI
    D.2.1.1.2Name of the Marketing Authorisation holderSOCIETA' ITALIANA ACETILENE e DERIVATI "S.I.A.D." 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 nameINALOSSIN 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOSSIDO DI AZOTO
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameNitric oxide
    D.3.10 Strength
    D.3.10.1Concentration unit PPM part per million
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Congenital diaphragmatic hernia with pulmonary hypertension
    Ernia diaframmatica congenita isolata e ipertensione polmonare.
    E.1.1.1Medical condition in easily understood language
    Congenital diaphragmatic hernia with pulmonary hypertension
    Ernia diaframmatica congenita isolata e ipertensione polmonare.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine if there is a difference in OI after 12 hours after the initiation of the study drug in CDH patients, treated either with iNO or with intravenous sildenafil.
    L'obiettivo principale di questo studio è determinare se c'è una differenza nell'OI dopo 12 ore dall'inizio del farmaco in studio nei pazienti con CDH, trattati con iNO o con sildenafil per via endovenosa.
    E.2.2Secondary objectives of the trial
    • To compare the incidence of pulmonary hypertension in the absence of pulmonary vasodilator therapy and study treatment failure on day 14 on echocardiography and/or death within the first 28 days of life To compare overall mortality
    • To compare the incidence of treatment failure
    • To compare the time on intervention drug
    • To compare the need for ECMO
    • To compare the number of ventilator free days on day 28
    • To compare the vasoactive-inotropic support score before and after starting the intervention drug
    • To compare laboratory markers for pulmonary vascular endothelial damage and pulmonary hypertension
    • To compare the use of other medication given for pulmonary hypertension
    • To compare the use of pulmonary and/or cardiac medication after discharge
    • To compare the incidence of long-term pulmonary hypertension at the age of 6 and 12 months
    • To compare the incidence of chronic lung disease
    • To compare the incidence of neurological abnormalities
    • Confrontare l'incidenza di ipertensione polmonare in assenza di terapia vasodilatatrice polmonare e fallimento del trattamento in studio al giorno 14 all'eco e/o morte entro i primi 28 giorni di vita Confrontare la mortalità complessiva
    • Confrontare l'incidenza del fallimento del trattamento
    • Confrontare il tempo sul farmaco di intervento
    • Confrontare la necessità di ECMO
    • Confrontare il numero di giorni senza ventilatore il giorno 28
    • Confrontare il punteggio di supporto vasoattivo-inotropo prima e dopo l'inizio del farmaco di intervento
    • Confrontare i marker di laboratorio per il danno endoteliale vascolare polmonare e l'ipertensione polmonare
    • Confrontare l'uso di altri farmaci somministrati per l'ipertensione polmonare
    • Confrontare l'uso di farmaci polmonari e/o cardiaci dopo la dimissione
    • Confrontare l'incidenza della malattia a lungo termine a 6 e 12 mesi
    • Confrontare l'incidenza della malattia polmonare cronica
    • Confrontare l'incidenza di anomalie neurologiche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria in the first week of life:
    1) Diagnosis of CDH and pulmonary hypertension defined as 2 of the following 4 criteria:
    I. Systolic PAP> 2/3 systemic systolic pressure estimated by echocardiography
    II. RV dilatation/septal displacement, RV dysfunction +/- LV dysfunction
    III. Pre-post ductal SpO2 difference > 10%
    IV. OI>20.
    2) Parental informed consent
    3) Children born at or after a gestational age of 34 weeks
    4) Newborns who received a foetal intervention may be included
    Per poter partecipare a questo studio, un soggetto deve soddisfare tutti i seguenti criteri nella prima settimana di vita:
    1) Neonati con ernia diaframmatica congenita isolata e ipertensione polmonare definita come 2 dei seguenti 4 criteri:
    • Pressione sistolica in arteria polmonare > 2/3 della pressione sistolica sistemica stimata ecocardiograficamente
    • Dilatazione del ventricolo destro, alterazioni del setto interventricolari, disfunsione del ventricolo destro e/o sinistro.
    • Saturazione pre e post duttale differenziale > 10%
    • Indice di ossigenazione >20
    2) consenso dei genitori ottenuto
    3) età gestazionale = 34 settimane
    4) neonati che hanno effettuato terapia fetale (plug)
    E.4Principal exclusion criteria
    - Severe chromosomal anomaly, like trisomy 18 or trisomy 13, which may imply a decision to stop or not to start life-saving medical treatment
    - Severe cardiac anomaly, expected to need corrective surgery in the first 60 days of life (such as transposition of the great arteries, truncus arteriosus, coarctation aortae or double outlet right ventricle)
    - Renal anomalies associated with oligohydramnios
    - Severe orthopaedic and skeletal deformities, which are likely to influence thoracic, and / or lung development (such as chest wall deformities and spine anomalies)
    - Severe anomalies of the central nervous system
    - Patients born in another centre, transported with iNO
    - Exclusion criteria as defined in paragraph 4.3 of the SPC of sildenafil and paragraph 4.3 of iNO. For infants the relevant exclusion criteria are severe hepatic failure, allergy for components of the elements used in sildenafil, the use of strong CYP3A4-inhibitors such as intraconazol and the presence of a severe intracardiac shunt.
    • Anomalie cromosomiche maggiori
    • Anomalie cardiache severe che necessitano correzione entro i primi 60 giorni di vita
    • Anomalie renali con oligoidramnios
    • Deformità scheletriche severe che influenzano lo sviluppo toracico e polmonare
    • Anomalie severe del sistema nervoso centrale
    • Pazienti nati in altri centri e già trattati con iNO
    • Criteri di esclusione come definiti al paragrafo 4.3 del RCP del sildenafil e al paragrafo 4.3 della iNO. Per i lattanti i criteri di esclusione rilevanti sono l'insufficienza epatica grave, l'allergia ai componenti degli elementi utilizzati nel sildenafil, l'uso di potenti inibitori del CYP3A4 come l'intraconazolo e la presenza di uno shunt intracardiaco grave.
    E.5 End points
    E.5.1Primary end point(s)
    Change in oxygenation index 12 hours after initiation of treatment in CDH patients, treated either with iNO or with intravenous sildenafil.
    Differenza nell'OI dopo 12 ore di trattamento tra i pazienti affetti da CDH trattati con iNO rispetto a quelli trattati con sildenafil per via endovenosa
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 hours after initiation of treatment
    12 ore dopo l’inizio del trattamento
    E.5.2Secondary end point(s)
    • Overall mortality in the first year of life
    • Requirement of ECMO (only for ECMO centres)
    • Treatment failure (see paragraph 8.3, failure criteria)
    • Severity and presence of pulmonary hypertension on day 1 and/or just before starting the study drug, after 24 hours, on day 14, on day 28 or at discharge (whatever comes first), at 6 months and 1 year according to the following echocardiographic parameters as described by the cardiologist: systolic PAP < or > 2/3 systemic systolic pressure, RV dilatation/septal displacement, RV dysfunction +/- LV dysfunction. (see Case Record Form)
    • Number ventilator free days on day 28 (deaths are counted as worst outcome)
    • Number of intervention therapy free days on day 14
    Fraction of days requiring treatment for pulmonary hypertension during the hospital admission, described as the use of iNO, sildenafil, prostanoids, endothelin 1 antagonists, and/or other medication for pulmonary hypertension
    • The level of specific laboratory markers and urine, up to day 28, to describe the severity and presence of pulmonary hypertension.
    • Vasoactive-inotropic support score before and 12 hours after starting study medication. This score is calculated with: (dopamine (mcg/kg/min) + dobutamine (mcg/kg/min) + 100x adrenaline (mcg/kg/min) + 10x milrinone (mcg/kg/min) + 10.000x vasopressin (U/kg/min) + 100x noradrenaline (mcg/kg/min)) (45)
    • Requirement of PH medication, described as oral sildenafil, bosentan and/or a prostanoid at discharge and/or during the first year of life.
    • Severity of chronic lung disease using need for supplemental oxygen on day 28 and 56.
    • Long-term pulmonary hypertension using echocardiography at the age of 6 and 12 months.
    • The development of neurological abnormalities evaluated with an ultrasound of the brain before start of intervention drug, after surgery and before discharge.
    • External validation of sildenafil PKPD mode
    - Mortalità complessiva nel primo anno di vita
    - Necessità di ECMO (solo per i centri ECMO)
    - Incidenza di fallimento del trattamento (vd par. 8.3)
    - Gravità e presenza di ipertensione polmonare al giorno 1 e / o appena prima di iniziare il farmaco in studio, dopo 24 ore, il giorno 14, il giorno 28 o alla dimissione, a 6 mesi e 1 anno secondo i parametri ecocardiografici descritti dal cardiologo (vd CRF)
    - Giorni senza ventilatore il giorno 28
    - Giorni senza terapia d’intervento il giorno 14
    - Trattamento con farmaci somministrati per l’ipertensione polmonare durante il ricovero ospedaliero
    - Livello di specifici marcatori di laboratorio e urine, fino al giorno 28, a descrivere la gravità e la presenza di ipertensione polmonare
    - Punteggio di supporto vasoattivo-inotropo prima e 12 ore dopo l’inizio del farmaco in studio
    - Necessità di farmaci alla dimissione e/o nel primo anno di vita
    - Gravità della malattia polmonare cronica con necessità di ossigeno supplementare nei giorni 28 e 56
    - Ipertensione polmonare a lungo termine all’ecocardiografia a 6 e 12 mesi
    - Sviluppo di anomalie neurologiche
    - Validazione di sildenafil
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 24 hours
    day of surgery and day after surgery
    day of starting ECMO and day after ECMO
    day 14 and day 28 or at discharge (whichever comes first)
    day 56
    6 and 12 months
    12 e 24 ore
    giorno dell'intervento e giorno dopo l'intervento
    giorno di inizio ECMO e giorno dopo ECMO
    giorno 14 e giorno 28 o alla dimissione (a seconda del caso che si verifica per
    primo)
    giorno 56
    6 e 12 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    ossido nitrico inalato
    inhaled nitric oxide gas
    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 concerned2
    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 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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 30
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 300
    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) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    As the patients are newborns, parents will be asked for informed consent
    Neonati
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 330
    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)
    If pulmonary hypertension still exists on day 14, study therapy can be changed to other
    pulmonary hypertension treatment, for instance sildenafil orally. After day 14 treatment
    of pulmonary hypertension will be at the discretion of the local treatment team.
    Se l'ipertensione polmonare esiste ancora il giorno 14, la terapia di studio può essere
    modificata ad altri trattamenti di ipertensione polmonare, ad esempio il sildenafil per
    via orale. Dopo il giorno 14 il trattamento dell'ipertensione polmonare sarà a
    discrezione del team di trattamento locale.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CDH Euroconsortium
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-06-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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