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    Summary
    EudraCT Number:2021-005881-17
    Sponsor's Protocol Code Number:RIN-PF-303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-005881-17
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON-2)
    Estudio de fase 3, multinacional, aleatorizado, doble ciego y controlado con placebo de la eficacia y la seguridad de treprostinil inhalado en sujetos con fibrosis pulmonar idiopática (TETON-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy and safety of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis
    Estudio para evaluar la eficacia y la seguridad de treprostinil inhalado en sujetos con fibrosis pulmonar idiopática
    A.4.1Sponsor's protocol code numberRIN-PF-303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05255991
    A.5.4Other Identifiers
    Name:INDNumber:149587
    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 SponsorUNITED THERAPEUTICS CORPORATION
    B.1.3.4CountryUnited States
    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 supportUNITED THERAPEUTICS CORPORATION
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnited Therapeutics Corporation
    B.5.2Functional name of contact pointRegulatory Department
    B.5.3 Address:
    B.5.3.1Street Address55 T.W. Alexander Drive, PO Box 14186
    B.5.3.2Town/ cityNC
    B.5.3.3Post code27709
    B.5.3.4CountryUnited States
    B.5.4Telephone number34900834223
    B.5.5Fax numberNA
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 Yes
    D.2.1.1.1Trade name TYVASO® (treprostinil) inhalation solution, for oral inhalation use
    D.2.1.1.2Name of the Marketing Authorisation holderUnited Therapeutics Corp.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/22/2588
    D.3 Description of the IMP
    D.3.1Product nameTreprostinil
    D.3.4Pharmaceutical form Nebulisation solution
    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 INNTreprostinil
    D.3.9.1CAS number 81846-19-7
    D.3.9.4EV Substance CodeSUB21168
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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 Yes
    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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis
    Fibrosis pulmonar idiopática
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis
    Fibrosis pulmonar idiopática
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    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 the study is to evaluate the safety and efficacy of inhaled treprostinil in subjects with IPF.
    El objetivo principal del estudio consiste en evaluar la seguridad y la eficacia de treprostinil inhalado en sujetos con FPI.
    E.2.2Secondary objectives of the trial
    Not Applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject gives voluntary informed consent to participate in the study.
    2. Subject is ≥40 years of age, inclusive, at the time of signing informed consent.
    3. The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of HRCT (performed within the previous 12 months) and if available, surgical lung biopsy. HRCT imaging must be "consistent with UIP", defined as meeting either criteria A, B, and C; or criteria A and C; or criteria B and C below:
    a. Subpleural and basal predominant honeycombing
    b. Subpleural and basal predominant reticular pattern with peripheral traction bronchiectasis or traction bronchiolectasis
    c. Absence of atypical features (eg, predominant ground-glass opacity, nodules, consolidation, etc). If ground-glass opacity is present, it must be less than the accompanying reticular pattern.
    Subjects with HRCT features deemed indeterminate for IPF (subpleural and basal predominant, subtle, reticulating pattern of fibrosis) may be considered for inclusion if coupled with a histopathological pattern of "UIP" or "probable UIP" on surgical lung biopsy and confirmed by central review.
    4. FVC ≥45% predicted at Screening.
    5. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ≥30 days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not permitted.
    6. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will do 1 of the following:
    a. Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
    b. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
    i. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide.
    Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as
    amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential.
    7. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
    8. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
    1. Consentimiento informado otorgado voluntariamente por el sujeto para participar en el estudio.
    2. Edad mínima de 40 años en el momento de firmar el consentimiento informado.
    3. Diagnóstico de FPI según las directrices de práctica clínica de la ATS/ERS/JRS/ALAT de 2018 (Raghu 2018) y confirmado mediante una evaluación centralizada de una TCAR (realizada en los 12 meses previos) y, si está disponible, de una biopsia pulmonar quirúrgica. Las imágenes de TCAR deben ser "compatibles con neumonía intersticial usual (NIU)", definida como el cumplimiento de los criterios A, B y C, los criterios A y C o los criterios B y C siguientes:
    a. Patrón en panal de predominio subpleural y basal.
    b. Patrón reticular de predominio subpleural y basal con bronquiectasias por tracción o bronquiolectasias por tracción periféricas.
    c. Ausencia de características atípicas (p. ej., opacidad predominante en vidrio esmerilado, nódulos, consolidación, etc). En caso de haber opacidad en vidrio esmerilado, ha de ser menor que el patrón reticular acompañante.
    Podrá considerarse la inclusión de sujetos con características de TCAR que se consideren indeterminadas en cuanto a FPI (predominio subpleural y basal, patrón reticular sutil de fibrosis) en caso de combinarse con un patrón histopatológico de "NIU" o "NIU probable" en la biopsia pulmonar quirúrgica y de confirmarse mediante una evaluación centralizada.
    4. FVC ≥45% del valor teórico en la visita de selección.
    5. Los sujetos tratados con pirfenidona o nintedanib deberán haber recibido una dosis estable y optimizada durante ≥30 días antes del momento basal. No se permite el uso concomitante de pirfenidona ni nintedanib.
    6. Las mujeres en edad fértil no podrán estar embarazadas (confirmado mediante una prueba de embarazo en orina en las visitas de selección y basal) ni en período de lactancia y deberán cumplir una de las condiciones siguientes:
    a. Abstenerse de mantener relaciones sexuales (cuando sea acorde con su modo de vida preferido y habitual).
    b. Utilizar dos métodos anticonceptivos muy eficaces y médicamente aceptables durante todo el estudio y hasta al menos 30 días después de suspender el fármaco del estudio.
    i. Se consideran métodos anticonceptivos muy eficaces y médicamente aceptables los anticonceptivos hormonales aprobados (orales, inyectables e implantables) y los métodos de barrera (como preservativo o diafragma) cuando se utilizan junto con un espermicida.
    Las mujeres esterilizadas con éxito (histerectomía, salpingectomía bilateral u ovariectomía bilateral) o posmenopáusicas (definido como la presencia de amenorrea durante al menos 12 meses consecutivos) no se consideran en edad fértil.
    7. Los varones con una pareja en edad fértil deberán utilizar preservativo durante todo el tratamiento y hasta al menos 48 horas después de suspender el fármaco del estudio.
    8. En opinión del investigador, el sujeto es capaz de comunicarse eficazmente con el personal del estudio y se le considera fiable, está dispuesto y es probable que coopere con los requisitos del protocolo, incluida la asistencia a todas las visitas del estudio.
    E.4Principal exclusion criteria
    1. Subject is pregnant or lactating
    2. Subject has primary obstructive airway physiology: FEV1/FVC <0.70 at Screening.
    3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
    4. The subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours of any study-related efficacy assessments.
    5. Use of any of the following medications:
    a. Azathioprine (AZA), cyclosporine, mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) >20 mg/day or the combination of
    OCS+AZA+N-acetylcysteine within 30 days prior to Baseline.
    b. Cyclophosphamide within 60 days prior to Baseline
    c. Rituximab within 6 months prior to Baseline
    6. The subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
    7. Exacerbation of IPF or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of IPF or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to
    Baseline to be eligible.
    8. Uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
    9. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.
    10. Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible.
    11. Life expectancy <6 months due to IPF or a concomitant illness.
    12. Acute pulmonary embolism within 90 days prior to Baseline
    1. Mujer embarazada o en período de lactancia.
    2. Fisiología obstructiva primaria de las vías respiratorias: FEV1/FVC < 0,70 en la visita de selección.
    3. Intolerancia o falta significativa de eficacia a una prostaciclina o un análogo de la prostaciclina que motivó su suspensión o incapacidad para ajustar eficazmente dicho tratamiento.
    4. Recepción de cualquier tratamiento aprobado contra la HAP, entre ellos, tratamiento con prostaciclina (epoprostenol, treprostinil, iloprost o beraprost; excepto para una prueba de vasorreactividad aguda), agonistas de los receptores IP (selexipag), antagonistas de los receptores de la endotelina, inhibidores de la fosfodiesterasa de tipo 5 (PDE5) o estimuladores de la guanilato ciclasa soluble, en los 60 días previos al momento basal. Se permite el uso a demanda de un inhibidor de la PDE5 por disfunción eréctil, siempre que no se tomen dosis en las 48 horas previas a una evaluación de la eficacia relacionada con el estudio.
    5. Uso de alguno de los medicamentos siguientes:
    a. Azatioprina (AZA), ciclosporina, micofenolato mofetilo, tacrólimus, corticosteroides orales (CO) >20 mg/día o la combinación de CO+AZA+N acetilcisteína en los 30 días previos al momento basal.
    b. Ciclofosfamida en los 60 días previos al momento basal.
    c. Rituximab en los 6 meses previos al momento basal.
    6. Recepción de oxigenoterapia >10 l/min por cualquier modo de administración, en reposo, en el momento basal.
    7. Reagudización de la FPI o infección pulmonar o de las vías respiratorias superiores activa en los 30 días previos al momento basal. Para poder participar, los sujetos deberán haber completado cualquier pauta de antibióticos o corticosteroides para tratar la infección o reagudización más de 30 días antes del momento basal. En caso de hospitalización por una reagudización de la FPI o una infección pulmonar o de las vías respiratorias superiores, para poder participar, los sujetos deberán haber recibido el alta más de 90 días antes del momento basal.
    8. Cardiopatía no controlada, definida como infarto de miocardio en los 6 meses previos al momento basal o angina de pecho inestable en los 30 días previos al momento basal.
    9. En opinión del investigador, el sujeto presenta cualquier proceso que podría dificultar la interpretación de las evaluaciones del estudio o afectar a su participación o cooperación.
    10. Uso de cualquier otro fármaco o dispositivo experimental o participación en cualquier estudio de investigación en el que el sujeto haya recibido una intervención médica (es decir, procedimiento, dispositivo o medicación/suplemento) en los 30 días previos a la selección. Podrán participar sujetos que estén participando en estudios no intervencionistas, observacionales o de registro.
    11. Esperanza de vida inferior a 6 meses por la FPI o por una enfermedad concomitante.
    12. Embolia pulmonar aguda en los 90 días previos al momento basal.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of the study is the change in absolute forced vital capacity (FVC) in subjects with IPF from baseline to Week 52.
    El criterio de valoración principal del estudio es la variación de la capacidad vital forzada (FVC) absoluta entre el momento basal y la semana 52 en sujetos con FPI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 52.
    Desde el momento basal a la semana 52
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints of the study are:
    • Time to clinical worsening (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC)
    • Time to first acute exacerbation of IPF
    • Overall survival at Week 52
    • Change from baseline in % predicted FVC at Week 52
    • Change from baseline in King’s Brief Interstitial Lung Disease Questionnaire (K-BILD) score at Week 52
    Los criterios de valoración secundarios del estudio son:
    • Tiempo hasta el empeoramiento clínico (incluido el tiempo hasta la muerte, la hospitalización por causas respiratorias o una disminución relativa ≥10% del porcentaje de FVC del valor teórico).
    • Tiempo hasta la primera reagudización de la FPI.
    • Supervivencia global en la semana 52.
    • Variación del porcentaje de FVC del valor teórico entre el momento basal y la semana 52.
    • Variación de la puntuación del Cuestionario breve sobre la neumopatía intersticial de King (K-BILD) entre el momento basal y la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Week 52.
    Desde el momento basal a la semana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Argentina
    Australia
    Chile
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Taiwan
    France
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    Denmark
    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
    Last Patient Last Visit
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days19
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 376
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 396
    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)
    Subjects who complete the Week 52 Visit may be offered the opportunity to enter an OLE study after completing the final study visit.
    A los pacientes que completen la visita de la semana 52, despues de completar la visita final del estudio, se les ofrecerá la oportunidad de entrar en un estudio abierto de extensión
    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 Decision2022-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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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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