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    Summary
    EudraCT Number:2017-004072-59
    Sponsor's Protocol Code Number:1245-0167
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-14
    Trial results View 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 number2017-004072-59
    A.3Full title of the trial
    A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF) (EMPERIAL – preserved)
    Estudio de Fase III aleatorizado, doble ciego para evaluar el efecto de 12 semanas se tratamientos con Empagliflozina 10mg administrada una vez al dia, comparada con placebo, sobre la capacidad de ejercicio y los síntomas de insuficiencia cardíaca en pacientes con Insuficiencia Cardíaca Crónica y fracción de eyección preservada (HFpEF) (EMPERIAL-preserved)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study tests empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looks at how far patients can walk in 6 minutes and at their heart failure symptoms
    En este estudio se analiza la empagliflozina en pacientes con insuficiencia cardíaca crónica con fracción de eyección conservada (ICFEc). En el estudio se observan la distancia que pueden recorrer los pacientes en 6 minutos y los síntomas de la insuficiencia cardíaca.
    A.3.2Name or abbreviated title of the trial where available
    EMPERIAL - preserved
    A.4.1Sponsor's protocol code number1245-0167
    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 SponsorBoehringer-Ingelheim España, S.A.
    B.1.3.4CountrySpain
    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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+34934045100
    B.5.5Fax number+34934045580
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 JARDIANCE
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEmpagliflozin
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNEMPAGLIFLOZIN
    D.3.9.1CAS number 864070-44-0
    D.3.9.3Other descriptive nameEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Heart Failure with preserved Ejection Fraction (HFpEF)
    Insuficiencia cardíaca crónica con fracción de eyección preservada (HFpEF)
    E.1.1.1Medical condition in easily understood language
    Chronic Heart Failure with preserved Ejection Fraction (HFpEF)
    Insuficicencia cardíaca crónica con fracción de eyección preservada (HFpEF)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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 of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic heart failure (CHF) with preserved ejection fraction (LVEF > 40%).
    El objetivo primario del ensayo es evaluar el efecto de empagliflozina 10mg versus placebo en la capacidad al ejercicio usando la prueba de 6 minutos marcha (6MWT) en pacientes con insuficiencia cardíaca crónica (CHF) con fracción de eyección preservada (LVEF > 40%).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess Patient-Reported Outcome (PRO)
    Los objetivos secundarios son la evaluación de eventos reportados por el paciente (PRO)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Of full age of consent (according to local legislation, usually ≥ 18 years) at screening.
    2. Male or female patients. Women of child bearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
    3. Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial
    4. Six minute walk test (6MWT) distance ≤350 m at screening and at baseline.
    5. Patients with CHF diagnosed for at least 3 months before Visit 1, and currently in NYHA class II-IV
    6. Chronic heart failure (CHF) with preserved Ejection fraction (EF) defined as left ventricle ejection fraction(LVEF) > 40 % as per echocardiography at Visit 1 per local reading and no prior measurement of LVEF ≤ 40% under stable conditions.
    7. Elevated N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/ml for patients without atrial fibrillation (AF), OR > 600 pg/ml for patients with AF, as analysed at the Central laboratory at Visit 1
    8. Patients must have at least one of the following evidence of heart failure (HF):
    a. Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1, OR
    b. Documented Hospitalization for Heart Failure (HHF) within 12 months prior to Visit 1
    9. Patients must be on appropriate and stable dose of oral diuretics, consistent with prevailing cardiovascular (CV) guidelines for at least 2 weeks prior to Visit 1 to control symptoms.
    10. Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).
    1. En edad de consentimiento (según legislación local, normalmente ≥ 18 años) en el momento del screening.
    2. Pacientes hombres o mujeres. Las mujeres con capacidad de concebir hijos deben están listas y dispuestas a utilizar métodos anticonceptivos altamente efectivos según ICH M3 (R2) que resulten en un bajo porcentaje de fallo, menor al 1% al año, cuando se usan de forma consistente y correcta. Una lista de los métodos anticonceptivos que cumplen estos criterios se encuentra en la información al paciente.
    3. Consentimiento informado por escrito, firmado y fechado de acuerdo con ICH GCP y la legislación local antes de ser admitidos al ensayo.
    4. Distancia ≤350 m en la prueba 6MWT en visita de selección y al inicio (baseline)
    5. Pacientes con insuficiancia cardíaca crónica diagnosticada al menos 3 meses antes de la Visita 1, y actualmente en NYHA clase II-IV
    6. Insuficiencia cardíaca crónica (CHF) con fracción de eyeción preservada (EF) definido como fracción de eyección del ventrículo izquierdo (LVEF) > 40 % por ecocardiografia en la visita 1 por lectura local y sin una valoración previa de LVEF ≤ 40% en condiciones estables.
    7. Elevado péptido natriurético N-Terminal Pro-Brain (NT-proBNP) > 300 pg/ml para pacientes sin fibrilación auricular (AF), OR > 600 pg/mg para pacientes con AF, según análisis del laboratorio central en la Visita 1.
    8. Los pacientes deben tener al menos una de las siguientes evidencias de insuficiencia cardíaca (HF):
    a. Enfermedad cardíaca estructural (dilatación auricular izquierda y/o hipertrofia ventricular izquierda) documentada por ecocardiograma en la Visita 1, O
    b. Hospitalización documentada for insuficiencia cardíaca (HHF) en los 12 meses previos a la visita 1
    9. Los pacientes deben estar tratados con una dosis apropiada y estable de diuréticos orales, consistente con las guías cardiovasculares (CV) en vigor durante al menos 2 semanas antes de la visita 1, para controlar los síntomas
    10. Clinicamente estable en la aleatorización sin signos de descompensación de la insuficicnecia cardíaca (según evaluación del investigador).
    E.4Principal exclusion criteria
    1. Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or transient ischemic attack in past 90 days prior to Visit 1
    2. Acute decompensated HF (exacerbation of CHF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
    3. Previous or current participation in another Empaglifozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0168)
    4. Type 1 Diabetes Mellitus (T1DM)
    5. Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
    6. Symptomatic hypotension or a systolic blood pressure (SBP) < 100 mmHg at Visit 1 or 2
    7. SBP ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2
    8. Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 1 (Screening)
    9. Unstable angina pectoris in past 30 days prior to Visit 1
    10. Largest distance walked in 6 minutes (6MWTD) at baseline <100m.
    11. Any presence of condition that precludes exercise testing such as:
    -claudication,
    -uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
    -significant musculoskeletal disease,
    -primary pulmonary hypertension,
    -severe obesity (body mass index ≥40.0 kg/m2),
    -orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
    -amputation with artificial limb without stable prosthesis function for the past 3 months
    -Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWT
    12. Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
    13. ICD implantation within 1 month prior to Visit 1 or planned during the course of the trial
    14. Implanted cardiac resynchronisation therapy (CRT)
    15. Treatment with i.v. iron therapy or erythropoietin (EPO) within 3 months prior to screening.
    16. Further exclusion criteria applies
    1. Infarto de miocardio (aumento en las enzimas cardíacas en combinación con síntomas de isquemia o cambios isquémicos de ECG desarrollados recientemente), cirugia de bypass arteriocoronario u otra cirugía cardiovascular mayor, accidente cerebrovascular, o ataque isquémico transitorio en los últimos 90 días anteriores a la Visita 1.
    2. Insuficiencia cardíaca aguda descompensada (exacerbación de la insuficiencia cardíaca crónica) que requiera diuréticos intravenosos (i.v.), inotrópicos i.v. o vasodilatadores i.v., o dispositivo de asistencia ventricular izquierda en las 4 semanas previas a la visita 1, y/o durante el período de selección hasta la visita 2
    3. Participación actual o previa en otro ensayo de Empagliflozina para insuficiencia cardíaca (es decir: ensayos 1245.110, 1245.121, 1245.168)
    4. Diabetes Mellitus tipo 1 (DM1)
    5. Isuficiencia renal, definida como eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) o que requiera dialisis, según se determine en la visita 1
    6. Hipotensión sintomática o presión arterial sistólica (SBP)< 100mmHg en la visita 1 o 2
    7. SBP ≥ 180 mmHg en la visita 1 o 2, o SBP >160mmHg en las visitas 1 y 2
    8. Fibrilación auricular o flutter auricular con una frecuencia cardíaca en reposo > 110 bpm documentado por ECG en la visita 1 (Screening)
    9. Angina de pecho inestable en los 30 dias antes de la visita 1
    10. Distancia más larga recorrida en la prueba de 6 minutos marcha (6MWT) <100m en la basal.
    11. Presencia de cualquier condición que excluya el test del ejercicio como:
    - claudicación,
    - bradiarritmia o taquiarritmia no controladas (según criterio del investigador),
    - enfermedad musculo-esquelética significativa,
    - hipertensión pulmonar primaria,
    - obesidad severa (índice de massa corporal ≥40.0 kg/m2),
    - condiciones ortopédicas que limiten la capacidad de andar (como artritis en la pierna, rodilla o lesiones de cadera),
    - amputación con miembro artificial sin función estable de la prótesis en los últimos 3 meses
    - cualquier condición que en opinión del investigador pudiera contraindicar la evaluación del 6MWT
    12. Pacientes en un programa estructurado de entrenamiento (según evaluación del investigador) en 1 mes antes del período de selección o que planifiquen comenzar uno durante el curso de este ensayo.
    13.implantación de ICDen un mes antes de la visita 1 o planificado durnate el curso del ensayo
    14. Terapia de resincronización cardíaca (CRT) implantada
    15. Tratamiento con terapia con hierro o eritropoyetina (EPO) i.v. en los 3 meses anteriores al período de selección
    16. Se aplican otros criterios de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    1. The primary endpoint is the change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions
    1. La variable principal es el cambio desde el momento basal hasta la semana 12 en la capacidad de ejercicio, medido como la distancia recorrida en 6 minutos en condiciones estandarizadas
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 0 and Week 12
    1. Semana 0 y semana 12
    E.5.2Secondary end point(s)
    1. Change from baseline to week 12 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS)
    2. Change from baseline to week 12 in Chronic Heart Failure Questionnaire Self- Administered Standardized format (CHQ-SAS) dyspnea score
    3. Change from baseline to week 6 in exercise capacity as measured by the distance walked in 6 minutes
    4. Change from baseline in Clinical Congestion Score at week 12
    5. Change from baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at week 12
    6. Change from baseline in Patient Global Impression of Dyspnea Severity at week 12
    7. Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at week 12
    8. Patient Global Impression of Change in Dyspnea at week 12
    9. Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) at week 12
    1. Cambio desde el moemnto basal hasta la semana 12 en el Cuestionario de cardiomiopatía de Kansas City (KCCQ) Puntuación total de síntomas (TSS)
    2. Cambio desde el momento basal hasta la semana 12 en el Cuestionario de insuficiencia cardíaca crónica Cuestionario estandarizado de disnea autoadministrado (CHQ-SAS)
    3. Cambio en la capacidad de ejercicio medido como distancia recorrida en 6 minutos desde el momento basal hasta la semana 6
    4. Cambio en la puntuación en congestión clínica desde el momento basal hasta la semana 12
    5. Cambio desde el moemnto basal hasta la semana 12 en la Impresión Global de Gravedad del paciente sobre los síntomas de insuficiencia cardíaca
    6. Cambio desde el imomento basal hasta la semana 12 en la impresión global del paciente de la gravedadde la disnea
    7. Impresión global del paciente de cambio en síntomas de insuficiencia cardíaca a la semana 12
    8. Impresión global del paciente de cambio en disnea a la semana 12
    9. Cambio desde el momento basal hasta la semana 12 en la fracción N-terminal del pro-péptido natriurético cerebral de tipo B
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 0 and Week 12
    2. Week 0 and Week 12
    3. Week 0 and Week 6
    4. Week 0 and Week 12
    5. Week 0 and Week 12
    6. Week 0 and Week 12
    7. Week 12
    8. Week 12
    9. Week 0 and Week 12
    1. Semana 0 y semana 12
    2. Semana 0 y semana 12
    3. Semana 0 y semana 6
    4. Semana 0 y semana 12
    5. Semana 0 y semana 12
    6. Semana 0 y semana 12
    7. Semana 12
    8. Semana 12
    9. Semana 0 y semana 12
    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 No
    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 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 EEA41
    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
    Canada
    Germany
    Greece
    Italy
    Poland
    Portugal
    Spain
    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
    Última visita del último paciente
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 300
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 218
    F.4.2.2In the whole clinical trial 300
    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)
    Patients will be offered standard medical care
    Se ofrecerá a los pacientes el cuidado médico estándar
    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 Decision2018-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-09
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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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