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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-003759-40
    Sponsor's Protocol Code Number:CKJX839A12402
    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:2021-12-28
    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 number2021-003759-40
    A.3Full title of the trial
    Efficacy, safety, tolerability and quality of life of ongoing individually optimized  lipid-lowering therapy with or without inclisiran (KJX839) – a randomized, placebo-controlled, double-blind multicenter phase IV study in participants with hypercholesterolemia
    Estudio de fase IV, multicéntrico, aleatorizado, doble ciego y controlado con placebo de la eficacia, seguridad, tolerabilidad y calidad de vida de un tratamiento en curso hipolipemiante, optimizado individualmente, con o sin inclisirán (KJX839), en participantes con hipercolesterolemia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to understand if inclisiran is better than a placebo at lowering LDL-cholesterol, is safe and can have an impact on patient quality of life, when given along with other lipid lowering medications.
    Estudio para comprender si el inclisiran es mejor que un placebo para reducir el colesterol LDL, es seguro y puede tener un impacto en la calidad de vida del paciente, cuando se administra junto con otros medicamentos para reducir los lípidos.
    A.4.1Sponsor's protocol code numberCKJX839A12402
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34930353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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.2.1.2Country 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 nameInclisiran
    D.3.2Product code KJX839
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINCLISIRAN
    D.3.9.1CAS number 1639324-58-5
    D.3.9.2Current sponsor codeKJX839
    D.3.9.3Other descriptive nameInclisiran sodium
    D.3.9.4EV Substance CodeSUB182427
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypercholesterolemia
    Hipercolesterolemia
    E.1.1.1Medical condition in easily understood language
    Hypercholesterolemia, specifically elevated low density lipoprotein cholesterol (LDL-C), is one of the major risk factors for the development of coronary heart disease (CHD)
    La hipercolesterolemia,específicamente elevados niveles de colesterol de lipoproteínas de baja densidad (LDL-C),es uno de los principales factores de riesgo para el desarrollo de enfermedad coronaria
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Inclisiran, on top of ongoing individually optimized LLT, compared to placebo, on top of ongoing individually optimized LLT, on reaching a participant's individual LDL-C target as defined in 2019 ESC/EAS guidelines for the management of dyslipidemias (Mach et al 2020)
    Superioridad de inclisirán comparado con placebo, ambos en combinación con un tratamiento en curso hipolipemiante (THL), optimizado individualmente, en alcanzar el objetivo de C-LDL del participante conforme a las guías de la ESC/EAS de 2019 para el control de las dislipidemias (Mach et al., 2020)
    E.2.2Secondary objectives of the trial
    Inclisiran, on top of ongoing individually optimized LLT, compared to placebo, on top of ongoing individually optimized LLT, on:
    •Reducing mean LDL-C levels over the double-blind study period.
    •Muscle-related adverse events.
    •Annualized number of days pain is experienced using a pain diary.
    •Pain-related quality of life at day 360 using the Short-Form Brief Pain Inventory (SF-BPI).
    Demostrar la superioridad de inclisirán en combinación con un THL en curso optimizado individualmente comparado con placebo en combinación con un THL en curso optimizado individualmente con respecto a:
    •La reducción de los niveles medios de C-LDL durante el periodo doble ciego del estudio.
    • Los acontecimientos adversos musculares.
    • El número de días al año que se sufre dolor, utilizando un diario del dolor.
    • La calidad de vida relacionada con el dolor el día 360 mediante el Short-Form Brief Pain Inventory (SF-BPI).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female participants >/= 18 years of age.
    • Participants meeting one of the following CV category:
    • Very high risk participants with the following:
    -Documented Atherosclerotic cardiovascular disease (ASCVD)
    i. Acute coronary syndrome: Unstable angina or myocardial infarction.
    ii. Stable angina.
    iii. Coronary revascularization.
    iv. Unequivocally documented ASCVD upon prior imaging.
    v. Stroke and TIA.
    vi. Peripheral artery disease (PAD).
    - Diabetes mellitus (DM) with target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), or at least >/= 3 major risk factors, or early onset of Type 1 DM of long duration (> 20 years).
    - A calculated SCORE2 >/= 7.5% for age < 50 years; SCORE2 >/= 10% for age 50-69 years; SCORE2-OP >/= 15% for age >/= 70 years to estimate 10-year risk of fatal and non-fatal cardiovascular disease (CVD).
    - Pre-existing diagnosis of heterozygous familial hypercholesterolemia (HeFH) with ASCVD or with another major risk factor.

    • High risk participants with the following:
    - Markedly elevated single risk factors, in particular total cholesterol > 8mmol/L (>310 mg/dL), LDL-C > 4.9 mmol/dL (> 190 mg/dL), or blood pressure >/= 180/110 mmHg
    - Pre-existing diagnosis of HeFH without other major risk factors.
    - Diabetes Mellitus (DM) without target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), with DM duration >/= 10 years or other additional risk factor.
    - Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2).
    - A calculated SCORE2 2.5 to <7.5% for age < 50 years, SCORE2 5 to < 10% for age 50-69 years; SCORE2-OP 7.5 to < 15% for age >/= 70 years to estimate 10-year risk of fatal and non-fatal CVD.

    • LDL-C levels at screening and baseline:
    - in participants with very high cardiovascular risk: serum LDL-C >/= 1.4 mmol/l (>/= 55 mg/dL).
    - in participants with high cardiovascular risk: serum LDL-C >/= 1.8 mmol/l (>/= 70 mg/dL).
    • Participant on a stable dose of a statin for >/= 30 days at screening.
    • Participants on the individual MTD of statin for >/= 30 days at baseline.
    • Fasting triglyceride < 400 mg/dL (< 4.52 mmol/L) at screening and baseline.
    • Participantes de ambos sexos >/= 18 años de edad.
    • Participantes que cumplan una de las siguientes categorías cardiovasculares:
    • Participantes de riesgo muy alto con lo siguiente:
    - Enfermedad cardiovascular aterosclerótica (ECA) documentada.
    i. Síndrome coronario agudo: angina inestable o infarto de miocardio.
    ii. Angina estable.
    iii. Revascularización coronaria.
    iv. ECA inequívocamente documentada con imágenes anteriores.
    v. Ictus y AIT.
    vi. Enfermedad arterial periférica (EAP).
    - Diabetes mellitus (DM) con daño en un órgano diana (como microalbuminuria, retinopatía o neuropatía), o al menos ≥ 3 factores de riesgo significativo, o aparición temprana de DM de tipo 1 de larga duración (> 20 años).
    - SCORE2 >/= 7,5 % para aquellos < 50 años de edad; SCORE2 >/= 10 % para aquellos entre 50 y 69 años; SCORE2-OP >/= 15 % para aquellos >/= 70 años para determinar el riesgo a los 10 años de enfermedad cardiovascular (ECV) mortal y no mortal.
    - Diagnóstico preexistente de hipercolesterolemia familiar heterocigótica (HFHe) con ECA o con otro factor de riesgo significativo.

    • Participantes de riesgo alto con lo siguiente:
    - Factores de riesgo individual muy elevados, en particular colesterol total > 8 mmol/l (> 310 mg/dl), C-LDL > 4,9 mmol/dl (> 190 mg/dl), o presión arterial >/= 180/110 mm Hg.
    - Diagnóstico preexistente de HFHe sin otros factores de riesgo significativos.
    - Diabetes Mellitus (DM) sin daño en un órgano diana (como microalbuminuria, retinopatía o neuropatía), con una duración de la DM >/= 10 años u otro factor de riesgo adicional.
    - Enfermedad renal crónica moderada (TFGe 30-59 ml/min/1,73 m2).
    - SCORE2 de 2,5 a <7,5 % para aquellos < 50 años de edad; SCORE2 de 5 a < 10 % para aquellos entre 50 y 69 años; SCORE2-OP de 7,5 a < 15 % para aquellos >/= 70 años para determinar el riesgo a los 10 años de ECV mortal y no mortal.

    • Niveles de C-LDL en la selección y la basal:
    - En participantes con riesgo cardiovascular muy alto: C-LDL en suero >/= 1,4 mmol/l (>/= 55 mg/dl).
    - En participantes con riesgo cardiovascular alto: C-LDL en suero ≥ 1,8 mmol/l (>/= 70 mg/dl).
    • Participantes con una dosis estable de una estatina durante >/= 30 días en la selección.
    • Participantes que reciban una MTD individual de estatina durante >/= 30 días en la basal.
    • Triglicéridos en ayunas < 400 mg/dl (< 4,52 mmol/l) en la selección y la basal.
    E.4Principal exclusion criteria
    • Participants on more than one other lipid-lowering drug on top of statin at screening visit.
    • Participants with a known intolerance to rosuvastatin at screening or baseline visit.
    • Previous (within 90 days of screening), current or planned treatment with a monoclonal antibody (mAb) directed towards PCSK9 (e.g. evolocumab, alirocumab) at screening or baseline visit.
    • Previous exposure to inclisiran or any other non-mAb PCSK9 targeted therapy, either as an investigational or marketed drug within 2 years prior to screening or baseline visit.
    • Previous, current or planned treatment with LDL-apheresis at screening or baseline visit.
    • Liver and CK: (a) Active liver disease defined as any current infectious, neoplastic, or metabolic pathology of the liver or (b) unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation > 2x ULN (except for participants with Gilbert's syndrome), or (c) creatine kinase (CK) >5x ULN at screening or baseline visit.
    • Participant with severe renal impairment defined by eGFR < 30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at screening or baseline visit.
    • Acute coronary syndrome, ischemic stroke or TIA, coronary revascularization or peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 3 months prior to the screening or baseline visit.
    • Heart failure New York Heart Association (NYHA) class IV at screening or baseline visit
    • Pregnant or nursing (lactating) women at screening or baseline visit.
    • Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing of study treatment.
    • Participantes que reciban más de un fármaco hipolipemiante adicional a la estatina en la visita de selección.
    • Participantes con una intolerancia conocida a la rosuvastatina en la visita de selección o basal.
    • Tratamiento previo (durante los 90 días anteriores a la selección), actual o previsto con un anticuerpo monoclonal (AM) dirigido a PCSK9 (p. ej., evolocumab, alirocumab) en la visita de selección o basal.
    • Exposición previa a inclisirán o a cualquier otro tratamiento no-AM dirigido a PCSK9, bien un fármaco en investigación o comercializado, durante los 2 años anteriores a la visita de selección o basal.
    • Tratamiento previo, actual o previsto con aféresis de LDL en la visita de selección o basal.
    • Hígado y CK: a) Enfermedad hepática activa definida como cualquier patología actual del hígado infecciosa, neoplásica o metabólica o b) aumento inexplicado de la alanino aminotransferasa (ALT) o aspartato aminotransferasa (AST) >3 x LSN, o de la bilirrubina total >2 x LSN (salvo los participantes con síndrome de Gilbert), o c) creatina quinasa (CK) >5 x LSN en la visita de selección o basal.
    • Participantes con alteración renal grave definida por TFGe < 30 ml/min/1,73 m2 calculada mediante la fórmula de modificación de la dieta en la enfermedad renal (MDRD) en la visita de selección o basal.
    • Síndrome coronario agudo, accidente cerebrovascular isquémico, o AIT, revascularización coronaria, procedimiento de revascularización arterial periférica o amputación debida a una enfermedad aterosclerótica < 3 meses antes de la visita de selección o basal.
    • Insuficiencia cardíaca de clase IV de la Asociación de Cardiología de Nueva York (NYHA) en la visita de selección o basal.
    • Mujeres embarazadas o en periodo de lactancia en la visita de selección o basal.
    • Mujeres con posibilidad de quedarse embarazadas salvo que utilicen métodos anticonceptivos altamente eficaces durante la administración del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving individual LDL-C target (< 55 mg/dL or < 70 mg/dL) at day 90
    Proporción de participantes que alcanzan el objetivo individual de C-LDL (< 55 mg/dl o < 70 mg/dl) el día 90
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    Día 90
    E.5.2Secondary end point(s)
    •Relative change (percentage from baseline to mean LDL-C level) over the double-blind treatment period.
    •Proportion of participants experiencing at least one muscle-related AE as defined in the Standardized MedDRA Queries (SMQ) rhabdomyolysis / myopathy from day 1 to day 360.
    •Proportion of participants experiencing self-reported pain.
    Annualized number of days participants experiencing self-reported pain from baseline to day 360.
    •Change from baseline in SF-BPI pain severity score to day 360
    Change from baseline in SF-BPI pain interference score to day 360.
    Proportion of participants with clinically relevant change in SF-BPI pain severity score from baseline to day 360.
    Proportion of participants with clinically relevant change in SF-BPI pain interference score from baseline to day 360.
    • El cambio relativo (porcentaje del cambio desde el valor basal hasta la media del nivel de C-LDL) durante el periodo doble ciego del estudio.
    • Los acontecimientos adversos musculares, según la proporción de participantes que presentan al menos un AA muscular (SMQ rabdomiolisis/miopatía) desde el día 1 al día 360.
    • El número de días al año que se sufre dolor, según la proporción de participantes que presentan dolor comunicado por ellos mismos desde la basal hasta el día 360 utilizando un diario del dolor.
    • La calidad de vida relacionada con el dolor el día 360 mediante el Short-Form Brief Pain Inventory (SF-BPI), según el cambio en las puntuaciones de la intensidad y la interferencia del dolor del SF-BPI desde la basal hasta el día 360 y la proporción de participantes con un cambio de interés clínico en las puntuaciones de la intensidad y la interferencia del dolor del SF-BPI desde la basal hasta el día 360.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to day 360.
    Desde el valor basal hasta el día 360
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability , quality of life
    Tolerabilidad , calidad de vida
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA144
    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 No
    E.8.7Trial has a data monitoring committee No
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 792
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 968
    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 state102
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1760
    F.4.2.2In the whole clinical trial 1760
    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)
    Participants who complete participation in this trial and continue to derive clinical benefit from the treatment based on the investigator’s evaluation may receive post-trial access, if inclisiran is not locally available.
    Los participantes que completen su participación en este ensayo y continúen obteniendo beneficios clínicos del tratamiento según la evaluación del investigador pueden recibir acceso al tratamiento posterior al ensayo, si inclisiran no está disponible localmente.
    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 Decision2022-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-11
    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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