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    Summary
    EudraCT Number:2010-021590-37
    Sponsor's Protocol Code Number:A4061058
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-021590-37
    A.3Full title of the trial
    A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY
    A.4.1Sponsor's protocol code numberA4061058
    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 SponsorPfizer Inc 235 East 42nd Street, New York, NY10017
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ city New York
    B.5.3.3Post codeNY 10017
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailClinicalTrials.govCallCentrere@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAxitinib
    D.3.2Product code AG-013736
    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 INNaxitinib
    D.3.9.1CAS number 319460-85-0
    D.3.9.2Current sponsor codeAG-013736
    D.3.9.3Other descriptive nameN-Methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAxintinib
    D.3.2Product code AG-013736
    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 INNaxitinib
    D.3.9.1CAS number 319460-85-0
    D.3.9.2Current sponsor codeAG-013736
    D.3.9.3Other descriptive nameN-Methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 2
    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
    Hepatocellular carcinoma (HCC)
    E.1.1.1Medical condition in easily understood language
    Liver Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10019829
    E.1.2Term Hepatocellular carcinoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
     To compare the OS of patients with advanced HCC receiving axtitinib + best supportive care (BSC) versus (vs) placebo + BSC following failure of one prior antiangiogenic therapy.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
     To compare PFS between both arms
     To compare TTP between both arms
     To compare overall response rate (ORR) between both arms
     To evaluate DR within each treatment arm
     To compare CBR between both arms
     To evaluate the safety and tolerability of axitinib in this patient population
     To evaluate the pharmacokinetics of axitinib in this patient population.
     To compare patients’ health-related quality of life (HRQoL) and health status between both arms.
     To evaluate baseline blood VEGF-C level as a potential predictive biomarker of axitinib efficacy.
     To evaluate blood soluble protein concentrations and RNA transcripts associated with angiogenesis or tumor growth.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Locally advanced or metastatic HCC confirmed by histology or cytology (diagnosis of HCC obtained from a prior tumor biopsy specimen is acceptable) or liver mass confirmed as HCC by one or more imaging modalities, including triphasic contrastenhanced helical CT, triphasic dynamic contrast-enhanced MRI and contrast-enhanced ultrasonography, and not amenable to local therapy.
    2. Failure of one prior antiangiogenic therapy (patients must have received at least 4 weeks of prior therapy). Antiangiogenic agents include sorafenib, bevacizumab and brivanib. Failure is defined as either a) documented progressive disease (per RECIST version 1.1) while receiving prior therapy or after the last dose of prior therapy; or b) intolerance to the prior antiangiogenic therapy. Intolerance to prior antiangiogenic therapy (at any dose and/or duration) is defined as documented treatment-related grade 3 or 4 adverse events that led to treatment discontinuation.
    3. Presence of either measurable or non-measurable disease according to RECIST (version 1.1).
    4. Child-Pugh Class A (score 5-6) or B (score 7 only) disease. Score for ascites/hepatic encephalopathy must be 1; for the determination of the Child-Pugh Class
    5. At least 2 weeks since the last dose of prior systemic treatment, radiotherapy, or surgical procedure. All treatment-related toxicities must have resolved to NCI CTCAE Version
    3.0 grade ≤1 or back to baseline except for alopecia or hypothyroidism.
    6. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ≤140 mm Hg, and the baseline diastolic blood pressure readings must be ≤90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
    7. Eighteen years of age or older.
    8. ECOG performance status 0 or 1.
    9. Life expectancy of ≥ 8 weeks.
    10. Required baseline laboratory data within the following parameters:
     Neutrophils ≥ 1,500/≥L
     Platelets ≥ 75,000/≥L
     Hemoglobin ≥ 9.0 g/dL
     Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) ≤ 5 x ULN
     Serum creatinine ≤ 1.5 x ULN
     INR <1.7 or prothrombin time (PT)< 4 seconds above ULN (i.e. Child-Pugh Score is
    no greater than 1)
     Serum albumin ≥ 2.8 g/dL (i.e. Child-Pugh Score is no greater than 2)
     Total bilirubin ≤ 3 mg/dL (i.e. Child-Pugh Score is no greater than 2)
     Urinary protein <2+ by urine dipstick. If dipstick is ≥2+ then a 24 hour urine
    collection should be done and the patient may enter only if urinary protein is <2.0 g per 24 hours.
    11. Signed and dated informed consent indicating that the patient (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment.
    12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of patient-reported outcome (PRO) questionnaires.
    E.4Principal exclusion criteria
    1. Prior treatment of advanced HCC with more than one prior first-line systemic therapy.
    2. Any prior local therapy (such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection or cryoablation) within 2 weeks of study screening.
    3. Prior history of liver transplant.
    4. Presence of hepatic encephalopathy and/or clinically relevant ascites (e.g., that can be classified as Child-Pugh encephalopathy or ascites of 2 or 3 points).
    5. Presence of main portal vein invasion by HCC.
    6. NCI CTCAE grade ≥ 3 hemorrhage within 4 weeks of starting study treatment, or
    variceal hemorrhage of any grade within 12 months of study screening.
    7. Presence of esophageal varices of greater than grade 2 according to Paquet classification (grade 2 allowed only if on prophylactic treatment) or esophageal varices in the presence of any red signs and/or serious or non-healing wound/ulcer.
    8. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study screening.9. Any of the following within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, portal vein thrombosis, deep vein thrombosis or pulmonary embolism.
    10. History of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
    11. Alcohol intake within 7 days of study screening and anticipated alcohol intake during the study.
    12. Current use or anticipated need for treatment with botanical formulation having an approved indication for cancer treatment, such as “Xiao Chai Hu Tang”, “Kanglaite”, etc
    13. Current use or anticipated need for treatment with drugs that are known potent
    cytochrome P450 (CYP) 3A4/5 inhibitors (e.g., grapefruit juice, verapamil, ketoconazole, nefazodone, itraconazole, miconazole, erythromycin, telithromycin, clarithromycin,indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).
    14. Current use or anticipated need for treatment with drugs that are known CYP3A4/5 or CYP1A2 inducers (e.g., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John’s wort).
    15. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
    16. Gastrointestinal abnormalities including:
     inability to take oral medication;
     requirement for intravenous alimentation;
     prior surgical procedures affecting absorption including total gastric resection;
     treatment for active peptic ulcer disease in the past 6 months;
     active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
     malabsorption syndromes.
    17. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
    18. History of a malignancy (other than HCC) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years.
    19. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
    20. Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 6 months after discontinuing study treatment. The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate.21.
    Other severe acute or chronic medical or psychiatric condition or laboratory abnormality
    that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    RandomizedPortion:
    Overall Survival evaluated for 3 years after the last subject is randomized.

    Non-randomized Portion
    • Plasma PK (Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F, Vz/F) and tolerability of single-agent axitinib following continuous dosing. Assessed Cycle 1 Day 15
    • First-cycle DLT (Child-Pugh Class B, Score 7 population only).
    • Type, incidence, severity, timing, seriousness, and relatedness of adverse events, laboratory abnormalities based upon the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. will be assessed throughout the study.
    E.5.2Secondary end point(s)
     PFS
     TTP
     ORR
     DR
     CBR
     Type, incidence, severity (graded by the National Cancer Institute [NCI] Common
    Terminology Criteria for Adverse Events [CTCAE], version 3.0), timing, seriousness,
    and relatedness of adverse events and laboratory abnormalities
     Axitinib population PK analysis
     Patient Reported Outcome (PRO) of health-related quality of life and disease-related
    symptoms as measured by the Functional Assessment of Cancer Therapy –
    Hepatobiliary questionnaire (FACT-Hep) and health status measured by the EuroQol
    EQ-5D Self-Report Questionnaire (EQ-5D).
     Plasma soluble proteins [including but not limited to AFP, VEGF-A, VEGF-C, sVEGFR, HGF, sHGFR]
     Plasma RNA transcripts associated with angiogenesis and tumor growth.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Tumor assessment including CT/MRI will be required at baseline and every 8 weeks. Response (CR/PR) requires confirmation at least 4 weeks after the response is noted.
    • Safety assessment (for adverse events) will be carried out throughout the study and at the 28 day follow-up visit.
    • Axitinib Population PK analysis - assessed Day 1 of Cycle 1, 2 and 3
    • Patient Reported Outcome (PRO) of health-related quality of life and disease-related symptoms as well as Health status will be assessed every 4 weeks during the study, end of treatment and at the 28 day follow-up visit.
    • Plasma soluble proteins will be assessed, at baseline, Cycle 2 Day 1 and end of treatment.
    • Plasma RNA transcripts will be assessed, at baseline, Cycle 2 Day 1 and end of treatment.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Bulgaria
    China
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Japan
    Korea, Republic of
    Singapore
    Slovakia
    Taiwan
    Turkey
    United Kingdom
    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
    End of Trial in all participating countries is defined as the time at which:
     Enrolment is completed according to protocol planned sample size, and assessments and requirements are completed as per protocol.
     The stated objectives of the trial are achieved.
     Recommendation by DMC.
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 200
    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 Decision2011-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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