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    Clinical Trial Results:
    A Prospective Multicenter Phase III Clinical Evaluation of the Safety and Efficacy of Lumason™/SonoVue® in Subjects Undergoing Pharmacologic Stress Echocardiography with Dobutamine for the Diagnosis of Coronary Artery Disease

    Summary
    EudraCT number
    		 2015-001713-28
    Trial protocol
    		 DE  
    Global end of trial date
    25 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2021
    First version publication date
    20 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BR1-141
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02522481
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bracco Imaging S.p.A
    Sponsor organisation address
    Via Folli 50, Milan, Italy, 20134
    Public contact
    Global Medical & Regulatory Affairs, Bracco Suisse SA, +41 228848803, patricia.caillon@bracco.com
    Scientific contact
    Global Medical & Regulatory Affairs, Bracco Suisse SA, +41 228848803, patricia.caillon@bracco.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective(s): • To assess the efficacy of LUMASON/SonoVue-enhanced dobutamine stress echocardiography (DSE) in subjects with suspected or known coronary artery disease (CAD) having suboptimal left ventricular (LV) endocardial border delineation (EBD) at unenhanced echocardiography in terms of: 1) Sensitivity and specificity for the detection or exclusion of CAD in unenhanced versus SonoVue-enhanced DSE using coronary angiography or clinical follow-up as the truth standard; 2) Critical shift from suboptimal (≥2 adjacent segments inadequate on any apical view) at unenhanced dobutamine stress echocardiography (UE-DSE) to adequate images (reduction of suboptimal adjacent segments) for LV EBD at contrast-enhanced dobutamine stress echocardiography (CE-DSE).
    Protection of trial subjects
    Investigators agreed to make no informal changes to the protocol, except when necessary to protect the safety, the rights or the welfare of subjects. In addition, the Sponsor ensures insurance coverage for damages concerning the subject during the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 37
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Italy: 60
    Country: Number of subjects enrolled
    United States: 74
    Worldwide total number of subjects
    175
    EEA total number of subjects
    97
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    76
    From 65 to 84 years
    98
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Patient In: 24 September 2015, Last Patient Out: 07 November 2017, Off-Site Blinded Read: 25 February 2018

    Pre-assignment
    Screening details
    		 175 subjects were enrolled, however, 2 subjects were not dosed (withdrew consent prior to dose administration), therefore, only 173 subjects were included in the Safety Population. One additional subject discontinued study participation due to a reason other than adverse event, therefore, 172 subjects completed the study.

    Pre-assignment period milestones
    Number of subjects started
    		 175
    Number of subjects completed
    		 173

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 LUMASON/SonoVue
    Arm description
    		 LUMASON/SonoVue (Sulfur hexafluoride lipid-type A microspheres/Sulphur hexafluoride microbubbles) 2 mL intravenous injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    LUMASON/SonoVue
    Investigational medicinal product code
    Other name
    Lumason, SonoVue
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ultrasound contrast agent administered as 2 single-dose 2-mL intravenous injections during rest and stress echocardiography

    Number of subjects in period 1 [1]
    		LUMASON/SonoVue
    Started
    173
    Completed
    172
    Not completed
    1
         Extravasation of contrast
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 175 subjects enrolled in the study; however, 2 subjects withdrew consent prior to contrast administration leaving 173 subjects who received intravenous SonoVue.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 173 173
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 76 76
        From 65-84 years
    		 96 96
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ( 10.47 ) -
    Gender categorical
    Units: Subjects
        Female
    		 52 52
        Male
    		 121 121
    Race
    Units: Subjects
        White
    		 160 160
        Black
    		 4 4
        Asian
    		 5 5
        Other
    		 4 4
    Height
    Units: centimetres
        arithmetic mean (standard deviation)
    		 169.3 ( 10.49 ) -
    Weight
    Units: kilograms
        arithmetic mean (standard deviation)
    		 86.99 ( 21.781 ) -
    Body Mass Index
    Units: kilograms per meters-squared
        arithmetic mean (standard deviation)
    		 30.33 ( 7.252 ) -

    End points

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    End points reporting groups
    Reporting group title
    LUMASON/SonoVue
    Reporting group description
    		 LUMASON/SonoVue (Sulfur hexafluoride lipid-type A microspheres/Sulphur hexafluoride microbubbles) 2 mL intravenous injection

    Subject analysis set title
    Sensitivity for Detection or Exclusion of CAD
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The diagnostic performance of the echocardiographic images was compared to the truth standard to determine sensitivity and specificity. A diagnosis of coronary artery disease (CAD) was determined for both the echo images and truth standard (positive diagnosis for CAD is defined as >/= 50% stenosis of any vessel on coronary angiography or if no coronary angiography is performed the occurrence of a cardiac event based on clinical information for up to 6 months post dose; otherwise the diagnosis is negative). Results for sensitivity are reflected based on difference between contrast enhanced stress echo and unenhanced stress echo. Results for analysis of data based on majority assessment from the three off-site blinded readers are presented. Sensitivity is the percentage of correctly diagnosed subjects by stress echo over the total positive subjects according to the truth standard.

    Subject analysis set title
    Specificity for Detection or Exclusion of CAD
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The diagnostic performance of the echocardiographic images was compared to the truth standard to determine sensitivity and specificity. A diagnosis of coronary artery disease (CAD) was determined for both the echo images and truth standard (positive diagnosis for CAD is defined as >/= 50% stenosis of any vessel on coronary angiography or if no coronary angiography is performed the occurrence of a cardiac event based on clinical information for up to 6 months post dose; otherwise the diagnosis is negative). Results for specificity are reflected based on difference between contrast enhanced stress echo and unenhanced stress echo. Results for analysis of data based on majority assessment from the three off-site blinded readers are presented. Specificity is the percentage of correctly diagnosed subjects by stress echo over the total negative subjects according to the truth standard.

    Subject analysis set title
    Critical Shift from Sub- to Optimal Echocardiographic Images
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Reader-Specific Percentages of Participants Identified as having a Critical Shift from Suboptimal to Optimal Echocardiographic Images The percentage of subjects with suboptimal images (defined as >= 2 adjacent segments with inadequate left ventricular endocardial border delineation (LV EBD) in any of the 3 apical views) at unenhanced stress echo converted to adequate (reduction of suboptimal segments in any of the 3 apical views) at contrast-enhanced stress echo. Analysis population for EBD included all subjects who received LUMASON/SonoVue and had EBD data available at peak stress for both UE-DSE and CE-DSE.

    Subject analysis set title
    Total LV EBD (Unenhanced)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analysis population for EBD included all subjects who received LUMASON/SonoVue and had EBD data available at peak stress for both UE-DSE and CE-DSE.

    Subject analysis set title
    Total LV EBD (Contrast-enhanced)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analysis population for EBD included all subjects who received LUMASON/SonoVue and had EBD data available at peak stress for both UE-DSE and CE-DSE.

    Subject analysis set title
    Change in Total LV EBD (Difference [CE-DSE - UE-DSE])
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analysis population for EBD included all subjects who received LUMASON/SonoVue and had EBD data available at peak stress for both UE-DSE and CE-DSE.

    Subject analysis set title
    Dummy set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    EudraCT does not allow single arm/group statistical analysis. Due to the limitations with the EudraCT system, a Dummy set was created and used as a comparison group. This dummy set is a work-around to that limitation. No subjects in this set.

    Primary: Sensitivity for Detection or Exclusion of Coronary Artery Disease (CAD)

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    End point title
    		 Sensitivity for Detection or Exclusion of Coronary Artery Disease (CAD)
    End point description
    Analysis population for coronary artery disease (CAD) included all subjects who received LUMASON/SonoVue, had overall diagnostic conclusion of CAD available at peak stress for both unenhanced dobutamine stress echocardiography (UE-DSE) and contrast-enhanced dobutamine stress echocardiography (CE-DSE) and had a definite truth standard diagnosis (Positive, Negative) for CAD (coronary angiography or 6 months collection of cardiac events follow-up data).
    End point type
    Primary
    End point timeframe
    Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed.
    End point values
    		 Sensitivity for Detection or Exclusion of CAD Dummy set
    Number of subjects analysed
    87
    1 [1]
    Units: Percentage of Participants
        number (not applicable)
    8.0
    0
    Notes
    [1] - Due to limitations with the EudraCT system, a Dummy set was created as a comparison group. N=0.
    Statistical analysis title
    		 Difference between CE-DSE and UE-DSE
    Statistical analysis description
    Analysis population for coronary artery disease (CAD) included all subjects who received Lumason/SonoVue, had overall diagnostic conclusion of CAD available at peak stress for both UE-DSE and CE-DSE and had a definite truth standard diagnosis (Positive, Negative) for CAD (coronary angiography or 6 months collection of cardiac events follow-up data).
    Comparison groups
    Sensitivity for Detection or Exclusion of CAD v Dummy set
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.0896
    Method
    		 Mcnemar
    Confidence interval
    Notes
    [2] - Difference between contrast-enhanced dobutamine stress echo (CE-DSE) and unenhanced dobutamine stress echo (UE-DSE) (CE-DSE - UE-DSE) EudraCT does not allow single arm/group statistical analysis. Due to the limitations with the EudraCT system, a Dummy set was created and used as a comparison group. This dummy set is a work-around to that limitation. No subjects in this set. Therefore, N=87.

    Primary: Specificity for Detection or Exclusion of Coronary Artery Disease (CAD)

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    End point title
    		 Specificity for Detection or Exclusion of Coronary Artery Disease (CAD)
    End point description
    Analysis population for coronary artery disease (CAD) included all subjects who received Lumason/SonoVue, had overall diagnostic conclusion of CAD available at peak stress for both unenhanced dobutamine stress echocardiography (UE-DSE) and contrast-enhanced dobutamine stress echocardiography (CE-DSE) and had a definite truth standard diagnosis (Positive, Negative) for CAD (coronary angiography or 6 months collection of cardiac events follow-up data).
    End point type
    Primary
    End point timeframe
    Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed.
    End point values
    		 Specificity for Detection or Exclusion of CAD Dummy set
    Number of subjects analysed
    83
    1 [3]
    Units: Percentage of Participants
        number (not applicable)
    33.7
    0
    Notes
    [3] - Due to limitations with the EudraCT system, a Dummy set was created as a comparison group. N=0.
    Statistical analysis title
    		 Difference between CE-DSE and UE-DSE
    Statistical analysis description
    Analysis population for coronary artery disease (CAD) included all subjects who received Lumason/SonoVue, had overall diagnostic conclusion of CAD available at peak stress for both unenhanced dobutamine stress echocardiography (UE-DSE) and contrast-enhanced dobutamine stress echocardiography (CE-DSE) and had a definite truth standard diagnosis (Positive, Negative) for CAD (coronary angiography or 6 months collection of cardiac events follow-up data).
    Comparison groups
    Specificity for Detection or Exclusion of CAD v Dummy set
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.0001
    Method
    		 Mcnemar
    Confidence interval
    Notes
    [4] - Difference between contrast-enhanced dobutamine stress echocardiography (CE-DSE) and unenhanced dobutamine stress echocardiography (UE-DSE) (CE-DSE - UE-DSE) EudraCT does not allow single arm/group statistical analysis. Due to the limitations with the EudraCT system, a Dummy set was created and used as a comparison group. This dummy set is a work-around to that limitation. No subjects in this set. Therefore, N=83.

    Primary: Critical Shift from Suboptimal to Optimal Echocardiographic Images

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    End point title
    		 Critical Shift from Suboptimal to Optimal Echocardiographic Images [5]
    End point description
    The percentage of subjects with suboptimal images (defined as >=2 adjacent segments with inadequate left ventricular endocardial border delineation [LV EBD] in any of the 3 apical views) at unenhanced stress dobutamine echocardiography (UE-DSE) converted to adequate (reduction of suboptimal segments in any of the 3 apical views) at contrast-enhanced stress dobutamine echocardiography (CE-DSE).
    End point type
    Primary
    End point timeframe
    Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed for this end point.
    End point values
    		 Critical Shift from Sub- to Optimal Echocardiographic Images
    Number of subjects analysed
    167
    Units: Percentage of Participants
    number (confidence interval 95%)
        Reader 1 (CE-DSE)
    84.4 (74.4 to 91.7)
        Reader 2 (CE-DSE)
    93.7 (87.9 to 97.2)
        Reader 3 (CE-DSE)
    78.8 (67.0 to 87.9)
    No statistical analyses for this end point

    Secondary: Change in Total LV EBD

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    End point title
    		 Change in Total LV EBD
    End point description
    Measured as the change in the total left ventricular endocardial border delineation (LV EBD) score based on the 17 segments, from peak stress unenhanced versus peak stress contrast-enhanced. Total LV EBD score ranges from 0 to 34 and higher score is better outcome.
    End point type
    Secondary
    End point timeframe
    Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed.
    End point values
    		 Total LV EBD (Unenhanced) Total LV EBD (Contrast-enhanced) Change in Total LV EBD (Difference [CE-DSE - UE-DSE])
    Number of subjects analysed
    167
    167
    167
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Reader 1
    17.5 ( 10.83 )
    28.1 ( 8.32 )
    10.6 ( 11.98 )
        Reader 2
    13.4 ( 8.57 )
    30.5 ( 4.81 )
    17.1 ( 7.87 )
        Reader 3
    17.8 ( 7.04 )
    23.6 ( 7.47 )
    5.8 ( 9.17 )
    No statistical analyses for this end point

    Secondary: Summary of Adverse Events

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    End point title
    		 Summary of Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    From the time of signed informed consent up to 72 hours post dose.
    End point values
    		 LUMASON/SonoVue
    Number of subjects analysed
    173
    Units: Number of Subjects
        Number of Subjects with Adverse Events (AEs)
    21
        Number of Subjects with AEs of Mild Intensity
    15
        Number of Subjects with AEs of Moderate Intensity
    5
        Number of Subjects with AEs of Severe Intensity
    1
        Number of Subects with Serious Adverse Events
    3
        Number of Subjects Who Discontinued due to AEs
    0
        Number of Deaths
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) that occurred from the time the subject signed Informed Consent until 72 hours after the last administration of LUMASON/SonoVue or until the subject underwent cardiac intervention, whichever came first, were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    LUMASON/SonoVue Safety Population
    Reporting group description
    		 All AEs that occurred from the time the subject signed the informed consent until 72 hours after the last administration of Lumason/SonoVue or until the subject underwent cardiac intervention, whichever came first, were recorded.

    Serious adverse events
    		 LUMASON/SonoVue Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 173 (1.73%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 LUMASON/SonoVue Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 173 (10.40%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Electrocardiogram change
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Haematocrit increased
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Troponin increased
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Cardiac disorders
    Bifascicular block
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Bradycardia
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1
    Gastrointestinal infection
         subjects affected / exposed
    2 / 173 (1.16%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 173 (1.16%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 173 (0.58%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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