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    Clinical Trial Results:
    Comparison of 2 Infusion Devices with Respect to Pharmacokinetics, Safety, and Tolerability of Hizentra®: Investigational Wearable Infusor and the Crono S-PID-50 Infusion Pump

    Summary
    EudraCT number
    		 2016-003798-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Mar 2020
    First version publication date
    05 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IgPro20_1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Behring
    Sponsor organisation address
    Emil-von-Behring-Str. 76, Marburg, Germany,
    Public contact
    Trial Registration Coordinator, CSL Behring LLC, clinicaltrials@cslbehring.com
    Scientific contact
    Trial Registration Coordinator, CSL Behring LLC, clinicaltrials@cslbehring.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the AUC0-7 days of IgG during the last week of each study period (Weeks 4 & 8) after subcutaneous (SC) infusion of the same IgPro20 dose with the Investigational Wearable Infusor (IWI) vs Crono S-PID-50 Infusion Pump (CP) in PID patients.
    Protection of trial subjects
    This study was carried out in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines and standard operating procedures for clinical research and development at CSL Behring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jun 2018
    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
    United States: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    0
    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)
    2
    Adults (18-64 years)
    15
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 30 subjects were screened, of which 23 subjects were enrolled. This is a crossover study in which subjects were then randomized into either Sequence 1 or Sequence 2. • Sequence 1: IgPro20 administered with CP in Period 1 and with IWI in Period 2. • Sequence 2: IgPro20 administered with IWI in Period 1 and with CP in Period 2.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Crono S-PID50 Pump (CP)
    Arm description
    		 A liquid formulation of normal human IgG at a concentration of 20% administered via the Crono S-PID50 Pump as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hizentra
    Investigational medicinal product code
    Other name
    IgPro20, Human normal immunoglobulin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose

    Arm title
    		 Investigational Wearable Infusor (IWI)
    Arm description
    		 A liquid formulation of normal human IgG at a concentration of 20% administered via the Investigational Wearable Infusor (IWI) as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hizentra
    Investigational medicinal product code
    Other name
    IgPro20, Human normal immunoglobulin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose

    Number of subjects in period 1
    		Crono S-PID50 Pump (CP) Investigational Wearable Infusor (IWI)
    Started
    11
    12
    Completed
    10
    12
    Not completed
    1
    0
         Failure to meet randomization criteria
    1
    -
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Crono S-PID50 Pump (CP)
    Arm description
    		 A liquid formulation of normal human IgG at a concentration of 20% administered via the Crono S-PID50 Pump as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hizentra
    Investigational medicinal product code
    Other name
    IgPro20, Human normal immunoglobulin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose

    Arm title
    		 Investigational Wearable Infusor (IWI)
    Arm description
    		 A liquid formulation of normal human IgG at a concentration of 20% administered via the Investigational Wearable Infusor (IWI) as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hizentra
    Investigational medicinal product code
    Other name
    IgPro20, Human normal immunoglobulin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose

    Number of subjects in period 2
    		Crono S-PID50 Pump (CP) Investigational Wearable Infusor (IWI)
    Started
    10
    12
    Completed
    10
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 This is a crossover study so subjects were randomized into either Sequence 1 or into Sequence 2. • Sequence 1: IgPro20 administered with CP in Period 1 and with IWI in Period 2. • Sequence 2: IgPro20 administered with IWI in Period 1 and with CP in Period 2.

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 23 23
    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)
    		 2 2
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.7 ± 16.84 -
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Crono S-PID50 Pump (CP)
    Reporting group description
    		 A liquid formulation of normal human IgG at a concentration of 20% administered via the Crono S-PID50 Pump as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose

    Reporting group title
    Investigational Wearable Infusor (IWI)
    Reporting group description
    		 A liquid formulation of normal human IgG at a concentration of 20% administered via the Investigational Wearable Infusor (IWI) as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose
    Reporting group title
    Crono S-PID50 Pump (CP)
    Reporting group description
    		 A liquid formulation of normal human IgG at a concentration of 20% administered via the Crono S-PID50 Pump as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose

    Reporting group title
    Investigational Wearable Infusor (IWI)
    Reporting group description
    		 A liquid formulation of normal human IgG at a concentration of 20% administered via the Investigational Wearable Infusor (IWI) as a weekly subcutaneous infusion at the subject's individual pre-study steady-state therapeutic dose

    Subject analysis set title
    CP (PKS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Pharmacokinetic Analysis Set (PKS) comprised of all evaluable subjects who used the correct device in each treatment period, completed all the IgPro20 infusions with dosing within ±◦20% of an average prescribed weekly dose, and had at least 1 quantifiable PK measurement after CP infusions.

    Subject analysis set title
    CP (SPKS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PK Sensitivity Analysis Set (SPKS) comprised of all evaluable subjects who had used the correct device in each treatment period had at least 1 quantifiable PK measurement after CP infusions.

    Subject analysis set title
    CP (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set (SAF) comprised of all subjects in the FAS who received at least 1 complete or partial dose of IgPro20 with CP infusions. The Full Analysis Set (FAS) comprised of all subjects who provided informed consent/assent and who were randomized.

    Subject analysis set title
    IWI (PKS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Pharmacokinetic Analysis Set (PKS) comprised of all evaluable subjects who used the correct device in each treatment period, completed all the IgPro20 infusions with dosing within ±◦20% of an average prescribed weekly dose, and had at least 1 quantifiable PK measurement after IWI infusions.

    Subject analysis set title
    IWI (SPKS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PK Sensitivity Analysis Set (SPKS) comprised of all evaluable subjects who had used the correct device in each treatment period had at least 1 quantifiable PK measurement after IWI infusions.

    Subject analysis set title
    IWI (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set (SAF) comprised of all subjects in the FAS who received at least 1 complete or partial dose of IgPro20 with IWI infusions. The Full Analysis Set (FAS) comprised of all subjects who provided informed consent/assent and who were randomized.

    Primary: Area under IgG concentration-time curve (AUC0-7 days) of IgG during the last weekly dosing interval for each period for each device group for IgPro20

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    End point title
    		 Area under IgG concentration-time curve (AUC0-7 days) of IgG during the last weekly dosing interval for each period for each device group for IgPro20
    End point description
    End point type
    Primary
    End point timeframe
    Up to 7 days after infusion
    End point values
    		 CP (PKS) IWI (PKS)
    Number of subjects analysed
    8 [1]
    12 [2]
    Units: h*g/L
    geometric mean (standard deviation)
        Period 1 (CP, n=8; IWI, n=12)
    1767 ± 1.12
    1864 ± 1.23
        Period 2 (CP, n=12; IWI, n=8)
    1871 ± 1.21
    1724 ± 1.09
    Notes
    [1] - Due to crossover: CP (n=20)
    [2] - Due to crossover: IWI (n=20)
    Statistical analysis title
    		 IWI vs CP
    Comparison groups
    CP (PKS) v IWI (PKS)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3378
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.01

    Secondary: Maximum IgG serum concentration (Cmax) of IgPro20

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    End point title
    		 Maximum IgG serum concentration (Cmax) of IgPro20
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 7 days
    End point values
    		 CP (PKS) IWI (PKS)
    Number of subjects analysed
    8 [3]
    12 [4]
    Units: g/L
        geometric mean (standard deviation)
    11.7 ± 1.24
    11.4 ± 1.20
    Notes
    [3] - Due to crossover: CP (n=20)
    [4] - Due to crossover: IWI (n=20)
    Statistical analysis title
    		 IWI vs CP
    Comparison groups
    CP (PKS) v IWI (PKS)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.2917
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.02

    Secondary: Trough IgG serum concentration (Ctrough) of IgPro20

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    End point title
    		 Trough IgG serum concentration (Ctrough) of IgPro20
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 7 days
    End point values
    		 CP (PKS) IWI (PKS)
    Number of subjects analysed
    8 [5]
    12 [6]
    Units: g/L
        geometric mean (standard deviation)
    10.9 ± 1.25
    10.3 ± 1.17
    Notes
    [5] - Due to crossover: CP (n=20)
    [6] - Due to crossover: IWI (n=20)
    Statistical analysis title
    		 IWI vs CP
    Comparison groups
    CP (PKS) v IWI (PKS)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1188
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1

    Secondary: Weekly trough IgG serum concentration (Ctrough) of IgPro20

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    End point title
    		 Weekly trough IgG serum concentration (Ctrough) of IgPro20
    End point description
    End point type
    Secondary
    End point timeframe
    Before each infusion
    End point values
    		 CP (SAF) IWI (SAF)
    Number of subjects analysed
    10 [7]
    12 [8]
    Units: g/L
    arithmetic mean (standard deviation)
        Week 1 (CP,n=10;IWI,n=12)
    10.6 ± 3.46
    11.0 ± 2.24
        Week 2 (CP,n=10;IWI,n=12)
    9.87 ± 0.699
    10.6 ± 2.28
        Week 3 (CP,n=10;IWI,n=12)
    9.74 ± 0.807
    10.8 ± 2.13
        Week 4 (CP,n=10;IWI,n=12)
    11.0 ± 3.66
    10.8 ± 1.98
        Week 5 (CP,n=12;IWI,n=10)
    10.9 ± 2.26
    9.73 ± 0.884
        Week 6 (CP,n=12;IWI,n=10)
    10.9 ± 2.18
    9.87 ± 0.730
        Week 7 (CP,n=12;IWI,n=10)
    11.0 ± 2.14
    9.87 ± 0.634
        Week 8 (CP,n=12;IWI,n=10)
    11.0 ± 2.03
    9.83 ± 0.944
    Notes
    [7] - Due to crossover: CP (n=22)
    [8] - Due to crossover: IWI (n=22)
    No statistical analyses for this end point

    Secondary: Subjects with treatment-emergent adverse events (TEAEs)

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    End point title
    		 Subjects with treatment-emergent adverse events (TEAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 CP (SAF) IWI (SAF)
    Number of subjects analysed
    11 [9]
    12 [10]
    Units: Subjects
    number (not applicable)
        Number of subjects
    16
    12
        Percent of subjects
    69.6
    54.5
    Notes
    [9] - Due to crossover: CP (n=23)
    [10] - Due to crossover: IWI (n=22)
    No statistical analyses for this end point

    Secondary: Subjects with TEAEs related to IgPro20 only

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    End point title
    		 Subjects with TEAEs related to IgPro20 only
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 CP (SAF) IWI (SAF)
    Number of subjects analysed
    11 [11]
    12 [12]
    Units: Subjects
    number (not applicable)
        Number of subjects
    7
    5
        Percent of subjects
    30.4
    22.7
    Notes
    [11] - Due to crossover: CP (n=23)
    [12] - Due to crossover: IWI (n=22)
    No statistical analyses for this end point

    Secondary: Subjects with TEAEs related to devices only

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    End point title
    		 Subjects with TEAEs related to devices only
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 CP (SAF) IWI (SAF)
    Number of subjects analysed
    11 [13]
    12 [14]
    Units: Subjects
    number (not applicable)
        Number of subjects
    3
    2
        Percent of subjects
    13.0
    9.1
    Notes
    [13] - Due to crossover: CP (n=23)
    [14] - Due to crossover: IWI (n=22)
    No statistical analyses for this end point

    Secondary: Subjects with TEAEs related to IgPro20/device combination

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    End point title
    		 Subjects with TEAEs related to IgPro20/device combination
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 CP (SAF) IWI (SAF)
    Number of subjects analysed
    11 [15]
    12 [16]
    Units: Subjects
    number (not applicable)
        Number of subjects
    3
    2
        Percent of subjects
    13.0
    9.1
    Notes
    [15] - Due to crossover: CP (n=23)
    [16] - Due to crossover: IWI (n=22)
    No statistical analyses for this end point

    Secondary: Subjects with serious TEAEs

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    End point title
    		 Subjects with serious TEAEs
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 CP (SAF) IWI (SAF)
    Number of subjects analysed
    11 [17]
    12 [18]
    Units: Subjects
    number (not applicable)
        Number of subjects
    0
    0
        Percent of subjects
    0
    0
    Notes
    [17] - Due to crossover: CP (n=23)
    [18] - Due to crossover: IWI (n=22)
    No statistical analyses for this end point

    Secondary: Time to Onset and Duration of injection site reactions (ISRs)

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    End point title
    		 Time to Onset and Duration of injection site reactions (ISRs)
    End point description
    Time to onset (h) of injection site reactions will be calculated as: Date and time of start of ISR after infusion - date and time of start of preceding infusion. Duration (h) of injection site reactions will be calculated as: Date and time of stop of event - date and time of start of event.
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 CP (SAF) IWI (SAF)
    Number of subjects analysed
    11 [19]
    12 [20]
    Units: hours
    arithmetic mean (standard deviation)
        Time to onset
    0.49 ± 0.730
    0.47 ± 0.295
        Duration
    19.32 ± 29.381
    26.90 ± 40.500
    Notes
    [19] - Due to crossover: CP (n=23). Number of injection site reactions = 35.
    [20] - Due to crossover: IWI (n=22). Number of injection site reactions = 26.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 8 weeks for each subject
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    CP (SAF)
    Reporting group description
    		 -

    Reporting group title
    IWI (SAF)
    Reporting group description
    		 -

    Serious adverse events
    		 CP (SAF) IWI (SAF)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CP (SAF) IWI (SAF)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 23 (47.83%)
    6 / 22 (27.27%)
    General disorders and administration site conditions
    Injection site induration
         subjects affected / exposed
    5 / 23 (21.74%)
    5 / 22 (22.73%)
         occurrences all number
    17
    17
    Injection site pain
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 22 (4.55%)
         occurrences all number
    8
    5
    Injection site erythema
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 22 (4.55%)
         occurrences all number
    6
    1
    Injection site pruritus
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 22 (4.55%)
         occurrences all number
    4
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    Sinusitis
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Nov 2018
    Removal of testing for HIV-2; Change to timing of vital signs after end of infusion from 2h ± 5 min after start of infusion to 10 ± 5 min after end of infusion
    05 Jun 2019
    Modification of the PKS dataset; addition of the SPKS dataset; correction of the dosing accuracy for the IWI and CP residual volume calculation

    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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