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    Clinical Trial Results:
    Evaluation of the subcutaneous administration of 30 mg of S 78989 versus placebo and evaluation of the subcutaneous administration of 60 mg of S78989 versus placebo on the reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation. A 28-weeks, randomised, double-blind, parallel-group, placebo controlled, international multicentre exploratory pilot study.

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-002677-53
    Trial protocol
    		 FI   NL  
    Global end of trial date
    24 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2016
    First version publication date
    23 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CL2-78989-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes, France, 92284 Cedex
    Public contact
    Clinical Studies Department, Institut de Recherches Internationales Servier, 33 155724366, clinicaltrials@servier.com
    Scientific contact
    Clinical Studies Department, Institut de Recherches Internationales Servier, 33 155724366, clinicaltrials@servier.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
    24 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to evaluate the effect of 4 successive monthly subcutaneous (SC) administrations of 30 mg of S78989 (gevokizumab) versus placebo as a first step, and 60 mg of S78989 (gevokizumab) versus placebo as a second step, on the reduction of arterial wall inflammation in adult patients with marked arterial wall inflammation following a recent acute coronary syndrome (ACS). The primary objective was to evaluate the effect of S78989 compared to placebo on arterial wall inflammation assessed by 18-Fluorodeoxyglucose-positron emission tomography/computed tomography (18FDG-PET/CT), in the most diseased region of interest (ROI) of both carotids and thoracic aortic walls. Part A (gevokizumab 30 mg vs placebo) and Part B (gevokizumab 60 mg vs placebo) are presented in parallel. However, it is to be noted that Part B of the trial was conducted after Part A and involved independent selection, randomisation, treatment and follow-up of patients.
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
    Background therapy
    		 Usual cardiovascular treatment
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2012
    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
    Canada: 55
    Country: Number of subjects enrolled
    Finland: 28
    Country: Number of subjects enrolled
    Netherlands: 10
    Worldwide total number of subjects
    93
    EEA total number of subjects
    38
    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)
    67
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Selected patients were male or females of non-childbearing potential, 50 years of age or older with a recent ACS defined as association of a chest pain episode or its equivalent and elevated troponin, PCI or significant coronary stenosis and had revascularisation procedures completed and received statins for at least 3 months at a stable dose.

    Period 1
    Period 1 title
    Treatment (W0 to W28) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: gevokizumab 30 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gevokizumab 30 mg
    Investigational medicinal product code
    S 78989 Gevokizumab
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Randomised patients received fixed dose 30 mg SC administrations of gevokizumab at baseline and then, every 4 weeks, for 12 weeks.

    Arm title
    		 Part A: Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Randomised patients received SC administrations of matching placebo at baseline and then, every 4 weeks for 12 weeks.

    Arm title
    		 Part B: gevokizumab 60 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gevokizumab 60 mg
    Investigational medicinal product code
    S 78989 Gevokizumab
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Randomised patients received fixed dose 60 mg SC administrations of gevokizumab at baseline and then, every 4 weeks, for 12 weeks.

    Arm title
    		 Part B: Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Randomised patients received SC administrations of matching placebo at baseline and then, every 4 weeks for 12 weeks.

    Number of subjects in period 1
    		Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Started
    32
    16
    31
    14
    Completed
    32
    16
    31
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: gevokizumab 30 mg
    Reporting group description
    		 -

    Reporting group title
    Part A: Placebo
    Reporting group description
    		 -

    Reporting group title
    Part B: gevokizumab 60 mg
    Reporting group description
    		 -

    Reporting group title
    Part B: Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo Total
    Number of subjects
    		 32 16 31 14 93
    Age categorical
    Units: Subjects
        < 65 years
    		 23 13 20 11 67
        >= 65 years
    		 9 3 11 3 26
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.3 ± 6.7 59.4 ± 6 60.8 ± 6.1 59.2 ± 6.5 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 4 1 9
        Male
    		 30 14 27 13 84

    End points

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    End points reporting groups
    Reporting group title
    Part A: gevokizumab 30 mg
    Reporting group description
    		 -

    Reporting group title
    Part A: Placebo
    Reporting group description
    		 -

    Reporting group title
    Part B: gevokizumab 60 mg
    Reporting group description
    		 -

    Reporting group title
    Part B: Placebo
    Reporting group description
    		 -

    Primary: Change from Baseline to W16 in mean max target to background ratio (TBR) assessed by FDG-PET/CT within the most diseased segment (MDS) of the left carotid region of interest (ROI)

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    End point title
    		 Change from Baseline to W16 in mean max target to background ratio (TBR) assessed by FDG-PET/CT within the most diseased segment (MDS) of the left carotid region of interest (ROI)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: standard uptake value
        median (inter-quartile range (Q1-Q3))
    0.01 (-0.15 to 0.15)
    -0.04 (-0.15 to 0.11)
    -0.075 (-0.17 to 0.045)
    0.16 (-0.05 to 0.26)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.19
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.31
         upper limit
    		 -0.03

    Primary: Change from Baseline to W16 in max mean TBR assessed by FDG-PET/CT within the MDS of the left carotid ROI

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    End point title
    		 Change from Baseline to W16 in max mean TBR assessed by FDG-PET/CT within the MDS of the left carotid ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    0.05 (-0.14 to 0.17)
    0.03 (-0.25 to 0.12)
    -0.045 (-0.115 to 0.1)
    0.12 (-0.02 to 0.24)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: Placebo v Part A: gevokizumab 30 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.22
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.02

    Primary: Change from Baseline to W16 in average mean TBR assessed by FDG-PET/CT within the MDS of the left carotid ROI

    		 Close Top of page
    End point title
    		 Change from Baseline to W16 in average mean TBR assessed by FDG-PET/CT within the MDS of the left carotid ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    0.02 (-0.11 to 0.12)
    0.01 (-0.15 to 0.11)
    -0.035 (-0.16 to 0.075)
    0.16 (-0.04 to 0.22)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.15
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0

    Primary: Change from Baseline to W16 in max max TBR assessed by FDG-PET/CT within the MDS of the left carotid ROI

    		 Close Top of page
    End point title
    		 Change from Baseline to W16 in max max TBR assessed by FDG-PET/CT within the MDS of the left carotid ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    0.06 (-0.1 to 0.25)
    -0.06 (-0.16 to 0.09)
    -0.045 (-0.145 to 0.065)
    0.13 (-0.06 to 0.29)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus matching placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hoges & Lehman estimate
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.3
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus matching placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 -0.01

    Primary: Change from Baseline to W16 in mean max TBR assessed by FDG-PET/CT within the MDS of the right carotid ROI

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    End point title
    		 Change from Baseline to W16 in mean max TBR assessed by FDG-PET/CT within the MDS of the right carotid ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    -0.03 (-0.09 to 0.09)
    0.02 (-0.12 to 0.06)
    -0.025 (-0.08 to 0.1)
    0.04 (-0.14 to 0.12)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.12
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.12

    Primary: Change from Baseline to W16 in max mean TBR assessed by FDG-PET/CT within the MDS of the right carotid ROI

    		 Close Top of page
    End point title
    		 Change from Baseline to W16 in max mean TBR assessed by FDG-PET/CT within the MDS of the right carotid ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    -0.05 (-0.12 to 0.06)
    0 (-0.12 to 0.1)
    -0.02 (-0.1 to 0.14)
    0.03 (-0.09 to 0.11)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.1
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.13

    Primary: Change from Baseline to W16 in average mean TBR assessed by FDG-PET/CT within the MDS of the right carotid ROI

    		 Close Top of page
    End point title
    		 Change from Baseline to W16 in average mean TBR assessed by FDG-PET/CT within the MDS of the right carotid ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    -0.03 (-0.1 to 0.07)
    0 (-0.13 to 0.04)
    -0.01 (-0.09 to 0.12)
    0.03 (-0.07 to 0.11)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.12
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.12

    Primary: Change from Baseline to W16 in max max TBR assessed by FDG-PET/CT within the MDS of the right carotid ROI

    		 Close Top of page
    End point title
    		 Change from Baseline to W16 in max max TBR assessed by FDG-PET/CT within the MDS of the right carotid ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    -0.05 (-0.13 to 0.07)
    0.04 (-0.11 to 0.14)
    -0.025 (-0.17 to 0.16)
    0.05 (-0.1 to 0.1)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.1
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: Placebo v Part B: gevokizumab 60 mg
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.15

    Primary: Change from Baseline to W16 in mean max TBR assessed by FDG-PET/CT within the MDS of the thoracic aorta ROI

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    End point title
    		 Change from Baseline to W16 in mean max TBR assessed by FDG-PET/CT within the MDS of the thoracic aorta ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    0 (-0.12 to 0.17)
    -0.12 (-0.28 to 0.06)
    0.02 (-0.17 to 0.09)
    0.02 (-0.21 to 0.11)
    Statistical analysis title
    		 Part A; gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.3
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.25

    Primary: Change from Baseline to W16 in max mean TBR assessed by FDG-PET/CT within the MDS of the thoracic aorta ROI

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    End point title
    		 Change from Baseline to W16 in max mean TBR assessed by FDG-PET/CT within the MDS of the thoracic aorta ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    0.09 (-0.01 to 0.17)
    -0.02 (-0.17 to 0.13)
    -0.01 (-0.15 to 0.12)
    0.08 (-0.15 to 0.24)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.24
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.11

    Primary: Change from Baseline to W16 in average mean TBR assessed by FDG-PET/CT within the MDS of the thoracic aorta ROI

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    End point title
    		 Change from Baseline to W16 in average mean TBR assessed by FDG-PET/CT within the MDS of the thoracic aorta ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    0.02 (-0.05 to 0.12)
    -0.02 (-0.1 to 0.06)
    0.01 (-0.15 to 0.1)
    0.05 (-0.12 to 0.24)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: gevokizumab 30 mg v Part A: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.16
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.1

    Primary: Change from Baseline to W16 in max max TBR assessed by FDG-PET/CT within the MDS of the thoracic aorta ROI

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    End point title
    		 Change from Baseline to W16 in max max TBR assessed by FDG-PET/CT within the MDS of the thoracic aorta ROI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to W16
    End point values
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Number of subjects analysed
    32
    16
    31
    14
    Units: Standard Uptake Value
        median (inter-quartile range (Q1-Q3))
    0.07 (-0.14 to 0.24)
    -0.2 (-0.38 to 0.02)
    0 (-0.19 to 0.2)
    -0.02 (-0.22 to 0.16)
    Statistical analysis title
    		 Part A: gevokizumab 30 mg versus placebo
    Comparison groups
    Part A: Placebo v Part A: gevokizumab 30 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.43
    Statistical analysis title
    		 Part B: gevokizumab 60 mg versus placebo
    Comparison groups
    Part B: gevokizumab 60 mg v Part B: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hodges & Lehman estimate
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.3

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to W28
    Adverse event reporting additional description
    The section non-serious adverse events presented emergent adverse events on treatment and included serious adverse events (SAEs). The causality and seriousness of reported SAEs are reported according to the investigator's opinion. The Sponsor took these decisions to be compliant with the existing ICH E3 Clinical Study Report.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Part A: gevokizumab 30 mg
    Reporting group description
    		 -

    Reporting group title
    Part A: Placebo
    Reporting group description
    		 -

    Reporting group title
    Part B: gevokizumab 60 mg
    Reporting group description
    		 -

    Reporting group title
    Part B: Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 32 (12.50%)
    2 / 16 (12.50%)
    2 / 31 (6.45%)
    2 / 14 (14.29%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial prostatitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: gevokizumab 30 mg Part A: Placebo Part B: gevokizumab 60 mg Part B: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 32 (71.88%)
    14 / 16 (87.50%)
    14 / 31 (45.16%)
    8 / 14 (57.14%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 16 (0.00%)
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         occurrences all number
    2
    0
    1
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 16 (0.00%)
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    0
    2
    1
    Fatigue
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Injection site erythema
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 16 (12.50%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    0
    1
    Cough
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Depression
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood creatinine phosphokinase increased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 16 (12.50%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 16 (0.00%)
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 16 (6.25%)
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eructation
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    0
    2
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    0
    1
    Bursitis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 16 (0.00%)
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Costochondritis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 32 (15.63%)
    4 / 16 (25.00%)
    4 / 31 (12.90%)
    4 / 14 (28.57%)
         occurrences all number
    5
    4
    5
    4
    Sinusitis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Erysipelas
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 31 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infected skin ulcer
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jan 2013
    - Modification of study duration (28 weeks) at the request of Health Canada - Modification of PET/CT central reading procedure to improve precision and validity of the results - Various minor changes to the protocol
    19 Feb 2013
    International harmonisation of the protocol by applying the changes described in the first amendment (31 January 2015) to centres in the Netherlands and Finland.
    22 Aug 2013
    - Addition of a new cohort of 45 patients treated with gevokizumab 60 mg or placebo - Various minor changes to the protocol - Extension of the period of the study from December 2013 to October 2014

    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.
    In this EudraCT report data for Part A and Part B are presented in parallel. However, it is to be noted that Part B of the trial was conducted after Part A and involved independent selection, randomisation, treatment and follow-up of patients.
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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