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    Clinical Trial Results:
    Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest including 12-month follow-up Part 1: 3-day treatment period including an 8-week follow-up period Part 2: extended 12-month follow-up period A phase 3, multi-centre, randomised, parallel group, double-blind, vehicle-controlled trial

    Summary
    EudraCT number
    		 2015-002449-71
    Trial protocol
    		 GB  
    Global end of trial date
    14 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Dec 2018
    First version publication date
    20 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0084-1193
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02547233
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.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
    27 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the efficacy of LEO 43204 gel (0.018% for face/chest) in AK when applied topically once daily for three consecutive days as field treatment
    Protection of trial subjects
    This clinical trial was conducted in accordance with the principles of the revision current at the start of the trial of the World Medical Association (WMA), Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects. All subjects received written and verbal information concerning the clinical trial. This information emphasised that participation in the clinical trial was voluntary and that the subject could withdraw from the clinical trial at any time and for any reason. All subjects were given an opportunity to ask questions and were given sufficient time to consider before consenting.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    United States: 244
    Worldwide total number of subjects
    305
    EEA total number of subjects
    61
    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)
    107
    From 65 to 84 years
    193
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 437 subjects were enrolled across 4 countries: United States, United Kingdom, France, and Spain. 130 were screening failures, and 307 subjects were randomised to 1 of the 2 treatment groups

    Pre-assignment
    Screening details
    		 437 subjects were enrolled, 130 were screening failures, and 307 subjects were randomised.

    Period 1
    Period 1 title
    3-day Treatment and 8-week Follow-up
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LEO 43204 0.018% Gel
    Arm description
    		 Treatment once daily with LEO 43204 0.018% gel for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 43204 0.018% Gel
    Investigational medicinal product code
    Other name
    Ingenol disoxate
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Applied topically once daily for 3 consecutive days.

    Arm title
    		 Vehicle Gel
    Arm description
    		 Treatment once daily with vehicle gel for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
    Arm type
    		 Placebo

    Investigational medicinal product name
    LEO 43204 Vehicle Gel
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Applied topically once daily for 3 consecutive days

    Number of subjects in period 1
    		LEO 43204 0.018% Gel Vehicle Gel
    Started
    205
    100
    Completed
    203
    92
    Not completed
    2
    8
         Unacceptable Local Skin Response
    1
    -
         Consent withdrawn by subject
    -
    7
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    -
    1
    Period 2
    Period 2 title
    12-month Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Follow-up phase: LEO 43204 0.018% Gel
    Arm description
    		 Treatment once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 43204 0.018% Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Applied topically once daily for 3 consecutive days.

    Arm title
    		 Follow-up phase: Vehicle Gel
    Arm description
    		 Treatment once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
    Arm type
    		 Placebo

    Investigational medicinal product name
    LEO 43204 Vehicle Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Applied topically once daily for 3 consecutive days

    Number of subjects in period 2 [1]
    		Follow-up phase: LEO 43204 0.018% Gel Follow-up phase: Vehicle Gel
    Started
    199
    84
    Completed
    185
    67
    Not completed
    14
    17
         Consent withdrawn by subject
    10
    10
         Other
    -
    1
         Lost to follow-up
    3
    3
         Lack of efficacy
    1
    2
         Protocol deviation
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Of the 295 subjects who completed the 3-day treatment and 8-week Follow-up period, 4 subjects in the ingenol disoxate gel group and 8 subjects in the vehicle group were not included in the 12-month Follow-up because they withdrew after Week 8.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LEO 43204 0.018% Gel
    Reporting group description
    		 Treatment once daily with LEO 43204 0.018% gel for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.

    Reporting group title
    Vehicle Gel
    Reporting group description
    		 Treatment once daily with vehicle gel for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.

    Reporting group values
    		 LEO 43204 0.018% Gel Vehicle Gel Total
    Number of subjects
    		 205 100 305
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 73 34 107
        From 65-84 years
    		 129 64 193
        85 years and over
    		 3 2 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.2 ( 8.9 ) 67.4 ( 9.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 67 38 105
        Male
    		 138 62 200

    End points

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    End points reporting groups
    Reporting group title
    LEO 43204 0.018% Gel
    Reporting group description
    		 Treatment once daily with LEO 43204 0.018% gel for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.

    Reporting group title
    Vehicle Gel
    Reporting group description
    		 Treatment once daily with vehicle gel for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
    Reporting group title
    Follow-up phase: LEO 43204 0.018% Gel
    Reporting group description
    		 Treatment once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.

    Reporting group title
    Follow-up phase: Vehicle Gel
    Reporting group description
    		 Treatment once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.

    Primary: Complete Clearance of Actinic Keratosis (AK)

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    End point title
    		 Complete Clearance of Actinic Keratosis (AK)
    End point description
    Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs in the treatment area. The table shows the percentage of mean number of subjects across imputations with complete clearance.
    End point type
    Primary
    End point timeframe
    At Week 8
    End point values
    		 LEO 43204 0.018% Gel Vehicle Gel
    Number of subjects analysed
    205
    100
    Units: percentage of subjects
        number (confidence interval 95%)
    31.3 (24.9 to 37.6)
    1.0 (-1.0 to 3.1)
    Statistical analysis title
    		 Analysis 1
    Statistical analysis description
    Mean number of subjects across imputations.
    Comparison groups
    LEO 43204 0.018% Gel v Vehicle Gel
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Ratio of clearance rates
    Point estimate
    30.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.28
         upper limit
    		 218
    Notes
    [1] - Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.

    Secondary: Partial Clearance (Multiple Imputation)

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    End point title
    		 Partial Clearance (Multiple Imputation)
    End point description
    Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of subjects across imputations with partial clearance.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 LEO 43204 0.018% Gel Vehicle Gel
    Number of subjects analysed
    205
    100
    Units: percentage of subjects
        number (confidence interval 95%)
    55.8 (49.0 to 62.7)
    4.6 (0.3 to 8.9)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites. The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.
    Comparison groups
    Vehicle Gel v LEO 43204 0.018% Gel
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Ratio of clearance rates
    Point estimate
    12.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.73
         upper limit
    		 31.78

    Secondary: Partial Clearance (Multiple Imputation)

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    End point title
    		 Partial Clearance (Multiple Imputation)
    End point description
    Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of subjects across imputations with partial clearance.
    End point type
    Secondary
    End point timeframe
    At Week 4
    End point values
    		 LEO 43204 0.018% Gel Vehicle Gel
    Number of subjects analysed
    205
    100
    Units: percentage of subjects
        number (confidence interval 95%)
    56.6 (49.7 to 63.4)
    5.5 (0.9 to 10.2)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    LEO 43204 0.018% Gel v Vehicle Gel
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.001
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Ratio of clearance rates
    Point estimate
    10.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.43
         upper limit
    		 23.97
    Notes
    [2] - Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites. The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.

    Secondary: Percent Reduction in AK Count in the Treatment Area Compared to Baseline

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    End point title
    		 Percent Reduction in AK Count in the Treatment Area Compared to Baseline
    End point description
    The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 LEO 43204 0.018% Gel Vehicle Gel
    Number of subjects analysed
    205
    100
    Units: percentage of reduction
        arithmetic mean (confidence interval 95%)
    72.1 (68.3 to 75.5)
    7.3 (-7.8 to 20.3)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    LEO 43204 0.018% Gel v Vehicle Gel
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Week 8 AK count ratio
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 0.37
    Notes
    [3] - The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.
    [4] - Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
    Adverse event reporting additional description
    Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    LEO 43204 0.018% Gel - Treatment Period Including Follow-up
    Reporting group description
    		 Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days.

    Reporting group title
    Vehicle Gel - Treatment Period Including Follow-up
    Reporting group description
    		 Treatment with vehicle gel once daily for 3 consecutive days.

    Reporting group title
    LEO 43204 0.018% Gel - Extended Follow-up
    Reporting group description
    		 Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days.

    Reporting group title
    Vehicle Gel - Extended Follow-up
    Reporting group description
    		 Treatment with vehicle gel once daily for 3 consecutive days.

    Serious adverse events
    		 LEO 43204 0.018% Gel - Treatment Period Including Follow-up Vehicle Gel - Treatment Period Including Follow-up LEO 43204 0.018% Gel - Extended Follow-up Vehicle Gel - Extended Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 205 (0.98%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (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
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (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
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (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
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (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
    Hyponatraemia
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (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
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 LEO 43204 0.018% Gel - Treatment Period Including Follow-up Vehicle Gel - Treatment Period Including Follow-up LEO 43204 0.018% Gel - Extended Follow-up Vehicle Gel - Extended Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    134 / 205 (65.37%)
    3 / 100 (3.00%)
    23 / 199 (11.56%)
    3 / 84 (3.57%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    4 / 205 (1.95%)
    1 / 100 (1.00%)
    9 / 199 (4.52%)
    1 / 84 (1.19%)
         occurrences all number
    4
    1
    9
    1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    8 / 205 (3.90%)
    2 / 100 (2.00%)
    10 / 199 (5.03%)
    1 / 84 (1.19%)
         occurrences all number
    8
    2
    10
    1
    Injury, poisoning and procedural complications
    Scar
         subjects affected / exposed
    0 / 205 (0.00%)
    0 / 100 (0.00%)
    9 / 199 (4.52%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    9
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 205 (4.88%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    10
    0
    0
    0
    General disorders and administration site conditions
    Application site discomfort
         subjects affected / exposed
    6 / 205 (2.93%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    6
    0
    0
    0
    Application site pain
         subjects affected / exposed
    120 / 205 (58.54%)
    1 / 100 (1.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    120
    1
    0
    0
    Application site paraesthesia
         subjects affected / exposed
    5 / 205 (2.44%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    5
    0
    0
    0
    Application site pruritus
         subjects affected / exposed
    71 / 205 (34.63%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    71
    0
    0
    0
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    8 / 205 (3.90%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    8
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    11 / 205 (5.37%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    11
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    6 / 205 (2.93%)
    0 / 100 (0.00%)
    0 / 199 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    6
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2016
    The protocol was updated to specify the method (an interactive web response system) for ensuring that the trial enrolled a minimum of 15% and a maximum of 25% of chest-treated subjects. The amendment also clarified which medications were allowed and prohibited during the extended follow-up period: lesion-directed laser treatment was added to the allowed medications, and Actikerall, even as lesion-directed treatment, and laser treatment as field treatment were prohibited.

    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
    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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