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    Clinical Trial Results:
    A Phase 2 Multicenter, 36-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years

    Summary
    EudraCT number
    		 2012-001681-15
    Trial protocol
    		 HU   BE   PT   IT  
    Global end of trial date
    10 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2016
    First version publication date
    17 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-390MR_207
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01642615
    WHO universal trial number (UTN)
    		 U1111-1128-6117
    Sponsors
    Sponsor organisation name
    Takeda Development Center Americas, Inc.
    Sponsor organisation address
    One Takeda Parkway, Deerfield, United States, 60015
    Public contact
    Study Registration Call Centre, Takeda Global Research & Development Center, Inc., 001 877-825-3327, medicalinformation@tpna.com
    Scientific contact
    Study Registration Call Centre, Takeda Global Research & Development Center, Inc., 001 877-825-3327, medicalinformation@tpna.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
    13 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 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
    United States: 22
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    Portugal: 4
    Worldwide total number of subjects
    62
    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)
    62
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 18 investigative sites in Mexico, Poland, Portugal and the United States from 22 June 2012 (first participant to sign the informed consent) to 10 November 2014.

    Pre-assignment
    Screening details
    		 63 adolescents with a diagnosis of erosive esophagitis (EE) were enrolled in the dexlansoprazole delayed release 60 mg capsules open label phase. One participant did not take study drug. Participants with healed EE were randomized into one of 2 treatment groups: dexlansoprazole delayed release 30 mg capsules or placebo in the maintenance phase

    Pre-assignment period milestones
    Number of subjects started
    		 63 [1]
    Number of subjects completed
    		 62

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did not receive treatment: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant did not receive study medication and therefore was not accounted for in the worldwide number enrolled.
    Period 1
    Period 1 title
    Open Label Healing Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Healing Phase: Dexlansoprazole 60 mg
    Arm description
    		 Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    dexslansoprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg delayed release capsules

    Number of subjects in period 1
    		Healing Phase: Dexlansoprazole 60 mg
    Started
    62
    Safety Analysis Set
    62
    Completed
    58
    Not completed
    4
         Pretreatment Event/Adverse Event
    1
         Major Protocol Deviation
    1
         Voluntary Withdrawal
    1
         Lost to follow-up
    1
    Period 2
    Period 2 title
    Double Blind Maintenance Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maintenance Phase: Dexlansoprazole 30 mg
    Arm description
    		 Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    dexlansoprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    delayed release capsules

    Arm title
    		 Maintenance Phase: Placebo
    Arm description
    		 Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo-matching dexlansoprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    dexlansoprazole placebo-matching capsules

    Number of subjects in period 2 [2]
    		Maintenance Phase: Dexlansoprazole 30 mg Maintenance Phase: Placebo
    Started
    25
    26
    Completed
    18
    20
    Not completed
    7
    6
         Pretreatment Event/Adverse Event
    1
    -
         Voluntary Withdrawal
    5
    2
         Requires Treatment with Another Drug
    -
    1
         Lack of efficacy
    1
    3
    Notes
    [2] - 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: Only participants with healing of EE at the end of the Open-Label Phase were eligible to participate in the Maintenance Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Healing Phase: Dexlansoprazole 60 mg
    Reporting group description
    		 Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.

    Reporting group values
    		 Healing Phase: Dexlansoprazole 60 mg Total
    Number of subjects
    		 62 62
    Age categorical
    Units: Subjects
        12 to 14 years
    		 24 24
        15 to 17 years
    		 38 38
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.8 ± 1.64 -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 38 38
    Race/Ethnicity, Customized
    Units: Subjects
        Not Hispanic or Latino
    		 16 16
        Hispanic or Latino
    		 6 6
        Not Collected outside the United States
    		 40 40
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 1 1
        White
    		 61 61
    Smoking Classification
    Units: Subjects
        Never smoked
    		 61 61
        Current smoker
    		 1 1
        Ex-smoker
    		 0 0
    Helicobacter pylori (H. pylori) Status
    Units: Subjects
        Positive
    		 0 0
        Negative
    		 61 61
        Unknown
    		 1 1
    Erosive Esophagitis Present
    Units: Subjects
        Yes
    		 62 62
        No
    		 0 0
    [Baseline EE Grade (LA Classification)]
    A=1 (or more) mucosal break 5 mm or less that does not extend between the tops of two mucosal folds, B=1 (or more) mucosal break more than 5 mm-long that does not extend between the tops of two mucosal folds, C=1 (or more) mucosal break that is continuous between the tops of two or more mucosal folds but that involves less than 75% of the circumference and D=1 (or more) mucosal break that involves at least 75% of the esophageal circumference.
    Units: Subjects
        Grade A
    		 34 34
        Grade B
    		 26 26
        Grade C
    		 1 1
        Grade D
    		 1 1
    Region of Enrollment
    Units: Subjects
        United States
    		 22 22
        Portugal
    		 4 4
        Poland
    		 34 34
        Mexico
    		 2 2
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 165.5 ± 9.68 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 61.86 ± 17.06 -
    Body Mass index (BMI)
    BMI is calculated using the weight and height.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 22.34 ± 5.086 -

    End points

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    End points reporting groups
    Reporting group title
    Healing Phase: Dexlansoprazole 60 mg
    Reporting group description
    		 Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
    Reporting group title
    Maintenance Phase: Dexlansoprazole 30 mg
    Reporting group description
    		 Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.

    Reporting group title
    Maintenance Phase: Placebo
    Reporting group description
    		 Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.

    Primary: Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period

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    End point title
    		 Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period [1]
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis not done.
    End point values
    		 Healing Phase: Dexlansoprazole 60 mg
    Number of subjects analysed
    62
    Units: percentage of participants
    number (not applicable)
        Diarrhoea
    6.5
        Nasopharyngitis
    6.5
        Headache
    12.9
        Oropharyngeal pain
    8.1
    No statistical analyses for this end point

    Primary: Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period

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    End point title
    		 Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period [2]
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.
    End point type
    Primary
    End point timeframe
    From Week 8 to Week 24
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis not done.
    End point values
    		 Maintenance Phase: Dexlansoprazole 30 mg Maintenance Phase: Placebo
    Number of subjects analysed
    25
    26
    Units: percentage of participants
    number (not applicable)
        Abdominal pain
    12
    11.5
        Abdominal pain upper
    4
    7.7
        Erosive oesophagitis
    4
    7.7
        Diarrhoea
    0
    7.7
        Pyrexia
    0
    7.7
        Nasopharyngitis
    12
    15.4
        Pharyngitis
    12
    0
        Sinusitis
    12
    0
        Upper respiratory tract infection
    8
    0
        Bronchitis
    8
    3.8
        Headache
    24
    15.4
        Insomnia
    8
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8

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    End point title
    		 Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8
    End point description
    Healing of EE was assessed by endoscopy.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Healing Phase: Dexlansoprazole 60 mg
    Number of subjects analysed
    58
    Units: percentage of participants
        number (confidence interval 95%)
    87.9 (76.7 to 95)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24

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    End point title
    		 Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24
    End point description
    Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy.
    End point type
    Secondary
    End point timeframe
    From Week 8 to Week 24
    End point values
    		 Maintenance Phase: Dexlansoprazole 30 mg Maintenance Phase: Placebo
    Number of subjects analysed
    22
    24
    Units: percentage of participants
        number (confidence interval 95%)
    81.8 (59.7 to 94.8)
    58.3 (36.6 to 77.9)
    No statistical analyses for this end point

    Secondary: Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment

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    End point title
    		 Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment
    End point description
    Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Healing Phase: Dexlansoprazole 60 mg
    Number of subjects analysed
    62
    Units: percent of days
        arithmetic mean (standard deviation)
    59.6 ± 30.46
    No statistical analyses for this end point

    Secondary: Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24

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    End point title
    		 Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24
    End point description
    The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.
    End point type
    Secondary
    End point timeframe
    Weeks 8 to 24
    End point values
    		 Maintenance Phase: Dexlansoprazole 30 mg Maintenance Phase: Placebo
    Number of subjects analysed
    24
    26
    Units: percent of days
        arithmetic mean (standard deviation)
    76.7 ± 29.82
    68.9 ± 26.04
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 Weeks
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Healing Phase: Dexlansoprazole 60 mg
    Reporting group description
    		 Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.

    Reporting group title
    Maintenance Phase: Dexlansoprazole 30 mg
    Reporting group description
    		 Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.

    Reporting group title
    Maintenance Phase: Placebo
    Reporting group description
    		 Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.

    Serious adverse events
    		 Healing Phase: Dexlansoprazole 60 mg Maintenance Phase: Dexlansoprazole 30 mg Maintenance Phase: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 25 (8.00%)
    1 / 26 (3.85%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Erosive oesophagitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Substance abuse
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    H1N1 influenza
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Healing Phase: Dexlansoprazole 60 mg Maintenance Phase: Dexlansoprazole 30 mg Maintenance Phase: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 62 (38.71%)
    14 / 25 (56.00%)
    11 / 26 (42.31%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 62 (12.90%)
    6 / 25 (24.00%)
    4 / 26 (15.38%)
         occurrences all number
    9
    9
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 25 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 62 (4.84%)
    3 / 25 (12.00%)
    3 / 26 (11.54%)
         occurrences all number
    4
    3
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 25 (4.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    1
    2
    Diarrhoea
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 25 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    5
    0
    2
    Erosive oesophagitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 25 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 62 (8.06%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
         occurrences all number
    5
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 25 (8.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    3
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 25 (8.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 62 (6.45%)
    3 / 25 (12.00%)
    4 / 26 (15.38%)
         occurrences all number
    5
    3
    4
    Pharyngitis
         subjects affected / exposed
    3 / 62 (4.84%)
    3 / 25 (12.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    3
    0
    Sinusitis
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 25 (12.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 25 (8.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Apr 2012
    1. In order to decrease the number of required biopsies and to allow flexibility for standard of care, the duodenal biopsies were removed and a serologic test was specified for use to screen for celiac disease. 2. To ensure compliance with local ethical and regulatory requirements, P450 CYP2C19 genotype testing was not required when local regulations prohibited it. Storage and use of samples were also clarified.
    25 Apr 2013
    1. In order to allow for a pre-screening endoscopy to be used for eligibility if all other protocol requirements were met, an allowance was made for the screening endoscopy to have been performed within 1 week prior to signing the informed consent/assent form. 2. In order to add flexibility for the time allowed for screening, a window of 5 days was added to the Screening Period. 3. The number of biopsies required at Screening was reduced in order to increase flexibility and to be aligned with standard of care for biopsy collection. 4. H. pylori test procedures were clarified, particularly for instances in which pre-screening endoscopy results were used to determine eligibility. 5. Exclusion criterion was updated regarding HIV status. 6. Exclusion criterion regarding alcohol use was updated to account for regional differences. 7. Inclusion and exclusion criterion were updated to account for allowance of endoscopies done prior to Screening and other H. pylori test methods. 8. Alternate dosing options were added to accommodate children who could not swallow the capsule.

    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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