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    Clinical Trial Results:
    Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib

    Summary
    EudraCT number
    		 2014-004278-40
    Trial protocol
    		 PL  
    Global end of trial date
    15 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Apr 2023
    First version publication date
    30 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA180-597
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02297139
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    29 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this clinical study was to provide dasatinib treatment to participants who have participated on a prior protocol investigating dasatinib and to monitor the safety and tolerability of dasatinib.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Poland: 16
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    9
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 17 participants were treated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prostate Cancer
    Arm description
    		 Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasatinib tablet administered once a day by mouth

    Arm title
    		 Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Arm description
    		 Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasatinib tablet administered once a day by mouth

    Number of subjects in period 1
    		Prostate Cancer Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Started
    1
    16
    Completed
    0
    0
    Not completed
    1
    16
         Disease progression
    -
    1
         Study drug toxicity
    -
    4
         Maximum clinical benefit
    1
    -
         Other reasons
    -
    8
         Participant request to discontinue study treatment
    -
    1
         Administrative reason by sponsor
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prostate Cancer
    Reporting group description
    		 Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.

    Reporting group title
    Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Reporting group description
    		 Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.

    Reporting group values
    		 Prostate Cancer Chronic Phase - Chronic Myeloid Leukemia (CP-CML) Total
    Number of subjects
    		 1 16 17
    Age categorical
    Units: Participants
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1 8 9
        From 65-84 years
    		 0 8 8
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        median (full range (min-max))
    		 58 (58 to 58) 64.5 (35 to 75) -
    Sex: Female, Male
    Units: Participants
        Female
    		 0 8 8
        Male
    		 1 8 9
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 0 16 16
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 0 15 15
        Unknown or Not Reported
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Prostate Cancer
    Reporting group description
    		 Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.

    Reporting group title
    Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Reporting group description
    		 Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.

    Primary: Number of Participants Who Received Dasatinib Treatment

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    End point title
    		 Number of Participants Who Received Dasatinib Treatment [1]
    End point description
    Number of participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
    End point type
    Primary
    End point timeframe
    From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
    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: Only summary statistics planned for this endpoint.
    End point values
    		 Prostate Cancer Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Number of subjects analysed
    1
    16
    Units: Participants
    1
    16
    No statistical analyses for this end point

    Primary: Duration of Treatment

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    End point title
    		 Duration of Treatment [2]
    End point description
    Duration of treatment for participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
    End point type
    Primary
    End point timeframe
    From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
    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: Only summary statistics planned for this endpoint.
    End point values
    		 Prostate Cancer Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Number of subjects analysed
    1
    16
    Units: Months
        median (full range (min-max))
    25.3 (25.3 to 25.3)
    55.9 (4.0 to 75.5)
    No statistical analyses for this end point

    Secondary: Number of Participants with Serious Adverse Events

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    End point title
    		 Number of Participants with Serious Adverse Events
    End point description
    Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
    End point type
    Secondary
    End point timeframe
    From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
    End point values
    		 Prostate Cancer Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Number of subjects analysed
    1
    16
    Units: Participants
    0
    8
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events

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    End point title
    		 Number of Participants with Adverse Events
    End point description
    Number of Participants with Adverse Events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
    End point type
    Secondary
    End point timeframe
    From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
    End point values
    		 Prostate Cancer Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Number of subjects analysed
    1
    16
    Units: Participants
    1
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs and NSAEs assessed from first dose to 30 days after last dose (up to approximately 77 months). Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
    Reporting group description
    		 Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.

    Reporting group title
    Prostate Cancer
    Reporting group description
    		 Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.

    Serious adverse events
    		 Chronic Phase - Chronic Myeloid Leukemia (CP-CML) Prostate Cancer
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 16 (50.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Thyroid neoplasm
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hydrothorax
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Chronic Phase - Chronic Myeloid Leukemia (CP-CML) Prostate Cancer
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 16 (93.75%)
    1 / 1 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Thyroid neoplasm
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 16 (37.50%)
    0 / 1 (0.00%)
         occurrences all number
    7
    0
    Phlebitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    Reproductive system and breast disorders
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    6 / 16 (37.50%)
    0 / 1 (0.00%)
         occurrences all number
    8
    0
    Hydrothorax
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood testosterone increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Mitral valve incompetence
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Angina pectoris
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Erythema multiforme
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Renal cyst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Spinal pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    4 / 16 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 16 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    Pneumonia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0

    More information

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

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

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