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    Clinical Trial Results:
    A Multi-centre, Open-label, Long-term, Safety Trial of Clin RA Gel in the Treatment of Acne Vulgaris.

    Summary
    EudraCT number
    		 2010-022912-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Jan 2005

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

    Trial information

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    Trial identification
    Sponsor protocol code
    MP-1501-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medicis Pharmaceutical Corp.
    Sponsor organisation address
    8125 North Hayden Road, Scottsdale, United States, AZ 85258
    Public contact
    Group leader study manager, MEDA Pharma GmbH & Co KG, +49 6172 888 01, 42b@medapharma.de
    Scientific contact
    Head of Corporate Clinical Affairs, MEDA Pharma GmbH & Co KG, +49 6172 888 01, 42b@medapharma.de
    Sponsor organisation name
    Dow Pharmaceutical Sciences, Inc.
    Sponsor organisation address
    1330A Redwood Way, Petaluma, United States, CA 94954- 1169
    Public contact
    Group leader study manager, MEDA Pharma GmbH & Co KG, +49 6172 888 01, 42b@medapharma.de
    Scientific contact
    Head of Corporate Clinical Affairs, MEDA Pharma GmbH & Co KG, +49 6172 888 01, 42b@medapharma.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000892-PIP01-10
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    11 Apr 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2005
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the long-term safety of the new combination therapy as a single therapy or with other concomitant acne medications for a six month period or one year period.
    Protection of trial subjects
    No specific additional measures to minimise pain and distress were required. The subjects could withdraw from treatment at any time and for any reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2004
    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: 442
    Worldwide total number of subjects
    442
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    242
    Adults (18-64 years)
    200
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Male or female subjects of any race, 12 years of age or older, with mild, moderate, or severe acne vulgaris.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Cohort 1
    Arm description
    		 Cohort 1 consists of all subjects who entered the long-term study and are the population of subjects in the 0 to 6 Month analyses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clin RA Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Topical application of study drug (active ingredients: Clindamycin phosphate 1.2% and Tretinoin 0.025% ) was made to the face once daily prior to bedtime, as directed by the investigator. After cleansing, the study drug was applied as a thin coating and rubbed into the skin. Total weekly dosage of study drug was anticipated to be no more than approximately 5 g/week.

    Arm title
    		 Cohort 2
    Arm description
    		 Cohort 2 consists of those subjects in Cohort 1 who continued to participate in the study past their 6-month visit and are the population of subjects in the 7 to 12-month analyses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clin RA Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Topical application of study drug (active ingredients: Clindamycin phosphate 1.2% and Tretinoin 0.025% ) was made to the face once daily prior to bedtime, as directed by the investigator. After cleansing, the study drug was applied as a thin coating and rubbed into the skin. Total weekly dosage of study drug was anticipated to be no more than approximately 5 g/week.

    Number of subjects in period 1
    		Cohort 1 Cohort 2
    Started
    442
    213
    Completed
    352
    195
    Not completed
    90
    18
         Acne flair
    1
    -
         Adverse event, non-fatal
    3
    -
         Not reported
    -
    2
         Subject request
    40
    8
         Lost to follow-up
    44
    7
         Protocol deviation
    1
    -
         Investigator request
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Cohort 1 consists of all subjects who entered the long-term study and are the population of subjects in the 0 to 6 Month analyses.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Cohort 2 consists of those subjects in Cohort 1 who continued to participate in the study past their 6-month visit and are the population of subjects in the 7 to 12-month analyses.

    Reporting group values
    		 Cohort 1 Cohort 2 Total
    Number of subjects
    		 442 213
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 20.4 ( 8.41 ) 20.16 ( 8.27 ) -
    Gender categorical
    Units: Subjects
        Female
    		 263 128 263
        Male
    		 179 85 179
    Evaluator's Global Severity Score at Baseline
    Units: Subjects
        Clear
    		 0 0 0
        Almost Clear
    		 0 0 0
        Mild
    		 217 106 217
        Moderate
    		 166 79 166
        Severe
    		 59 28 59
        Very Severe
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Cohort 1 consists of all subjects who entered the long-term study and are the population of subjects in the 0 to 6 Month analyses.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Cohort 2 consists of those subjects in Cohort 1 who continued to participate in the study past their 6-month visit and are the population of subjects in the 7 to 12-month analyses.

    Primary: Evaluator's Global Severity Score at Month 1

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    End point title
    		 Evaluator's Global Severity Score at Month 1 [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    Month 1 after baseline.
    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: No other statistical analyses besides descriptive statistics available for this end point.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 1.
    End point values
    		 Cohort 1
    Number of subjects analysed
    424 [3]
    Units: subjects
        Clear
    0
        Almost Clear
    34
        Mild
    237
        Moderate
    134
        Severe
    16
        Very Severe
    1
        Not Reported
    2
    Notes
    [3] - 424 subjects available at month 1.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 2

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    End point title
    		 Evaluator's Global Severity Score at Month 2 [4] [5]
    End point description
    End point type
    Primary
    End point timeframe
    Month 2 after baseline.
    Notes
    [4] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 1.
    End point values
    		 Cohort 1
    Number of subjects analysed
    395 [6]
    Units: subjects
        Clear
    6
        Almost Clear
    87
        Mild
    211
        Moderate
    86
        Severe
    5
        Very Severe
    0
        Not Reported
    0
    Notes
    [6] - 395 subjects avalibale at month 2.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 3

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    End point title
    		 Evaluator's Global Severity Score at Month 3 [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    Month 3 after baseline.
    Notes
    [7] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 1.
    End point values
    		 Cohort 1
    Number of subjects analysed
    384 [9]
    Units: subjects
        Clear
    19
        Almost Clear
    108
        Mild
    179
        Moderate
    76
        Severe
    2
        Very Severe
    0
        Not Reported
    0
    Notes
    [9] - 384 subjects avaliable at month 3.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 4

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    End point title
    		 Evaluator's Global Severity Score at Month 4 [10] [11]
    End point description
    End point type
    Primary
    End point timeframe
    Month 4 after baseline.
    Notes
    [10] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 1.
    End point values
    		 Cohort 1
    Number of subjects analysed
    367 [12]
    Units: subjects
        Clear
    20
        Almost Clear
    129
        Mild
    154
        Moderate
    63
        Severe
    1
        Very Severe
    0
        Not Reported
    0
    Notes
    [12] - 367 subjects available at month 4.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 5

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    End point title
    		 Evaluator's Global Severity Score at Month 5 [13] [14]
    End point description
    End point type
    Primary
    End point timeframe
    Month 5 after baseline.
    Notes
    [13] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 1.
    End point values
    		 Cohort 1
    Number of subjects analysed
    354 [15]
    Units: subjects
        Clear
    24
        Almost Clear
    133
        Mild
    138
        Moderate
    58
        Severe
    1
        Very Severe
    0
        Not Reported
    0
    Notes
    [15] - 354 subjects available at month 5.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 6

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    End point title
    		 Evaluator's Global Severity Score at Month 6 [16] [17]
    End point description
    End point type
    Primary
    End point timeframe
    Month 6 after baseline.
    Notes
    [16] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 1.
    End point values
    		 Cohort 1
    Number of subjects analysed
    351 [18]
    Units: subjects
        Clear
    32
        Almost Clear
    124
        Mild
    132
        Moderate
    60
        Severe
    3
        Very Severe
    0
        Not Reported
    0
    Notes
    [18] - 351 subjects available at month 6.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 7

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    End point title
    		 Evaluator's Global Severity Score at Month 7 [19] [20]
    End point description
    End point type
    Primary
    End point timeframe
    Month 7 after baseline.
    Notes
    [19] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 2.
    End point values
    		 Cohort 2
    Number of subjects analysed
    206 [21]
    Units: subjects
        Clear
    17
        Almost Clear
    77
        Mild
    82
        Moderate
    28
        Severe
    2
        Very Severe
    0
        Not Reported
    0
    Notes
    [21] - 206 subjects available at month 7.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 8

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    End point title
    		 Evaluator's Global Severity Score at Month 8 [22] [23]
    End point description
    End point type
    Primary
    End point timeframe
    Month 8 after baseline.
    Notes
    [22] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 2.
    End point values
    		 Cohort 2
    Number of subjects analysed
    200 [24]
    Units: subjects
        Clear
    23
        Almost Clear
    68
        Mild
    76
        Moderate
    32
        Severe
    0
        Very Severe
    0
        Not Reported
    1
    Notes
    [24] - 200 subjects available at month 8.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 9

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    End point title
    		 Evaluator's Global Severity Score at Month 9 [25] [26]
    End point description
    End point type
    Primary
    End point timeframe
    Month 9 after baseline.
    Notes
    [25] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 2.
    End point values
    		 Cohort 2
    Number of subjects analysed
    201 [27]
    Units: subjects
        Clear
    17
        Almost Clear
    80
        Mild
    72
        Moderate
    30
        Severe
    2
        Very Severe
    0
        Not Reported
    0
    Notes
    [27] - 201 subjects available at month 9.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 10

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    End point title
    		 Evaluator's Global Severity Score at Month 10 [28] [29]
    End point description
    End point type
    Primary
    End point timeframe
    Month 10 after baseline.
    Notes
    [28] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 2.
    End point values
    		 Cohort 2
    Number of subjects analysed
    198 [30]
    Units: subjects
        Clear
    16
        Almost Clear
    81
        Mild
    74
        Moderate
    24
        Severe
    3
        Very Severe
    0
        Not Reported
    0
    Notes
    [30] - 198 subjects available at month 10.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 11

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    End point title
    		 Evaluator's Global Severity Score at Month 11 [31] [32]
    End point description
    End point type
    Primary
    End point timeframe
    Month 11 after baseline.
    Notes
    [31] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 2.
    End point values
    		 Cohort 2
    Number of subjects analysed
    196 [33]
    Units: subjects
        Clear
    22
        Almost Clear
    75
        Mild
    69
        Moderate
    29
        Severe
    1
        Very Severe
    0
        Not Reported
    0
    Notes
    [33] - 196 subjects available at month 11.
    No statistical analyses for this end point

    Primary: Evaluator's Global Severity Score at Month 12

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    End point title
    		 Evaluator's Global Severity Score at Month 12 [34] [35]
    End point description
    End point type
    Primary
    End point timeframe
    Month 12 after baseline.
    Notes
    [34] - 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: No other statistical analyses besides descriptive statistics available for this end point.
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point reports only statistics for the arm Cohort 2.
    End point values
    		 Cohort 2
    Number of subjects analysed
    195 [36]
    Units: subjects
        Clear
    36
        Almost Clear
    76
        Mild
    62
        Moderate
    18
        Severe
    3
        Very Severe
    0
        Not Reported
    0
    Notes
    [36] - 195 subjects available at month 12.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study duration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.0
    Reporting groups
    Reporting group title
    Safety Evaluable Population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Evaluable Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 442 (1.36%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Bunion operation
         subjects affected / exposed
    1 / 442 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 442 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Eclampsia
         subjects affected / exposed
    1 / 442 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Caesarean section
         subjects affected / exposed
    1 / 442 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 442 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 442 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 442 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 442 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 Safety Evaluable Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    197 / 442 (44.57%)
    Injury, poisoning and procedural complications
    Sunburn
         subjects affected / exposed
    12 / 442 (2.71%)
         occurrences all number
    12
    Road traffic accident
         subjects affected / exposed
    5 / 442 (1.13%)
         occurrences all number
    5
    Joint sprain
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Post procedural pain
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    21 / 442 (4.75%)
         occurrences all number
    21
    Sinus headache
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    General disorders and administration site conditions
    Application site dermatitis
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Application site desquamation
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Application site dryness
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    7 / 442 (1.58%)
         occurrences all number
    7
    Seasonal allergy
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 442 (1.13%)
         occurrences all number
    5
    Toothache
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 442 (1.36%)
         occurrences all number
    6
    Pharyngolaryngeal pain
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    29 / 442 (6.56%)
         occurrences all number
    29
    Dermatitis contact
         subjects affected / exposed
    5 / 442 (1.13%)
         occurrences all number
    5
    Photosensitivity reaction
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 442 (1.36%)
         occurrences all number
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    17 / 442 (3.85%)
         occurrences all number
    17
    Sinusitis
         subjects affected / exposed
    13 / 442 (2.94%)
         occurrences all number
    13
    Ear infection
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Bronchitis
         subjects affected / exposed
    4 / 442 (0.90%)
         occurrences all number
    4
    Gastroenteritis viral
         subjects affected / exposed
    6 / 442 (1.36%)
         occurrences all number
    6
    Fungal infection
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Pharyngitis streptococcal
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    4 / 442 (0.90%)
         occurrences all number
    4
    Viral infection
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Tooth infection
         subjects affected / exposed
    3 / 442 (0.68%)
         occurrences all number
    3
    Gastroenteritis
         subjects affected / exposed
    5 / 442 (1.13%)
         occurrences all number
    5
    Upper respiratory tract infection
         subjects affected / exposed
    33 / 442 (7.47%)
         occurrences all number
    33
    Urinary tract infection
         subjects affected / exposed
    4 / 442 (0.90%)
         occurrences all number
    4

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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
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    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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