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    Clinical Trial Results:
    Taste and palatability of Orfadin suspension. An open, non-controlled 3-day study in pediatric patients with hereditary tyrosinemia type 1 treated with Orfadin.

    Summary
    EudraCT number
    		 2012-002286-36
    Trial protocol
    		 DE   GB  
    Global end of trial date
    01 Mar 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Sobi.NTBC-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01734889
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Swedish Orphan Biovitrum AB
    Sponsor organisation address
    Tomtebodavägen 23, Stockholm, Sweden, 11276
    Public contact
    Medical Director, Swedish Orphan Biovitrum AB, 0046 86970000, anders.broijersen@sobi.com
    Scientific contact
    Medical Director, Swedish Orphan Biovitrum AB, 0046 86970000, anders.broijersen@sobi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000784-PIP02-11
    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
    01 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the acceptability of the suspension in the pediatric population.
    Protection of trial subjects
    Monitoring procedures performed prior to, during, and upon completion of the study have verified that this study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 4
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    6
    Children (2-11 years)
    6
    Adolescents (12-17 years)
    6
    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
    		 -

    Pre-assignment
    Screening details
    		 Patients less than 18 years old with HT-1 currently managed on Orfadin (nitisinone) capsules.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The objective of this study was to demonstrate that taste and palatability of the suspension are acceptable to the patients, especially those who are too young to swallow capsules. The objective was not to compare the taste of the suspension with that of the capsules,nor to evaluate different flavors of the suspension. Therefore, an open, non-randomized designwas used.

    Arms
    Arm title
    		 Overall study
    Arm description
    		 All subjects receive the same study treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Orfadin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Orfadin suspension 4 mg/mL. Twice daily for three days, dose as current with Orfadin capsules

    Number of subjects in period 1
    		Overall study
    Started
    18
    Completed
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 18 18
    Age categorical
    Units: Subjects
        <5
    		 6 6
        5-<18
    		 12 12
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 9 9
    Subject analysis sets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of IMP

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who received at least one dose of IMP and had at least one taste or acceptability assessment

    Subject analysis set title
    Per protocol analysis set (PPAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who had completed the questionnaire at all occasions

    Subject analysis set title
    < 5 years (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Analyses of the data were made using subgroups <5 years and 5 to <18 years considered more appropriate for evaluation of taste and palatability and also related to the children’s ability to swallow capsules, as described in the clinical study report Sections 6.7.3.3 and 6.7.3.4

    Subject analysis set title
    5 - <18 years (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Analyses of the data were made using subgroups <5 years and 5 to <18 years considered more appropriate for evaluation of taste and palatability and also related to the children’s ability to swallow capsules, as described in the clinical study report Sections 6.7.3.3 and 6.7.3.4

    Subject analysis sets values
    		 Safety analysis set Full analysis set (FAS) Per protocol analysis set (PPAS) < 5 years (FAS) 5 - <18 years (FAS)
    Number of subjects
    18
    18
    18
    6
    12
    Age categorical
    Units: Subjects
        <5
    6
    6
    6
    6
    6
        5-<18
    12
    12
    12
    12
    12
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    9
    9
    9
    3
    6
        Male
    9
    9
    9
    3
    6

    End points

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    End points reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 All subjects receive the same study treatment

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of IMP

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who received at least one dose of IMP and had at least one taste or acceptability assessment

    Subject analysis set title
    Per protocol analysis set (PPAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who had completed the questionnaire at all occasions

    Subject analysis set title
    < 5 years (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Analyses of the data were made using subgroups <5 years and 5 to <18 years considered more appropriate for evaluation of taste and palatability and also related to the children’s ability to swallow capsules, as described in the clinical study report Sections 6.7.3.3 and 6.7.3.4

    Subject analysis set title
    5 - <18 years (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Analyses of the data were made using subgroups <5 years and 5 to <18 years considered more appropriate for evaluation of taste and palatability and also related to the children’s ability to swallow capsules, as described in the clinical study report Sections 6.7.3.3 and 6.7.3.4

    Primary: Taste score on Day 3 for subjects aged 5 - <18 years (Median)

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    End point title
    		 Taste score on Day 3 for subjects aged 5 - <18 years (Median) [1]
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the taste of the suspension on 5-graded verbal/numerical scales
    End point type
    Primary
    End point timeframe
    Taste score at the last dose of the suspension on Day 3
    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 statistical analyses was performed.
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: N/A
        median (full range (min-max))
    4 (2 to 5)
    No statistical analyses for this end point

    Primary: Taste score on Day 3 for subjects 5 to < 18 years (Categories)

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    End point title
    		 Taste score on Day 3 for subjects 5 to < 18 years (Categories) [2]
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the taste of the suspension on 5-graded verbal/numerical scales
    End point type
    Primary
    End point timeframe
    Taste score for the last dose on Day 3
    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: No statistical analyses was performed.
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: Number of subjects
        Very bad taste (1)
    0
        Bad taste (2)
    1
        Neither good nor bad taste (3)
    3
        Good taste (4)
    4
        Very good taste (5)
    4
    No statistical analyses for this end point

    Primary: Acceptability score on Day 3 for subjects < 5 years (Median)

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    End point title
    		 Acceptability score on Day 3 for subjects < 5 years (Median) [3]
    End point description
    For subjects younger than 5 years of age, one of the parents rated the child’s acceptability of the suspension on a verbal/numerical scale.
    End point type
    Primary
    End point timeframe
    Acceptability score at the last dose of the suspension on Day 3
    Notes
    [3] - 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 statistical analyses was performed.
    End point values
    		 < 5 years (FAS)
    Number of subjects analysed
    6
    Units: N/A
        median (full range (min-max))
    5 (4 to 5)
    No statistical analyses for this end point

    Primary: Acceptability score on Day 3 for subjects < 5 years (Categories)

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    End point title
    		 Acceptability score on Day 3 for subjects < 5 years (Categories) [4]
    End point description
    For subjects younger than 5 years of age, one of the parents rated the child’s acceptability of the suspension on a verbal/numerical scale.
    End point type
    Primary
    End point timeframe
    Acceptability score at the last dose of the suspension on Day 3
    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 statistical analyses was performed.
    End point values
    		 < 5 years (FAS)
    Number of subjects analysed
    6
    Units: Number of subjects
        Very badly (1)
    0
        Badly (2)
    0
        Neither well nor badly (3)
    0
        Well (4)
    2
        Very well (5)
    4
    No statistical analyses for this end point

    Secondary: Taste score on Day 1 for subjects aged 5 - <18 years (Median)

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    End point title
    		 Taste score on Day 1 for subjects aged 5 - <18 years (Median)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the taste of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: N/A
        median (full range (min-max))
    4 (3 to 5)
    No statistical analyses for this end point

    Secondary: Taste score on Day 1 for subjects aged 5 - <18 years (Categories)

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    End point title
    		 Taste score on Day 1 for subjects aged 5 - <18 years (Categories)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the taste of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: Number of subjects
        Very bad taste (1)
    0
        Bad taste (2)
    0
        Neither good nor bad taste (3)
    1
        Good taste (4)
    6
        Very good taste (5)
    5
    No statistical analyses for this end point

    Secondary: Taste score on Day 2 for subjects aged 5 - <18 years (Median)

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    End point title
    		 Taste score on Day 2 for subjects aged 5 - <18 years (Median)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the taste of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: N/A
        median (full range (min-max))
    4 (3 to 5)
    No statistical analyses for this end point

    Secondary: Taste score on Day 2 for subjects aged 5 - <18 years (Categories)

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    End point title
    		 Taste score on Day 2 for subjects aged 5 - <18 years (Categories)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the taste of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: Number of subjects
        Very bad taste (1)
    0
        Bad taste (2)
    0
        Neither good nor bad taste (3)
    3
        Good taste (4)
    6
        Very good taste (5)
    3
    No statistical analyses for this end point

    Secondary: Acceptability score Day 1 for subjects < 5 years (Median)

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    End point title
    		 Acceptability score Day 1 for subjects < 5 years (Median)
    End point description
    For subjects younger than 5 years of age, one of the parents rated the child’s acceptability of the suspension on a verbal/numerical scale.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 < 5 years (FAS)
    Number of subjects analysed
    6
    Units: N/A
        median (full range (min-max))
    4.5 (4 to 5)
    No statistical analyses for this end point

    Secondary: Acceptability score Day 1 for subjects < 5 years (Categories)

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    End point title
    		 Acceptability score Day 1 for subjects < 5 years (Categories)
    End point description
    For subjects younger than 5 years of age, one of the parents rated the child’s acceptability of the suspension on a verbal/numerical scale.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 < 5 years (FAS)
    Number of subjects analysed
    6
    Units: Number of subjects
        Very badly (1)
    0
        Badly (2)
    0
        Neither well nor badly (3)
    0
        Well (4)
    3
        Very well (5)
    3
    No statistical analyses for this end point

    Secondary: Acceptability score Day 2 for subjects < 5 years (Median)

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    End point title
    		 Acceptability score Day 2 for subjects < 5 years (Median)
    End point description
    For subjects younger than 5 years of age, one of the parents rated the child’s acceptability of the suspension on a verbal/numerical scale.
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 < 5 years (FAS)
    Number of subjects analysed
    6
    Units: N/A
        median (full range (min-max))
    5 (4 to 5)
    No statistical analyses for this end point

    Secondary: Acceptability score on Day 2 for subjects < 5 years (Categories)

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    End point title
    		 Acceptability score on Day 2 for subjects < 5 years (Categories)
    End point description
    For subjects younger than 5 years of age, one of the parents rated the child’s acceptability of the suspension on a verbal/numerical scale.
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 < 5 years (FAS)
    Number of subjects analysed
    6
    Units: Number of subjects
        Very badly (1)
    0
        Badly (2)
    0
        Neither well nor badly (3)
    0
        Well (4)
    1
        Very well (5)
    5
    No statistical analyses for this end point

    Secondary: Palatability score on Day 1 for subjects aged 5 - <18 years (Median)

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    End point title
    		 Palatability score on Day 1 for subjects aged 5 - <18 years (Median)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the palatability of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: N/A
        median (full range (min-max))
    4 (3 to 5)
    No statistical analyses for this end point

    Secondary: Palatability score on Day 1 for subjects aged 5 - <18 years (Categories)

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    End point title
    		 Palatability score on Day 1 for subjects aged 5 - <18 years (Categories)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the palatability of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: Number of subjects
        Very bad (1)
    0
        Bad (2)
    0
        Neither good nor bad (3)
    3
        Good (4)
    4
        Very good (5)
    5
    No statistical analyses for this end point

    Secondary: Palatability score on Day 2 for subjects aged 5 - <18 years (Median)

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    End point title
    		 Palatability score on Day 2 for subjects aged 5 - <18 years (Median)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the palatability of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: N/A
        median (full range (min-max))
    4 (2 to 5)
    No statistical analyses for this end point

    Secondary: Palatability score on Day 2 for subjects aged 5 - <18 years (Categories)

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    End point title
    		 Palatability score on Day 2 for subjects aged 5 - <18 years (Categories)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the palatability of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: Number of subjects
        Very bad (1)
    0
        Bad (2)
    1
        Neither good nor bad (3)
    4
        Good (4)
    3
        Very good (5)
    4
    No statistical analyses for this end point

    Secondary: Palatability score on Day 3 for subjects aged 5 - <18 years (Median)

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    End point title
    		 Palatability score on Day 3 for subjects aged 5 - <18 years (Median)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the palatability of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: N/A
        median (full range (min-max))
    4 (2 to 5)
    No statistical analyses for this end point

    Secondary: Palatability score on Day 3 for subjects aged 5 - <18 years (Categories)

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    End point title
    		 Palatability score on Day 3 for subjects aged 5 - <18 years (Categories)
    End point description
    Subjects who were 5 to < 18 years of age were asked to rate the palatability of the suspension on 5-graded verbal/numerical scales
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 5 - <18 years (FAS)
    Number of subjects analysed
    12
    Units: Number of subjects
        Very bad (1)
    0
        Bad (2)
    1
        Neither good nor bad (3)
    2
        Good (4)
    4
        Very good (5)
    5
    No statistical analyses for this end point

    Secondary: Overall acceptability

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    End point title
    		 Overall acceptability
    End point description
    At the end of the treatment period (last dose on Day 3), an overall question was filled out by the subject if possible, otherwise by the parent: “Would you/your child accept taking the new medicine again?”. The response alternatives were “Yes” or “No”.
    End point type
    Secondary
    End point timeframe
    After last dose on Day 3
    End point values
    		 Full analysis set (FAS)
    Number of subjects analysed
    18
    Units: Number of subjects
        Yes
    14
        No
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The AE reporting period began on administration of the first dose of IMP and ended at the last study visit (1 w after last dose of IMP).The SAE reporting period began when the subject had signed the informed consent until 28 days past the last dose of IMP
    Adverse event reporting additional description
    All directly observed AEs, and all AEs spontaneously reported by the subject, were recorded in the CRF. In addition, each subject was questioned about AEs during the follow-up telephone contact. The question asked was “Since you/your child began taking the Orfadin suspension, have you/has your child had any health problems?”
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    <5 years
    Reporting group description
    		 -

    Reporting group title
    5-<18 years
    Reporting group description
    		 -

    Reporting group title
    Safety analysis set
    Reporting group description
    		 -

    Serious adverse events
    		 <5 years 5-<18 years Safety analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 <5 years 5-<18 years Safety analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 12 (16.67%)
    4 / 18 (22.22%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Mouth hemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Regurgitation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    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
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