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    Clinical Trial Results:
    A multicentre, randomised, double-blind, two arm, parallel group, pilot study to assess the effect of Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.

    Summary
    EudraCT number
    		 2012-004470-25
    Trial protocol
    		 GB  
    Global end of trial date
    23 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jun 2017
    First version publication date
    11 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GA1214
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Reckitt Benckiser Healthcare (UK) Ltd
    Sponsor organisation address
    Dansom Lane, Hull, United Kingdom, HU8 7DS
    Public contact
    Medical Director, Gastroenterology, Reckitt Benckiser, +44 1482 326151,
    Scientific contact
    Medical Director, Gastroenterology, Reckitt Benckiser, +44 1482 326151,
    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
    16 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this pilot study is to assess the efficacy of Gaviscon® Double Action Mint compared with Matched Placebo Liquid in the suppression of GORD symptoms in patients whose symptoms are inadequately controlled by once daily PPI therapy alone.
    Protection of trial subjects
    This study was conducted in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and the ethical principles contained within the Declaration of Helsinki, as referenced in EU Directive 2001/20/EC.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 2013
    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: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    51
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted in 1 centre in the United Kingdom.

    Pre-assignment
    Screening details
    		 A total of 83 participants were screened of which 31 subjects were screen failures and 52 were randomised.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo 20 ml by mouth 4 times a day for 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    20 ml taken 4 times a day for 7 days.

    Arm title
    		 Gaviscon Double Action Mint
    Arm description
    		 Gaviscon Double Action Mint 20 ml by mouth 4 times a day for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gaviscon Double Action Mint
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    20 ml taken 4 times a day for 7 days.

    Number of subjects in period 1
    		Placebo Gaviscon Double Action Mint
    Started
    26
    26
    Completed
    26
    26

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 20 ml by mouth 4 times a day for 7 days.

    Reporting group title
    Gaviscon Double Action Mint
    Reporting group description
    		 Gaviscon Double Action Mint 20 ml by mouth 4 times a day for 7 days.

    Reporting group values
    		 Placebo Gaviscon Double Action Mint Total
    Number of subjects
    		 26 26 52
    Age categorical
    ITT population
    Units: Subjects
        Adults (18-64 years)
    		 25 26 51
        From 65-84 years
    		 1 0 1
    Age continuous
    Intent-to-treat(ITT) population: All patients who were recruited to the study and had at least one day of complete heartburn and dyspepsia data post-baseline. This population was used for summaries of efficacy and baseline data.
    Units: years
        arithmetic mean (standard deviation)
    		 45.3 ± 12.32 45.4 ± 10.7 -
    Gender categorical
    ITT population
    Units: Subjects
        Female
    		 14 8 22
        Male
    		 12 18 30
    Race
    ITT population
    Units: Subjects
        Caucasian
    		 26 26 52
    Smoking habits (last 3 months)
    ITT population
    Units: Subjects
        Non-smoker
    		 14 20 34
        Smoker
    		 12 6 18
    Alcohol use
    ITT population
    Units: Subjects
        Non-drinker
    		 26 26 52
        Drinker
    		 0 0 0
    Drugs of abuse (last 3 months)
    IIT population
    Units: Subjects
        No
    		 26 26 52
        Yes
    		 0 0 0
    Body Mass Index (BMI)
    ITT population
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 30.41 ± 6.214 30.09 ± 6.074 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 20 ml by mouth 4 times a day for 7 days.

    Reporting group title
    Gaviscon Double Action Mint
    Reporting group description
    		 Gaviscon Double Action Mint 20 ml by mouth 4 times a day for 7 days.

    Primary: Change in mean HRDQ Score - Heartburn and Regurgitation Combined from baseline

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    End point title
    		 Change in mean HRDQ Score - Heartburn and Regurgitation Combined from baseline
    End point description
    ITT Population Heartburn Regurgitation and Dyspepsia Questionnaire (HRDQ): HRDQ is a self-assessed patient questionnaire designed to measure and evaluate specific GORD symptoms of heartburn, regurgitation and dyspepsia. Night time events and duration of symptoms were also assessed. The daily score is calculated as intensity x frequency, where intensity is scored as 0 = none, 1 = mild, 2 = moderate and 3 = severe and frequency was scored as 0 = none, 1 = once, 2 = twice, 3 = thrice, 4 = 4 or 5 times, 5 = 6 – 10 times and 6 = more than 10 times per day or constant. A HRDQ score of 0 represents no symptoms and a HRDQ score of 36 represents the highest frequency/severity of symptoms of heartburn and regurgitation combined.
    End point type
    Primary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: units on a scale
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    9.09 ± 5.74
    8.91 ± 5.34
        Visit 3, Post-baseline
    5.38 ± 4.81
    3.19 ± 3.23
        Change from baseline to post-baseline
    -3.7 ± 4.22
    -5.72 ± 3.52
    Statistical analysis title
    		 Change in HRDQ Score - Heartburn and Regurgitation
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in HRDQ Score – Heartburn

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    End point title
    		 Change From Baseline in HRDQ Score – Heartburn
    End point description
    ITT Population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: units on a scale
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    5.5 ± 3.39
    5.23 ± 3.51
        Visit 3, Post-baseline
    3.2 ± 2.78
    1.88 ± 1.99
        Change from baseline to post-baseline
    -2.3 ± 2.56
    -3.35 ± 2.52
    Statistical analysis title
    		 Change in HRDQ Score - Heartburn
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0208
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in HRDQ Score – Regurgitation

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    End point title
    		 Change From Baseline in HRDQ Score – Regurgitation
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: units on a scale
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    3.59 ± 2.64
    3.68 ± 2.88
        Visit 3, Post-baseline
    2.19 ± 2.18
    1.31 ± 1.41
        Change from baseline to post-baseline
    -1.4 ± 2.02
    -2.37 ± 2.02
    Statistical analysis title
    		 Change in HRDQ Score - Regurgitation
    Comparison groups
    Gaviscon Double Action Mint v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0181
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in HRDQ Score – Dyspepsia

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    End point title
    		 Change From Baseline in HRDQ Score – Dyspepsia
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: units on a scale
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    3.98 ± 3.41
    3.32 ± 3.78
        Visit 3, Post-baseline
    2.02 ± 2.36
    1.5 ± 2.24
        Change from baseline to post-baseline
    -1.96 ± 2.7
    -1.82 ± 2.09
    Statistical analysis title
    		 Change in HRDQ Score - Dyspepsia
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6357
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Frequency of Heartburn (HRDQ Score)

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    End point title
    		 Change From Baseline in Frequency of Heartburn (HRDQ Score)
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: Number of Events
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    2.97 ± 1.41
    2.86 ± 1.53
        Visit 3, Post-baseline
    2.07 ± 1.45
    1.38 ± 1.19
        Change from baseline to post-baseline
    -0.9 ± 1.03
    -1.47 ± 1.1
    Statistical analysis title
    		 Change in HRDQ Score - Frequency of Heartburn
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0229
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Frequency of Regurgitation (HRDQ Score)

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    End point title
    		 Change From Baseline in Frequency of Regurgitation (HRDQ Score)
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: Number of Events
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    1.97 ± 1.27
    2.04 ± 1.18
        Visit 3, Post-baseline
    1.47 ± 1.28
    0.97 ± 0.91
        Change from baseline to post-baseline
    -0.5 ± 0.88
    -1.06 ± 0.82
    Statistical analysis title
    		 Change in HRDQ Score - Frequency of Regurgitation
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0125
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Frequency of Dyspepsia (HRDQ Score)

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    End point title
    		 Change From Baseline in Frequency of Dyspepsia (HRDQ Score)
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: Number of Events
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    2.26 ± 1.66
    1.82 ± 1.59
        Visit 3, Post-baseline
    1.32 ± 1.53
    1.01 ± 1.22
        Change from baseline to post-baseline
    -0.93 ± 1.06
    -0.81 ± 0.89
    Statistical analysis title
    		 Change in HRDQ Score - Frequency of Dyspepsia
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9515
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Number of Symptom-Free Days (HRDQ)

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    End point title
    		 Change From Baseline in Number of Symptom-Free Days (HRDQ)
    End point description
    ITT population A symptom-free day is defined as a day where the respective symptoms: heartburn, regurgitation and dyspepsia (all derived from the HRDQ) had a value for frequency of 0.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: Days
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    0.38 ± 1.02
    0.23 ± 0.71
        Visit 3, Post-baseline
    1.31 ± 1.85
    1.73 ± 2.28
        Change from baseline to post-baseline
    0.92 ± 1.5
    1.5 ± 1.87
    Statistical analysis title
    		 Change in Number of Symptom - Free Days (HRDQ)
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1717
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in number of symptom-free days (ReQuest)

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    End point title
    		 Change in number of symptom-free days (ReQuest)
    End point description
    ITT population ReQuest GI is a self-assessed, dimension-orientated scale designed to evaluate treatment response on a daily basis in patients suffering from GORD. The scale assesses 4 dimensions of GORD. Intensity is measured on a 100-mm VAS and frequency on a 7-point Likert scale (0 to 10 times/constant per day). The range of the ReQuest™ GI score is from 0 reflecting no symptoms to 30.77 reflecting the highest severity/frequency of symptoms. A symptom-free day is defined as a day where the respective symptoms: acid complaints, upper abdominal/stomach complaints, lower abdominal/digestive complaints and nausea (all derived from ReQuest™) had a value for frequency of 0.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: Days
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    0.73 ± 1.46
    0.23 ± 0.65
        Visit 3, Post-baseline
    1.81 ± 2.33
    1.85 ± 2.4
        Change from baseline to post-baseline
    1.08 ± 1.83
    1.62 ± 2.16
    Statistical analysis title
    		 Change in Number of Symptom - Free Days (ReQuest)
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3002
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Number of Days With Night Time Symptoms

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    End point title
    		 Change From Baseline in Number of Days With Night Time Symptoms
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: Days
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    4.31 ± 2.51
    3.94 ± 2.15
        Visit 3, Post-baseline
    2.92 ± 2.83
    2 ± 2.47
        Change from baseline to post-baseline
    -1.38 ± 1.94
    -1.94 ± 2.07
    Statistical analysis title
    		 Change in Number of Days With Night Time Symptoms
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2458
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Duration of Symptoms

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    End point title
    		 Change From Baseline in Duration of Symptoms
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: minutes
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    188.23 ± 202.47
    142.85 ± 151.3
        Visit 3, Post-baseline
    111.52 ± 174.05
    56.82 ± 87.51
        Change from baseline to post-baseline
    -76.71 ± 105.19
    -86.02 ± 85.73
    Statistical analysis title
    		 Change in Duration of Symptoms
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2314
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in ReQuest GI Scores

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    End point title
    		 Change From Baseline in ReQuest GI Scores
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: units on a scale
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    5.94 ± 5.46
    6.88 ± 5.91
        Visit 3, Post-baseline
    3.25 ± 4.21
    2.49 ± 2.8
        Change from baseline to post-baseline
    -2.69 ± 3.59
    -4.4 ± 3.89
    Statistical analysis title
    		 Change in ReQuest GI Scores
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0656
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in the Patient Satisfaction Score

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    End point title
    		 Change in the Patient Satisfaction Score
    End point description
    ITT population Patient satisfaction with medication in controlling their symptoms was assessed in response to the question: Thinking back over the past 7 days and the medication you received, how satisfied are you with the control of your symptoms? The patient was to draw a perpendicular line on a 10-cm VAS, with anchors at 0 = Very Dissatisfied and 10 = Very Satisfied. To assure compliance with the protocol requirements, quality checks on the VAS score measurements were performed by the monitor.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Placebo Gaviscon Double Action Mint
    Number of subjects analysed
    26
    26
    Units: units on a scale
    arithmetic mean (standard deviation)
        Visit 2, Baseline
    2.57 ± 1.66
    3.11 ± 1.8
        Visit 3, Post-baseline
    5.26 ± 3.52
    7.42 ± 2.34
        Change from baseline to post-baseline
    2.8 ± 4.16
    4.36 ± 3.14
    Statistical analysis title
    		 Change in Patient Satisfaction Score
    Comparison groups
    Placebo v Gaviscon Double Action Mint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0101
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Visit 3
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 20 ml by mouth 4 times a day for 7 days.

    Reporting group title
    Gaviscon Double Action Mint
    Reporting group description
    		 Gaviscon Double Action Mint 20 ml by mouth 4 times a day for 7 days.

    Serious adverse events
    		 Placebo Gaviscon Double Action Mint
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Gaviscon Double Action Mint
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 26 (19.23%)
    7 / 26 (26.92%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    4 / 26 (15.38%)
    2 / 26 (7.69%)
         occurrences all number
    4
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Retching
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0

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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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