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    Clinical Trial Results:
    Pilot study with Staatl. Fachingen STILL for functional dyspepsia (particularly heartburn)

    Summary
    EudraCT number
    		 2013-001256-36
    Trial protocol
    		 DE  
    Global end of trial date
    04 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2022
    First version publication date
    25 Apr 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FACH/023212
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fachingen Heil- und Mineralbrunnen GmbH
    Sponsor organisation address
    Brunnenstrasse 11, Birlenbach OT Fachingen/Lahn, Germany, 65626
    Public contact
    Marketing Staatl. Fachingen, Fachingen Heil- und Mineralbrunnen GmbH, 0049 6432983468, heiner.wolters@fachingen.de
    Scientific contact
    Marketing Staatl. Fachingen, Fachingen Heil- und Mineralbrunnen GmbH, 0049 6432983468, heiner.wolters@fachingen.de
    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
    14 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigation of the efficacy and tolerability of Staatl. Fachingen STILL in the pre / post comparison. Efficacy parameters: -Therapeutic course based on the questionnaire data (questionnaires "Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI)) -Difference in the frequency of heartburn episodes per week -Difference in the subjective perception of well-being (SF-12 questionnaire ) -Differences in laboratory parameters (liver function, lipid metabolism) -Difference in body weight -Global assessment of efficacy by patient and investigator Tolerability parameters: -Adverse events (AEs) -Difference in blood pressure -Global assessment of tolerability by patient and investigator
    Protection of trial subjects
    Prior to recruitment of patients, all relevant documents of the clinical study were submitted and proved by the Independent Ethics Committees (IECs) responsible for the participating investigators. Written consent documents embodied the elements of informed consent as described in the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice (GCP) and were in accordance with all applicable laws and regulations. The informed consent form and patient information sheet described the planned and permitted uses, transfers and disclosures of the patient's personal data and personal health information for purposes of conducting the study. The informed consent form and the patient information sheet further explained the nature of the study, its objectives and potential risks and benefits as well as the date informed consent was given. Before being enrolled in the clinical trial, every patient was informed that participation in this trial was voluntary and that he/she could withdraw from the study at any time without giving a reason and without having to fear any loss in his/her medical care. The patient’s consent was obtained in writing before the start of the study. By signing the informed consent, the patient declared that he/she was participating voluntarily and intended to follow the study protocol instructions and the instructions of the investigator and to answer the questions asked during the course of the trial.
    Background therapy
    		 Patients were instructed to use medication for treatment of heartburn only in case of an emergency as a rescue medication. Intake of rescue medication was documented by the patients in a diary.
    Evidence for comparator
    		 No comparator was used for this pilot study.
    Actual start date of recruitment
    10 Jul 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
    Germany: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Data sets are available for 56 patients.

    Pre-assignment
    Screening details
    		 25 screening failures were documented.

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

    Arms
    Arm title
    		 Treatment
    Arm description
    		 This treatment arm has been created due to technical reason, as no single arm trial can be eneterd into the system. All data given for this fictive treatment arm are similar to the data given for the full analysis set
    Arm type
    		 Experimental

    Investigational medicinal product name
    Heilwasser Staatl. Fachingen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Daily intake of 1,5 liters throughout the day. 200-500 ml of IMP should be drunk 15 - 30 minutes before each main meal or with the meal, if needed.

    Number of subjects in period 1
    		Treatment
    Started
    56
    Completed
    56

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 This treatment arm has been created due to technical reason, as no single arm trial can be eneterd into the system. All data given for this fictive treatment arm are similar to the data given for the full analysis set

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 56 56
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 56 56
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.0 ( 12.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 26 26
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set includes all patients, who have taken the IMP at least once and from whom safety parameters are available.

    Subject analysis set title
    FAS population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set includes all patients who haven taken the IMP at least once and from whom efficacy data were available.

    Subject analysis set title
    VCAS population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The VCAS analysis set includes all patients who used the IMP according to the clinical trial protocol and from whom no serious deviation from the protocoll were documented.

    Subject analysis sets values
    		 Safety population FAS population VCAS population
    Number of subjects
    56
    53
    40
    Age categorical
    Units: Subjects
        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)
    56
    53
    40
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.0 ( 12.0 )
    36.2 ( 11.7 )
    35.7 ( 11.9 )
    Gender categorical
    Units: Subjects
        Female
    30
    28
    22
        Male
    26
    25
    18

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 This treatment arm has been created due to technical reason, as no single arm trial can be eneterd into the system. All data given for this fictive treatment arm are similar to the data given for the full analysis set

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set includes all patients, who have taken the IMP at least once and from whom safety parameters are available.

    Subject analysis set title
    FAS population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set includes all patients who haven taken the IMP at least once and from whom efficacy data were available.

    Subject analysis set title
    VCAS population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The VCAS analysis set includes all patients who used the IMP according to the clinical trial protocol and from whom no serious deviation from the protocoll were documented.

    Primary: Frequency of heartburn episodes

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    End point title
    		 Frequency of heartburn episodes
    End point description
    End point type
    Primary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: number per week
    arithmetic mean (standard deviation)
        V2
    7.09 ( 7.49 )
    7.09 ( 7.49 )
        V3
    3.02 ( 2.64 )
    3.02 ( 2.64 )
        V4
    2.32 ( 3.44 )
    2.32 ( 3.44 )
    Statistical analysis title
    		 Change of frequency of heartburn (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.01
         upper limit
    		 -2.14
    Variability estimate
    Standard deviation
    Dispersion value
    7.01
    Notes
    [1] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system
    Statistical analysis title
    		 Change of frequency of heartburn (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.05
         upper limit
    		 -2.5
    Variability estimate
    Standard deviation
    Dispersion value
    8.24
    Notes
    [2] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system

    Primary: Duration of heartburn per week

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    End point title
    		 Duration of heartburn per week
    End point description
    End point type
    Primary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: minute
    arithmetic mean (standard deviation)
        V2
    35.2 ( 41.4 )
    35.2 ( 41.4 )
        V3
    16.3 ( 17.4 )
    16.3 ( 17.4 )
        V4
    9.4 ( 11.6 )
    9.4 ( 11.6 )
    Statistical analysis title
    		 Change of duration of heartburn (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -18.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.9
         upper limit
    		 -9.7
    Variability estimate
    Standard deviation
    Dispersion value
    32.8
    Notes
    [3] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of duration of heartburn (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -25.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.8
         upper limit
    		 -15.6
    Variability estimate
    Standard deviation
    Dispersion value
    36.4
    Notes
    [4] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: RDQ dimension heartburn

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    End point title
    		 RDQ dimension heartburn
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: Score
    arithmetic mean (standard deviation)
        V2
    6.36 ( 4.56 )
    6.36 ( 4.56 )
        V3
    4.23 ( 3.85 )
    4.23 ( 3.85 )
        V4
    1.92 ( 2.40 )
    1.92 ( 2.40 )
    Statistical analysis title
    		 Change RDQ dimension heartburn (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.002
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.44
         upper limit
    		 -0.82
    Variability estimate
    Standard deviation
    Dispersion value
    4.74
    Notes
    [5] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change RDQ dimension heartburn (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.57
         upper limit
    		 -3.3
    Variability estimate
    Standard deviation
    Dispersion value
    4.11
    Notes
    [6] - explorative

    Secondary: RDQ dimension regurgitation

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    End point title
    		 RDQ dimension regurgitation
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    52
    52
    Units: Score
    arithmetic mean (standard deviation)
        V2
    7.46 ( 4.25 )
    7.46 ( 4.25 )
        V3
    4.08 ( 3.58 )
    4.08 ( 3.58 )
        V4
    2.60 ( 2.96 )
    2.60 ( 2.96 )
    Statistical analysis title
    		 Change of RDQ dimension regurgitation (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.59
         upper limit
    		 -2.18
    Variability estimate
    Standard deviation
    Dispersion value
    4.32
    Notes
    [7] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of RDQ dimension regurgitation (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.04
         upper limit
    		 3.69
    Variability estimate
    Standard deviation
    Dispersion value
    4.21
    Notes
    [8] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: RDQ dimension GERD

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    End point title
    		 RDQ dimension GERD
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    52
    52
    Units: Score
    arithmetic mean (standard deviation)
        V2
    13.79 ( 6.32 )
    13.79 ( 6.32 )
        V3
    8.23 ( 5.36 )
    8.23 ( 5.36 )
        V4
    4.56 ( 3.93 )
    4.56 ( 3.93 )
    Statistical analysis title
    		 Change of RDQ dimension GERD (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.34
         upper limit
    		 -3.77
    Variability estimate
    Standard deviation
    Dispersion value
    6.4
    Notes
    [9] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of RDQ dimension GERD (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.1
         upper limit
    		 -7.36
    Variability estimate
    Standard deviation
    Dispersion value
    6.69
    Notes
    [10] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: RDQ dimension dyspepsia

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    End point title
    		 RDQ dimension dyspepsia
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    51
    51
    Units: Score
    arithmetic mean (standard deviation)
        V2
    6.24 ( 4.16 )
    6.24 ( 4.16 )
        V3
    3.86 ( 3.30 )
    3.86 ( 3.30 )
        V4
    2.47 ( 3.05 )
    2.47 ( 3.05 )
    Statistical analysis title
    		 Change of RDQ dimension dyspepsia (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.49
         upper limit
    		 -1.25
    Variability estimate
    Standard deviation
    Dispersion value
    3.97
    Notes
    [11] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of RDQ dimension dyspepsia (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.99
         upper limit
    		 -2.54
    Variability estimate
    Standard deviation
    Dispersion value
    4.35
    Notes
    [12] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: GLQI totals score

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    End point title
    		 GLQI totals score
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: Score
    arithmetic mean (standard deviation)
        V2
    108.3 ( 16.0 )
    108.3 ( 16.0 )
        V3
    115.8 ( 13.9 )
    115.8 ( 13.9 )
        V4
    121.5 ( 14.0 )
    121.5 ( 14.0 )
    Statistical analysis title
    		 Change of GLQI total score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.18
         upper limit
    		 10.8
    Variability estimate
    Standard deviation
    Dispersion value
    12
    Notes
    [13] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of GLQI total score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.7
         upper limit
    		 16.6
    Variability estimate
    Standard deviation
    Dispersion value
    12.51
    Notes
    [14] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: GLQI dimension symptoms

    		 Close Top of page
    End point title
    		 GLQI dimension symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: Score
    arithmetic mean (standard deviation)
        V2
    56.2 ( 9.0 )
    56.2 ( 9.0 )
        V3
    60.9 ( 8.0 )
    60.9 ( 8.0 )
        V4
    65.0 ( 7.9 )
    65.0 ( 7.9 )
    Statistical analysis title
    		 Change of GLQI dimension symptoms (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.53
         upper limit
    		 6.98
    Variability estimate
    Standard deviation
    Dispersion value
    8.06
    Notes
    [15] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of GLQI dimension symptoms (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.74
         upper limit
    		 10.96
    Variability estimate
    Standard deviation
    Dispersion value
    7.64
    Notes
    [16] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: GLQI dimension emotions

    		 Close Top of page
    End point title
    		 GLQI dimension emotions
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    13.2 ( 2.7 )
    13.2 ( 2.7 )
        V3
    14.2 ( 2.2 )
    14.2 ( 2.2 )
        V4
    14.4 ( 2.0 )
    14.4 ( 2.0 )
    Statistical analysis title
    		 Change of GLQI dimension emotions (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.002
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.5
    Variability estimate
    Standard deviation
    Dispersion value
    2.06
    Notes
    [17] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of GLQI dimension emotions (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    P-value
    		 = 0.002
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.85
    Variability estimate
    Standard deviation
    Dispersion value
    2.57
    Notes
    [18] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: GLQI dimension physical function

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    End point title
    		 GLQI dimension physical function
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: Score
    arithmetic mean (standard deviation)
        V2
    20.8 ( 3.9 )
    20.8 ( 3.9 )
        V3
    22.5 ( 3.7 )
    22.5 ( 3.7 )
        V4
    23.3 ( 3.8 )
    23.3 ( 3.8 )
    Statistical analysis title
    		 Change of GLQI "physical function" (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 2.63
    Variability estimate
    Standard deviation
    Dispersion value
    3.22
    Notes
    [19] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of GLQI "physical function" (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.55
         upper limit
    		 3.55
    Variability estimate
    Standard deviation
    Dispersion value
    3.6
    Notes
    [20] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: GLQI dimension social function

    		 Close Top of page
    End point title
    		 GLQI dimension social function
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: Score
    arithmetic mean (standard deviation)
        V2
    14.4 ( 2.3 )
    14.4 ( 2.3 )
        V3
    14.5 ( 2.3 )
    14.5 ( 2.3 )
        V4
    15.0 ( 1.8 )
    15.0 ( 1.8 )
    Statistical analysis title
    		 Change of GLQI "social function" (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    P-value
    		 = 0.519
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 0.62
    Variability estimate
    Standard deviation
    Dispersion value
    1.69
    Notes
    [21] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change of GLQI "social function" (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [22]
    P-value
    		 = 0.017
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 1.2
    Variability estimate
    Standard deviation
    Dispersion value
    1.94
    Notes
    [22] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: QOLRAD domain "emotional distress"

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    End point title
    		 QOLRAD domain "emotional distress"
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    5.74 ( 1.17 )
    5.74 ( 1.17 )
        V3
    6.36 ( 0.77 )
    6.36 ( 0.77 )
        V4
    6.57 ( 0.72 )
    6.57 ( 0.72 )
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 0.94
    Variability estimate
    Standard deviation
    Dispersion value
    1.12
    Notes
    [23] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [24]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.13
    Variability estimate
    Standard deviation
    Dispersion value
    1.06
    Notes
    [24] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: QOLRAD domain "sleep disturbance"

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    End point title
    		 QOLRAD domain "sleep disturbance"
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    5.75 ( 1.12 )
    5.75 ( 1.12 )
        V3
    6.27 ( 0.78 )
    6.27 ( 0.78 )
        V4
    6.57 ( 0.70 )
    6.57 ( 0.70 )
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    P-value
    		 = 0.003
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 0.86
    Variability estimate
    Standard deviation
    Dispersion value
    1.23
    Notes
    [25] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [26]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.11
    Variability estimate
    Standard deviation
    Dispersion value
    1.05
    Notes
    [26] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: QOLRAD domain "food/drink problems"

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    End point title
    		 QOLRAD domain "food/drink problems"
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    5.22 ( 1.17 )
    5.22 ( 1.17 )
        V3
    6.07 ( 0.75 )
    6.07 ( 0.75 )
        V4
    6.38 ( 0.72 )
    6.38 ( 0.72 )
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.12
    Variability estimate
    Standard deviation
    Dispersion value
    1
    Notes
    [27] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [28]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.44
    Variability estimate
    Standard deviation
    Dispersion value
    1.02
    Notes
    [28] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: QOLRAD domain "physical/social functioning

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    End point title
    		 QOLRAD domain "physical/social functioning
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 4 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    6.20 ( 0.80 )
    6.20 ( 0.80 )
        V3
    6.56 ( 0.61 )
    6.56 ( 0.61 )
        V4
    6.77 ( 0.47 )
    6.77 ( 0.47 )
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 0.54
    Variability estimate
    Standard deviation
    Dispersion value
    0.65
    Notes
    [29] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [30]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.78
    Variability estimate
    Standard deviation
    Dispersion value
    0.74
    Notes
    [30] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: QOLRAD domain "vitality"

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    End point title
    		 QOLRAD domain "vitality"
    End point description
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    5.48 ( 1.14 )
    5.48 ( 1.14 )
        V3
    5.94 ( 0.93 )
    5.94 ( 0.93 )
        V4
    6.37 ( 0.79 )
    6.37 ( 0.79 )
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    P-value
    		 = 0.003
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 0.75
    Variability estimate
    Standard deviation
    Dispersion value
    1.08
    Notes
    [31] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Changes in QOLRAD domain score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [32]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.17
    Variability estimate
    Standard deviation
    Dispersion value
    1
    Notes
    [32] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 1

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    End point title
    		 SF-12 questionnaire - Question 1
    End point description
    Question 1: General health condition
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    2.49 ( 0.72 )
    2.49 ( 0.72 )
        V3
    2.42 ( 0.66 )
    2.42 ( 0.66 )
        V4
    2.38 ( 0.79 )
    2.38 ( 0.79 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [33]
    P-value
    		 = 0.438
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.12
    Variability estimate
    Standard deviation
    Dispersion value
    0.7
    Notes
    [33] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    P-value
    		 = 0.254
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.1
    Variability estimate
    Standard deviation
    Dispersion value
    0.83
    Notes
    [34] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 2

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    End point title
    		 SF-12 questionnaire - Question 2
    End point description
    Question 2: Difficulties with moderate physical activities
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    2.85 ( 0.36 )
    2.85 ( 0.36 )
        V3
    2.89 ( 0.32 )
    2.89 ( 0.32 )
        V4
    2.94 ( 0.23 )
    2.94 ( 0.23 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [35]
    P-value
    		 = 0.485
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.15
    Variability estimate
    Standard deviation
    Dispersion value
    0.39
    Notes
    [35] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [36]
    P-value
    		 = 0.058
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.2
    Variability estimate
    Standard deviation
    Dispersion value
    0.35
    Notes
    [36] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 3

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    End point title
    		 SF-12 questionnaire - Question 3
    End point description
    Question 3: Difficulties climbing stairs
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    2.87 ( 0.34 )
    2.87 ( 0.34 )
        V3
    2.89 ( 0.32 )
    2.89 ( 0.32 )
        V4
    2.94 ( 0.23 )
    2.94 ( 0.23 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    P-value
    		 = 0.659
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.11
    Variability estimate
    Standard deviation
    Dispersion value
    0.31
    Notes
    [37] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [38]
    P-value
    		 = 0.044
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.15
    Variability estimate
    Standard deviation
    Dispersion value
    0.27
    Notes
    [38] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 4

    		 Close Top of page
    End point title
    		 SF-12 questionnaire - Question 4
    End point description
    Question 4: Less task completed than intended (physical health)
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    1.79 ( 0.41 )
    1.79 ( 0.41 )
        V3
    1.87 ( 0.34 )
    1.87 ( 0.34 )
        V4
    1.87 ( 0.34 )
    1.87 ( 0.34 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [39]
    P-value
    		 = 0.209
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.21
    Variability estimate
    Standard deviation
    Dispersion value
    0.43
    Notes
    [39] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [40]
    P-value
    		 = 0.252
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.21
    Variability estimate
    Standard deviation
    Dispersion value
    0.43
    Notes
    [40] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 5

    		 Close Top of page
    End point title
    		 SF-12 questionnaire - Question 5
    End point description
    Question 5 : Ability to only do certain things (physical health)
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    1.91 ( 0.30 )
    1.91 ( 0.30 )
        V3
    1.91 ( 0.30 )
    1.91 ( 0.30 )
        V4
    1.94 ( 0.23 )
    1.94 ( 0.23 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [41]
    P-value
    		 = 1
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.08
    Variability estimate
    Standard deviation
    Dispersion value
    0.28
    Notes
    [41] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [42]
    P-value
    		 = 0.485
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.15
    Variability estimate
    Standard deviation
    Dispersion value
    0.39
    Notes
    [42] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 6

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    End point title
    		 SF-12 questionnaire - Question 6
    End point description
    Question 4: Less task completed than intended (mental health)
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    1.68 ( 0.47 )
    1.68 ( 0.47 )
        V3
    1.79 ( 0.41 )
    1.79 ( 0.41 )
        V4
    1.87 ( 0.34 )
    1.87 ( 0.34 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [43]
    P-value
    		 = 0.033
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.009
         upper limit
    		 0.22
    Variability estimate
    Standard deviation
    Dispersion value
    0.38
    Notes
    [43] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [44]
    P-value
    		 = 0.006
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.22
    Variability estimate
    Standard deviation
    Dispersion value
    0.44
    Notes
    [44] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 7

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    End point title
    		 SF-12 questionnaire - Question 7
    End point description
    Question 7 : Not being able to work concentrated (mental health)
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    1.89 ( 0.32 )
    1.89 ( 0.32 )
        V3
    1.87 ( 0.34 )
    1.87 ( 0.34 )
        V4
    1.94 ( 0.23 )
    1.94 ( 0.23 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [45]
    P-value
    		 = 0.659
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.07
    Variability estimate
    Standard deviation
    Dispersion value
    0.31
    Notes
    [45] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [46]
    P-value
    		 = 0.083
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.13
    Variability estimate
    Standard deviation
    Dispersion value
    0.23
    Notes
    [46] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 8

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    End point title
    		 SF-12 questionnaire - Question 8
    End point description
    Question 8: Pain during daily routine
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    1.66 ( 0.73 )
    1.66 ( 0.73 )
        V3
    1.40 ( 0.72 )
    1.40 ( 0.72 )
        V4
    1.17 ( 0.38 )
    1.17 ( 0.38 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [47]
    P-value
    		 = 0.056
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.01
    Variability estimate
    Standard deviation
    Dispersion value
    0.98
    Notes
    [47] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [48]
    P-value
    		 = 0.001
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 -0.27
    Variability estimate
    Standard deviation
    Dispersion value
    0.8
    Notes
    [48] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 9

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    End point title
    		 SF-12 questionnaire - Question 9
    End point description
    Question 9: calm and relaxed
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    2.92 ( 1.04 )
    2.92 ( 1.04 )
        V3
    2.68 ( 1.00 )
    2.68 ( 1.00 )
        V4
    2.60 ( 1.17 )
    2.60 ( 1.17 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [49]
    P-value
    		 = 0.14
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.58
         upper limit
    		 0.09
    Variability estimate
    Standard deviation
    Dispersion value
    1.19
    Notes
    [49] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [50]
    P-value
    		 = 0.107
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 0.08
    Variability estimate
    Standard deviation
    Dispersion value
    1.42
    Notes
    [50] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 10

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    End point title
    		 SF-12 questionnaire - Question 10
    End point description
    Question 10: Full of energy
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    3.23 ( 1.14 )
    3.23 ( 1.14 )
        V3
    3.08 ( 1.12 )
    3.08 ( 1.12 )
        V4
    2.68 ( 0.98 )
    2.68 ( 0.98 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [51]
    P-value
    		 = 0.28
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.13
    Variability estimate
    Standard deviation
    Dispersion value
    1.01
    Notes
    [51] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [52]
    P-value
    		 = 0.002
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 -0.2
    Variability estimate
    Standard deviation
    Dispersion value
    1.25
    Notes
    [52] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 11

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    End point title
    		 SF-12 questionnaire - Question 11
    End point description
    Question 11: discouraged and sad
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    52
    52
    Units: score
    arithmetic mean (standard deviation)
        V2
    4.90 ( 0.87 )
    4.90 ( 0.87 )
        V3
    5.02 ( 0.94 )
    5.02 ( 0.94 )
        V4
    4.98 ( 1.08 )
    4.98 ( 1.08 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [53]
    P-value
    		 = 0.371
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.38
    Variability estimate
    Standard deviation
    Dispersion value
    0.92
    Notes
    [53] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [54]
    P-value
    		 = 0.584
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.36
    Variability estimate
    Standard deviation
    Dispersion value
    1.01
    Notes
    [54] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: SF-12 questionnaire - Question 12

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    End point title
    		 SF-12 questionnaire - Question 12
    End point description
    Question 12: Impairment of contact with other people
    End point type
    Secondary
    End point timeframe
    V2 (baseline) V3 (after 3 weeks) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: score
    arithmetic mean (standard deviation)
        V2
    4.51 ( 0.72 )
    4.51 ( 0.72 )
        V3
    4.53 ( 0.82 )
    4.53 ( 0.82 )
        V4
    4.55 ( 0.77 )
    4.55 ( 0.77 )
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V3)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [55]
    P-value
    		 = 0.855
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.23
    Variability estimate
    Standard deviation
    Dispersion value
    0.75
    Notes
    [55] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.
    Statistical analysis title
    		 Change in SF-12 score (V2 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [56]
    P-value
    		 = 0.749
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.28
    Variability estimate
    Standard deviation
    Dispersion value
    0.85
    Notes
    [56] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: ALAT (Alanine Transaminase)

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    End point title
    		 ALAT (Alanine Transaminase)
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: µkat/l
    arithmetic mean (standard deviation)
        V1
    0.430 ( 0.184 )
    0.430 ( 0.184 )
        V4
    0.408 ( 0.181 )
    0.408 ( 0.181 )
    Statistical analysis title
    		 Change of ALAT (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [57]
    P-value
    		 = 0.152
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.022
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.01
    Variability estimate
    Standard deviation
    Dispersion value
    0.111
    Notes
    [57] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: ASAT (Aspartate transaminase)

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    End point title
    		 ASAT (Aspartate transaminase)
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: µkat/l
    arithmetic mean (standard deviation)
        V1
    0.402 ( 0.115 )
    0.402 ( 0.115 )
        V4
    0.400 ( 0.124 )
    0.400 ( 0.124 )
    Statistical analysis title
    		 Change of ASAT (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [58]
    P-value
    		 = 0.893
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.002
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.03
    Variability estimate
    Standard deviation
    Dispersion value
    0.091
    Notes
    [58] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: AP (Alkaline phosphatase)

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    End point title
    		 AP (Alkaline phosphatase)
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: µkat/l
    arithmetic mean (standard deviation)
        V1
    1.07 ( 0.28 )
    1.07 ( 0.28 )
        V4
    1.10 ( 0.28 )
    1.10 ( 0.28 )
    Statistical analysis title
    		 Change of AP (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [59]
    P-value
    		 = 0.221
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.07
    Variability estimate
    Standard deviation
    Dispersion value
    0.15
    Notes
    [59] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: g-GT (Gamma-glutamyltransferase)

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    End point title
    		 g-GT (Gamma-glutamyltransferase)
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: µkat/l
    arithmetic mean (standard deviation)
        V1
    0.374 ( 0.225 )
    0.374 ( 0.225 )
        V4
    0.362 ( 0.218 )
    0.362 ( 0.218 )
    Statistical analysis title
    		 Change of g-GT (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [60]
    P-value
    		 = 0.354
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.012
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.02
    Variability estimate
    Standard deviation
    Dispersion value
    0.091
    Notes
    [60] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: Bilirubin

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    End point title
    		 Bilirubin
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: µmol/l
    arithmetic mean (standard deviation)
        V1
    13.59 ( 7.74 )
    13.59 ( 7.74 )
        V4
    13.84 ( 8.60 )
    13.84 ( 8.60 )
    Statistical analysis title
    		 Change of bilirubin (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [61]
    P-value
    		 = 0.789
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 2.16
    Variability estimate
    Standard deviation
    Dispersion value
    6.91
    Notes
    [61] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: Triglycerides

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    End point title
    		 Triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: mmol/l
    arithmetic mean (standard deviation)
        V1
    1.26 ( 0.66 )
    1.26 ( 0.66 )
        V4
    1.20 ( 0.64 )
    1.20 ( 0.64 )
    Statistical analysis title
    		 Change of triglycerides (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [62]
    P-value
    		 = 0.465
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.11
    Variability estimate
    Standard deviation
    Dispersion value
    0.58
    Notes
    [62] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: Cholesterol

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    End point title
    		 Cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: mmol/l
    arithmetic mean (standard deviation)
        V1
    5.19 ( 1.05 )
    5.19 ( 1.05 )
        V4
    5.27 ( 1.10 )
    5.27 ( 1.10 )
    Statistical analysis title
    		 Change of cholesterol (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [63]
    P-value
    		 = 0.274
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.23
    Variability estimate
    Standard deviation
    Dispersion value
    0.54
    Notes
    [63] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: LDL (Low-density lipoprotein)

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    End point title
    		 LDL (Low-density lipoprotein)
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: mmol/l
    arithmetic mean (standard deviation)
        V1
    3.23 ( 0.94 )
    3.23 ( 0.94 )
        V4
    3.23 ( 0.97 )
    3.23 ( 0.97 )
    Statistical analysis title
    		 Change of LDL (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [64]
    P-value
    		 = 0.909
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.14
    Variability estimate
    Standard deviation
    Dispersion value
    0.47
    Notes
    [64] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: HDL (High-density lipoprotein)

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    End point title
    		 HDL (High-density lipoprotein)
    End point description
    End point type
    Secondary
    End point timeframe
    V1 (screening) V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: mmol/l
    arithmetic mean (standard deviation)
        V1
    1.45 ( 0.36 )
    1.45 ( 0.36 )
        V4
    1.48 ( 0.34 )
    1.48 ( 0.34 )
    Statistical analysis title
    		 Change of HDL (V1 vs. V4)
    Comparison groups
    Treatment v FAS population
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other [65]
    P-value
    		 = 0.259
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.08
    Variability estimate
    Standard deviation
    Dispersion value
    0.16
    Notes
    [65] - explorative Treatment arm was added due to work around for single arm trial. Thus, a total of 106 instead of 53 are given automatically by the system.

    Secondary: Global Assessment of Efficacy by Investigator

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    End point title
    		 Global Assessment of Efficacy by Investigator
    End point description
    End point type
    Secondary
    End point timeframe
    V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: percent
    number (not applicable)
        very good
    39.6
    39.6
        good
    54.7
    54.7
        moderate
    5.7
    5.7
        bad
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Global Assessment of Efficacy by Patients

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    End point title
    		 Global Assessment of Efficacy by Patients
    End point description
    End point type
    Secondary
    End point timeframe
    V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: percent
    number (not applicable)
        very good
    37.7
    37.7
        good
    54.7
    54.7
        moderate
    5.7
    5.7
        bad
    1.9
    1.9
    No statistical analyses for this end point

    Secondary: Global Assessment of Tolerability by Investigator

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    End point title
    		 Global Assessment of Tolerability by Investigator
    End point description
    End point type
    Secondary
    End point timeframe
    V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: percentage
    number (not applicable)
        very good
    83.0
    83.0
        good
    17.0
    17.0
        moderate
    0.0
    0.0
        bad
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Global Assessment of Tolerability by Patients

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    End point title
    		 Global Assessment of Tolerability by Patients
    End point description
    End point type
    Secondary
    End point timeframe
    V4 (after 6 weeks)
    End point values
    		 Treatment FAS population
    Number of subjects analysed
    53
    53
    Units: percent
    number (not applicable)
        very good
    79.2
    79.2
        good
    18.9
    18.9
        moderate
    1.9
    1.9
        bad
    0.0
    0.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    V3 - V4
    Adverse event reporting additional description
    Recording and Dokumentation of AEs at V3 (after 3 weeks) and V4 (after 6 weeks)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Safety-Population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety-Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Safety-Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 56 (7.14%)
    Injury, poisoning and procedural complications
    Contusion
    Additional description: Contusion, right hand
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Gastrointestinal disorders
    Meteorism
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Nov 2013
    - Adjustment of the age for inclusion criterions: 18-65 years instead of 18-55 years - Adjustment of exclusion criterions: Helicobacter pylori infection deleted as exclusion criterion - New chapter (10.7): Detection of a possible helicobacter pylori infection with a 13C-urea breath test at visit 1 -Amendment to the chapter 13.4 "statistical methods": Formation of subgroups to examine potential influencing factors on the course of therapy now possible
    17 Dec 2013
    - Amendment to Chapter 10.7 regaring the possibility of helicobacter pylori infection: Exclusion of the patient from the study if investigator decides that an antibiotic therapy is required du to H. pylori infection.

    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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