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    Clinical Trial Results:
    Monocenter, prospective, randomized placebo-controlled, double blind phase II trial to evaluate protective effects of Gingko biloba extract EGb 761® on temporary hearing damage caused by noise.

    Summary
    EudraCT number
    		 2013-000614-38
    Trial protocol
    		 DE  
    Global end of trial date
    16 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Sep 2017
    First version publication date
    28 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MW010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Willmar Schwabe GmbH & Co. KG
    Sponsor organisation address
    Willmar-Schwabe-Str. 4, Karlsruhe, Germany, 76227
    Public contact
    Abteilung Medizinische Wissenschaft, Dr. Willmar Schwabe GmbH & Co. KG, +49 07243106573, mw010@schwabe.de
    Scientific contact
    Abteilung Medizinische Wissenschaft, Dr. Willmar Schwabe GmbH & Co. KG, +49 07243106573, mw010@schwabe.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
    26 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the efficacy of EGb 761® against temporary hearing impairment due to noise (bilaterally 5 minutes 110 dB broadband noise) in healthy subjects.
    Protection of trial subjects
    Safety monitoring (adverse events [AEs], serious adverse events [SAEs], adverse drug reactions [ADRs]), assessment of laboratory data (blood chemistry, hematology), physical examination, ECG and vital signs.
    Background therapy
    		 None
    Evidence for comparator
    		 Not applicable. Placebo-controlled trial; no active comparator was used.
    Actual start date of recruitment
    02 Jul 2014
    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: 202
    Worldwide total number of subjects
    202
    EEA total number of subjects
    202
    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)
    202
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 202 subjects were enrolled and randomized. The duration of the recruitment phase was about two years. First subject was enrolled on 02-Jul-2014 (FPFV).

    Pre-assignment
    Screening details
    		 Suitable subjects were selected by the investigator according to the eligibility criteria specified in the protocol. 225 subjects were screened. 23 of the subjects were deemed screening failures. 202 subjects were enrolled into the trial.

    Pre-assignment period milestones
    Number of subjects started
    		 225 [1]
    Number of subjects completed
    		 202

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Inclusion criteria not met: 12
    Reason: Number of subjects
    		 Exclusion criteria not met: 8
    Reason: Number of subjects
    		 Not specified: 3
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 225 patients have been screened. 23 patients were deemed screening failures and were considered not eligible for participation. 202 patients were actually enrolled and randomized.
    Period 1
    Period 1 title
    Randomization
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EGb 761(R)
    Arm description
    		 Randomization | no study drug administration
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo
    Arm description
    		 Randomization | no study drug administration
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		EGb 761(R) Placebo
    Started
    100
    102
    Completed
    99
    101
    Not completed
    1
    1
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    1
    -
    Period 2
    Period 2 title
    Baseline
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EGb 761(R)
    Arm description
    		 Baseline | no study drug administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    EGb 761
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EGb 761 120 mg b.i.d. | p.o.

    Arm title
    		 Placebo
    Arm description
    		 Baseline | no study drug administration
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily one film-coated tablet of placebo matching EGb 761 p.o. for four weeks.

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Demographic and baseline characteristics were evaluated prior to randomization. However, a baseline period was set in this database for technical reasons to correctly enter demographic and baseline data, as the number of subjects in "the reporting group" is automatically set and cannot be changed. The reason for this is that the number of subjects for which demographic and baseline data was evaluated was different from the total number of randomized subjects.
    Number of subjects in period 2 [3]
    		EGb 761(R) Placebo
    Started
    99
    101
    Completed
    99
    101
    Notes
    [3] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The total number of randomized subjects (n=202) was higher than the number of subjects for which baseline data and demographic data was evaluated (n=200). Demographic and baseline characteristics were only evaluated for subjects included in the safety set (SAF; n=200).
    Period 3
    Period 3 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EGb 761(R)
    Arm description
    		 EGb 761(R) 120 mg b.i.d. | p.o.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EGb 761(R)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EGb 761(R) 120 mg b.i.d. | p.o.

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching EGb 761 b.i.d. | p.o.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily one film-coated tablet of placebo matching EGb 761 p.o. for four weeks.

    Number of subjects in period 3
    		EGb 761(R) Placebo
    Started
    99
    101
    Completed
    98
    100
    Not completed
    1
    1
         Physician decision
    1
    -
         Adverse event, non-fatal
    -
    1
    Period 4
    Period 4 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EGb 761(R)
    Arm description
    		 Follow-up | no study drug administration
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo
    Arm description
    		 Follow-up | no study drug administration
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		EGb 761(R) Placebo
    Started
    98
    100
    Completed
    98
    100

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EGb 761(R)
    Reporting group description
    		 Baseline | no study drug administration

    Reporting group title
    Placebo
    Reporting group description
    		 Baseline | no study drug administration

    Reporting group values
    		 EGb 761(R) Placebo Total
    Number of subjects
    		 99 101 200
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 99 101 200
        Not recorded
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 22.2 ( 1.9 ) 21.6 ( 2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 99 101 200
    Ethnic origin
    Units: Subjects
        Asian
    		 1 1 2
        Caucasian
    		 97 100 197
        Other: Arabic
    		 1 0 1
    Height (cm)
    Units: cm
        arithmetic mean (standard deviation)
    		 182.6 ( 6.9 ) 182.5 ( 7 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 78.9 ( 10.5 ) 79.4 ( 12.8 ) -
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 23.6 ( 2.4 ) 23.7 ( 2.9 ) -
    Subject analysis sets

    Subject analysis set title
    EGb 761(R) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis

    Subject analysis set title
    Placebo - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis

    Subject analysis set title
    EGb 761(R) - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol analysis

    Subject analysis set title
    Placebo - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol analysis

    Subject analysis set title
    EGb 761(R) - SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population

    Subject analysis set title
    Placebo - SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population

    Subject analysis sets values
    		 EGb 761(R) - FAS Placebo - FAS EGb 761(R) - PPS Placebo - PPS EGb 761(R) - SAF Placebo - SAF
    Number of subjects
    98
    100
    90
    88
    99
    101
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    99
    101
        Not recorded
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Ethnic origin
    Units: Subjects
        Asian
        Caucasian
        Other: Arabic
    Height (cm)
    Units: cm
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    EGb 761(R)
    Reporting group description
    		 Randomization | no study drug administration

    Reporting group title
    Placebo
    Reporting group description
    		 Randomization | no study drug administration
    Reporting group title
    EGb 761(R)
    Reporting group description
    		 Baseline | no study drug administration

    Reporting group title
    Placebo
    Reporting group description
    		 Baseline | no study drug administration
    Reporting group title
    EGb 761(R)
    Reporting group description
    		 EGb 761(R) 120 mg b.i.d. | p.o.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching EGb 761 b.i.d. | p.o.
    Reporting group title
    EGb 761(R)
    Reporting group description
    		 Follow-up | no study drug administration

    Reporting group title
    Placebo
    Reporting group description
    		 Follow-up | no study drug administration

    Subject analysis set title
    EGb 761(R) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis

    Subject analysis set title
    Placebo - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis

    Subject analysis set title
    EGb 761(R) - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol analysis

    Subject analysis set title
    Placebo - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol analysis

    Subject analysis set title
    EGb 761(R) - SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population

    Subject analysis set title
    Placebo - SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population

    Primary: Average increase in auditory threshold [all frequencies] - FAS

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    End point title
    		 Average increase in auditory threshold [all frequencies] - FAS
    End point description
    FAS Analysis
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    9.9 ( 4.6 )
    10.3 ( 5.3 )
    Statistical analysis title
    		 2-sided t-test (all frequencies) - FAS
    Statistical analysis description
    Analysis of the FAS: 2-sided t-test to compare the average increase of auditory thresholds over all frequencies of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5923
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Average increase in auditory threshold [all frequencies] - PPS

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    End point title
    		 Average increase in auditory threshold [all frequencies] - PPS
    End point description
    PPS analysis
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    9.8 ( 4.4 )
    10.4 ( 5.4 )
    Statistical analysis title
    		 2-sided t-test (all frequencies) - PPS
    Statistical analysis description
    Analysis of the PPS: 2-sided t-test to compare the average increase of auditory thresholds over all frequencies of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4641
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Average increase in auditory thresholds over 3, 4, 6 and 8 kHz - FAS

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    End point title
    		 Average increase in auditory thresholds over 3, 4, 6 and 8 kHz - FAS
    End point description
    Analysis of FAS
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: db
        arithmetic mean (standard deviation)
    11.9 ( 5.2 )
    12.8 ( 6.4 )
    Statistical analysis title
    		 2-sided t-test (3,4,6 and 8 kHz) - FAS
    Statistical analysis description
    Analysis of the FAS | Sensitivity Analysis 1: 2-sided t-test to compare the average increase of auditory thresholds over 3, 4, 6 and 8 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2661
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Average increase in auditory thresholds over 3, 4, 6 and 8 kHz - PPS

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    End point title
    		 Average increase in auditory thresholds over 3, 4, 6 and 8 kHz - PPS
    End point description
    Analysis of PPS
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    11.7 ( 5 )
    12.7 ( 6.4 )
    Statistical analysis title
    		 2-sided t-test (3,4,6 and 8 kHz) - PPS
    Statistical analysis description
    Analysis of the PPS | Sensitivity Analysis 1: 2-sided t-test to compare the average increase of auditory thresholds over 3, 4, 6 and 8 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2373
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Average increase in auditory thresholds | ANCOVA - FAS

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    End point title
    		 Average increase in auditory thresholds | ANCOVA - FAS
    End point description
    ANCOVA of average increase in auditory thresholds with treatment as inter-subject factor and time between end of irradiation and start of audiometry after irradiation as covariate.
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: db
        least squares mean (standard error)
    9.9846 ( 0.4707 )
    10.2571 ( 0.466 )
    Statistical analysis title
    		 ANCOVA - FAS
    Statistical analysis description
    Analysis of the FAS:
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.6813
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - Treatment df=1; F=0.17; p=0.6813 Audiometry lag [min] df=1; F=26.82; p<0.0001

    Primary: Average increase in auditory thresholds | ANCOVA - PPS

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    End point title
    		 Average increase in auditory thresholds | ANCOVA - PPS
    End point description
    ANCOVA of average increase in auditory thresholds with treatment as inter-subject factor and time between end of irradiation and start of audiometry after irradiation as covariate.
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: db
        least squares mean (standard error)
    10.0884 ( 0.4748 )
    10.0733 ( 0.4802 )
    Statistical analysis title
    		 ANCOVA - PPS
    Statistical analysis description
    Analysis of the PPS
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9822 [2]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [2] - Treatment df=1; F=0.00; p=0.9822 Audiometry lag [min] df=1; F=39.44; p<0.0001

    Primary: Change in auditory threshold at 3 kHz - FAS

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    End point title
    		 Change in auditory threshold at 3 kHz - FAS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    97 [3]
    100
    Units: db
        arithmetic mean (standard deviation)
    10 ( 5.6 )
    10.7 ( 7.7 )
    Notes
    [3] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test (3 kHz) - FAS
    Statistical analysis description
    Analysis of the FAS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 3 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4848
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 4 kHz - FAS

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    End point title
    		 Change in auditory threshold at 4 kHz - FAS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: db
        arithmetic mean (standard deviation)
    14.7 ( 8.8 )
    15.8 ( 9.6 )
    Statistical analysis title
    		 Two sided t-test (4 kHz) - FAS
    Statistical analysis description
    Analysis of the FAS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 4 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4017
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 6 kHz - FAS

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    End point title
    		 Change in auditory threshold at 6 kHz - FAS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    12.8 ( 5.4 )
    14.1 ( 6.3 )
    Statistical analysis title
    		 Two sided t-test (6 kHz) - FAS
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.1236
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [4] - Analysis of the FAS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 6 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.

    Primary: Change in auditory threshold at 8 kHz - FAS

    		 Close Top of page
    End point title
    		 Change in auditory threshold at 8 kHz - FAS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    9.9 ( 4.8 )
    10.5 ( 5.7 )
    Statistical analysis title
    		 Two sided t-test (8 kHz) - FAS
    Statistical analysis description
    Analysis of the FAS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 8 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4187
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 10 kHz - FAS

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    End point title
    		 Change in auditory threshold at 10 kHz - FAS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    8.7 ( 5.1 )
    7.9 ( 5 )
    Statistical analysis title
    		 Two sided t-test (10 kHz) - FAS
    Statistical analysis description
    Analysis of the FAS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 10 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2521
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 11.2 kHz - FAS

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    End point title
    		 Change in auditory threshold at 11.2 kHz - FAS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    97 [5]
    100
    Units: dB
        arithmetic mean (standard deviation)
    7.2 ( 5.8 )
    6.9 ( 5.7 )
    Notes
    [5] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test (11.2 kHz) - FAS
    Statistical analysis description
    Analysis of the FAS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 11.2 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7022
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 12.5 kHz - FAS

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    End point title
    		 Change in auditory threshold at 12.5 kHz - FAS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    97 [6]
    100
    Units: dB
        arithmetic mean (standard deviation)
    6.2 ( 6.1 )
    6.3 ( 6.4 )
    Notes
    [6] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test (12.5 kHz) - FAS
    Statistical analysis description
    Analysis of the FAS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 12.5 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9751
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 3 kHz - PPS

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    End point title
    		 Change in auditory threshold at 3 kHz - PPS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    89 [7]
    88
    Units: dB
        arithmetic mean (standard deviation)
    9.8 ( 5.4 )
    10.5 ( 7.8 )
    Notes
    [7] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test (3 kHz) - PPS
    Statistical analysis description
    Analysis of the PPS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 3 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4526
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 4 kHz - PPS

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    End point title
    		 Change in auditory threshold at 4 kHz - PPS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    14.2 ( 8.3 )
    15.7 ( 9.3 )
    Statistical analysis title
    		 Two sided t-test (4 kHz) - PPS
    Statistical analysis description
    Analysis of the PPS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 4 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2734
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 6 kHz - PPS

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    End point title
    		 Change in auditory threshold at 6 kHz - PPS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    12.7 ( 5.3 )
    14.1 ( 6.3 )
    Statistical analysis title
    		 Two sided t-test (6 kHz) - PPS
    Statistical analysis description
    Analysis of the PPS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 6 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1313
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 8 kHz - PPS

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    End point title
    		 Change in auditory threshold at 8 kHz - PPS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    10.1 ( 4.8 )
    10.6 ( 5.9 )
    Statistical analysis title
    		 Two sided t-test (8 kHz) - PPS
    Statistical analysis description
    Analysis of the PPS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 8 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5327
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 10 kHz - PPS

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    End point title
    		 Change in auditory threshold at 10 kHz - PPS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    8.7 ( 5.1 )
    7.9 ( 5.2 )
    Statistical analysis title
    		 Two sided t-test (10 kHz) - PPS
    Statistical analysis description
    Analysis of the PPS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 10 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3362
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 11.2 kHz - PPS

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    End point title
    		 Change in auditory threshold at 11.2 kHz - PPS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    89 [8]
    88
    Units: dB
        arithmetic mean (standard deviation)
    7.1 ( 5.7 )
    7.3 ( 5.9 )
    Notes
    [8] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test (11.2 kHz) - PPS
    Statistical analysis description
    Analysis of the PPS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 11.2 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8692
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in auditory threshold at 12.5 kHz - PPS

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    End point title
    		 Change in auditory threshold at 12.5 kHz - PPS
    End point description
    End point type
    Primary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication (visit 03)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    89 [9]
    88
    Units: dB
        arithmetic mean (standard deviation)
    6.2 ( 6 )
    6.5 ( 6.5 )
    Notes
    [9] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test (12.5 kHz) - PPS
    Statistical analysis description
    Analysis of the PPS| Sensitivity Analysis 2: Two sided t-test to compare the change of auditory thresholds at 12.5 kHz of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7715
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (3 kHz) - FAS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (3 kHz) - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    97 [10]
    100
    Units: No. of subjects with increased threshold
    2
    0
    Notes
    [10] - Data for one subject missing.
    Statistical analysis title
    		 Fisher Exact Test (3 kHz) - FAS
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2412
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (4 kHz) - FAS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (4 kHz) - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: No. of subjects with increased threshold
    1
    0
    Statistical analysis title
    		 Fisher Exact Test (4 kHz) - FAS
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4949
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (6 kHz) - FAS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (6 kHz) - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04)
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: No. of subjects with increased threshold
    1
    2
    Statistical analysis title
    		 Fisher Exact Test (6 kHz) - FAS
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (8 kHz) - FAS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (8 kHz) - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: No. of subjects with increased threshold
    4
    3
    Statistical analysis title
    		 Fisher Exact Test (8 kHz) - FAS
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7195
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (10 kHz) - FAS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (10 kHz) - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: No. of subjects with increased threshold
    5
    4
    Statistical analysis title
    		 Fisher Exact Test (10 kHz) - FAS
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7463
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (11.2 kHz) - FAS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (11.2 kHz) - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    97 [11]
    100
    Units: No. of subjects with increased threshold
    9
    5
    Notes
    [11] - Data for one subject missing.
    Statistical analysis title
    		 Fisher Exact Test (11.2 kHz) - FAS
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.278
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (12.5 kHz) - FAS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (12.5 kHz) - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    97 [12]
    100
    Units: No. of subjects with increased threshold
    9
    8
    Notes
    [12] - Data for one subject missing.
    Statistical analysis title
    		 Fisher Exact Test (12.5 kHz) - FAS
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8037
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) - FAS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) - FAS
    End point description
    Results display decrease observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    96 [13]
    99 [14]
    Units: dB
        arithmetic mean (standard deviation)
    0.2 ( 1.5 )
    -0.1 ( 1.9 )
    Notes
    [13] - Data for two subjects missing.
    [14] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2714
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post - V3pre) - FAS

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    End point title
    		 Decrease of the DPOAE (V3post - V3pre) - FAS
    End point description
    Results display decrease observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    99 [15]
    Units: dB
        arithmetic mean (standard deviation)
    -2.1 ( 2.1 )
    -2.2 ( 2 )
    Notes
    [15] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V3post-V3pre) - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7052
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the TEOAE (V4-V3pre) - FAS

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    End point title
    		 Decrease of the TEOAE (V4-V3pre) - FAS
    End point description
    Results display decrease observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    -0.4 ( 1.7 )
    -0.2 ( 1.3 )
    Statistical analysis title
    		 Two sided t-test TEOAE (V4-V3pre) - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of TEOAE from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3392
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the TEOAE (V3post - V3pre) - FAS

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    End point title
    		 Decrease of the TEOAE (V3post - V3pre) - FAS
    End point description
    Results display decrease observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    -1.6 ( 3.4 )
    -2 ( 4 )
    Statistical analysis title
    		 Two sided t-test TEOAE (V3post-V3pre) - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of TEOAE at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5442
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of TEOAE suppression (V4-V3pre) - FAS

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    End point title
    		 Decrease of TEOAE suppression (V4-V3pre) - FAS
    End point description
    Results display decrease observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    99 [16]
    Units: dB
        arithmetic mean (standard deviation)
    -0.3 ( 1.6 )
    -0.1 ( 1.7 )
    Notes
    [16] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test TEOAE suppress. (V4-V3pre) - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE suppression from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5679
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of TEOAE suppression (V3post - V3pre) - FAS

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    End point title
    		 Decrease of TEOAE suppression (V3post - V3pre) - FAS
    End point description
    Results display decrease observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    99 [17]
    Units: dB
        arithmetic mean (standard deviation)
    -0.4 ( 3.6 )
    -0.5 ( 4.2 )
    Notes
    [17] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test TEOAE suppr. (V3post-V3pre) - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of TEOAE suppression at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8136
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (3 kHz) - PPS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (3 kHz) - PPS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    89 [18]
    88
    Units: No. of subjects with increased threshold
    2
    0
    Notes
    [18] - Data for one subject missing.
    Statistical analysis title
    		 Fisher Exact Test (3 kHz) - PPS
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4972
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (4 kHz) - PPS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (4 kHz) - PPS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: No. of subjects with increased threshold
    1
    0
    Statistical analysis title
    		 Fisher Exact Test (4 kHz) - PPS
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (6 kHz) - PPS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (6 kHz) - PPS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: No. of subjects with increased threshold
    1
    2
    Statistical analysis title
    		 Fisher Exact Test (6 kHz) - PPS
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6186
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (8 kHz) - PPS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (8 kHz) - PPS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: No. of subjects with increased threshold
    3
    3
    Statistical analysis title
    		 Fisher Exact Test (8 kHz) -PPS
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (10 kHz) - PPS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (10 kHz) - PPS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: No. of subjects with increased threshold
    4
    4
    Statistical analysis title
    		 Fisher Exact Test (10 kHz) - PPS
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (11.2 kHz) - PPS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (11.2 kHz) - PPS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: No. of subjects with increased threshold
    8
    5
    Statistical analysis title
    		 Fisher Exact Test (11.2 kHz) - PPS
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5662
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Subjects with increase of auditory threshold > 5 dB (12.5 kHz) - PPS

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    End point title
    		 Subjects with increase of auditory threshold > 5 dB (12.5 kHz) - PPS
    End point description
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04)
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    89 [19]
    88
    Units: No. of subjects with increased threshold
    8
    7
    Notes
    [19] - Data for one subject missing.
    Statistical analysis title
    		 Fisher Exact Test (12.5 kHz) - PPS
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) - PPS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) - PPS
    End point description
    Results display decrease observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    88 [20]
    87 [21]
    Units: dB
        arithmetic mean (standard deviation)
    0.1 ( 1.6 )
    -0.1 ( 2 )
    Notes
    [20] - Data for two subjects missing.
    [21] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761 vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3326
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post - V3pre) - PPS

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    End point title
    		 Decrease of the DPOAE (V3post - V3pre) - PPS
    End point description
    Results display decrease observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -2.1 ( 2.1 )
    -2.2 ( 2 )
    Statistical analysis title
    		 Two sided t-test DPOAE (V3post-V3pre) - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761 vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7454
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the TEOAE (V4-V3pre) - PPS

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    End point title
    		 Decrease of the TEOAE (V4-V3pre) - PPS
    End point description
    Results display decrease observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -0.4 ( 1.8 )
    -0.3 ( 1.3 )
    Statistical analysis title
    		 Two sided t-test TEOAE (V4-V3pre) - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of TEOAE from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761 vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6945
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the TEOAE (V3post - V3pre) - PPS

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    End point title
    		 Decrease of the TEOAE (V3post - V3pre) - PPS
    End point description
    Results display decrease observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -1.7 ( 3.5 )
    -1.7 ( 3.1 )
    Statistical analysis title
    		 Two sided t-test TEOAE (V3post-V3pre) - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of TEOAE at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8556
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of TEOAE suppression (V4-V3pre) - PPS

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    End point title
    		 Decrease of TEOAE suppression (V4-V3pre) - PPS
    End point description
    Results display decrease observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    87 [22]
    Units: dB
        arithmetic mean (standard deviation)
    -0.2 ( 1.7 )
    -0.3 ( 1.6 )
    Notes
    [22] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test TEOAE suppress. (V4-V3pre) - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE suppression from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8686
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of TEOAE suppression (V3post - V3pre) - PPS

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    End point title
    		 Decrease of TEOAE suppression (V3post - V3pre) - PPS
    End point description
    Results display decrease observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    87 [23]
    Units: dB
        arithmetic mean (standard deviation)
    -0.4 ( 3.8 )
    -0.3 ( 3.8 )
    Notes
    [23] - Data for one subject missing.
    Statistical analysis title
    		 Two sided t-test TEOAE suppr. (V3post-V3pre) - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of TEOAE suppression at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9032
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: DPOAE Growth Function - FAS

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    End point title
    		 DPOAE Growth Function - FAS
    End point description
    DPOAE growth function at 4004 Hz, Signal-to-noise ratio (SNR) measured at 5 predefined sound level pairs.
    End point type
    Secondary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication prior (visit 03-pre) and after (visit 03-post) accoustic Irradiation.
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    91
    95
    Units: dB
        least squares mean (standard error)
    8.0261 ( 0.3805 )
    7.6022 ( 0.3726 )
    Statistical analysis title
    		 ANCOVA DPOAE Growth Function (SNR) - FAS
    Statistical analysis description
    Analysis of the FAS: ANCOVA of DPOAE growth function (at 4 kHz) taking into account measured levels of eliciting sounds, irradiation, time lag since irradiation, body side, and treatment group to compare differences between changes in SNR after acoustic irradiation of subjects receiving EGb 761(R) vs . Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0104 [24]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [24] - p-value for interaction timepoint (pre vs. post irradiation) x treatment

    Secondary: DPOAE Growth Function - PPS

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    End point title
    		 DPOAE Growth Function - PPS
    End point description
    DPOAE growth function at 4004 Hz, Signal-to-noise ratio (SNR) measured at 5 predefined sound level pairs
    End point type
    Secondary
    End point timeframe
    Measurements performed after 4-weeks of treatment with study medication prior (visit 03-pre) and after (visit 03-post) accoustic Irradiation.
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    83
    84
    Units: dB
        least squares mean (standard error)
    8.4504 ( 0.4007 )
    7.4385 ( 0.3987 )
    Statistical analysis title
    		 ANCOVA DPOAE Growth Function (SNR) - PPS
    Statistical analysis description
    Analysis of the PPS: ANCOVA of DPOAE growth function (at 4 kHz) taking into account measured levels of eliciting sounds, irradiation, time lag since irradiation, body side, and treatment group to compare differences between changes in SNR after acoustic irradiation of subjects receiving EGb 761(R) vs . Placebo
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0245 [25]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [25] - p-value for interaction timepoint (pre vs. post irradiation) x treatment

    Secondary: Decrease of the DPOAE (V4-V3pre) | 1.0 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 1.0 kHz - FAS
    End point description
    Results display decrease measured at 1.0 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    96 [26]
    100
    Units: dB
        arithmetic mean (standard deviation)
    -0.3 ( 4.1 )
    -0.8 ( 5.2 )
    Notes
    [26] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 1.0 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 1.0 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5027
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 1.4 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 1.4 kHz - FAS
    End point description
    Results display decrease measured at 1.4 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    96 [27]
    100
    Units: dB
        arithmetic mean (standard deviation)
    0.7 ( 3.8 )
    -0.1 ( 4.8 )
    Notes
    [27] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 1.4 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 1.4 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2113
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 2.0 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 2.0 kHz - FAS
    End point description
    Results display decrease measured at 2.0 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    96 [28]
    100
    Units: dB
        arithmetic mean (standard deviation)
    0.6 ( 3.7 )
    -0.4 ( 4.1 )
    Notes
    [28] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 2.0 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 2.0 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0685
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 2.8 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 2.8 kHz - FAS
    End point description
    Results display decrease measured at 2.8 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    96 [29]
    100
    Units: dB
        arithmetic mean (standard deviation)
    0 ( 3 )
    0 ( 4.3 )
    Notes
    [29] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 2.8 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 2.8 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.935
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 4.0 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 4.0 kHz - FAS
    End point description
    Results display decrease measured at 4.0 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    96 [30]
    100
    Units: dB
        arithmetic mean (standard deviation)
    0.3 ( 3.1 )
    -0.3 ( 3.2 )
    Notes
    [30] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 4.0 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 4.0 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2061
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 6.0 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 6.0 kHz - FAS
    End point description
    Results display decrease measured at 6.0 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    96 [31]
    100
    Units: dB
        arithmetic mean (standard deviation)
    0.5 ( 2.8 )
    0.2 ( 3.7 )
    Notes
    [31] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 6.0 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 6.0 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5657
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 1.0 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 1.0 kHz - FAS
    End point description
    Results display decrease measured at 1.0 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    -2.1 ( 4.2 )
    -1.7 ( 3.4 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 1.0 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 1.0 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4471
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 1.4 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 1.4 kHz - FAS
    End point description
    Results display decrease measured at 1.4 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    -1.4 ( 3.5 )
    -1.5 ( 5 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 1.4 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 1.4 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9261
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 2.0 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 2.0 kHz - FAS
    End point description
    Results display decrease measured at 2.0 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    -1.5 ( 3.7 )
    -2.1 ( 3.3 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 2.0 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 2.0 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2475
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 2.8 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 2.8 kHz - FAS
    End point description
    Results display decrease measured at 2.8 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    -2.4 ( 3.5 )
    -2.5 ( 4.3 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 2.8 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 2.8 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8236
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 4.0 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 4.0 kHz - FAS
    End point description
    Results display decrease measured at 4.0 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    -4.4 ( 5 )
    -6.1 ( 7.2 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 4.0 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 4.0 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0544
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 6.0 kHz - FAS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 6.0 kHz - FAS
    End point description
    Results display decrease measured at 6.0 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - FAS Placebo - FAS
    Number of subjects analysed
    98
    100
    Units: dB
        arithmetic mean (standard deviation)
    -5.5 ( 4.6 )
    -5.1 ( 5.1 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 6.0 kHz - FAS
    Statistical analysis description
    Analysis of the FAS| Two sided t-test to compare changes in decrease of DPOAE measured at 6.0 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - FAS v Placebo - FAS
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.559
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 1.0 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 1.0 kHz - PPS
    End point description
    Results display decrease measured at 1.0 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    88
    88 [32]
    Units: dB
        arithmetic mean (standard deviation)
    -0.2 ( 4.2 )
    -0.6 ( 5.2 )
    Notes
    [32] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 1.0 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 1.0 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5861
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 1.4 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 1.4 kHz - PPS
    End point description
    Results display decrease measured at 1.4 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    88 [33]
    88
    Units: dB
        arithmetic mean (standard deviation)
    0.7 ( 3.9 )
    -0.2 ( 5 )
    Notes
    [33] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 1.4 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 1.4 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1721
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 2.0 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 2.0 kHz - PPS
    End point description
    Results display decrease measured at 2.0 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    88 [34]
    88
    Units: dB
        arithmetic mean (standard deviation)
    0.6 ( 3.8 )
    -0.5 ( 4.3 )
    Notes
    [34] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 2.0 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 2.0 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0683
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 2.8 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 2.8 kHz - PPS
    End point description
    Results display decrease measured at 2.8 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    88 [35]
    88
    Units: dB
        arithmetic mean (standard deviation)
    0 ( 3 )
    0 ( 4.3 )
    Notes
    [35] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 2.8 kHz - PPS
    Statistical analysis description
    Analysis of thePPS| Two sided t-test to compare changes in decrease of DPOAE measured at 2.8 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9919
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 4.0 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 4.0 kHz - PPS
    End point description
    Results display decrease measured at 4.0 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    88 [36]
    88
    Units: dB
        arithmetic mean (standard deviation)
    0.3 ( 3.2 )
    -0.2 ( 3.2 )
    Notes
    [36] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 4.0 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 4.0 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3572
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V4-V3pre) | 6.0 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V4-V3pre) | 6.0 kHz - PPS
    End point description
    Results display decrease measured at 6.0 kHz observed four weeks after treatment discontinuation (visit 04) compared to values recorded four weeks after treatment Initiation prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment and 4 weeks of follow-up (visit 04).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    88 [37]
    88
    Units: dB
        arithmetic mean (standard deviation)
    0.5 ( 2.8 )
    0.1 ( 3.7 )
    Notes
    [37] - Data for two subjects missing.
    Statistical analysis title
    		 Two sided t-test DPOAE (V4-V3pre) | 6.0 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 6.0 kHz from V3 (prior to acoustic Irradiation) to V4 of subjects receiving EGb 761(R) vs. subjects receiving Placebo
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4432
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 1.0 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 1.0 kHz - PPS
    End point description
    Results display decrease measured at 1.0 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -2.3 ( 4.3 )
    -1.6 ( 3.3 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 1.0 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 1.0 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2238
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 1.4 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 1.4 kHz - PPS
    End point description
    Results display decrease measured at 1.4 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -1.5 ( 3.5 )
    -1.4 ( 4.1 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 1.4 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 1.4 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8761
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 2.0 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 2.0 kHz - PPS
    End point description
    Results display decrease measured at 2.0 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -1.6 ( 3.8 )
    -2.2 ( 3.3 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 2.0 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 2.0 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    Placebo - PPS v EGb 761(R) - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2789
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 2.8 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 2.8 kHz - PPS
    End point description
    Results display decrease measured at 2.8 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -2.5 ( 3.5 )
    -2.6 ( 4 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 2.8 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 2.8 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8756
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 4.0 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 4.0 kHz - PPS
    End point description
    Results display decrease measured at 4.0 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -4.1 ( 4.8 )
    -5.8 ( 6.9 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 4.0 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 4.0 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0627
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Decrease of the DPOAE (V3post-V3pre) | 6.0 kHz - PPS

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    End point title
    		 Decrease of the DPOAE (V3post-V3pre) | 6.0 kHz - PPS
    End point description
    Results display decrease measured at 6.0 kHz observed four weeks after treatment initiation (visit 03-post) after accoustic irradiation compared to values prior to acoustic irradiation (visit 03-pre).
    End point type
    Secondary
    End point timeframe
    Measurements were performed after 4 weeks of treatment (visit 03).
    End point values
    		 EGb 761(R) - PPS Placebo - PPS
    Number of subjects analysed
    90
    88
    Units: dB
        arithmetic mean (standard deviation)
    -5.3 ( 4.4 )
    -4.8 ( 4.8 )
    Statistical analysis title
    		 2-sided t-test DPOAE (V3post-V3pre)| 6.0 kHz - PPS
    Statistical analysis description
    Analysis of the PPS| Two sided t-test to compare changes in decrease of DPOAE measured at 6.0 kHz at V3 prior to acoustic Irradiation and after acoustic Irradiation of subjects receiving EGb 761(R) vs. subjects receiving Placebo.
    Comparison groups
    EGb 761(R) - PPS v Placebo - PPS
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4664
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were reported during the entire study course.
    Adverse event reporting additional description
    AEs reported prior to first administration of study medication were reported as medical history. AEs reported after administration of study medication were defined as treatment emergent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    EGb 761(R) - SAF
    Reporting group description
    		 EGb 761(R) 120 mg b.i.d. | p.o.

    Reporting group title
    Placebo - SAF
    Reporting group description
    		 Placebo matching EGb 761 b.i.d. | p.o.

    Serious adverse events
    		 EGb 761(R) - SAF Placebo - SAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EGb 761(R) - SAF Placebo - SAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 99 (9.09%)
    6 / 101 (5.94%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 99 (9.09%)
    6 / 101 (5.94%)
         occurrences all number
    10
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 May 2014
    The protocol had to be changed as the actual technical conditions of the measuring apparatus were different from the conditions specified in the protocol. All changes made to the protocol were approved according to local law (GCP-V §10 (1)).
    18 Dec 2014
    Changes to the protocol were related to secondary endpoints (TEOAEs and DPOAEs) due to technical requirements. All changes made to the protocol were approved according to local law (GCP-V §10 (1))

    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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