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    Clinical Trial Results:
    A Comparison of LY2605541 versus Insulin Glargine Alone or in Combination with Pre-study Oral Antihyperglycemic Medications in Patients with Type 2 Diabetes Mellitus Previously Treated with Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Study

    Summary
    EudraCT number
    		 2011-005866-39
    Trial protocol
    		 ES   DE   GR   CZ  
    Global end of trial date
    17 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2018
    First version publication date
    02 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I2R-MC-BIDJ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01582451
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14703
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center , Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    17 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: - Change in participants' overall blood sugar control - The rate of night time low blood sugar episodes - The number of participants that reach blood sugar targets without low blood sugar episodes at night - The rate of low blood sugar episodes reported over a 24-hour period
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 255
    Country: Number of subjects enrolled
    Czech Republic: 30
    Country: Number of subjects enrolled
    Greece: 21
    Country: Number of subjects enrolled
    Spain: 39
    Country: Number of subjects enrolled
    Romania: 30
    Country: Number of subjects enrolled
    Israel: 24
    Country: Number of subjects enrolled
    Russian Federation: 26
    Country: Number of subjects enrolled
    Germany: 41
    Worldwide total number of subjects
    466
    EEA total number of subjects
    161
    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)
    295
    From 65 to 84 years
    169
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No text entered.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Insulin Peglispro (LY2605541)
    Arm description
    		 Insulin peglispro (LY2605541) was administered by subcutaneous (SQ) injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin peglispro
    Investigational medicinal product code
    Other name
    LY2605541
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications (OAMs) whose use is not excluded in combination with insulin.

    Arm title
    		 Insulin glargine
    Arm description
    		 Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAMs whose use is not excluded in combination with insulin.

    Number of subjects in period 1
    		Insulin Peglispro (LY2605541) Insulin glargine
    Started
    307
    159
    Received at least 1 dose of study drug
    305
    159
    Completed
    275
    139
    Not completed
    32
    20
         Adverse event, serious fatal
    3
    3
         Consent withdrawn by subject
    13
    9
         Physician decision
    3
    -
         Adverse event, non-fatal
    1
    3
         Sponsor Decision
    1
    -
         Lost to follow-up
    -
    2
         Protocol deviation
    11
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Insulin Peglispro (LY2605541)
    Reporting group description
    		 Insulin peglispro (LY2605541) was administered by subcutaneous (SQ) injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG).

    Reporting group title
    Insulin glargine
    Reporting group description
    		 Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.

    Reporting group values
    		 Insulin Peglispro (LY2605541) Insulin glargine Total
    Number of subjects
    		 307 159 466
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 307 157 464
        85 years and over
    		 0 2 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.84 ( 8.52 ) 60.38 ( 10.10 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 132 66 198
        Male
    		 175 93 268
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 57 25 82
        Not Hispanic or Latino
    		 215 115 330
        Unknown or Not Reported
    		 35 19 54
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 2
        Asian
    		 4 2 6
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Black or African American
    		 17 9 26
        White
    		 280 148 428
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 2 0 2
    Region of Enrollment
    Units: Subjects
        United States
    		 170 85 255
        Czech Republic
    		 20 10 30
        Greece
    		 16 5 21
        Spain
    		 27 12 39
        Romania
    		 16 14 30
        Israel
    		 16 8 24
        Russian Federation
    		 17 9 26
        Germany
    		 25 16 41

    End points

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    End points reporting groups
    Reporting group title
    Insulin Peglispro (LY2605541)
    Reporting group description
    		 Insulin peglispro (LY2605541) was administered by subcutaneous (SQ) injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG).

    Reporting group title
    Insulin glargine
    Reporting group description
    		 Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.

    Primary: Change from baseline to 26-week endpoint in hemoglobin A1c (HbA1c)

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    End point title
    		 Change from baseline to 26-week endpoint in hemoglobin A1c (HbA1c)
    End point description
    HbA1c is a test that measures a participant’s average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
    End point type
    Primary
    End point timeframe
    Baseline, 26 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    302 [1]
    157 [2]
    Units: percentage of HbA1c
        least squares mean (standard error)
    -0.82 ( 0.04 )
    -0.29 ( 0.06 )
    Notes
    [1] - Participants who were randomized, had at least 1 dose of study drug and evaluable data.
    [2] - Participants who were randomized, had at least 1 dose of study drug and evaluable data.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    MMRM approach that adjusts for missing data through a variance-covariance structure.
    Comparison groups
    Insulin Peglispro (LY2605541) v Insulin glargine
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline to 52 weeks in HbA1c

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    End point title
    		 Change from baseline to 52 weeks in HbA1c
    End point description
    LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    302 [3]
    157 [4]
    Units: percentage of HbA1c
        least squares mean (standard error)
    -0.67 ( 0.05 )
    -0.22 ( 0.06 )
    Notes
    [3] - Participants who were randomized, had at least 1 dose of study drug and evaluable data.
    [4] - Participants who were randomized, had at least 1 dose of study drug and evaluable data.
    No statistical analyses for this end point

    Secondary: Rate of total and nocturnal hypoglycemia events (adjusted by 30 days)

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    End point title
    		 Rate of total and nocturnal hypoglycemia events (adjusted by 30 days)
    End point description
    Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks and Baseline through 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    304 [5]
    159 [6]
    Units: events/participant/30 days
    least squares mean (standard error)
        Total hypoglycemia, 0-26 weeks
    1.55 ( 0.13 )
    1.98 ( 0.19 )
        Total hypoglycemia, 0-52 weeks
    1.24 ( 0.10 )
    1.62 ( 0.15 )
        Nocturnal hypoglycemia, 0-26 weeks
    0.43 ( 0.06 )
    1.04 ( 0.15 )
        Nocturnal hypoglycemia, 0-52 weeks
    0.35 ( 0.06 )
    0.88 ( 0.14 )
    Notes
    [5] - Participants who were randomized, had at least 1 dose of study drug and evaluable data.
    [6] - Participants who were randomized, had at least 1 dose of study drug and evaluable data.
    No statistical analyses for this end point

    Secondary: Percentage of participants that have total and nocturnal hypoglycemic events

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    End point title
    		 Percentage of participants that have total and nocturnal hypoglycemic events
    End point description
    Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks and Baseline through 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    304 [7]
    159 [8]
    Units: percentage of participants
    number (not applicable)
        Total hypoglycemia, 0-26 weeks
    76.3
    80.5
        Total hypoglycemia, 0-52 weeks
    80.3
    83.0
        Nocturnal hypoglycemia, 0-26 weeks
    46.1
    62.3
        Nocturnal hypoglycemia, 0-52 weeks
    50.3
    67.3
    Notes
    [7] - Participants who were randomized, had at least 1 dose of study medication, and had evaluable data.
    [8] - Participants who were randomized, had at least 1 dose of study medication, and had evaluable data.
    No statistical analyses for this end point

    Secondary: Percentage of participants with HbA1c equal to or less than (≤) 6.5% and less than (<) 7.0%

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    End point title
    		 Percentage of participants with HbA1c equal to or less than (≤) 6.5% and less than (<) 7.0%
    End point description
    The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
    End point type
    Secondary
    End point timeframe
    26 and 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    302 [9]
    157 [10]
    Units: percentage of participants
    number (not applicable)
        HbA1c ≤6.5%, 26 weeks
    50.3
    28.7
        HbA1c ≤6.5%, 52 weeks
    43.4
    28.0
        HbA1c <7.0%, 26 weeks
    72.5
    52.2
        HbA1c <7.0%, 52 weeks
    63.9
    45.9
    Notes
    [9] - All randomized participants who had 1 dose of study drug and evaluable HbA1c data.
    [10] - All randomized participants who had 1 dose of study drug and evaluable HbA1c data.
    No statistical analyses for this end point

    Secondary: Percentage of participants with HbA1c <7.0% and without nocturnal hypoglycemia

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    End point title
    		 Percentage of participants with HbA1c <7.0% and without nocturnal hypoglycemia
    End point description
    Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.
    End point type
    Secondary
    End point timeframe
    26 and 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    302 [11]
    157 [12]
    Units: percentage of participants
    number (not applicable)
        26 weeks
    40.1
    18.5
        52 weeks
    34.8
    10.2
    Notes
    [11] - Randomized participants who had 1 dose of study drug and evaluable Hb1ac data.
    [12] - All randomized participants who had 1 dose of study drug and evaluable HbA1c data.
    No statistical analyses for this end point

    Secondary: Fasting serum glucose (FSG) (by laboratory)

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    End point title
    		 Fasting serum glucose (FSG) (by laboratory)
    End point description
    LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG.
    End point type
    Secondary
    End point timeframe
    26 and 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    302 [13]
    157 [14]
    Units: milligrams per deciliter (mg/dL)
    least squares mean (standard error)
        26 weeks
    103.80 ( 1.88 )
    119.50 ( 2.64 )
        52 weeks
    107.61 ( 1.94 )
    115.74 ( 2.72 )
    Notes
    [13] - Randomized participants who had at least 1 dose of study drug and evaluable FSG data.
    [14] - Randomized participants who had at least 1 dose of study drug and evaluable FSG data.
    No statistical analyses for this end point

    Secondary: Fasting blood glucose (FBG) (by self monitoring)

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    End point title
    		 Fasting blood glucose (FBG) (by self monitoring)
    End point description
    LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG.
    End point type
    Secondary
    End point timeframe
    26 and 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    303 [15]
    158 [16]
    Units: milligrams per deciliter (mg/dL)
    least squares mean (standard error)
        26 weeks
    106.32 ( 1.08 )
    104.50 ( 1.51 )
        52 weeks
    110.61 ( 1.19 )
    107.46 ( 1.68 )
    Notes
    [15] - Randomized participant who received at least 1 dose of study drug and had evaluable FBG data.
    [16] - Randomized participant who received at least 1 dose of study drug and had evaluable FBG data.
    No statistical analyses for this end point

    Secondary: Intra-participant variability in fasting blood glucose (FBG)

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    End point title
    		 Intra-participant variability in fasting blood glucose (FBG)
    End point description
    FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability.
    End point type
    Secondary
    End point timeframe
    26 and 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    302 [17]
    158 [18]
    Units: mg/dL
    least squares mean (standard error)
        26 weeks
    13.70 ( 0.57 )
    17.90 ( 0.80 )
        52 weeks
    14.18 ( 0.65 )
    17.38 ( 0.91 )
    Notes
    [17] - Randomized participants who had at least 1 dose of study drug and evaluable FBG data.
    [18] - Randomized participants who had at least 1 dose of study drug and evaluable FBG data.
    No statistical analyses for this end point

    Secondary: 6-point self-monitored blood glucose (SMBG)

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    End point title
    		 6-point self-monitored blood glucose (SMBG)
    End point description
    SMBG measurements were taken at 6 time points (pre-morning meal [fasting], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal [fasting] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values.
    End point type
    Secondary
    End point timeframe
    26 and 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    288 [19]
    148 [20]
    Units: mg/dL
    least squares mean (standard error)
        Pre-morning meal, 26 weeks (n=288, 148)
    107.93 ( 1.30 )
    104.11 ( 1.83 )
        Pre-midday meal, 26 weeks (n=287, 145)
    120.87 ( 2.20 )
    132.56 ( 3.11 )
        Pre-evening meal, 26 weeks (n=287, 146)
    125.87 ( 2.18 )
    141.45 ( 3.08 )
        Bedtime, 26 weeks (n=285, 143)
    146.54 ( 2.61 )
    161.48 ( 3.69 )
        0300 hours, 26 weeks (n=281, 142)
    118.43 ( 2.04 )
    120.42 ( 2.87 )
        Pre-morning meal next day, 26 weeks (n=288, 148)
    106.28 ( 1.36 )
    102.79 ( 1.90 )
        Pre-morning meal, 52 weeks (n=288, 148)
    110.84 ( 1.39 )
    108.22 ( 1.94 )
        Pre-midday meal, 52 weeks (n=287, 145)
    121.34 ( 2.17 )
    130.55 ( 3.06 )
        Pre-evening meal, 52 weeks (n=287, 146)
    128.53 ( 2.00 )
    141.31 ( 2.82 )
        Bedtime, 52 weeks (n=285, 143)
    146.92 ( 2.37 )
    161.83 ( 3.34 )
        0300 hours, 52 weeks (n=281, 142)
    122.23 ( 1.96 )
    121.07 ( 2.76 )
        Pre-morning meal next day, 52 weeks (n=288, 148)
    110.38 ( 1.41 )
    106.68 ( 1.97 )
    Notes
    [19] - Randomized participant who received at least 1 dose of study drug and had evalauble SMBG data.
    [20] - Randomized participant who received at least 1 dose of study drug and had evalauble SMBG data.
    No statistical analyses for this end point

    Secondary: HbA1c

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    End point title
    		 HbA1c
    End point description
    LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
    End point type
    Secondary
    End point timeframe
    26 and 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    302 [21]
    157 [22]
    Units: percentage of HbA1c
    least squares mean (standard error)
        26 weeks
    6.60 ( 0.04 )
    7.13 ( 0.06 )
        52 weeks
    6.75 ( 0.05 )
    7.20 ( 0.06 )
    Notes
    [21] - Randomized participants who received at least 1 dose of study drug and had evaluable HbA1c data.
    [22] - Randomized participants who received at least 1 dose of study drug and had evaluable HbA1c data.
    No statistical analyses for this end point

    Secondary: Insulin dose per kilogram of body weight

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    End point title
    		 Insulin dose per kilogram of body weight
    End point description
    Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose.
    End point type
    Secondary
    End point timeframe
    26 and 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    304 [23]
    159 [24]
    Units: units per kilogram per day (U/kg/day)
    least squares mean (standard error)
        26 weeks
    0.57 ( 0.01 )
    0.49 ( 0.01 )
        52 weeks
    0.57 ( 0.01 )
    0.49 ( 0.02 )
    Notes
    [23] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    [24] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    No statistical analyses for this end point

    Secondary: Number of insulin dose adjustments to steady-state

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    End point title
    		 Number of insulin dose adjustments to steady-state
    End point description
    The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use).
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    304 [25]
    159 [26]
    Units: number of dose adjustments
        least squares mean (standard error)
    4.06 ( 0.16 )
    2.75 ( 0.20 )
    Notes
    [25] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    [26] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    No statistical analyses for this end point

    Secondary: European Quality of Life - 5 Dimension (EuroQol-5D) score

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    End point title
    		 European Quality of Life - 5 Dimension (EuroQol-5D) score
    End point description
    The EuroQol-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use), and baseline EuroQol-5D score.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    290 [27]
    146 [28]
    Units: units on a scale
        least squares mean (standard error)
    0.87 ( 0.01 )
    0.88 ( 0.01 )
    Notes
    [27] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    [28] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    No statistical analyses for this end point

    Secondary: Insulin Treatment Satisfaction Questionnaire (ITSQ) score

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    End point title
    		 Insulin Treatment Satisfaction Questionnaire (ITSQ) score
    End point description
    ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    291 [29]
    148 [30]
    Units: units on a scale
        least squares mean (standard error)
    85.69 ( 0.63 )
    84.43 ( 0.89 )
    Notes
    [29] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    [30] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    No statistical analyses for this end point

    Secondary: Adult Low Blood Sugar Survey (LBSS) score

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    End point title
    		 Adult Low Blood Sugar Survey (LBSS) score
    End point description
    LBSS (also referenced as Hypoglycemia Fear Survey – II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    292 [31]
    148 [32]
    Units: units on a scale
        least squares mean (standard error)
    16.57 ( 0.77 )
    15.63 ( 1.08 )
    Notes
    [31] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    [32] - Randomized participants who received at least 1 dose of study drug and had evaluable data.
    No statistical analyses for this end point

    Secondary: Change from baseline in body weight

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    End point title
    		 Change from baseline in body weight
    End point description
    LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 weeks, 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    303 [33]
    157 [34]
    Units: kilograms (kg)
    least squares mean (standard error)
        26 weeks
    0.50 ( 0.17 )
    0.94 ( 0.24 )
        52 weeks
    0.69 ( 0.23 )
    1.32 ( 0.32 )
    Notes
    [33] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    [34] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    No statistical analyses for this end point

    Secondary: Change from baseline in lipid profile

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    End point title
    		 Change from baseline in lipid profile
    End point description
    Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 weeks, 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    302 [35]
    157 [36]
    Units: mg/dL
    least squares mean (standard error)
        Cholesterol, 26 weeks
    2.24 ( 1.60 )
    3.70 ( 2.25 )
        Cholesterol, 52 weeks
    -1.35 ( 1.63 )
    2.78 ( 2.29 )
        HDL-C, 26 weeks
    -1.74 ( 0.37 )
    -0.06 ( 0.52 )
        HDL-C, 52 weeks
    -3.52 ( 0.37 )
    -2.01 ( 0.51 )
        LDL-C, 26 weeks
    -0.05 ( 1.43 )
    4.54 ( 2.00 )
        LDL-C, 52 weeks
    -3.38 ( 1.45 )
    3.41 ( 2.03 )
        Triglycerides, 26 weeks
    22.53 ( 3.73 )
    -2.90 ( 5.23 )
        Triglycerides, 52 week
    27.39 ( 4.00 )
    12.02 ( 5.59 )
    Notes
    [35] - Randomized participant who received at least 1 dose of study drug and had evaluable data.
    [36] - Randomized participant who received at least 1 dose of study drug and had evaluable data.
    No statistical analyses for this end point

    Secondary: Number of Participants With Change in anti-LY2605541 antibodies

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    End point title
    		 Number of Participants With Change in anti-LY2605541 antibodies
    End point description
    The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline through 52 weeks
    End point values
    		 Insulin Peglispro (LY2605541) Insulin glargine
    Number of subjects analysed
    301 [37]
    157 [38]
    Units: participants
        number (not applicable)
    70
    30
    Notes
    [37] - All randomized participants who received at least 1 dose of study drug and had evaluable data.
    [38] - All randomized participants who received at least 1 dose of study drug and had evaluable data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to 52 weeks
    Adverse event reporting additional description
    I2R-MC-BIDJ
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Insulin Glargine
    Reporting group description
    		 Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose was based on dose of prestudy basal insulin and adjusted based on FBG.

    Reporting group title
    Insulin Peglispro (LY2605541)
    Reporting group description
    		 Insulin peglispro (LY2605541) was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on prestudy basal insulin and adjusted based on FBG.

    Serious adverse events
    		 Insulin Glargine Insulin Peglispro (LY2605541)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 159 (13.84%)
    35 / 305 (11.48%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    endometrial adenocarcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pituitary tumour benign
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectosigmoid cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transitional cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    cardiac death
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    multi-organ failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ovarian cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    uterine prolapse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    pulmonary hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    mental status changes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    cardiac vein perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    laceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lower limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative respiratory failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    acute coronary syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acute myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arrhythmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    cardiac failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac tamponade
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery occlusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    sick sinus syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    cerebral artery stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lacunar infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    angle closure glaucoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    inguinal hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    urethral obstruction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    intervertebral disc disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tendon disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    arthritis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia staphylococcal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hypoglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypovolaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (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: 3%
    Non-serious adverse events
    		 Insulin Glargine Insulin Peglispro (LY2605541)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    103 / 159 (64.78%)
    223 / 305 (73.11%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    adenoma benign
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    basal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    benign neoplasm of adrenal gland
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    colon adenoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    lipoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    melanocytic naevus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    monoclonal gammopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    seborrhoeic keratosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    aortic stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 159 (3.14%)
    8 / 305 (2.62%)
         occurrences all number
    5
    8
    hypertensive crisis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    intra-abdominal haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    peripheral coldness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    varicose vein
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    angioplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    atrial septal defect repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    cardiac ablation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    cardiac pacemaker insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    cataract operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    4 / 305 (1.31%)
         occurrences all number
    0
    8
    colon polypectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    4 / 305 (1.31%)
         occurrences all number
    0
    4
    coronary angioplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    coronary arterial stent insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    coronary artery bypass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    debridement
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    endodontic procedure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    gastric bypass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    gastrostomy tube insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    hysterectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    inguinal hernia repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    intervertebral disc operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    intraocular lens implant
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    leg amputation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    limb operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    medical device removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    mitral valve repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    oral surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    osteosynthesis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    osteotomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    2
    percutaneous coronary intervention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    peripheral nerve operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    polypectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    salpingo-oophorectomy bilateral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    sigmoidectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    spinal fusion surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    strabismus correction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    tendon sheath incision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    tendon transfer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    tenotomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    thoracotomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    thyroidectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    toe amputation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    tooth extraction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    3
    tracheostomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    transurethral prostatectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    uterine dilation and curettage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    vitrectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    early satiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    face oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 159 (2.52%)
    3 / 305 (0.98%)
         occurrences all number
    4
    3
    inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    influenza like illness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    injection site hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    injection site injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    injection site nodule
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    injection site oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    injection site reaction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    injury associated with device
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    5 / 305 (1.64%)
         occurrences all number
    2
    5
    pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Immune system disorders
    allergy to arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    drug hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    food allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    house dust allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    seasonal allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    3 / 305 (0.98%)
         occurrences all number
    1
    3
    Reproductive system and breast disorders
    balanoposthitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    cystocele
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dysmenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    3
    0
    erectile dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    genital discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    metrorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    2
    ovarian cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    3
    postmenopausal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    prostatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    sexual dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 305 (0.33%)
         occurrences all number
    2
    1
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 159 (5.66%)
    16 / 305 (5.25%)
         occurrences all number
    9
    17
    dysphonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    2 / 305 (0.66%)
         occurrences all number
    2
    2
    dyspnoea exertional
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    epistaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    3 / 305 (0.98%)
         occurrences all number
    2
    3
    haemoptysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    nasal congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    oropharyngeal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 159 (4.40%)
    6 / 305 (1.97%)
         occurrences all number
    8
    6
    paranasal sinus hypersecretion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    productive cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    pulmonary congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    respiratory tract congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    rhinitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    rhinorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    sinus congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    5 / 305 (1.64%)
         occurrences all number
    1
    5
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    throat irritation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 159 (3.14%)
    2 / 305 (0.66%)
         occurrences all number
    5
    2
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    4 / 305 (1.31%)
         occurrences all number
    2
    4
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    4 / 305 (1.31%)
         occurrences all number
    0
    4
    mood altered
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    mood swings
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    neurosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    panic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    sleep disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    stress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    arteriogram coronary
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    arthroscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    biopsy skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    blood cholesterol increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    blood creatinine increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    blood iron decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    blood lactate dehydrogenase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    blood potassium abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    blood potassium increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    blood pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    blood uric acid increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    3
    carotid bruit
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    catheterisation cardiac
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    colonoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    electrocardiogram st segment depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    electrocardiogram t wave abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    endoscopy upper gastrointestinal tract
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    heart rate irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    hepatic enzyme increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    international normalised ratio increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    intraocular pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    liver function test abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    low density lipoprotein increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    prostatic specific antigen increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    serum ferritin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    weight decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    acetabulum fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    bone contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    4 / 305 (1.31%)
         occurrences all number
    3
    4
    epicondylitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    excoriation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    0 / 305 (0.00%)
         occurrences all number
    4
    0
    eye injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    fractured coccyx
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    heat exhaustion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    joint injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    ligament sprain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    limb injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    limb traumatic amputation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    meniscus injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    muscle rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    muscle strain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    2 / 305 (0.66%)
         occurrences all number
    2
    2
    nail avulsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    post-traumatic neck syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    procedural pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    rib fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    road traffic accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    scratch
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    tendon rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    thermal burn
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    upper limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    wound
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    atrial septal defect
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    2 / 305 (0.66%)
         occurrences all number
    2
    2
    bradycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    bundle branch block right
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    cardiac failure congestive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    0 / 305 (0.00%)
         occurrences all number
    3
    0
    cardiomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    left ventricular dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    left ventricular hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    mitral valve incompetence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    supraventricular extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    systolic dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    ventricular extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    Nervous system disorders
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    4 / 305 (1.31%)
         occurrences all number
    0
    4
    cerebral atrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    cervical myelopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    cervicobrachial syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    cubital tunnel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dementia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    diabetic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 159 (3.14%)
    7 / 305 (2.30%)
         occurrences all number
    6
    8
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 159 (7.55%)
    17 / 305 (5.57%)
         occurrences all number
    27
    26
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    3
    leukoencephalopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    memory impairment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    5
    0
    neuropathy peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    paraesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    4 / 305 (1.31%)
         occurrences all number
    3
    4
    radiculitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    sciatica
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    3
    sinus headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    4
    1
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    tremor
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    viith nerve paralysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    vith nerve paralysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 159 (3.14%)
    3 / 305 (0.98%)
         occurrences all number
    5
    3
    leukopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    macrocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    splenomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    thrombocytopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    deafness unilateral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    ear pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    2 / 305 (0.66%)
         occurrences all number
    3
    2
    hypoacusis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    presbyacusis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    tinnitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    4 / 305 (1.31%)
         occurrences all number
    0
    4
    tympanic membrane perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    vertigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    vertigo positional
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Eye disorders
    age-related macular degeneration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    3
    cataract
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    5 / 305 (1.64%)
         occurrences all number
    0
    6
    conjunctivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    dacryostenosis acquired
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    diabetic retinal oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    dry eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    eye pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    eye swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    lacrimation increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    ocular discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    refraction disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    retinal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    retinopathy hypertensive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    vision blurred
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    vitreous floaters
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    4 / 305 (1.31%)
         occurrences all number
    0
    6
    abdominal distension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    7 / 305 (2.30%)
         occurrences all number
    3
    9
    abdominal pain lower
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 159 (2.52%)
    4 / 305 (1.31%)
         occurrences all number
    4
    6
    colitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    colitis microscopic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    constipation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 159 (2.52%)
    8 / 305 (2.62%)
         occurrences all number
    4
    8
    defaecation urgency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dental caries
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 159 (3.14%)
    19 / 305 (6.23%)
         occurrences all number
    5
    21
    dry mouth
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    duodenal ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dyspepsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    6 / 305 (1.97%)
         occurrences all number
    2
    6
    enterocolitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    epigastric discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    faecal incontinence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    flatulence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    food poisoning
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    gastric cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    gastric polyps
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    gastritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    3
    gastrointestinal angiodysplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    gastrointestinal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    haematochezia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    haemorrhoids
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    3
    hypoaesthesia oral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    impaired gastric emptying
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    irritable bowel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    large intestine polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    lip swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    loose tooth
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 159 (2.52%)
    12 / 305 (3.93%)
         occurrences all number
    7
    13
    oesophagitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    pancreatic cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    pancreatic insufficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    periodontal inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    rectal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    rectal polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    tooth disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    tooth impacted
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    toothache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    5 / 305 (1.64%)
         occurrences all number
    3
    5
    umbilical hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    9 / 305 (2.95%)
         occurrences all number
    3
    10
    Hepatobiliary disorders
    biliary dyskinesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    3 / 305 (0.98%)
         occurrences all number
    1
    3
    hepatic cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    hepatic steatosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    4 / 305 (1.31%)
         occurrences all number
    0
    4
    hepatocellular injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    hepatosplenomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    hypertransaminasaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    portal vein dilatation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    actinic keratosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    3 / 305 (0.98%)
         occurrences all number
    2
    3
    alopecia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dermal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    3
    dermatitis contact
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 305 (0.33%)
         occurrences all number
    2
    1
    diabetic foot
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dry skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    ecchymosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    eczema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    3 / 305 (0.98%)
         occurrences all number
    1
    3
    erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    hyperkeratosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    ingrowing nail
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    3 / 305 (0.98%)
         occurrences all number
    1
    3
    lentigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    lipodystrophy acquired
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    lipohypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    night sweats
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    onycholysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    2
    2
    psoriasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    10 / 305 (3.28%)
         occurrences all number
    1
    11
    rash erythematous
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    rash generalised
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    rash papular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    rosacea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    skin discolouration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    skin fissures
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    skin hyperpigmentation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    swelling face
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    acute prerenal failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    calculus bladder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dysuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    haematuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    1 / 305 (0.33%)
         occurrences all number
    3
    1
    microalbuminuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    nephrolithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    4 / 305 (1.31%)
         occurrences all number
    2
    4
    proteinuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    renal atrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    renal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    renal failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    renal failure chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 305 (0.33%)
         occurrences all number
    2
    1
    urethral haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    urinary retention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Endocrine disorders
    autoimmune thyroiditis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    hyperprolactinaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    hypogonadism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    hypothyroidism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    thyroid cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 159 (4.40%)
    16 / 305 (5.25%)
         occurrences all number
    7
    19
    arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    6 / 305 (1.97%)
         occurrences all number
    3
    6
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 159 (6.92%)
    21 / 305 (6.89%)
         occurrences all number
    13
    22
    bone pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    bursitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    chondropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dupuytren's contracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    flank pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    foot deformity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    intervertebral disc disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    intervertebral disc space narrowing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    joint swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    3
    medial tibial stress syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    muscle spasms
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    2 / 305 (0.66%)
         occurrences all number
    2
    2
    muscular weakness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    musculoskeletal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    6 / 305 (1.97%)
         occurrences all number
    4
    6
    myalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    2 / 305 (0.66%)
         occurrences all number
    3
    2
    neck pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    osteitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    5 / 305 (1.64%)
         occurrences all number
    3
    6
    osteochondrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 159 (5.66%)
    7 / 305 (2.30%)
         occurrences all number
    9
    7
    periarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 305 (0.33%)
         occurrences all number
    2
    1
    plantar fasciitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    spinal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    tendon disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    tendonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    3
    0
    trigger finger
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    abscess limb
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    acute sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    acute tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    bacterial infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 159 (3.14%)
    14 / 305 (4.59%)
         occurrences all number
    5
    14
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    5 / 305 (1.64%)
         occurrences all number
    2
    7
    cystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    3
    diverticulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    ear infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 305 (0.33%)
         occurrences all number
    2
    1
    erysipelas
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    fungal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    fungal skin infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    2
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 305 (0.33%)
         occurrences all number
    2
    1
    gastroenteritis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 159 (1.89%)
    2 / 305 (0.66%)
         occurrences all number
    3
    2
    helicobacter infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    herpes zoster
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    2 / 305 (0.66%)
         occurrences all number
    2
    2
    hordeolum
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    infected cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 159 (6.92%)
    13 / 305 (4.26%)
         occurrences all number
    13
    14
    laryngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    localised infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    2
    1
    lower respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    4
    nail infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    nasal abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    27 / 159 (16.98%)
    53 / 305 (17.38%)
         occurrences all number
    33
    68
    onychomycosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    oral candidiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    oral fungal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    oral herpes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    orchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    otitis media
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    paronychia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    periodontitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    pharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 305 (0.33%)
         occurrences all number
    3
    2
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    3 / 305 (0.98%)
         occurrences all number
    1
    3
    post procedural infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    respiratory tract infection viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    3
    rhinitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    3 / 305 (0.98%)
         occurrences all number
    2
    3
    sialoadenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 159 (5.66%)
    18 / 305 (5.90%)
         occurrences all number
    9
    19
    staphylococcal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    tinea infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    tinea pedis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    tooth abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 305 (0.98%)
         occurrences all number
    0
    3
    tooth infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    5 / 305 (1.64%)
         occurrences all number
    1
    5
    tracheobronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 159 (5.03%)
    16 / 305 (5.25%)
         occurrences all number
    11
    18
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 159 (2.52%)
    7 / 305 (2.30%)
         occurrences all number
    5
    8
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    4 / 305 (1.31%)
         occurrences all number
    1
    7
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    4 / 305 (1.31%)
         occurrences all number
    4
    4
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    wound infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    abnormal loss of weight
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    acidosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    decreased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    dehydration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    dyslipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    gout
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    3 / 305 (0.98%)
         occurrences all number
    2
    3
    hyperglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    3
    0
    hyperkalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 305 (0.66%)
         occurrences all number
    1
    2
    hyperuricaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 305 (0.66%)
         occurrences all number
    0
    2
    hypokalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0
    iron deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 305 (0.33%)
         occurrences all number
    1
    1
    obesity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 305 (0.33%)
         occurrences all number
    0
    1
    vitamin b12 deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 305 (0.00%)
         occurrences all number
    2
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 305 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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