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    Clinical Trial Results:
    Smoking Cessation of Young Adults in Northern Finland

    Summary
    EudraCT number
    		 2012-000596-16
    Trial protocol
    		 FI  
    Global end of trial date
    02 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Nov 2021
    First version publication date
    25 Nov 2021
    Other versions
    Summary report(s)
    		 Published Clinical Trial Article

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EETTMK:99/2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01531049
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lapand Hospital District/ Lapland Central Hospital
    Sponsor organisation address
    Ounasrinteentie 22, Rovaniemi, Finland, 96200
    Public contact
    Tuula Toljamo, Lapland Hospital District/ Lapland Central Hospital, +358 407218759, tuula.toljamo@lshp.fi
    Scientific contact
    Tuula Toljamo, Lapland Hospital District/ Lapland Central Hospital, +358 407218759, tuula.toljamo@lshp.fi
    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
    12 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of varenicline and nicotine patch therapy as a smoking cessation aid in young adults. The study included 52 weeks follow up, but only 26 weeks follow up were analysed and reported in the end.
    Protection of trial subjects
    To take part for the study was voluntary and all subjects were willing to quit smoking. All subjects that were recruited had a telephone number to the research nurse and it was recommended to call when having any problems. They were also asked at every follow up contact whether they had any side effects to study medication. Study nurse had continuous access to consult a doctor if needed.
    Background therapy
    		 None.
    Evidence for comparator
    		 Tobacco use is known to be a major health risk. The tobacco habit is often adopted at a young age. Nicotine replacement therapy and varenicline, the two comparators used in the trial, have been shown to be effective in smoking cessation in adults, but there were no evidence-based guidelines for smoking cessation targeted especially to young smokers. This is particularly true for young adults, a group that has been rarely analysed separately from either adolescent or adult smokers. Our study investigated the efficacy of varenicline and the nicotine patch therapy as a smoking cessation aid in volunteer daily smokers in their twenties.
    Actual start date of recruitment
    01 Mar 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 291
    Worldwide total number of subjects
    291
    EEA total number of subjects
    291
    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)
    291
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruited subjects were 18- to 26-year-old men and women who were recruited on a voluntary basis during 2012 until spring 2014 via community media, colleges and the army in northern parts of Finland.

    Pre-assignment
    Screening details
    		 The recruited subjects were daily smokers and motivated to quit as well as to be volunteers in this study that investigated different pharmacological treatments for smoking cessation with 52-week follow-up. Exclusion criteria: drug/alcohol abuse, allergy towards study medication, lactation, pregnancy or intension to become pregnant during study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo patch group
    Arm description
    		 Light smokers (Heaviness of smoking index points 0-2) were randomised to placebo or nicotine patch 10mg/16h arm. In placebo patch arm, subjects were treated with a placebo patch that resembled medication-type patch, but was not identical to the nicotine patch. The duration of placebo treatment was 8 weeks. The placebo arm were compared to nicotine patch 10mg/16h arm.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo patch
    Investigational medicinal product code
    Other name
    Leukomed T (brand name)
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    One patch daily for 8 weeks.

    Arm title
    		 Nicotine patch 10mg/16h group
    Arm description
    		 In this arm, subjects were light daily smokers and were treated with nicotine patch 10mg/16h for 8 weeks, and during analysis, this treatment arm was compared to placebo arm with light smokers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nicotine patch 10mg/16h
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    In this arm nicotine patch 10mg/16h were used with daily exchange and the duration of treatment was 8 weeks.

    Arm title
    		 Nicotine patch 15mg/16h group
    Arm description
    		 Heavy smokers (Heaviness of smoking index 3-6 points) were randomised to nicotine patch 15mg/16h arm or varenicline arm. In this arm, subjects were heavy smokers that were treated with nicotine patch 15mg/16h for 8 weeks and were compared to varenicline arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nicotine patch 15mg/16h
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    15mg/16h nicotine patch daily for 8 weeks.

    Arm title
    		 Varenicline group
    Arm description
    		 In this arm, the subjects were heavy smokers and treated with varenicline for 12 weeks. They were compared to heavy smokers in nicotine patch 15mg/16 h arm during analysis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Varenicline
    Investigational medicinal product code
    Other name
    Brand name was Champix (Pfizer).
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.5mg oral tablets once daily for 3 days and 0.5mg twice a day till the end of the first week. From the 2nd week until the end of the 12th week, the dosing was 1 mg twice a day.

    Number of subjects in period 1
    		Placebo patch group Nicotine patch 10mg/16h group Nicotine patch 15mg/16h group Varenicline group
    Started
    86
    94
    51
    60
    4 weeks phone call contact
    78
    88
    45
    60
    12 weeks counselling visit
    65
    74 [1]
    36 [2]
    51
    Completed
    64
    75
    38
    44
    Not completed
    22
    19
    13
    16
         Refused to use randomised therapy
    -
    1
    -
    -
         Moved to other city
    -
    1
    1
    -
         Lost to follow-up
    22
    15
    9
    15
         Lack of motivation
    -
    2
    1
    1
         Did not arrive to first visit
    -
    -
    1
    -
         Did not want to continue in randomised group
    -
    -
    1
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: If a subject missed a control visit but attended subsequent controls, his/her smoking status at the missed control was assumed to be the same as that recorded at the time when he/she came to the next control session.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: If a subject missed a control visit but attended subsequent controls, his/her smoking status at the missed control was assumed to be the same as that recorded at the time when he/she came to the next control session.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo patch group
    Reporting group description
    		 Light smokers (Heaviness of smoking index points 0-2) were randomised to placebo or nicotine patch 10mg/16h arm. In placebo patch arm, subjects were treated with a placebo patch that resembled medication-type patch, but was not identical to the nicotine patch. The duration of placebo treatment was 8 weeks. The placebo arm were compared to nicotine patch 10mg/16h arm.

    Reporting group title
    Nicotine patch 10mg/16h group
    Reporting group description
    		 In this arm, subjects were light daily smokers and were treated with nicotine patch 10mg/16h for 8 weeks, and during analysis, this treatment arm was compared to placebo arm with light smokers.

    Reporting group title
    Nicotine patch 15mg/16h group
    Reporting group description
    		 Heavy smokers (Heaviness of smoking index 3-6 points) were randomised to nicotine patch 15mg/16h arm or varenicline arm. In this arm, subjects were heavy smokers that were treated with nicotine patch 15mg/16h for 8 weeks and were compared to varenicline arm.

    Reporting group title
    Varenicline group
    Reporting group description
    		 In this arm, the subjects were heavy smokers and treated with varenicline for 12 weeks. They were compared to heavy smokers in nicotine patch 15mg/16 h arm during analysis.

    Reporting group values
    		 Placebo patch group Nicotine patch 10mg/16h group Nicotine patch 15mg/16h group Varenicline group Total
    Number of subjects
    		 86 94 51 60 291
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 20 (18 to 23.3) 21 (19 to 23) 22 (19 to 24) 21 (19 to 23.8) -
    Gender categorical
    Units: Subjects
        Female
    		 44 49 23 30 146
        Male
    		 42 45 28 30 145
    weight
    Units: kilogram(s)
        median (inter-quartile range (Q1-Q3))
    		 70.1 (61.0 to 82.7) 70.5 (62.0 to 78.2) 71.2 (61.5 to 82.9) 72.6 (62.2 to 79.7) -
    Motivation to quit
    Motivation to quit was reported in numeric scale 1 to 10 (1 for lowest motivation; 10 for highest motivation)
    Units: 1-10
        median (inter-quartile range (Q1-Q3))
    		 8 (7.0 to 8.0) 7 (6.0 to 8.0) 7 (6.0 to 8.0) 7 (6.0 to 8.0) -
    Number of daily cigarettes
    Units: number
        median (inter-quartile range (Q1-Q3))
    		 10 (8.0 to 15.0) 10 (7.0 to 14.3) 18 (15.0 to 20.0) 14 (10.0 to 20.0) -
    Height
    Units: cent
        arithmetic mean (standard deviation)
    		 170.6 ± 8.7 170.1 ± 8.9 171.7 ± 10.3 169.9 ± 7.8 -
    Smoking initiation age
    Units: year
        arithmetic mean (standard deviation)
    		 14.8 ± 2.3 15.3 ± 2.0 14.4 ± 2.0 14.1 ± 1.9 -
    Duration of smoking
    Units: year
        arithmetic mean (standard deviation)
    		 5.8 ± 3.1 5.9 ± 3.0 7.0 ± 2.7 7.3 ± 2.8 -
    Heaviness of Smoking Index (HSI)
    Heaviness of smoking Index consists of two questions: 1)How soon after wake up do you have your first cigarette? A. within 5 min (3points), B. 6-30min (2 points), C. 31-60 min. (1 point). 2) How many cigarettes do you typically smoke per day? A. 31 or more, B. 21-30, C. 11-20 (1 point).
    Units: cigarettes
        arithmetic mean (standard deviation)
    		 1.3 ± 0.8 1.3 ± 0.8 3.3 ± 0.9 3.5 ± 0.7 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo patch group
    Reporting group description
    		 Light smokers (Heaviness of smoking index points 0-2) were randomised to placebo or nicotine patch 10mg/16h arm. In placebo patch arm, subjects were treated with a placebo patch that resembled medication-type patch, but was not identical to the nicotine patch. The duration of placebo treatment was 8 weeks. The placebo arm were compared to nicotine patch 10mg/16h arm.

    Reporting group title
    Nicotine patch 10mg/16h group
    Reporting group description
    		 In this arm, subjects were light daily smokers and were treated with nicotine patch 10mg/16h for 8 weeks, and during analysis, this treatment arm was compared to placebo arm with light smokers.

    Reporting group title
    Nicotine patch 15mg/16h group
    Reporting group description
    		 Heavy smokers (Heaviness of smoking index 3-6 points) were randomised to nicotine patch 15mg/16h arm or varenicline arm. In this arm, subjects were heavy smokers that were treated with nicotine patch 15mg/16h for 8 weeks and were compared to varenicline arm.

    Reporting group title
    Varenicline group
    Reporting group description
    		 In this arm, the subjects were heavy smokers and treated with varenicline for 12 weeks. They were compared to heavy smokers in nicotine patch 15mg/16 h arm during analysis.

    Primary: Self-reported smoking abstinence at 12 weeks

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    End point title
    		 Self-reported smoking abstinence at 12 weeks
    End point description
    Abstinence rates at 12 week visit were compared in light smokers (placebo arm vs. nicotine patch 10mg/16h arm) and in heavy smokers (nicotine patch 15mg/16h arm vs. varenicline arm) separately.
    End point type
    Primary
    End point timeframe
    Primary end point was assessed at 12 weeks follow up visit (at the time of the end of treatment).
    End point values
    		 Placebo patch group Nicotine patch 10mg/16h group Nicotine patch 15mg/16h group Varenicline group
    Number of subjects analysed
    86
    94
    51
    60
    Units: Number of subjects
        Not smoking
    15
    22
    8
    22
        Continues smoking
    71
    72
    43
    38
    Statistical analysis title
    		 Cross-tabulation placebo vs. nicotine 10mg/16h
    Statistical analysis description
    The distribution of categorical variables between the study groups was compared with cross-tabulation. The difference between the observed proportions of abstinence (with 95% confidence interval) in the study groups was used as the effects size measure. The statistical significance of difference in tobacco abstinence rates were evaluated with chi-square test.
    Comparison groups
    Nicotine patch 10mg/16h group v Placebo patch group
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.36 [1]
    Method
    		 Chi-squared
    Parameter type
    		 Effect size
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 17.5
    Notes
    [1] - The were no statistically significant differences between the groups of light smokers (i.e. smokers randomised to placebo and nicotine patch 10mg/16h groups) at week 12.
    Statistical analysis title
    		 Cross-tabulation nicotine 15mg/16h vs. varenicline
    Statistical analysis description
    The distribution of categorical variables between the study groups was compared with cross-tabulation. The difference between the observed proportions of abstinence (with 95% confidence interval) in the study groups was used as the effects size measure. The statistical significance of difference in tobacco abstinence rates were evaluated with chi-square test.
    Comparison groups
    Nicotine patch 15mg/16h group v Varenicline group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.018 [2]
    Method
    		 Chi-squared
    Parameter type
    		 effect size
    Point estimate
    21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.4
         upper limit
    		 25.7
    Notes
    [2] - The was statistically significant difference between the groups of heavy smokers (i.e. smokers randomised to varenicline group and nicotine patch 15mg/16h groups) at week 12. Smoking abstinence was more common in varenicline group.

    Secondary: Self-reported smoking abstinence at 4 weeks

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    End point title
    		 Self-reported smoking abstinence at 4 weeks
    End point description
    Abstinence rates at 4 weeks were analysed between placebo arm and nicotine patch 10mg/16h arm and between nicotine patch 15mg/16h and varenicline arm.
    End point type
    Secondary
    End point timeframe
    Self-reported smoking abstinence at 4 weeks follow up phone call control.
    End point values
    		 Placebo patch group Nicotine patch 10mg/16h group Nicotine patch 15mg/16h group Varenicline group
    Number of subjects analysed
    86
    94
    51
    60
    Units: Number of subjects
        Not smoking
    17
    25
    10
    44
        Continues smoking
    69
    69
    41
    16
    Statistical analysis title
    		 Cross-tabulation placebo vs. nicotine 10mg/16h
    Comparison groups
    Placebo patch group v Nicotine patch 10mg/16h group
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.296
    Method
    		 Chi-squared
    Parameter type
    		 effect size
    Point estimate
    6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 18.8
    Statistical analysis title
    		 Cross-tabulation varenicline vs. nicotine 15mg/16h
    Statistical analysis description
    The distribution of categorical variables between the study groups was compared with cross-tabulation. The difference between the observed proportions of abstinence (with 95% confidence interval) in the study groups was used as the effects size measure. The statistical significance of difference in tobacco abstinence rates were evaluated with chi-square test.
    Comparison groups
    Nicotine patch 15mg/16h group v Varenicline group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Parameter type
    		 effect size
    Point estimate
    53.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.9
         upper limit
    		 66.6

    Secondary: Self-reported smoking abstinence at week 26

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    End point title
    		 Self-reported smoking abstinence at week 26
    End point description
    End point type
    Secondary
    End point timeframe
    Self-reported abstinence of smoking at week 26 follow up contact. 52 weeks follow up was included in study, but we did not analyse or report it in the end because it was thought not to be as important/interesting as other end points.
    End point values
    		 Placebo patch group Nicotine patch 10mg/16h group Nicotine patch 15mg/16h group Varenicline group
    Number of subjects analysed
    86
    94
    51
    60
    Units: Number of subjects
        Not smoking
    13
    19
    5
    11
        Continues smoking
    73
    75
    46
    49
    Statistical analysis title
    		 Cross-tabulation placebo vs. nicotine 10mg/16h
    Statistical analysis description
    The distribution of categorical variables between the study groups was compared with cross-tabulation. The difference between the observed proportions of abstinence (with 95% confidence interval) in the study groups was used as the effects size measure. The statistical significance of difference in tobacco abstinence rates were evaluated with chi-square test.
    Comparison groups
    Placebo patch group v Nicotine patch 10mg/16h group
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.437
    Method
    		 Chi-squared
    Parameter type
    		 effect size
    Point estimate
    5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 16.1
    Statistical analysis title
    		 Cross-tabulation nicotine 15mg/16h vs. varenicline
    Statistical analysis description
    The distribution of categorical variables between the study groups was compared with cross-tabulation. The difference between the observed proportions of abstinence (with 95% confidence interval) in the study groups was used as the effects size measure. The statistical significance of difference in tobacco abstinence rates were evaluated with chi-square test.
    Comparison groups
    Nicotine patch 15mg/16h group v Varenicline group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.28
    Method
    		 Chi-squared
    Parameter type
    		 effect size
    Point estimate
    8.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 21.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were requested at 4, 12, 26 and 52 weeks with an open question. In addition, all subjects were given a phone number for study nurse and they were advised to call if any questions or problems such as side effects came up.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo patch group
    Reporting group description
    		 -

    Reporting group title
    Nicotine patch 10mg/16h group
    Reporting group description
    		 -

    Reporting group title
    Nicotine patch 15mg/16h group
    Reporting group description
    		 -

    Reporting group title
    Varenicline group
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo patch group Nicotine patch 10mg/16h group Nicotine patch 15mg/16h group Varenicline group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 Placebo patch group Nicotine patch 10mg/16h group Nicotine patch 15mg/16h group Varenicline group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 86 (17.44%)
    26 / 93 (27.96%)
    16 / 49 (32.65%)
    36 / 60 (60.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 93 (0.00%)
    1 / 49 (2.04%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Pain of skin
    Additional description: At the side of the patch
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 93 (2.15%)
    3 / 49 (6.12%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    6
    0
    Paraesthesia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 93 (1.08%)
    2 / 49 (4.08%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    4
    0
    Headache
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 93 (0.00%)
    1 / 49 (2.04%)
    3 / 60 (5.00%)
         occurrences all number
    1
    0
    1
    3
    General disorders and administration site conditions
    Cutaneous symptom
    Additional description: Cutaneous irritation
         subjects affected / exposed
    7 / 86 (8.14%)
    19 / 93 (20.43%)
    8 / 49 (16.33%)
    1 / 60 (1.67%)
         occurrences all number
    8
    20
    16
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 86 (1.16%)
    5 / 93 (5.38%)
    1 / 49 (2.04%)
    25 / 60 (41.67%)
         occurrences all number
    1
    5
    2
    42
    Abdominal pain
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    5 / 60 (8.33%)
         occurrences all number
    0
    0
    0
    8
    Flatulence
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    0
    0
    2
    Constipation
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    0
    0
    2
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    11 / 60 (18.33%)
         occurrences all number
    0
    0
    0
    18
    Nervousness
         subjects affected / exposed
    6 / 86 (6.98%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    7
    0
    0
    0
    Insomnia
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    4 / 60 (6.67%)
         occurrences all number
    4
    0
    0
    7
    Anxiety
         subjects affected / exposed
    4 / 86 (4.65%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    4
    0
    0
    0
    Fatigue
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Sexual inhibition
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle discomfort
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 93 (1.08%)
    1 / 49 (2.04%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Metabolism and nutrition disorders
    Night sweats
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 93 (0.00%)
    0 / 49 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26709238
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