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    Clinical Trial Results:
    An evaluator-blinded multi-center study of combined treatment with Azzalure, Restylane/Emervel filler and Restylane skinbooster as compared to single treatment with either Azzalure alone or Restylane/Emervel filler alone

    Summary
    EudraCT number
    		 2014-001203-50
    Trial protocol
    		 SE  
    Global end of trial date
    17 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Feb 2020
    First version publication date
    13 Feb 2020
    Other versions
    Summary report(s)
    		 Cartier.2019.Repeated full-face aesthetic combination treatment

    Trial information

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    Trial identification
    Sponsor protocol code
    05DF1211
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02297503
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma/Q-Med AB
    Sponsor organisation address
    Seminariegatan 21, Uppsala, Sweden, 75228
    Public contact
    Medical Affairs Cecilia Skoglund, Galderma/Q-Med AB, +46 18489 1410, cecilia.skoglund@galderma.com
    Scientific contact
    Medical Affairs Cecilia Skoglund, Galderma/Q-Med AB, +46 18489 1410, cecilia.skoglund@galderma.com
    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
    13 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate if superior global facial aesthetic appearance can be achieved by combined treatment with Azzalure, Restylane/Emervel filler and Restylane skinbooster compared to single treatment with either Azzalure or Restylane/Emervel filler alone
    Protection of trial subjects
    N/A
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    01 Jul 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 39
    Country: Number of subjects enrolled
    France: 22
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    61
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First subject first visit: 03 Nov 2014 Last subject last visit: 17 Dec 2016

    Pre-assignment
    Screening details
    		 There were no screening failures in this study. Sixty-one subjects were randomized; of these, 60 were treated and one (randomized to treatment Group A) was excluded before treatment. This subject withdrew her consent prior to treatment due to a vasovagal episode.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    Independent evaluators (assessors) remained blinded to the treatment arm and to the sequence of subject photographs, i.e. they did not know whether a given photograph was taken after the single or combined treatments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A - Azzalure as single treatment
    Arm description
    		 Subjects in Group a received treatment with ≤50 s.U Azzalure as single treatment in glabellar lines. At month 6 and 12, both groups received combined treatment consisting of ≤50 s.U Azzalure in glabellar lines, ≤2 mL hyaluronic acid filler in nasolabial folds/cheeks and ≤1 mL Restylane Skinbooster. An additional Skinbooster treatment was given at Month 7.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azzalure
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A vial with 125 s.U of Azzalure powder was reconstituted in 0.63 mL NaCl 0.9% before injection (10 s.U per 0.05 mL of reconstituted solution). Azzalure was administered by intra-muscular injection of the glabellar lines; the recommended dose was 50 s.U in five injection points, one in the procerus and two in each corrugator (10 s.U/0.05 mL in each injection point).

    Arm title
    		 Group B - hyaluronic acid filler as single treatment
    Arm description
    		 Subjects in Group B received ≤1 mL hyaluronic acid filler in nasolabial folds/cheeks as single treatment. At month 6 and 12, both groups received combined treatment consisting of ≤50 s.U Azzalure in the glabellar lines, ≤2 mL hyaluronic acid filler in nasolabial folds/cheeks and ≤1 mL Restylane Skinbooster. An additional Skinbooster treatment was given at Month 7.
    Arm type
    		 Experimental

    Investigational medicinal product name
    N/A (medical device)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intradermal use
    Dosage and administration details
    A maximum of 1 mL (one syringe) of Restylane or Emervel filler was administered to nasolabial folds and/or cheeks at initial baseline treatment, and ≤2 mL was injected at month 6 and month 12.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: An open study design served the study objectives adequately, but to strengthen the results, photograph evaluators remained blinded to the treatment arm and to the sequence of photographs, i.e. they did not know whether a given photograph was taken after the single or combined treatment.
    Number of subjects in period 1
    		Group A - Azzalure as single treatment Group B - hyaluronic acid filler as single treatment
    Started
    30
    31
    Single treatment
    29
    31
    First combined treatment
    28
    28
    Second combined treatment
    28
    28
    Completed
    28
    27
    Not completed
    2
    4
         Consent withdrawn by subject
    1
    1
         Medical reason
    -
    1
         Pregnancy
    -
    1
         Lost to follow-up
    -
    1
         Exclusion criteria
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A - Azzalure as single treatment
    Reporting group description
    		 Subjects in Group a received treatment with ≤50 s.U Azzalure as single treatment in glabellar lines. At month 6 and 12, both groups received combined treatment consisting of ≤50 s.U Azzalure in glabellar lines, ≤2 mL hyaluronic acid filler in nasolabial folds/cheeks and ≤1 mL Restylane Skinbooster. An additional Skinbooster treatment was given at Month 7.

    Reporting group title
    Group B - hyaluronic acid filler as single treatment
    Reporting group description
    		 Subjects in Group B received ≤1 mL hyaluronic acid filler in nasolabial folds/cheeks as single treatment. At month 6 and 12, both groups received combined treatment consisting of ≤50 s.U Azzalure in the glabellar lines, ≤2 mL hyaluronic acid filler in nasolabial folds/cheeks and ≤1 mL Restylane Skinbooster. An additional Skinbooster treatment was given at Month 7.

    Reporting group values
    		 Group A - Azzalure as single treatment Group B - hyaluronic acid filler as single treatment Total
    Number of subjects
    		 30 31 61
    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)
    		 30 31 61
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 45.9 (36 to 50) 43.6 (36 to 49) -
    Gender categorical
    Units: Subjects
        Female
    		 30 30 60
        Male
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Group A - Azzalure as single treatment
    Reporting group description
    		 Subjects in Group a received treatment with ≤50 s.U Azzalure as single treatment in glabellar lines. At month 6 and 12, both groups received combined treatment consisting of ≤50 s.U Azzalure in glabellar lines, ≤2 mL hyaluronic acid filler in nasolabial folds/cheeks and ≤1 mL Restylane Skinbooster. An additional Skinbooster treatment was given at Month 7.

    Reporting group title
    Group B - hyaluronic acid filler as single treatment
    Reporting group description
    		 Subjects in Group B received ≤1 mL hyaluronic acid filler in nasolabial folds/cheeks as single treatment. At month 6 and 12, both groups received combined treatment consisting of ≤50 s.U Azzalure in the glabellar lines, ≤2 mL hyaluronic acid filler in nasolabial folds/cheeks and ≤1 mL Restylane Skinbooster. An additional Skinbooster treatment was given at Month 7.

    Primary: Global facial aesthetic appearance

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    End point title
    		 Global facial aesthetic appearance
    End point description
    Percentage of subjects that showed a superior global facial aesthetic appearance one month after the first combined treatment than one month after the single treatment, as assessed by blinded evaluation of photographs. Primary and secondary endpoints were defined in the CSP version that was approved for use at the French sites, whereas the Swedish amendment of the protocol did not define primary and secondary endpoints.
    End point type
    Primary
    End point timeframe
    Month 1, Month 7
    End point values
    		 Group A - Azzalure as single treatment Group B - hyaluronic acid filler as single treatment
    Number of subjects analysed
    27
    27
    Units: Percentage
    74
    93
    Statistical analysis title
    		 Global facial aesthetic appearance [1]
    Comparison groups
    Group A - Azzalure as single treatment v Group B - hyaluronic acid filler as single treatment
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    Method
    Parameter type
    		 Confidence interval
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50
         upper limit
    		 -
    Notes
    [1] - A low or upper value for the confidence interval may be missing. Values for both the lower and upper limit are expected to be provided with a 2-sided confidence interval.
    Justification: Global facial aesthetic appearance was analyzed using a 95% CI for the proportion of subjects for whom the photographs taken 1 month after first combined treatment showed superior global facial aesthetic appearance than the photographs taken after single treatment. The primary objective was to show that the 95% CI was above 50%, no upper limit was defined.
    [2] - Global facial aesthetic appearance was analyzed using a 95% CI for the proportion of subjects for whom the photographs taken one month after first combined treatment (Month 7) showed superior global facial aesthetic appearance over the photographs taken after single treatment (Month 1).

    Other pre-specified: Global facial aesthetic appearance

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    End point title
    		 Global facial aesthetic appearance
    End point description
    Percentage of subjects showing superior global facial aesthetic appearance after single, first combined and second combined treatment (blinded review of photographs).
    End point type
    Other pre-specified
    End point timeframe
    Month 1, Month 7, Month 13 (one month after each treatment).
    End point values
    		 Group A - Azzalure as single treatment Group B - hyaluronic acid filler as single treatment
    Number of subjects analysed
    23
    25
    Units: Percentage
        Superior Month 1
    22
    0
        Superior Month 7
    22
    44
        Superior Month 13
    56
    56
    No statistical analyses for this end point

    Other pre-specified: Global aesthetic improvement scale - investigator assessment

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    End point title
    		 Global aesthetic improvement scale - investigator assessment
    End point description
    Percentage of subjects assessed as improved (somewhat improved, much improved, and very much improved) on the Global Aesthetic Improvement Scale (GAIS) by investigators at timepoints Month 1, Month 7 and Month 13, i.e. one month after single treatment, first and second combined treatment.
    End point type
    Other pre-specified
    End point timeframe
    Month 1, Month 7, Month 13
    End point values
    		 Group A - Azzalure as single treatment Group B - hyaluronic acid filler as single treatment
    Number of subjects analysed
    29
    31
    Units: Percentage
        Improved Month 1
    100
    77
        Improved Month 7
    100
    68
        Improved Month 13
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Subject satisfaction with facial appearance

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    End point title
    		 Subject satisfaction with facial appearance
    End point description
    The subjects were asked to answer the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria was fulfilled for those subjects that answered "Very/somewhat satisfied".
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Month 1, Month 7, Month 13
    End point values
    		 Group A - Azzalure as single treatment Group B - hyaluronic acid filler as single treatment
    Number of subjects analysed
    29
    31
    Units: Percentage
        Satisfied Month 1
    55
    65
        Satisfied Month 7
    82
    93
        Satisfied Month 13
    86
    96
        Satisfied baseline
    21
    42
    No statistical analyses for this end point

    Other pre-specified: Wrinkle severity glabellar lines at rest - investigator assessment

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    End point title
    		 Wrinkle severity glabellar lines at rest - investigator assessment
    End point description
    The wrinkle severity of Azzalure treated glabellar lines at rest was evaluated by the investigator at all visits. A validated 5-grade photonumeric grading scale was used, where each severity grade was illustrated by as set of photographs. 0 = no glabella lines 1 = mild glabella lines 2 = moderate glabella lines 3 = severe glabella lines 4 = very severe glabella lines Improvement was defined as going from a higher score to a lower score.
    End point type
    Other pre-specified
    End point timeframe
    Months 7, 9, 12, 13, 15, 18
    End point values
    		 Group A - Azzalure as single treatment Group B - hyaluronic acid filler as single treatment
    Number of subjects analysed
    28
    28
    Units: Percentage
        Improved Month 7
    75
    71
        Improved Month 9
    61
    57
        Improved Month 12
    43
    32
        Improved Month 13
    86
    68
        Improved Month 15
    64
    52
        Improved Month 18
    54
    44
    No statistical analyses for this end point

    Other pre-specified: Wrinkle severity glabellar lines at maximum frown - investigator assessment

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    End point title
    		 Wrinkle severity glabellar lines at maximum frown - investigator assessment
    End point description
    The wrinkle severity of Azzalure treated glabellar lines at maximum frown was evaluated by the investigator at all visits. A validated 5-grade photonumeric grading scale was used, where each severity grade was illustrated by as set of photographs. 0 = no glabella lines 1 = mild glabella lines 2 = moderate glabella lines 3 = severe glabella lines 4 = very severe glabella lines Improvement was defined as going from a higher score to a lower score.
    End point type
    Other pre-specified
    End point timeframe
    Months 7, 9, 12, 13, 15, 18
    End point values
    		 Group A - Azzalure as single treatment Group B - hyaluronic acid filler as single treatment
    Number of subjects analysed
    28
    28
    Units: Percentage
        Month 7
    96
    100
        Month 9
    82
    96
        Month 12
    54
    29
        Month 13
    96
    100
        Month 15
    89
    85
        Month 18
    68
    67
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 years, 1 month, 15 days (first enrolment - last completed)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Group A after single treatment with Azzalure
    Reporting group description
    		 Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occured after the single treatment was given but before the 1st combined treatment was given.

    Reporting group title
    Group B (Filler): after single treatment
    Reporting group description
    		 Group B received hyaluronic acid filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occured after the single treatment was given but before the 1st combined treatment was given.

    Reporting group title
    Group A: after first combined treatment
    Reporting group description
    		 Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occured after the 1st combined treatment was given.

    Reporting group title
    Group B: after first combined treatment
    Reporting group description
    		 Group B received hyaluronic acid filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occured after the 1st combined treatment was given.

    Reporting group title
    Group A: after second combined treatment
    Reporting group description
    		 Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occured after the 2nd combined treatment was given.

    Reporting group title
    Group B: after second combined treatment
    Reporting group description
    		 Group B received hyaluronic acid filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occured after the 2nd combined treatment was given.

    Serious adverse events
    		 Group A after single treatment with Azzalure Group B (Filler): after single treatment Group A: after first combined treatment Group B: after first combined treatment Group A: after second combined treatment Group B: after second combined treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group A after single treatment with Azzalure Group B (Filler): after single treatment Group A: after first combined treatment Group B: after first combined treatment Group A: after second combined treatment Group B: after second combined treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 31 (12.90%)
    15 / 28 (53.57%)
    13 / 28 (46.43%)
    9 / 28 (32.14%)
    9 / 28 (32.14%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    VII nerve paralysis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    3 / 28 (10.71%)
    1 / 28 (3.57%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    3
    1
    2
    0
    Implant site bruising
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    7 / 28 (25.00%)
    4 / 28 (14.29%)
    5 / 28 (17.86%)
    4 / 28 (14.29%)
         occurrences all number
    0
    0
    7
    4
    5
    4
    Implant site oedema
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 28 (0.00%)
    3 / 28 (10.71%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    Inflammatory reaction
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Lump
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Swelling
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    2 / 28 (7.14%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    2
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Skin reaction
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Nephritic colic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    Common cold
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    2 / 28 (7.14%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    2
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    Tooth infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1

    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/31592825
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