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    Clinical Trial Results:
    Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes.

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-004984-27
    Trial protocol
    		 LT   FI   GB   CZ   DE   HU   LV   FR  
    Global end of trial date
    19 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Apr 2016
    First version publication date
    17 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN2211-3867
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01973231
    WHO universal trial number (UTN)
    		 U1111-1136-3644
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    21 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of liraglutide versus lixisenatide as add-on to metformin on glycaemic control after 26 weeks treatment in subjects with type 2 diabetes mellitus (T2DM)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (Seoul, Oct 2008) and ICH Good Clinical Practice (01-May-1996) and 21 CFR 312.120.
    Background therapy
    		 Stable dose of Metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day).
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    24 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 59
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    France: 30
    Country: Number of subjects enrolled
    Germany: 49
    Country: Number of subjects enrolled
    Hungary: 56
    Country: Number of subjects enrolled
    Italy: 40
    Country: Number of subjects enrolled
    Latvia: 48
    Country: Number of subjects enrolled
    Lithuania: 34
    Country: Number of subjects enrolled
    United Kingdom: 80
    Worldwide total number of subjects
    404
    EEA total number of subjects
    404
    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)
    321
    From 65 to 84 years
    82
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 56 sites in 9 countries as follows: Czech Republic: 5 sites; Finland: 4 sites; France: 6 sites; Germany: 8 sites; Hungary: 6 sites; Italy: 5 sites; Latvia: 6 sites; Lithuania: 5 sites; UK: 11 sites.

    Pre-assignment
    Screening details
    		 Not applicable

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide was to be injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection site did not have to be consistent throughout the trial. Injections could be done at any time of the day irrespective of meals. It was recommended that the time of injection was consistent throughout the trial. Subjects were instructed to perform an air shot before the first use of a new pre-filled pen. Subjects were to follow a dose escalation. Liraglutide was to be initiated with a starting dose of 0.6 mg/day, with subsequent weekly dose escalations of 0.6 mg/day in accordance with the approved dose escalation for liraglutide until the maintenance dose of 1.8 mg/day was reached. Escalation from 0.6 mg/day to 1.8 mg/day could be extended by 7 days if subjects did not tolerate an increase in dose during dose escalation according to the investigator’s opinion. The liraglutide dose of 1.8 mg/day was to remain unchanged throughout the remainder of the trial.

    Arm title
    		 Lixisenatide
    Arm description
    		 Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lixisenatide
    Investigational medicinal product code
    Other name
    Lyxumia®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lixisenatide was to be administered once daily, within the hour prior to the first meal of the day or the evening meal, in accordance with the approved SmPC (Summary of Product Characteristics) at the time of trial initiation and recruitment of subjects. Dose escalation for lixisenatide was according to the approved label. Following a starting dose of 10 μg, the dose was to be escalated to 20 μg from day 15 after randomisation. If a dose of lixisenatide was missed, it was to be injected within the hour prior to the next meal. Injections were to be done subcutaneously in the thigh, abdomen or upper arm. Trial drug medication with lixisenatide after dose escalation was to be continued at a fixed dose throughout the trial.

    Number of subjects in period 1
    		Liraglutide Lixisenatide
    Started
    202
    202
    Completed
    191
    190
    Not completed
    11
    12
         Consent withdrawn by subject
    7
    9
         unclassified
    2
    1
         Lost to follow-up
    1
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.

    Reporting group title
    Lixisenatide
    Reporting group description
    		 Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.

    Reporting group values
    		 Liraglutide Lixisenatide Total
    Number of subjects
    		 202 202 404
    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)
    		 155 166 321
        From 65-84 years
    		 46 36 82
        85 years and over
    		 1 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.3 ± 10.6 56.1 ± 10 -
    Gender, Male/Female
    Units: participants
        Female
    		 70 90 160
        Male
    		 132 112 244
    Glycosylated Haemoglobin (HbA1c)
    Units: Percent (%) glycosylated haemoglobin
        arithmetic mean (standard deviation)
    		 8.4 ± 0.723 8.43 ± 0.785 -
    Fasting plasma glucose (FPG)
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 10.47 ± 2.368 10.25 ± 2.254 -
    Body Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 101.89 ± 23.344 100.58 ± 19.949 -

    End points

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    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.

    Reporting group title
    Lixisenatide
    Reporting group description
    		 Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.

    Primary: Change in glycosylated haemoglobin (HbA1c)

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    End point title
    		 Change in glycosylated haemoglobin (HbA1c)
    End point description
    Change from baseline in HbA1c after 26 weeks of treatment.
    End point type
    Primary
    End point timeframe
    From baseline to week 26.
    End point values
    		 Liraglutide Lixisenatide
    Number of subjects analysed
    194
    191
    Units: Percent (%) glycosylated haemoglobin
        arithmetic mean (standard deviation)
    -1.809 ± 0.9159
    -1.238 ± 1.0085
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Liraglutide v Lixisenatide
    Number of subjects included in analysis
    385
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.44

    Secondary: Change in fasting plasma glucose (FPG)

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    End point title
    		 Change in fasting plasma glucose (FPG)
    End point description
    Change from baseline in FPG after 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    From baseline to week 26
    End point values
    		 Liraglutide Lixisenatide
    Number of subjects analysed
    194
    189
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.904 ± 2.2309
    -1.644 ± 2.1511
    No statistical analyses for this end point

    Secondary: Change in body weight

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    End point title
    		 Change in body weight
    End point description
    Change from baseline in body weight after 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    From baseline to week 26
    End point values
    		 Liraglutide Lixisenatide
    Number of subjects analysed
    194
    191
    Units: kg
        arithmetic mean (standard deviation)
    -4.24 ± 4.273
    -3.69 ± 4.746
    No statistical analyses for this end point

    Secondary: Subjects who achieve HbA1c below 7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) (yes/no)

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    End point title
    		 Subjects who achieve HbA1c below 7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) (yes/no)
    End point description
    Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no).
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    		 Liraglutide Lixisenatide
    Number of subjects analysed
    194
    191
    Units: percentage (%) of subjects
    number (not applicable)
        Yes
    74.2
    45.5
        No
    25.8
    54.5
    No statistical analyses for this end point

    Secondary: Subjects who achieve HbA1c equal to or below 6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists [AACE] target) (yes/no)

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    End point title
    		 Subjects who achieve HbA1c equal to or below 6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists [AACE] target) (yes/no)
    End point description
    Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no).
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    		 Liraglutide Lixisenatide
    Number of subjects analysed
    194
    191
    Units: percentage (%) of subjects
    number (not applicable)
        Yes
    54.6
    26.2
        No
    45.4
    73.8
    No statistical analyses for this end point

    Secondary: Subjects who achieve HbA1c below 7.0% (53 mmol/mol) and no weight gain (yes/no)

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    End point title
    		 Subjects who achieve HbA1c below 7.0% (53 mmol/mol) and no weight gain (yes/no)
    End point description
    Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no).
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    		 Liraglutide Lixisenatide
    Number of subjects analysed
    194
    191
    Units: percentage (%) of subjects
    number (not applicable)
        Yes
    66.5
    41.9
        No
    33.5
    58.1
    No statistical analyses for this end point

    Secondary: Number of treatment emergent adverse events (TEAEs)

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    End point title
    		 Number of treatment emergent adverse events (TEAEs)
    End point description
    A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment
    End point values
    		 Liraglutide Lixisenatide
    Number of subjects analysed
    202
    202
    Units: Events
        Events
    540
    435
        Serious
    13
    7
        Severe
    10
    3
        Moderate
    109
    84
        Mild
    421
    348
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0-26
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.

    Reporting group title
    Lixisenatide
    Reporting group description
    		 Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 μg once daily, the dose was escalated to 20 μg once daily from day 15 after randomisation.

    Serious adverse events
    		 Liraglutide Lixisenatide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 202 (5.94%)
    7 / 202 (3.47%)
         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)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (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
    Pyrexia
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer haemorrhage
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatic dysplasia
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety disorder due to a general medical condition
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 202 (0.50%)
         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
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diabetic foot infection
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Liraglutide Lixisenatide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    90 / 202 (44.55%)
    83 / 202 (41.09%)
    Investigations
    Lipase increased
         subjects affected / exposed
    17 / 202 (8.42%)
    5 / 202 (2.48%)
         occurrences all number
    17
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 202 (7.43%)
    17 / 202 (8.42%)
         occurrences all number
    31
    35
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    25 / 202 (12.38%)
    20 / 202 (9.90%)
         occurrences all number
    39
    22
    Dyspepsia
         subjects affected / exposed
    11 / 202 (5.45%)
    6 / 202 (2.97%)
         occurrences all number
    11
    9
    Nausea
         subjects affected / exposed
    44 / 202 (21.78%)
    44 / 202 (21.78%)
         occurrences all number
    67
    60
    Vomiting
         subjects affected / exposed
    14 / 202 (6.93%)
    18 / 202 (8.91%)
         occurrences all number
    18
    22
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 202 (6.44%)
    20 / 202 (9.90%)
         occurrences all number
    13
    22
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    13 / 202 (6.44%)
    5 / 202 (2.48%)
         occurrences all number
    13
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2013
    1.Changing inclusion criteria 3 and 4 according to ADA and EASD position statement: defining maximum tolerated dose for metformin and increasing HbA1c lower limit from 7.0% to 7.5% 2.Define “true abstinence” in exclusion criterion 3 3.Adding pancreatitis as MESI

    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.
    Not applicable
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