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    Clinical Trial Results:
    A phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS)

    Summary
    EudraCT number
    		 2012-000108-13
    Trial protocol
    		 DE  
    Global end of trial date
    11 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UKM10_0018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Münster
    Sponsor organisation address
    Albert-Schweitzer-Campus 1, Gebäude D5, Münster, Germany, 48149
    Public contact
    Klinik für Hautkrankheiten, Universitätsklinikum Münster, tobias.goerge@ukmuenster.de
    Scientific contact
    Klinik für Hautkrankheiten, Universitätsklinikum Münster, tobias.goerge@ukmuenster.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is the statistical evaluation of the therapeutic effects of rivaroxaban in patients with livedoid vasculopathy.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and the ICH Guidelines in Good Clinical Practice. The study was not started before the competent ethics committee had given a favorable opinion. Written informed consent was obtained from all patients and the study was only conducted as approved by the Ethics committee and the competent authority. Amendments were only implemented after approval.
    Background therapy
    		 Enoxaparin (1 mg/kg bodyweight) was allowed as backup medication in case of treatment failure.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    28 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    18
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited for the study from four university hospitals throughout Germany. The recruitment period was from December 2012 to May 2014.

    Pre-assignment
    Screening details
    		 Eligible patients were at least 18 years of age with confirmed diagnosis of livedoid vasculopathy and 40 points on the pain visual analogue scale. All patients were required to have a wash out phase of any previous treatment of at least 24 hours before study medication was administered. Patients with symptomatic bleeding disorders were excluded.

    Pre-assignment period milestones
    Number of subjects started
    		 28
    Number of subjects completed
    		 25

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 violation of inclusion criteria: 2
    Reason: Number of subjects
    		 lack of compliance: 1
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Rivaroxaban - Baseline
    Arm description
    		 Patients at baseline (before rivaroxaban treatment was initiated).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xarelto 10 mg
    Investigational medicinal product code
    Other name
    Rivaroxaban
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were treated orally with rivaroxaban at an initial dose of 10 mg twice daily and it was reduced to 10 mg once daily when pain decreased. It was also possible to initiate the treatment with a dose of 10 mg once daily. In case of insufficient pain reduction, rivaroxaban was increased to 10 mg twice daily.

    Number of subjects in period 1 [1]
    		Rivaroxaban - Baseline
    Started
    25
    Completed
    21
    Not completed
    4
         Consent withdrawn by subject
    1
         lack of compliance
    1
         Protocol deviation
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 28 Patients were enrolled in the study and were allocated for treatment with rivaroxaban. But three of the patients dropped out before the baseline examination because of violation of inclusion criteria (2 patients) or lack of compliance (1 patient). Therefore, only 25 patients started the baseline period.
    Period 2
    Period 2 title
    Week 4
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Rivaroxaban - Week 4
    Arm description
    		 Patients who received rivaroxaban for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xarelto 10 mg
    Investigational medicinal product code
    Other name
    Rivaroxaban
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were treated orally with rivaroxaban at an initial dose of 10 mg twice daily and it was reduced to 10 mg once daily when pain decreased. It was also possible to initiate the treatment with a dose of 10 mg once daily. In case of insufficient pain reduction, rivaroxaban was increased to 10 mg twice daily.

    Number of subjects in period 2
    		Rivaroxaban - Week 4
    Started
    21
    Completed
    20
    Not completed
    1
         Adverse event, non-fatal
    1
    Period 3
    Period 3 title
    Week 8
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Rivaroxaban - Week 8
    Arm description
    		 Patients who received rivaroxaban for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xarelto 10 mg
    Investigational medicinal product code
    Other name
    Rivaroxaban
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were treated orally with rivaroxaban at an initial dose of 10 mg twice daily and it was reduced to 10 mg once daily when pain decreased. It was also possible to initiate the treatment with a dose of 10 mg once daily. In case of insufficient pain reduction, rivaroxaban was increased to 10 mg twice daily.

    Number of subjects in period 3
    		Rivaroxaban - Week 8
    Started
    20
    Completed
    20
    Period 4
    Period 4 title
    Week 12
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Rivaroxaban - Week 12
    Arm description
    		 Patients who received rivaroxaban for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xarelto 10 mg
    Investigational medicinal product code
    Other name
    Rivaroxaban
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were treated orally with rivaroxaban at an initial dose of 10 mg twice daily and it was reduced to 10 mg once daily when pain decreased. It was also possible to initiate the treatment with a dose of 10 mg once daily. In case of insufficient pain reduction, rivaroxaban was increased to 10 mg twice daily.

    Number of subjects in period 4
    		Rivaroxaban - Week 12
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 25 25
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 16 16
        From 65-84 years
    		 9 9
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.84 ( 17.03 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Rivaroxaban - Baseline
    Reporting group description
    		 Patients at baseline (before rivaroxaban treatment was initiated).
    Reporting group title
    Rivaroxaban - Week 4
    Reporting group description
    		 Patients who received rivaroxaban for 4 weeks.
    Reporting group title
    Rivaroxaban - Week 8
    Reporting group description
    		 Patients who received rivaroxaban for 8 weeks.
    Reporting group title
    Rivaroxaban - Week 12
    Reporting group description
    		 Patients who received rivaroxaban for 12 weeks.

    Subject analysis set title
    Enoxaparin - Baseline to Week 12
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients who reached the end of the study (week 12) and needed backup treatment with enoxaparin.

    Primary: change in local pain between baseline and week 12

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    End point title
    		 change in local pain between baseline and week 12
    End point description
    The primary endpoint is the change in local pain measured on a visual analogue scale (VAS) between baseline and week 12.
    End point type
    Primary
    End point timeframe
    baseline and week 12
    End point values
    		 Rivaroxaban - Baseline Rivaroxaban - Week 12
    Number of subjects analysed
    20 [1]
    20 [2]
    Units: visual analogue scale (VAS) score
        median (inter-quartile range (Q1-Q3))
    65 (52 to 78)
    6 (1 to 14)
    Notes
    [1] - Endpoint could be assessed only for 20 patients, because 5 patients had dropped out before week 12.
    [2] - Endpoint could be assessed only for 20 patients, because 5 patients had dropped out before week 12.
    Statistical analysis title
    		 primary statistical analysis
    Statistical analysis description
    The primary analysis was performed with a significance level of α = 0.05. The null hypothesis was tested with a two-sided Wilcoxon test for paired data. It was conducted according to the ITT principle and is considered confirmatory. Therapeutic effectiveness was considered clinically relevant with a mean effect size in the primary endpoint of at least Δ/σ=0.7. A minimum sample size of 20 evaluable patients was necessary to demonstrate a significant therapeutic effect with a power of 80%.
    Comparison groups
    Rivaroxaban - Baseline v Rivaroxaban - Week 12
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 2-sided exact Wilcoxon test
    Parameter type
    		 Median difference (net)
    Point estimate
    62.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 41.89
         upper limit
    		 68.81

    Secondary: change in local pain between baseline and week 4

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    End point title
    		 change in local pain between baseline and week 4
    End point description
    The secondary endpoint is the change in local pain measured on a visual analogue scale (VAS) between baseline and week 4.
    End point type
    Secondary
    End point timeframe
    baseline and week 4
    End point values
    		 Rivaroxaban - Baseline Rivaroxaban - Week 4
    Number of subjects analysed
    21 [3]
    21 [4]
    Units: visual analogue scale (VAS) score
        median (inter-quartile range (Q1-Q3))
    65 (52 to 78)
    20 (9 to 30)
    Notes
    [3] - Endpoint could be assessed only for 21 patients, because 4 patients had dropped out before week 4.
    [4] - Endpoint could be assessed only for 21 patients, because 4 patients had dropped out before week 4.
    Statistical analysis title
    		 secondary statistical analysis
    Statistical analysis description
    Secondary endpoints were analyzed partly descriptively. In case of inductive analyses, two-sided Wilcoxon test for paired data were used and data were analyzed according to the intention-to-treat principle. These analyses are considered exploratory and are interpreted accordingly.
    Comparison groups
    Rivaroxaban - Baseline v Rivaroxaban - Week 4
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 2-sided exact Wilcoxon test
    Confidence interval

    Secondary: change in local pain between baseline and week 8

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    End point title
    		 change in local pain between baseline and week 8
    End point description
    The secondary endpoint is the change in local pain measured on a visual analogue scale (VAS) between baseline and week 8.
    End point type
    Secondary
    End point timeframe
    baseline and week 8
    End point values
    		 Rivaroxaban - Baseline Rivaroxaban - Week 8
    Number of subjects analysed
    20 [5]
    20 [6]
    Units: visual analogue scale (VAS) score
        median (inter-quartile range (Q1-Q3))
    65 (52 to 78)
    10 (2.5 to 21)
    Notes
    [5] - Endpoint could be assessed only for 20 patients, because 5 patients had dropped out before week 8.
    [6] - Endpoint could be assessed only for 20 patients, because 5 patients had dropped out before week 8.
    Statistical analysis title
    		 secondary statistical analysis
    Statistical analysis description
    Secondary endpoints were analyzed partly descriptively. In case of inductive analyses, two-sided Wilcoxon test for paired data were used and data were analyzed according to the intention-to-treat principle. These analyses are considered exploratory and are interpreted accordingly.
    Comparison groups
    Rivaroxaban - Baseline v Rivaroxaban - Week 8
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 2-sided exact Wilcoxon test
    Confidence interval

    Secondary: change in quality of life between baseline and week 4

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    End point title
    		 change in quality of life between baseline and week 4
    End point description
    The secondary endpoint is the change in quality of life measured with a Dermatology Life Quality Index (DLQI) questionnaire between baseline and week 4.
    End point type
    Secondary
    End point timeframe
    baseline and week 4
    End point values
    		 Rivaroxaban - Baseline Rivaroxaban - Week 4
    Number of subjects analysed
    21 [7]
    21 [8]
    Units: DLQI Score
        arithmetic mean (standard deviation)
    14.2 ( 6.93 )
    10.9 ( 6.76 )
    Notes
    [7] - Endpoint could be assessed only for 21 patients, because 4 patients had dropped out before week 4.
    [8] - Endpoint could be assessed only for 21 patients, because 4 patients had dropped out before week 4.
    Statistical analysis title
    		 secondary statistical analysis
    Statistical analysis description
    Secondary endpoints were analyzed partly descriptively. In case of inductive analyses, two-sided Wilcoxon test for paired data were used and data were analyzed according to the intention-to-treat principle. These analyses are considered exploratory and are interpreted accordingly.
    Comparison groups
    Rivaroxaban - Baseline v Rivaroxaban - Week 4
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 2-sided exact Wilcoxon test
    Confidence interval

    Secondary: change in quality of life between baseline and week 8

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    End point title
    		 change in quality of life between baseline and week 8
    End point description
    The secondary endpoint is the change in quality of life measured with a Dermatology Life Quality Index (DLQI) questionnaire between baseline and week 8.
    End point type
    Secondary
    End point timeframe
    baseline and week 8
    End point values
    		 Rivaroxaban - Baseline Rivaroxaban - Week 8
    Number of subjects analysed
    20 [9]
    20 [10]
    Units: DLQI Score
        arithmetic mean (standard deviation)
    14.2 ( 6.93 )
    8.25 ( 6.84 )
    Notes
    [9] - Endpoint could be assessed only for 20 patients, because 5 patients had dropped out before week 8.
    [10] - Endpoint could be assessed only for 20 patients, because 5 patients had dropped out before week 8.
    Statistical analysis title
    		 secondary statistical analysis
    Statistical analysis description
    Secondary endpoints were analyzed partly descriptively. In case of inductive analyses, two-sided Wilcoxon test for paired data were used and data were analyzed according to the intention-to-treat principle. These analyses are considered exploratory and are interpreted accordingly.
    Comparison groups
    Rivaroxaban - Baseline v Rivaroxaban - Week 8
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 2-sided exact Wilcoxon test
    Confidence interval

    Secondary: change in quality of life between baseline and week 12

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    End point title
    		 change in quality of life between baseline and week 12
    End point description
    The secondary endpoint is the change in quality of life measured with a Dermatology Life Quality Index (DLQI) questionnaire between baseline and week 12.
    End point type
    Secondary
    End point timeframe
    baseline and week 12
    End point values
    		 Rivaroxaban - Baseline Rivaroxaban - Week 12
    Number of subjects analysed
    20 [11]
    20 [12]
    Units: DLQI Score
        arithmetic mean (standard deviation)
    14.2 ( 6.93 )
    5.8 ( 4.95 )
    Notes
    [11] - Endpoint could be assessed only for 20 patients, because 5 patients had dropped out before week 12.
    [12] - Endpoint could be assessed only for 20 patients, because 5 patients had dropped out before week 12.
    Statistical analysis title
    		 secondary statistical analysis
    Statistical analysis description
    Secondary endpoints were analyzed partly descriptively. In case of inductive analyses, two-sided Wilcoxon test for paired data were used and data were analyzed according to the intention-to-treat principle. These analyses are considered exploratory and are interpreted accordingly.
    Comparison groups
    Rivaroxaban - Baseline v Rivaroxaban - Week 12
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 2-sided exact Wilcoxon test
    Confidence interval

    Secondary: Consumption of rescue medication - use of injections

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    End point title
    		 Consumption of rescue medication - use of injections
    End point description
    The secondary endpoint is the use of enoxaparin injections from baseline to week 12.
    End point type
    Secondary
    End point timeframe
    From baseline to week 12.
    End point values
    		 Enoxaparin - Baseline to Week 12
    Number of subjects analysed
    6
    Units: injections
        median (inter-quartile range (Q1-Q3))
    19 (3 to 60)
    No statistical analyses for this end point

    Secondary: Consumption of rescue medication - duration of administration

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    End point title
    		 Consumption of rescue medication - duration of administration
    End point description
    The secondary endpoint is the duration of enoxaparin administration from baseline to week 12.
    End point type
    Secondary
    End point timeframe
    From baseline to week 12.
    End point values
    		 Enoxaparin - Baseline to Week 12
    Number of subjects analysed
    6
    Units: days
        median (inter-quartile range (Q1-Q3))
    13 (3 to 30)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From enrollment in the study to week 12 (reported adverse events were followed up after week 12).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Safety group
    Reporting group description
    		 Adverse Events were evaluated descriptively according to the as-treated principle.

    Serious adverse events
    		 Safety group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 25 (12.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Superinfection
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 25 (56.00%)
    Investigations
    Heart rate increased
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Nervous system disorders
    Head discomfort
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    5
    Paraesthesia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Menorrhagia
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Gingival bleeding
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    2
    Petechiae
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Limb discomfort
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Tendon pain
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Infections and infestations
    Herpes virus infection
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2013
    The protocol was amended to add and modify some exclusion criteria and to modify the administration of the study medication in terms of initial dosing. At the beginning of the trial, the treatment was initiated with 10 mg rivaroxaban orally twice daily and was reduced to 10 mg orally once daily when pain decreased. After the amendment, the treatment was initiated with 10 mg rivaroxaban orally once daily and only in case of insufficient pain reduction, rivaroxaban was increased to 10 mg twice daily.

    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/26853646
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