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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pulmonary fibrosis.

    Summary
    EudraCT number
    		 2013-004404-19
    Trial protocol
    		 GB  
    Global end of trial date
    25 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2019
    First version publication date
    02 Jan 2019
    Other versions
    Summary report(s)
    		 clinical study report

    Trial information

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    Trial identification
    Sponsor protocol code
    Acadmed18013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02048644
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    hull and east yorkshire nhs hosptals trust
    Sponsor organisation address
    castle hill hospital, castle rd, cottingham, United Kingdom, hu16 5jq
    Public contact
    Wright, Hull and East Yorkshire Hospitals NHS Trust , 44 1482624067, c.e.wright@hull.ac.uk
    Scientific contact
    caroline Wright, Hull and East Yorkshire Hospitals NHS Trust , 44 1482624067, c.e.wright@hull.ac.uk
    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 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    There is a significant unmet medical need for the treatment of Idiopathic pulmonary fibrosis (IPF); there is no effective therapy for treatment of IPF in the UK, and only pirfenidone is approved for treatment. The main goal of the current study is to evaluate the effect of Fostair on the biomarkers of platelet activation in IPF disease. We believe that platelets- cell fragments which have a major role in wound healing, also have a pivotal role in the pathogenesis of IPF and whether this translates in to a clinically beneficial effect of Fostair on IPF disease. The primary objective of this study is to determine the effect of Fostair fine particle Metered dose inhaler on markers of pulmonary fibrosis. Primary endpoint will be a change in biomarkers of platelet activation.
    Protection of trial subjects
    continued in routine care
    Background therapy
    		 -
    Evidence for comparator
    		 No Comparators used
    Actual start date of recruitment
    03 Mar 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
    United Kingdom: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    2
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place within the pulmonary fibrosis clinics and also from the pulmonary fibrosis support group by informing patients of the ongoing studies. recruitment began on 11/06/2014

    Pre-assignment
    Screening details
    		 screening patirents were screened for eligibility to take part in the study main criteria were adults (40-85 years of age) with IPF diagnosis according to ATS/ERS Consensus Statement, Able to maintain O2 saturation of ≥ 89% while breathing room air at rest and a FVC (forced vital capacity) of 50-110% predicted value.

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Arm title
    		 baseline
    Arm description
    		 no treatmentnt
    Arm type
    		 baseline

    Investigational medicinal product name
    no product
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    baseline period no products given to subjects as title suggests BASELINE PERIOD

    Number of subjects in period 1
    		baseline
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    BDP/Formoterol 100/6 HFA pMDI combination inhaler and matched placebo were packed and supplied by Chiesi Ltd. The inhalers were identical; ensuring both patient and investigator remained blind to the active medication being received

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Fostair
    Arm description
    		 Budesonide phosphate (BDP)/Formoterol 100/6 HFA pMDI
    Arm type
    		 Experimental

    Investigational medicinal product name
    budesonide phosphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide phosphate (BDP)/Formoterol 100/6 HFA delivered by metered dose inhaler. 2 puffs BD. total dose budesonide /day 400 mcg

    Arm title
    		 placebo
    Arm description
    		 matched placebo metered dose inhalers. The inhalers were identical; to the test inhalers ensuring both patient and investigator blind
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    2 puffs of placebo twice a day

    Number of subjects in period 2
    		Fostair placebo
    Started
    19
    19
    Completed
    19
    17
    Not completed
    0
    2
         Adverse event, non-fatal
    -
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 no treatmentnt

    Reporting group values
    		 baseline Total
    Number of subjects
    		 20 20
    Age categorical
    subject population-patients with diagnosis of IPF
    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)
    		 18 18
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    patients with Idiopathic pulmonary fibrosis meeting study inclusion/exclusion criteria
    Units: years
        arithmetic mean (standard deviation)
    		 71.1 ( 8.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 no treatmentnt
    Reporting group title
    Fostair
    Reporting group description
    		 Budesonide phosphate (BDP)/Formoterol 100/6 HFA pMDI

    Reporting group title
    placebo
    Reporting group description
    		 matched placebo metered dose inhalers. The inhalers were identical; to the test inhalers ensuring both patient and investigator blind

    Primary: p SELECTIN expression

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    End point title
    		 p SELECTIN expression
    End point description
    Measured differences between the baseline and two treatments on AUC P-selectin expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
    End point type
    Primary
    End point timeframe
    recorded at baseline, following 4 week Fostair and following 4 week placebo inhalers with a 4week washout between therapy
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    17
    17
    17
    Units: AUC
        arithmetic mean (standard deviation)
    284 ( 124 )
    197 ( 72 )
    224 ( 80 )
    Statistical analysis title
    		 P-selectiin difference from baseline ANOVA
    Statistical analysis description
    measured differences between the baseline and Fostair on AUC P-selectin expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
    Comparison groups
    baseline v Fostair
    Number of subjects included in analysis
    34
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [1]
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.8
         upper limit
    		 140.6
    Variability estimate
    Standard deviation
    Notes
    [1] - ANOVA and Tukey post hoc test for multiple comparisons.
    Statistical analysis title
    		 P-selectin difference from baseline with placebo
    Statistical analysis description
    ANOVA and Tukey post hoc test for multiple comparisons.
    Comparison groups
    baseline v placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22
         upper limit
    		 141
    Variability estimate
    Standard deviation

    Primary: platelet fibrinogen expression

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    End point title
    		 platelet fibrinogen expression
    End point description
    Measured differences between the baseline and two treatments on AUC platelet fibrinogen expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
    End point type
    Primary
    End point timeframe
    measured at baseline, following 4 weeks Fostair and following 4 weeks placebo with a 4 week washout between treatments
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    17
    17
    17
    Units: AUC
        arithmetic mean (standard deviation)
    786 ( 152 )
    686 ( 188 )
    769 ( 154 )
    Statistical analysis title
    		 Platelet fibrinogen expression Fostair
    Statistical analysis description
    Measured differences between the baseline and Fostair treatment in AUC platelet-fibrinogen expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
    Comparison groups
    Fostair v baseline
    Number of subjects included in analysis
    34
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [2]
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53
         upper limit
    		 253
    Variability estimate
    Standard deviation
    Notes
    [2] - AUC Platelet fibrinogen expression obtained from ANOVA and Tukey post hoc test for multiple comparisons. Study was a crossover study thus only 17 patients analysed
    Statistical analysis title
    		 platelet fibrinogen expression with placebo
    Statistical analysis description
    Measured differences between the baseline and placebo on AUC Platelet fibrinogen expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
    Comparison groups
    placebo v baseline
    Number of subjects included in analysis
    34
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [3]
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -136
         upper limit
    		 169
    Variability estimate
    Standard deviation
    Notes
    [3] - AUC P-selectin expression obtained from ANOVA and Tukey post hoc test for multiple comparisons. the study was a crossover therefore only 17 patients data analysed

    Primary: platelet monocyte aggregates

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    End point title
    		 platelet monocyte aggregates
    End point description
    Differences between the baseline and two treatments on AUC platelet monocyte aggregates obtained from ANOVA and Tukey post hoc test for multiple comparisons.
    End point type
    Primary
    End point timeframe
    measured at baseline, following 4 weeks Fostair and following 4 weeks placebo inhalers with a 4 week washout between treatments
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    17
    17
    17
    Units: AUC
        arithmetic mean (standard deviation)
    344 ( 130 )
    330 ( 181 )
    382 ( 141 )
    Statistical analysis title
    		 platelet monocyte aggregates Fostair
    Statistical analysis description
    differences between the baseline and Fostair on AUC platelet monocyte aggregates (PMA) obtained from ANOVA and Tukey post hoc test for multiple comparisons.
    Comparison groups
    baseline v Fostair
    Number of subjects included in analysis
    34
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [4]
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -117
         upper limit
    		 144
    Variability estimate
    Standard deviation
    Notes
    [4] - Change from baseline AUC PMA from ANOVA and Tukey post hoc test for multiple comparisons. This was a crossover study thus 17 patients data analysed
    Statistical analysis title
    		 PMA- placebo
    Statistical analysis description
    Differences between the baseline and placebo AUC PMA obtained from ANOVA and Tukey post hoc test for multiple comparisons.
    Comparison groups
    baseline v placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [5]
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -168
         upper limit
    		 92.4
    Variability estimate
    Standard deviation
    Notes
    [5] - ANOVA and Tukey post hoc test for multiple comparisons. This was a crossover study thus 17 patients data analysed

    Secondary: Forced expired volume in 1 second

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    End point title
    		 Forced expired volume in 1 second
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline through to post 4 weeks foster and post 4 weeks placebo.
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    17 [6]
    17 [7]
    17 [8]
    Units: ml
        arithmetic mean (standard deviation)
    215 ( 56 )
    222 ( 58 )
    215 ( 62 )
    Notes
    [6] - FAS
    [7] - FAS
    [8] - FAS
    Statistical analysis title
    		 Paired test
    Comparison groups
    baseline v Fostair v placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Forced vital capacity

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    End point title
    		 Forced vital capacity
    End point description
    End point type
    Secondary
    End point timeframe
    measurement taken at baseline, at 4weeks post foster therapy, and at 4 weeks post placebo therapy. Each subject acted as own control, crossover study
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    17
    17
    17
    Units: ml
        arithmetic mean (standard deviation)
    264 ( 79 )
    270 ( 74 )
    268 ( 80 )
    Statistical analysis title
    		 paired ttest
    Statistical analysis description
    change from baseline in FVC following 4 weeks placebo was compared with change in FVC from baseline following 4 weeks fostair
    Comparison groups
    baseline v Fostair v placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: FEF25-75

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    End point title
    		 FEF25-75
    End point description
    End point type
    Secondary
    End point timeframe
    measured at baseline, at 4weeks post placebo and at 4weeks post fostair therapy
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    17
    17
    17
    Units: ml
        arithmetic mean (standard deviation)
    240 ( 98 )
    253 ( 72 )
    234 ( 84 )
    Statistical analysis title
    		 paired ttest
    Statistical analysis description
    compared change from baseline in FEF 25/75 with placebo with that of change in from baseline following fostair. crossover study
    Comparison groups
    baseline v Fostair v placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: FENO

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    End point title
    		 FENO
    End point description
    End point type
    Secondary
    End point timeframe
    Measured at baseline, following 4 weeks placebo and following 4 weeks treatment with fostair with 4 week interval between treatments
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    12 [9]
    12
    12
    Units: PPB
        arithmetic mean (standard deviation)
    19 ( 8 )
    18 ( 7 )
    18 ( 8 )
    Notes
    [9] - Only 12 patients were able to produce sputum at all relevant visits through out study as per protoco
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    compared change from baseline between fostair and placebo
    Comparison groups
    baseline v Fostair v placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 ≤ 0.05 [11]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [10] - compared baseline placebo and fostair with bonferoni. within group comparison as each individual acted as own control. only 12 subjects analysed
    [11] - a value<0.05 demonstrated significant difference

    Secondary: fev1/FVC

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    End point title
    		 fev1/FVC
    End point description
    End point type
    Secondary
    End point timeframe
    measured at baseline and at 4weeks post placebo and at 4 weeks post fostair with a 4 week interval between treatments.
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    17
    17
    17
    Units: ratio
        arithmetic mean (standard deviation)
    82 ( 6 )
    83 ( 4 )
    81 ( 5 )
    Statistical analysis title
    		 ANOVA
    Comparison groups
    baseline v Fostair v placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: KBILD

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    End point title
    		 KBILD
    End point description
    measuring total score for Kings Brief questionnaire for interstitial lung disease
    End point type
    Secondary
    End point timeframe
    measured at baseline, following 4 weeks placebo and following 4 weeks fostair
    End point values
    		 baseline Fostair placebo
    Number of subjects analysed
    17
    17
    17 [12]
    Units: score
        arithmetic mean (standard deviation)
    73 ( 17 )
    72 ( 19 )
    72 ( 20 )
    Notes
    [12] - not parallel study crossover on 17 analysed
    Statistical analysis title
    		 ANOVA
    Comparison groups
    baseline v Fostair v placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported at baseline, following 4 weeks treatment with placebo at the end of the 4 week interval (no therapy) and at the end of the 4 week treatment with fostair.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Full analysis set
    Reporting group description
    		 full analysis set

    Serious adverse events
    		 Full analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Cerebral ischaemia
    Additional description: Transient Ischaemic attack
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Full analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 20 (95.00%)
    Nervous system disorders
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    3
    Neck pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Colonoscopy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    4
    Catarrh
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Dyspnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    sore throat
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nasal polyps
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Pharyngitis bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Oral candidiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Dysphonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Local reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Muscle spasms
    Additional description: leg cramps
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         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
    02 Jul 2014
    1)Prohibited mediciation:- Irreversible cyclo-oxygenase inhibitors- Aspirin. To remove this class of medications from the list 2)Inclusion critera: 4. FVC of 50-80% predicted. To change this criteria to FVC of 50-110% predicted.
    21 Nov 2014
    1) Extension of certificate of analysis on the fostair/placebo inhalers 2) Supply of 20 additional kits with expiry increased to April 2015.

    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/2925571
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