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    Clinical Trial Results:
    Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension

    Summary
    EudraCT number
    		 2013-002950-56
    Trial protocol
    		 CZ   DE   AT   BE   GB   HU   NL   LT  
    Global end of trial date
    28 Sep 2016

    Results information
    Results version number
    		 v1
    This version publication date
    01 Jun 2018
    First version publication date
    18 Oct 2017
    Other versions
    		 v2 , v3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AC-055E201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02021292
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Actelion Pharmaceuticals Ltd.
    Sponsor organisation address
    Gewerbestrasse 16, Allschwil, Switzerland, 4123
    Public contact
    Clinical Trial Disclosure Desk, Actelion Pharmaceuticals Ltd., clinical-trials-disclosure@actelion.com
    Scientific contact
    Clinical Trial Disclosure Desk, Actelion Pharmaceuticals Ltd., clinical-trials-disclosure@actelion.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
    25 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) at rest in comparison with placebo in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
    Protection of trial subjects
    Prior to the start of the trial the study center consulted an Independent Ethics Committee (IEC), i.e., a review panel that was responsible for ensuring the protection of the rights, safety, and well-being of human patients involved in a clinical investigation. The sponsor ensured that the IEC consulted was adequately constituted to provide assurance of that protection, and maintained a list of committee members and their qualifications. The protocol and any material provided to the patient (such as a subject information sheet or description of the study used to obtain informed consent) were reviewed and approved by the appropriate IEC before the study was started. This study was conducted in full conformance with the principles of the ‘Declaration of Helsinki’ and with the laws and regulations of the country in which the research was conducted. Both Actelion and the investigator had the right to terminate the study at any time, and in such a case, were responsible for protecting the patients’ interests. Written informed consent was obtained from each individual participating in the study prior to any study procedure and after adequate explanation of the aims, methods, objectives, and potential hazards of the study. It was made clear to each patient that he or she was completely free to refuse to enter the study, or to withdraw from it at any time for any reason. A description of any incentives to participate in the study was provided in the informed consent form.
    Background therapy
    		 49 of 80 randomized subjects (61.3%) received PAH-specific background therapy at baseline (24 or 60% of subjects on macitentan and 25 or 62.5% of subjects on placebo).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    China: 24
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Lithuania: 2
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Russian Federation: 21
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Thailand: 4
    Country: Number of subjects enrolled
    Turkey: 2
    Country: Number of subjects enrolled
    Ukraine: 4
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    80
    EEA total number of subjects
    21
    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)
    52
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 48 sites in 20 countries screened subjects for recruitment. The study was conducted (i.e., randomized subjects) in a total of 36 sites across 16 countries: Belgium, China, Czech Republic, France, Germany, Hungary, Lithuania, Mexico, Poland, Russia, Thailand, Turkey, South Korea, Switzerland, Ukraine, and the United Kingdom.

    Pre-assignment
    Screening details
    		 The target screening period from Visit 1 up to Randomization was a maximum of 30 days, but a longer period (up to 60 days) was permitted with pre-approval from Actelion. A total of 186 subjects were screened.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Macitentan
    Arm description
    		 Macitentan 10 mg, oral tablet, to be taken once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Macitentan
    Investigational medicinal product code
    ACT-064992
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg tablet, once daily

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo oral tablet, to be taken once daily.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, once-daily

    Number of subjects in period 1
    		Macitentan Placebo
    Started
    40
    40
    Completed
    40
    37
    Not completed
    0
    3
         Physician decision
    -
    1
         Death
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Macitentan
    Reporting group description
    		 Macitentan 10 mg, oral tablet, to be taken once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo oral tablet, to be taken once daily.

    Reporting group values
    		 Macitentan Placebo Total
    Number of subjects
    		 40 40 80
    Age categorical
    Units: Subjects
        Age 18-64 years
    		 26 26 52
        Age 65-84 years
    		 14 14 28
    Age continuous
    Units: years
        median (full range (min-max))
    		 60.0 (20 to 80) 58.0 (23 to 78) -
    Gender categorical
    Units:
        Female
    		 26 25 51
        Male
    		 14 15 29
    Region of enrollment
    Units: Subjects
        Asia
    		 15 14 29
        Eastern Europe
    		 17 19 36
        Latin America
    		 1 1 2
        Western Europe
    		 7 6 13
    WHO functional class
    Units: Subjects
        class II
    		 12 6 18
        class III
    		 28 33 61
        class IV
    		 0 1 1
    Body Mass Index (BMI)
    Units: kg/m2
        median (full range (min-max))
    		 25.7 (19.8 to 47.5) 26.0 (18.3 to 36.2) -
    6-minute walk distance (6MWD)
    Units: meter
        arithmetic mean (standard deviation)
    		 353.0 ( 87.90 ) 351.2 ( 73.79 ) -
    Pulmonary vascular resistance (PVR)
    Units: dyn.sec/cm5
        arithmetic mean (standard deviation)
    		 929.2 ( 379.65 ) 984.3 ( 487.06 ) -
    Time since diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH)
    Units: years
        arithmetic mean (standard deviation)
    		 1.7 ( 2.36 ) 1.2 ( 1.95 ) -
    Subject analysis sets

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) included all subjects assigned to a study treatment. In order to adhere to the intention-to-treat principle as much as possible: 1) subjects were evaluated according to the study treatment they have been assigned to (which may be different from the study treatment they have received) and 2) all available data were included.

    Subject analysis sets values
    		 Full analysis set (FAS)
    Number of subjects
    80
    Age categorical
    Units: Subjects
        Age 18-64 years
    52
        Age 65-84 years
    28
    Age continuous
    Units: years
        median (full range (min-max))
    59.0 (20 to 80)
    Gender categorical
    Units:
        Female
    51
        Male
    29
    Region of enrollment
    Units: Subjects
        Asia
    29
        Eastern Europe
    36
        Latin America
    2
        Western Europe
    13
    WHO functional class
    Units: Subjects
        class II
    18
        class III
    61
        class IV
    1
    Body Mass Index (BMI)
    Units: kg/m2
        median (full range (min-max))
    25.7 (18.3 to 47.5)
    6-minute walk distance (6MWD)
    Units: meter
        arithmetic mean (standard deviation)
    352.1 ( 80.64 )
    Pulmonary vascular resistance (PVR)
    Units: dyn.sec/cm5
        arithmetic mean (standard deviation)
    956.8 ( 434.78 )
    Time since diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH)
    Units: years
        arithmetic mean (standard deviation)
    1.5 ( 2.16 )

    End points

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    End points reporting groups
    Reporting group title
    Macitentan
    Reporting group description
    		 Macitentan 10 mg, oral tablet, to be taken once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo oral tablet, to be taken once daily.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) included all subjects assigned to a study treatment. In order to adhere to the intention-to-treat principle as much as possible: 1) subjects were evaluated according to the study treatment they have been assigned to (which may be different from the study treatment they have received) and 2) all available data were included.

    Primary: Change from baseline to Week 16 in pulmonary vascular resistance (PVR) at rest.

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    End point title
    		 Change from baseline to Week 16 in pulmonary vascular resistance (PVR) at rest.
    End point description
    The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.
    End point type
    Primary
    End point timeframe
    From baseline to Week 16
    End point values
    		 Macitentan Placebo
    Number of subjects analysed
    40
    40
    Units: % of PVR at baseline (=100%)
        geometric mean (confidence interval 95%)
    73.0 (63.6 to 83.8)
    87.2 (78.5 to 96.7)
    Statistical analysis title
    		 Analysis of change in PVR
    Statistical analysis description
    The main analysis for the primary endpoint was the ANCOVA model on log-transformed percent of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate. From the adjusted model, the treatment effect at Week 16 (ratio of geometric means macitentan/placebo) was 0.84 (95% confidence limit: 0.70, 0.99; p = 0.041).
    Comparison groups
    Macitentan v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline to Week 24 in exercise capacity, as measured by the 6-minute walk distance (6MWD).

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    End point title
    		 Change from baseline to Week 24 in exercise capacity, as measured by the 6-minute walk distance (6MWD).
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24
    End point values
    		 Macitentan Placebo
    Number of subjects analysed
    40
    40
    Units: meter
    arithmetic mean (standard deviation)
        6MWD (m) at baseline
    353.0 ( 87.90 )
    351.2 ( 73.79 )
        6MWD (m) at Week 24
    388.0 ( 83.31 )
    352.2 ( 121.29 )
        Change from baseline to Week 24
    35.0 ( 52.52 )
    1.0 ( 83.24 )
    Statistical analysis title
    		 Analysis of change in 6MWD
    Statistical analysis description
    Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model. The least squares (LS) mean difference of change from baseline to Week 24 (treatment difference: macitentan vs placebo) was 34.04 m (95% confidence limit: 2.9, 65.2, p = 0.0326).
    Comparison groups
    Macitentan v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0326
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline to Week 24 in Borg dyspnea index collected at the end of the 6-minute walk test (6MWT).

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    End point title
    		 Change from baseline to Week 24 in Borg dyspnea index collected at the end of the 6-minute walk test (6MWT).
    End point description
    This outcome measures the difference in the Borg dyspnea index at Week 24 compared to baseline. The index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 (‘Nothing at all’) to 10 (‘Very, very severe – maximal’).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24
    End point values
    		 Macitentan Placebo
    Number of subjects analysed
    40
    40
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Borg dyspnea index score at baseline
    4.2 ( 2.52 )
    4.2 ( 2.14 )
        Borg dyspnea index score at Week 24
    4.1 ( 2.52 )
    4.4 ( 2.45 )
        Change from baseline to Week 24
    -0.1 ( 1.86 )
    0.3 ( 2.04 )
    Statistical analysis title
    		 Analysis of change in Borg dyspnea index
    Statistical analysis description
    Statistical model is Analysis of Covariance including Borg dyspnea index at baseline as a covariate, with Treatment as factor in the model. The least squares (LS) mean difference of change from baseline to Week 24 (macitentan vs placebo) was -0.39 (95% confidence limit: –1.21, 0.43; p=0.3492).
    Comparison groups
    Macitentan v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3492
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Proportion of subjects with worsening in WHO functional class from baseline to Week 24.

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    End point title
    		 Proportion of subjects with worsening in WHO functional class from baseline to Week 24.
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24
    End point values
    		 Macitentan Placebo
    Number of subjects analysed
    40
    40
    Units: Subjects
        Worsened
    0
    3
        Not worsened (total)
    40
    37
        Not worsened (unchanged)
    31
    29
        Not worsened (improved)
    9
    8
    Statistical analysis title
    		 Analysis of worsening in WHO functional class
    Statistical analysis description
    Logistic regression is used for macitentan vs placebo comparison with treatment and WHO functional class at baseline as factors in the model. The odds ratio for worsening WHO functional class at Week 24 (macitentan vs placebo) was 0.212 (95% confidence limit: < 0.001, 1.464, p = 0.0962).
    Comparison groups
    Macitentan v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0962
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From double-blind study treatment initiation up to 30 days after study treatment discontinuation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Macitentan_10_mg
    Reporting group description
    		 Reporting group 1 description

    Reporting group title
    Placebo
    Reporting group description
    		 Reporting group 2 description

    Serious adverse events
    		 Macitentan_10_mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 40 (7.50%)
    7 / 40 (17.50%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Weight increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Embolism
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Acute right ventricular failure
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         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
    		 Macitentan_10_mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 40 (55.00%)
    19 / 40 (47.50%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    4
    Haemoglobin decreased
         subjects affected / exposed
    6 / 40 (15.00%)
    0 / 40 (0.00%)
         occurrences all number
    7
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Syncope
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    8 / 40 (20.00%)
    4 / 40 (10.00%)
         occurrences all number
    10
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 40 (7.50%)
         occurrences all number
    2
    3
    Dyspnoea
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Epistaxis
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Pulmonary hypertension
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Back pain
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Bone pain
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Pain in extremity
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    4 / 40 (10.00%)
         occurrences all number
    1
    4
    Pharyngitis
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences all number
    4
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2

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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
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