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    Clinical Trial Results:
    Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment

    Summary
    EudraCT number
    2011-004765-32
    Trial protocol
    BE   SK   CZ   NL   IT  
    Global end of trial date
    13 Aug 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Aug 2020
    First version publication date
    09 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ST261-DM-11-005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Alfasigma S.p.A.
    Sponsor organisation address
    Via Ragazzi del '99, 5, Bologna, Italy,
    Public contact
    Serena Principe, Alfasigma S.p.A., serena.principe@alfasigma.com
    Scientific contact
    Giovanni Valentini, Alfasigma S.p.A., giovanni.valentini@alfasigma.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
    Interim
    Date of interim/final analysis
    15 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to compare the two treatment groups (ST 261 modified release tablets 1g/die vs. placebo) with respect to the proportion of patients with disease remission at the end of the 8 week s of treatment. Evaluation of safety and tolerability of ST 261 were also primary objectives of the study.
    Protection of trial subjects
    The study was conducted in compliance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline for Good Clinical Practice (GCP) and the applicable national regulations so as to assure that the rights, safety, and wellbeing of the participating study patients were protected consistent with the ethical principles that have their origin in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Jun 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    1 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 20
    Country: Number of subjects enrolled
    Russian Federation: 55
    Country: Number of subjects enrolled
    Slovakia: 17
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Czech Republic: 32
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Netherlands: 2
    Worldwide total number of subjects
    147
    EEA total number of subjects
    92
    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)
    136
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was spoconducted in 57 sites in Belgium (3 sites), Czech Republic (9 sites), Israel (8 sites), Italy (6 sites), The Netherlands (3 sites), Romania (8 sites), Russia (12 sites) and Slovakia (8 sites).

    Pre-assignment
    Screening details
    The study consisted of a screening period of up to 2 weeks. Patients with a diagnosis of active mildulcer ative colitis, under stable oral therapy, were screened for entry in the study.

    Pre-assignment period milestones
    Number of subjects started
    147
    Number of subjects completed
    147

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ST 261
    Arm description
    Patients randomized to this arm of the study were treated with ST 261 modified release tablets.
    Arm type
    Experimental

    Investigational medicinal product name
    ST 261 modified release tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients randomized to this arm of the study were treated with ST 261 modified release tablets administered orally in one 0.5 g tablet twice a day (before breakfast and before dinner) for 8 weeks.

    Arm title
    Placebo
    Arm description
    Patients randomized to this arm of the study were treated with placebo.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients randomized to this arm of the study were treated with placebo administered orally in one tablet twice a day (before breakfast and before dinner) for 8 weeks.

    Number of subjects in period 1
    ST 261 Placebo
    Started
    74
    73
    Completed
    53
    54
    Not completed
    21
    19
         Protocol deviation
    -
    1
         Sponsor's decision
    4
    3
         Study termination
    5
    4
         Lack of efficacy
    1
    -
         Withdrew from follow-up period
    3
    6
         Adverse event, non-fatal
    5
    3
         Consent withdrawn by subject
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ST 261
    Reporting group description
    Patients randomized to this arm of the study were treated with ST 261 modified release tablets.

    Reporting group title
    Placebo
    Reporting group description
    Patients randomized to this arm of the study were treated with placebo.

    Reporting group values
    ST 261 Placebo Total
    Number of subjects
    74 73 147
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.8 ± 13.55 44.4 ± 13.08 -
    Gender categorical
    Units: Subjects
        Female
    36 36 72
        Male
    38 37 75
    Subject analysis sets

    Subject analysis set title
    ITT/Safety population Arm ST261
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Intention-to-treat

    Subject analysis set title
    ITT/Safety population Arm Placebo
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Intention-to-treat

    Subject analysis sets values
    ITT/Safety population Arm ST261 ITT/Safety population Arm Placebo
    Number of subjects
    74
    73
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.8 ± 13.55
    44.4 ± 13.08
    Gender categorical
    Units: Subjects
        Female
    36
    36
        Male
    38
    37

    End points

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    End points reporting groups
    Reporting group title
    ST 261
    Reporting group description
    Patients randomized to this arm of the study were treated with ST 261 modified release tablets.

    Reporting group title
    Placebo
    Reporting group description
    Patients randomized to this arm of the study were treated with placebo.

    Subject analysis set title
    ITT/Safety population Arm ST261
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Intention-to-treat

    Subject analysis set title
    ITT/Safety population Arm Placebo
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Intention-to-treat

    Primary: Clinical/endoscopic remission

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    End point title
    Clinical/endoscopic remission
    End point description
    The primary endpoint was clinical/endoscopic remission, defined as a Disease Activity Index (DAI) ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score > 1, at the end of the 8 weeks treatment period/early termination. DAI has four sub-scales (stool frequency, rectal bleeding, mucosal appearance and physician's overall assessment of the disease severity) scored using four levels (0, 1, 2, 3). The DAI was calculated by summing the four sub-scores.
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    ITT/Safety population Arm ST261 ITT/Safety population Arm Placebo
    Number of subjects analysed
    74
    73
    Units: Subjects
    19
    31
    Statistical analysis title
    Conditional Power
    Statistical analysis description
    The Conditional Power is the probability, given the data observed at the information time t (0 < t < 1) of the interim analysis, that at the end of the 8 weeks period, the two-sided test verifying that the null hypothesis H0 versus the alternative hypothesis H1 is statistically significant at the level α (0.05 for the present studies). Unknown parameters were estimated with the observed data and under the H0 model. The Conditional Power threshold was estimated as 0.25.
    Comparison groups
    ITT/Safety population Arm Placebo v ITT/Safety population Arm ST261
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    ≤ 0.25 [1]
    Method
    Conditional Power
    Confidence interval
    Notes
    [1] - Here the Conditional Power threshold is reported (see Analysis description)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    ST 261
    Reporting group description
    Patients randomized to this arm of the study were treated with ST 261 modified release tablets.

    Reporting group title
    Placebo
    Reporting group description
    Patients randomized to this arm of the study were treated with placebo.

    Serious adverse events
    ST 261 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 73 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Cardiac disorders
    Myocardial Infarction
    Additional description: One death was reported during the study: a patient in the ST 261 treatment group died of myocardial infarction. The event was assessed as not related to the study treatment.
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    ST 261 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 74 (22.97%)
    22 / 73 (30.14%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    0
    2
    Surgical and medical procedures
    Tooth Extraction
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 74 (2.70%)
    2 / 73 (2.74%)
         occurrences all number
    2
    2
    Chest Pain
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Tablet Physical Issue
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Irritability
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Local Swelling
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Oedema Peripheral
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Fear
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Aggression
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Investigations
    Weight Increased
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Blood Fibrinogen Increased
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    C-Reactive Protein Increased
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    0
    2
    Cardiac disorders
    Bundle Branch Block Left
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Atrioventricular Block First Degree
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Anaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Vasomotor Rhinitis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 74 (1.35%)
    5 / 73 (6.85%)
         occurrences all number
    1
    5
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Haematochezia
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 73 (0.00%)
         occurrences all number
    3
    0
    Abdominal Pain
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    Colitis Ulcerative
         subjects affected / exposed
    2 / 74 (2.70%)
    4 / 73 (5.48%)
         occurrences all number
    2
    4
    Proctalgia
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    Colitis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Defaecation Urgency
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Frequent Bowel Movements
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    Painful Defaecation
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 74 (2.70%)
    1 / 73 (1.37%)
         occurrences all number
    2
    1
    Bone pain
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 73 (1.37%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Increased Appetite
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Electrolyte imbalance
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 73 (0.00%)
         occurrences all number
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    Herpes Simplex
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    Respiratory Tract Infection Viral
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2012
    Main changes included the following: -The term “parallel-group” was added to the title of the study. -The name of the Sponsor’s responsible physician was updated. -Expected times for site activation, recruitment and approximate total duration of the study were added to the protocol. -The required previous timeframe for patients to repeat the pancolonoscopy at screening was increased from six to twelve months. This would reduce the number of patients requested to undergo an invasive procedure if already done recently. -An exclusion criterion was added to exclude patients receiving treatment with drugs or products containing carnitine or carnitine derivatives during the three months preceding the screening. -The temperature at which the study medication should be maintained was reduced from 30ºC to 25ºC to be more conservative (according to the stability data) with the drug storage conditions. -Some procedural changes and clarifications of the text were made in response to recommendations from Ethics Committees.
    09 Jul 2012
    Main changes included the following: -Smoking history was added as a screening assessment to better characterize patients. -Due to the fluctuations in symptoms observed in mild patients over short periods of time, it was recommended by the DMB and the Steering Committee that the DAI sub-cores relevant to stool frequency and rectal bleeding be recorded twice during the screening period. -The timeframe of at least four weeks was removed from Inclusion Criterion 3. -Diaphragm and spermicidal agent were removed from Inclusion Criterion 7 as they were not considered to be reliable methods (Pearl Index > 1) and in order to fulfill the criterion of highly effective barrier method. -Patients who had been previously treated with biological agents were excluded from the study without taking any washout period into consideration (Exclusion Criterion 6). -Parasites were added in Exclusion Criterion 7. -Bleeding disorders were clarified in Exclusion Criterion 13: alterations of the coagulation factors or any concurrent other disease possibly causing digestive apparatus bleeding. -The decision to stop study treatment administration due to the use of disallowedmedications was left to the Investigators’ judgment. -The limitation that no more than 150 patients should belong to each study for the interim analysis was changed to 200 patients regardless of their origin. Also, the Independent Statistician was added as being responsible for the interim statistical analysis. In addition, the conditional power threshold was changed from Bt = 0.30 as minimum acceptable value for continuing the trial with no additional evaluations to At = 0.25 threshold under which the trial would be stopped.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    04 Jul 2013
    The present study was conducted in parallel with the Phase III study 2011-004770-28. In order to early terminate both of the two studies in case of futility, an interim analysis was planned to be performed by combining the samples (first 25% of the total planned patients for each study) of the two studies. The results of this analysis would lead to one of the following scenarios: close thestu dy for futility, or go ahead with the fixed sample size. No sample upsizing or downsizing was planned. This analysis was carried out as planned when 200 patients in total, regardless of which of the two studies they belonged to, were randomized and had reached the final efficacy evaluation (Week 8 or early termination), with no interruption in patient enrolment. The interim analysis was performed in an unblinded manner in the intention-to-treat (ITT) population by an Independent Reporting Statistician who was completely independent from the blinded study team and was not involved in any other duties relevant to the study. The results were given to the Data Monitoring Board (DMB) to review and provide the relevant recommendations according to pre-specified rules. The DMB reviewed the data summary from both studies dated 01 July 2013. Their conclusion was to stop the studies in accordance with the protocol and DMB Charter. This was on the basis of the conditional power as stated in the protocol. The primary reason for stopping the study was strong evidence of futility. The conditional power was 0.004 (below the 0.25 threshold indicated in the protocol). There were no clinical safety issues and no meaningful safety differences were seen.
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    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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