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    Clinical Trial Results:
    Double-blind, double-dummy, multi-center, randomized parallel group trial to demonstrate therapeutic equivalence of Salmeterol/Fluticasone MDI HEXAL (25 µg/125 µg per actuation) versus SeretideTM 125 (25 µg/125 µg per actuation) over a period of 12 weeks in adolescent and adult patients with persistent moderate asthma

    Summary
    EudraCT number
    		 2007-000134-39
    Trial protocol
    		 LT   HU   PL  
    Global end of trial date
    08 Jan 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Mar 2016
    First version publication date
    06 Feb 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Information about Articel 46 was not correct

    Trial information

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    Trial identification
    Sponsor protocol code
    2006-03-DOS-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HEXAL AG
    Sponsor organisation address
    Industriestraße 25, Holzkirchen, Germany, 83607
    Public contact
    Head of Clinical Research Department, Hexal AG, 0049 80249080,
    Scientific contact
    Head of Clinical Research Department, Hexal AG, 0049 80249080,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Aug 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jan 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the long-term efficacy and safety of Salmeterol/Fluticasone MDI HEXAL 25 μg/125 μg per actuation compared to SeretideTM 125 (25 μg/125 μg per actuation) in adolescent and adult patients suffering from moderate persistent asthma.
    Protection of trial subjects
    Safety assessments included adverse events (AEs), physical examination, ECG, vital signs and clinical laboratory data. This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 May 2007
    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
    Hungary: 75
    Country: Number of subjects enrolled
    Lithuania: 18
    Country: Number of subjects enrolled
    Poland: 98
    Country: Number of subjects enrolled
    Ukraine: 153
    Worldwide total number of subjects
    344
    EEA total number of subjects
    191
    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)
    30
    Adults (18-64 years)
    311
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Multi-center, double-blind, randomized, parallel group study in patients in adolescent and adult patients with persistent moderate asthma

    Pre-assignment
    Screening details
    		 A total number of 364 patients where screened and 344 patients were randomized. The study consisted of a 2-week run-in period and a 12-week blinded treatment period (14 weeks in total). A screening visit was followed by a 2-week run-in period during which all asthma treatments except reliever medication were to be stopped.

    Pre-assignment period milestones
    Number of subjects started
    		 364 [1]
    Number of subjects completed
    		 344

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 4
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Lost to follow-up: 3
    Reason: Number of subjects
    		 Ineligibility: 11
    Reason: Number of subjects
    		 Unsatisfactory Therapeutic Response: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 20 patients dropped out according to protocol.
    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
    		 Salmeterol/Fluticasone MDI HEXAL
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salmeterol/Fluticasone MDI HEXAL
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salmeterol/Fluticasone MDI HEXAL (25 μg/125 μg of Salmeterol/Fluticasone per actuation) 2x2 actuations per day

    Arm title
    		 Seretide
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    SeretideTM 125
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    SeretideTM 125 (25 μg/125 μg of Salmeterol/Fluticasone per actuation) Glaxo Wellcome UK Limited, United Kingdom 2x2 actuations per day

    Number of subjects in period 1
    		Salmeterol/Fluticasone MDI HEXAL Seretide
    Started
    171
    173
    Completed
    168
    164
    Not completed
    3
    9
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    2
    -
         Adverse event, serious non-fatal
    -
    2
         Lost to follow-up
    -
    3
         Lack of efficacy
    1
    -
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Salmeterol/Fluticasone MDI HEXAL
    Reporting group description
    		 -

    Reporting group title
    Seretide
    Reporting group description
    		 -

    Reporting group values
    		 Salmeterol/Fluticasone MDI HEXAL Seretide Total
    Number of subjects
    		 171 173 344
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    		 0 0 0
        Preterm newborn- gestational age < 37 wk
    		 0 0 0
        Newborns (0-27days)
    		 0 0 0
        Infants and toddlers (28days – 23months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 year)
    		 12 18 30
        From 18 - 64 years
    		 157 154 311
        From 65 – 84 years
    		 2 1 3
        Over 85 years
    		 0 0 0
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    		 44.2 ± 14.1 41.6 ± 14.8 -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    		 119 114 233
        Male
    		 52 59 111

    End points

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    End points reporting groups
    Reporting group title
    Salmeterol/Fluticasone MDI HEXAL
    Reporting group description
    		 -

    Reporting group title
    Seretide
    Reporting group description
    		 -

    Subject analysis set title
    Salmeterol/Fluticasone MDI HEXAL - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all subjects who were randomised, received at least one dose of IP

    Subject analysis set title
    Seretide - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all subjects who were randomised, received at least one dose of IP

    Subject analysis set title
    Salmeterol/Fluticasone MDI HEXAL - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all subjects who were randomised, received at least one dose of IP and had post-baseline FEV1 measure

    Subject analysis set title
    Seretide - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all subjects who were randomised, received at least one dose of IP and had post-baseline FEV1 measure

    Subject analysis set title
    Salmeterol/Fluticasone MDI HEXAL - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all subjects who were randomised, received at least one dose of IP and had post-baseline FEV1 measure, had no major protocol deviations and for who the blind was not broken

    Subject analysis set title
    Seretide - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all subjects who were randomised, received at least one dose of IP and had post-baseline FEV1 measure, had no major protocol deviations and for who the blind was not broken

    Primary: The mean change in FEV1 from baseline to the end of the 12 weeks treatment period

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    End point title
    		 The mean change in FEV1 from baseline to the end of the 12 weeks treatment period
    End point description
    The change from baseline at the end of the 12 weeks treatment period. Missing values of the primary endpoint were replaced using the last-value-carried-forward strategy as follows: in case if the FEV1 value was missing at Visit 4, the last value observed under treatment before Visit 4 was imputed as Visit 4 value. If there is no such last value under treatment, no imputation was made.
    End point type
    Primary
    End point timeframe
    End of 12 weeks treatment period
    End point values
    		 Salmeterol/Fluticasone MDI HEXAL - FAS Seretide - FAS Salmeterol/Fluticasone MDI HEXAL - PPS Seretide - PPS
    Number of subjects analysed
    171
    171
    165
    153
    Units: Litre
    arithmetic mean (standard deviation)
        Baseline, FEV1
    2.128 ± 0.511
    2.22 ± 0.507
    2.134 ± 0.503
    2.242 ± 0.518
        Endpoint, FEV1
    2.482 ± 0.735
    2.609 ± 0.686
    2.499 ± 0.731
    2.639 ± 0.69
        Change from Baseline
    0.354 ± 0.415
    0.39 ± 0.405
    0.364 ± 0.419
    0.397 ± 0.41
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The null hypothesis was that with respect to the change from baseline FEV1 the test formulation is inferior to the reference formulation, i.e. the difference in means is smaller than -200 mL in favor of the alternative hypothesis that the test product is equivalent to or better than the reference product. An Analysis of Covariance using treatment, pooled centre as factors and baseline FEV1 as a covariate.
    Comparison groups
    Salmeterol/Fluticasone MDI HEXAL - FAS v Seretide - FAS
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7283
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.025373
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.107422
         upper limit
    		 -
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The null hypothesis was that with respect to the change from baseline FEV1 the test formulation is inferior to the reference formulation, i.e. the difference in means is smaller than -200 mL in favor of the alternative hypothesis that the test product is equivalent to or better than the reference product. An Analysis of Covariance using treatment, pooled centre as factors and baseline FEV1 as a covariate.
    Comparison groups
    Salmeterol/Fluticasone MDI HEXAL - PPS v Seretide - PPS
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6598
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.018008
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.103966
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first intake of investigational product (IP) till the 14 days after the last intake of IP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Seretide - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Salmeterol/Fluticasone MDI HEXAL - Safety Set
    Reporting group description
    		 -

    Serious adverse events
    		 Seretide - Safety Set Salmeterol/Fluticasone MDI HEXAL - Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 173 (1.73%)
    1 / 171 (0.58%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (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
    Asthma
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (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
    		 Seretide - Safety Set Salmeterol/Fluticasone MDI HEXAL - Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 173 (23.12%)
    50 / 171 (29.24%)
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 173 (0.58%)
    1 / 171 (0.58%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 173 (0.58%)
    1 / 171 (0.58%)
         occurrences all number
    1
    2
    Asthma
         subjects affected / exposed
    4 / 173 (2.31%)
    3 / 171 (1.75%)
         occurrences all number
    4
    3
    Nasal congestion
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Dysphonia
         subjects affected / exposed
    10 / 173 (5.78%)
    11 / 171 (6.43%)
         occurrences all number
    10
    12
    Nasal polyps
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Pharyngolaryngeal pain
         subjects affected / exposed
    2 / 173 (1.16%)
    1 / 171 (0.58%)
         occurrences all number
    2
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Sneezing
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Conversion disorder
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Blood cortisol decreased
         subjects affected / exposed
    0 / 173 (0.00%)
    2 / 171 (1.17%)
         occurrences all number
    0
    2
    Blood pressure increased
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 173 (0.00%)
    2 / 171 (1.17%)
         occurrences all number
    0
    2
    White blood cell count increased
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    2 / 173 (1.16%)
    2 / 171 (1.17%)
         occurrences all number
    2
    2
    Tremor
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Keratitis
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Presbyopia
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 173 (1.16%)
    0 / 171 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Enteritis
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 173 (1.16%)
    0 / 171 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Synovial cyst
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 173 (0.58%)
    1 / 171 (0.58%)
         occurrences all number
    1
    2
    Acute tonsillitis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Bronchitis acute
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 173 (0.58%)
    1 / 171 (0.58%)
         occurrences all number
    1
    1
    Candidiasis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 173 (2.89%)
    14 / 171 (8.19%)
         occurrences all number
    7
    15
    Oral candidiasis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Pharyngeal candidiasis
         subjects affected / exposed
    1 / 173 (0.58%)
    4 / 171 (2.34%)
         occurrences all number
    1
    4
    Pharyngitis
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    6 / 173 (3.47%)
    6 / 171 (3.51%)
         occurrences all number
    6
    7
    Rhinitis
         subjects affected / exposed
    4 / 173 (2.31%)
    4 / 171 (2.34%)
         occurrences all number
    4
    4
    Viral infection
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Aug 2007
    Primary statistical hypothesis was changed from equivalence to non-inferiority, sample size was adjusted to reflect the change in the statistical hypothesis. Age and gender were removed from the ANCOVA model for the primary endpoint. Exclusion criteria and forbidden therapies were revised.

    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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