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    Clinical Trial Results:
    A randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of the PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.

    Summary
    EudraCT number
    		 2014-001062-10
    Trial protocol
    		 NL   DE  
    Global end of trial date
    08 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2016
    First version publication date
    02 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    000121
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02239692
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ferring Pharmaceuticals A/S
    Sponsor organisation address
    Kay Fiskers Plads 11, Copenhagen S, Denmark, 2300
    Public contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Scientific contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.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
    18 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.
    Protection of trial subjects
    Before obtaining the consent from patients, the Investigator appropriately explained the aims, methods, anticipated benefits, potential hazards, and any other aspects of the trial which are relevant to the patient’s decision to participate, in a language understood by the patient. The Investigator explained to the patients about their right of freedom to refuse to enter the trial or to withdraw from it at any time, without any consequences on their further care and without the need to justify their decision. The trial was conducted in accordance with the Declaration of Helsinki and in compliance with the International Conference on Harmonization-Good Clinical Practice guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Nov 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
    France: 15
    Country: Number of subjects enrolled
    Germany: 152
    Country: Number of subjects enrolled
    Netherlands: 37
    Worldwide total number of subjects
    204
    EEA total number of subjects
    204
    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)
    134
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 11 sites in Germany, France and the Netherlands from Nov 2014 to May 2015.

    Pre-assignment
    Screening details
    		 A total of 218 subjects were screened for this trial. Out of which 204 subjects fulfilled all inclusion and none of the exclusion criteria and were randomly assigned in a 2:1 ratio to either the PICOPREP tailored dosing schedule (n=131) or to the PICOPREP day-before dosing schedule (n=73).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    Subjects were randomised to one of the two dosing schedules according to a computer generated randomisation list prepared for all trial sites. The dosing schedule was not available to any member of the site staff involved in the conduct and evaluation of the trial, except the Investigator, and the unblinded trial coordinator, until the trial database was locked. The participating subjects and the monitor knew the treatment allocation once the subject was randomised.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PICOPREP day-before dosing schedule
    Arm description
    		 PICOPREP Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PICOPREP (Sodium picosulfate 10 mg, Magnesium oxide 3.5 g, and Citric acid 12 g)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.

    Arm title
    		 PICOPREP tailored dosing schedule
    Arm description
    		 PICOPREP Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PICOPREP (Sodium picosulfate 10 mg, Magnesium oxide 3.5 g, and Citric acid 12 g)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Considering the dosage regimens used in this trial, both Investigator and subjects (once randomised to a treatment group) were aware of the treatment provided. All members of the site personnel involved in the conduct and/or evaluation of the trial remained blinded to the treatment.
    Number of subjects in period 1
    		PICOPREP day-before dosing schedule PICOPREP tailored dosing schedule
    Started
    73
    131
    Completed
    67
    118
    Not completed
    6
    13
         Consent withdrawn by subject
    3
    5
         Physician decision
    -
    1
         Adverse event, non-fatal
    -
    1
         Other reason
    1
    -
         Incomplete colonoscopy
    1
    2
         Lost to follow-up
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PICOPREP day-before dosing schedule
    Reporting group description
    		 PICOPREP Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.

    Reporting group title
    PICOPREP tailored dosing schedule
    Reporting group description
    		 PICOPREP Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.

    Reporting group values
    		 PICOPREP day-before dosing schedule PICOPREP tailored dosing schedule Total
    Number of subjects
    		 73 131 204
    Age Categorical
    Units: subjects
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 49 85 134
        >=65 years
    		 24 46 70
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.6 ( 15.1 ) 58.4 ( 13.3 ) -
    Gender, Male/Female
    Units: subjects
        Female
    		 43 77 120
        Male
    		 30 54 84
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 3 5
        Not Hispanic or Latino
    		 71 128 199
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 73 130 203
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Height
    Units: meter (m)
        arithmetic mean (standard deviation)
    		 1.71 ( 0.088 ) 1.71 ( 0.094 ) -
    Weight
    Units: kilogram(Kg)
        arithmetic mean (standard deviation)
    		 75.3 ( 14.9 ) 77.4 ( 16.1 ) -
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 25.6 ( 4.33 ) 26.5 ( 4.71 ) -
    Subject analysis sets

    Subject analysis set title
    Intention-to-Treat (ITT) Analysis Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT analysis set consisted of all randomised subjects.

    Subject analysis set title
    Per-Protocol (PP) Analysis Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP analysis set consisted of ITT analysis set subjects who had no major protocol deviations that would impact efficacy analysis.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set comprised of all treated subjects and was analysed according to the actual treatment received.

    Subject analysis sets values
    		 Intention-to-Treat (ITT) Analysis Set Per-Protocol (PP) Analysis Set Safety Analysis Set
    Number of subjects
    204
    186
    195
    Age Categorical
    Units: subjects
        <=18 years
    0
    0
    0
        Between 18 and 65 years
    134
    122
    129
        >=65 years
    70
    64
    66
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    57.8 ( 13.9 )
    57.8 ( 14.3 )
    57.7 ( 14.1 )
    Gender, Male/Female
    Units: subjects
        Female
    120
    108
    115
        Male
    84
    78
    80
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    5
    5
    5
        Not Hispanic or Latino
    199
    181
    190
        Unknown or Not Reported
    0
    0
    0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    0
    0
        Asian
    1
    1
    1
        Native Hawaiian or Other Pacific Islander
    0
    0
    0
        Black or African American
    0
    0
    0
        White
    203
    185
    194
        More than one race
    0
    0
    0
        Unknown or Not Reported
    0
    0
    0
    Height
    Units: meter (m)
        arithmetic mean (standard deviation)
    1.71 ( 0.091 )
    1.71 ( 0.092 )
    1.71 ( 0.092 )
    Weight
    Units: kilogram(Kg)
        arithmetic mean (standard deviation)
    76.6 ( 15.7 )
    76.5 ( 15.5 )
    76.6 ( 15.5 )
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    26.2 ( 4.58 )
    26.1 ( 4.49 )
    26.2 ( 4.53 )

    End points

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    End points reporting groups
    Reporting group title
    PICOPREP day-before dosing schedule
    Reporting group description
    		 PICOPREP Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.

    Reporting group title
    PICOPREP tailored dosing schedule
    Reporting group description
    		 PICOPREP Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.

    Subject analysis set title
    Intention-to-Treat (ITT) Analysis Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT analysis set consisted of all randomised subjects.

    Subject analysis set title
    Per-Protocol (PP) Analysis Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP analysis set consisted of ITT analysis set subjects who had no major protocol deviations that would impact efficacy analysis.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set comprised of all treated subjects and was analysed according to the actual treatment received.

    Primary: Overall colon cleansing procedure (ITT) measured by the total Ottawa Scale

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    End point title
    		 Overall colon cleansing procedure (ITT) measured by the total Ottawa Scale
    End point description
    Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
    End point type
    Primary
    End point timeframe
    Day 1 (day of colonoscopy)
    End point values
    		 PICOPREP day-before dosing schedule PICOPREP tailored dosing schedule
    Number of subjects analysed
    73
    131
    Units: score on a scale
        arithmetic mean (standard deviation)
    8.2 ( 3.54 )
    4.2 ( 3.75 )
    Statistical analysis title
    		 Analysis of overall colon cleansing (ITT)
    Statistical analysis description
    Null hypothesis was no treatment difference between the two dosing schedules. Adjusted estimated treatment mean difference was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.
    Comparison groups
    PICOPREP day-before dosing schedule v PICOPREP tailored dosing schedule
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.0001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted estimated mean difference
    Point estimate
    -3.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.99
         upper limit
    		 -2.87
    Notes
    [1] - Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.
    [2] - p-value corresponds to a two-sided test of superiority.

    Primary: Overall Colon Cleansing Procedure (PP) Measured by the total Ottawa Scale

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    End point title
    		 Overall Colon Cleansing Procedure (PP) Measured by the total Ottawa Scale
    End point description
    Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
    End point type
    Primary
    End point timeframe
    Day 1 (day of colonoscopy)
    End point values
    		 PICOPREP day-before dosing schedule PICOPREP tailored dosing schedule
    Number of subjects analysed
    66
    120
    Units: score on a scale
        arithmetic mean (standard deviation)
    8.1 ( 3.38 )
    3.7 ( 3.14 )
    Statistical analysis title
    		 Analysis of overall colon cleansing (PP)
    Statistical analysis description
    Null hypothesis was no treatment difference between the two dosing schedules. Adjusted estimated treatment mean difference was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.
    Comparison groups
    PICOPREP day-before dosing schedule v PICOPREP tailored dosing schedule
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.0001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted estimated mean difference
    Point estimate
    -4.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.34
         upper limit
    		 -3.41
    Notes
    [3] - Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.
    [4] - p-value corresponds to a two-sided test of superiority.

    Secondary: Ascending colon cleansing responder status (ITT)

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    End point title
    		 Ascending colon cleansing responder status (ITT)
    End point description
    Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.
    End point type
    Secondary
    End point timeframe
    Day 1 (day of colonoscopy)
    End point values
    		 PICOPREP day-before dosing schedule PICOPREP tailored dosing schedule
    Number of subjects analysed
    73
    131
    Units: Percentage of subject
        number (not applicable)
    15.1
    61.1
    Statistical analysis title
    		 Analysis of ascending colon cleansing (ITT)
    Statistical analysis description
    Null hypothesis was no treatment difference between the two dosing schedules. The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.
    Comparison groups
    PICOPREP day-before dosing schedule v PICOPREP tailored dosing schedule
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Adjusted estimated odds ratio
    Point estimate
    9.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.36
         upper limit
    		 19.32
    Notes
    [5] - p-value corresponds to a two-sided test of superiority.

    Secondary: Frequency and intensity of adverse events

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    End point title
    		 Frequency and intensity of adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (screening) up to day 10 after colonoscopy
    End point values
    		 PICOPREP day-before dosing schedule PICOPREP tailored dosing schedule
    Number of subjects analysed
    70
    125
    Units: Number of subject
        Frequency of all adverse events
    4
    15
        Frequency of mild adverse events
    4
    12
        Frequency of moderate adverse events
    0
    2
        Frequency of severe adverse events
    0
    1
    No statistical analyses for this end point

    Secondary: Clinically significant changes in vital signs (pulse and blood pressure)

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    End point title
    		 Clinically significant changes in vital signs (pulse and blood pressure)
    End point description
    Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).
    End point type
    Secondary
    End point timeframe
    From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
    End point values
    		 PICOPREP day-before dosing schedule PICOPREP tailored dosing schedule
    Number of subjects analysed
    70
    125
    Units: Number of subject
        Clinically significant change in pulse
    0
    0
        Clinically significant change in blood pressure
    0
    0
    No statistical analyses for this end point

    Secondary: Clinically significant changes in laboratory values (haematology, clinical chemistry, coagulation and urinalysis)

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    End point title
    		 Clinically significant changes in laboratory values (haematology, clinical chemistry, coagulation and urinalysis)
    End point description
    Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.
    End point type
    Secondary
    End point timeframe
    From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
    End point values
    		 PICOPREP day-before dosing schedule PICOPREP tailored dosing schedule
    Number of subjects analysed
    70
    125
    Units: Number of subject
        Clinically significant change in haematology
    0
    0
        Clinically significant change in clinical chem
    0
    0
        Clinically significant change in coagulation
    0
    0
        Clinically significant change in urinalysis
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    PICOPREP tailored dosing schedule
    Reporting group description
    		 Subjects in this group received Dose 1 of PICOPREP 10-18 hours before colonoscopy and Dose 2 at 4-6 hours before colonoscopy.

    Reporting group title
    PICOPREP day-before dosing schedule
    Reporting group description
    		 Subjects in this group received Dose 1 of PICOPREP before 8:00 AM on day before colonoscopy and received Dose 2 at 6-8 hours after Dose 1.

    Serious adverse events
    		 PICOPREP tailored dosing schedule PICOPREP day-before dosing schedule
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Large intestinal obstruction
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (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
    		 PICOPREP tailored dosing schedule PICOPREP day-before dosing schedule
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 125 (11.20%)
    4 / 70 (5.71%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Gilbert's syndrome
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 125 (0.80%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 125 (4.00%)
    0 / 70 (0.00%)
         occurrences all number
    5
    0
    Diarrhoea
         subjects affected / exposed
    1 / 125 (0.80%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    1 / 125 (0.80%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eructation
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hypermagnesaemia
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 70 (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 Sep 2014
    The main reason for this amendment was to include the contraindications mentioned in the summary of products characteristics of PICOPREP, ‘Rhabdomyolysis, Nausea and vomiting, Severe dehydration, and Hypermagnesaemia’ to the list of exclusion criteria, as suggested by the Agence Nationale de Sécurité du Medicament et des Produits de Santé (ANMS) in France. In addition, minor changes and editorial clarifications have been made to the protocol. This was applicable for all sites.

    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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