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    Clinical Trial Results:
    Effects of Mg-orotate on cardiocirculatory performance and adaptations at the muscular level: A double-blind, randomized, explorative, placebo-controlled, cross-over pilot study

    Summary
    EudraCT number
    		 2013-003418-42
    Trial protocol
    		 DE  
    Global end of trial date
    14 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2022
    First version publication date
    01 Mar 2022
    Other versions
    Summary report(s)
    		 Trial Report Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    WOE_2013_TUE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Wörwag Pharma GmbH & Co. KG
    Sponsor organisation address
    Flugfeld-Allee 24, 71034 Böblingen, Germany,
    Public contact
    Global Clinical Research, Wörwag Pharma GmbH & Co. KG, +49 70316204416, claudia.reule@woerwagpharma.com
    Scientific contact
    Global Clinical Research, Wörwag Pharma GmbH & Co. KG, +49 70316204416, claudia.reule@woerwagpharma.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
    13 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We performed an explorative pilot study in healthy individuals to address the question whether Mg-orotate might generally affect parameters of cardiorespiratory fitness during a 4 week training intervention period. We further analyzed skeletal muscle expression levels of a panel of genes known to be involved in structural, functional, and metabolic adaptation pathways in order to elucidate potential impacts of Mg-orotate supplementation on skeletal muscle remodeling processes.
    Protection of trial subjects
    Before study initialization, favourable opinion was received from the Ethics Committee of the University Hospital of Tübingen and approval from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). This study is registered at EudraCT (2013-003418-42). The study was performed in compliance with ICH Good Clinical Practice (GCP) and the Declaration of Helsinki, including the archiving of essential documents. All subjects provided written informed consent to participate in the study prior to being screened. The subject information sheet detailed the procedures involved in the study (aims, methodology, potential risks, anticipated benefits) and the investigator explained these to each subject. Each subject signed the consent form to indicate that the information had been explained and understood. Every subject was then allowed time to consider the information presented before signing and dating the informed consent form to indicate that they fully understood the information, and willingly volunteered to participate in the study. Before the intake phase, 2 dropouts occured due to acute illness. These subjects were later reincluded after their recovery.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2016
    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
    Germany: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at University Hospital Tübingen (Germany) at the Department of Sports Medicine. A total of 12 healthy men between 18 and 35 were assessed for eligibility and randomized. No exclusions and 2 dropouts occured. The first participant was enrolled on September 27th, 2016, and the last study visit took place on February 14th, 2018

    Pre-assignment
    Screening details
    		 All subjects provided written informed consent to participate prior to being screened. At visit 1 a physical examination took place, vital signs were measured, lactate diagnostics based on spiroergometry were concluded, and blood samples were taken. At visit 2 the randomisation took place.

    Period 1
    Period 1 title
    Visit 2 - 4
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum, Placebo + Training
    Arm description
    		 4500mg magnesium orotate dihydrate per day for 28 days with training.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Magnesium orotate dihydrate
    Investigational medicinal product code
    Other name
    Magnerot Classic N
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of three tablets of 500mg Magnerot Classic N (Magnesium orotate dihydrate), three times per day (=4500mg/d) for 28 days.

    Arm title
    		 Placebo, Verum + Training
    Arm description
    		 Placebo for 28 days, with training
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three tablets of placebo, three times per day for 28 days.

    Arm title
    		 Verum, Placebo
    Arm description
    		 4500mg magnesium orotate dihydrate per day for 28 days without training.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Magnesium orotate dihydrate
    Investigational medicinal product code
    Other name
    Magnerot Classic N
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of three tablets of 500mg Magnerot Classic N (Magnesium orotate dihydrate), three times per day (=4500mg/d) for 28 days.

    Arm title
    		 Placebo, Verum
    Arm description
    		 Placebo for 28 days, without training
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three tablets of placebo, three times per day for 28 days.

    Number of subjects in period 1
    		Verum, Placebo + Training Placebo, Verum + Training Verum, Placebo Placebo, Verum
    Started
    3
    3
    3
    3
    Completed
    3
    3
    3
    3
    Period 2
    Period 2 title
    Visit 6 - 8
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum, Placebo + Training
    Arm description
    		 Placebo for 28 days, with training.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three tablets of placebo, three times per day for 28 days.

    Arm title
    		 Placebo, Verum + Training
    Arm description
    		 4500mg magnesium orotate dihydrate per day for 28 days with training.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Magnesium orotate dihydrate
    Investigational medicinal product code
    Other name
    Magnerot Classic N
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of three tablets of 500mg Magnerot Classic N (Magnesium orotate dihydrate), three times per day (=4500mg/d) for 28 days.

    Arm title
    		 Verum, Placebo
    Arm description
    		 Placebo for 28 days, without training.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three tablets of placebo, three times per day for 28 days.

    Arm title
    		 Placebo, Verum
    Arm description
    		 4500mg magnesium orotate dihydrate per day for 28 days without training.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Magnesium orotate dihydrate
    Investigational medicinal product code
    Other name
    Magnerot Classic N
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of three tablets of 500mg Magnerot Classic N (Magnesium orotate dihydrate), three times per day (=4500mg/d) for 28 days.

    Number of subjects in period 2
    		Verum, Placebo + Training Placebo, Verum + Training Verum, Placebo Placebo, Verum
    Started
    3
    3
    3
    3
    Completed
    3
    3
    3
    3
    Period 3
    Period 3 title
    Visit 1
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 No Training
    Arm description
    		 Subjects performed no training parallel to the intake of the verum/placebo.
    Arm type
    		 Screening

    Investigational medicinal product name
    Magnesium orotate dihydrate
    Investigational medicinal product code
    Other name
    Magnerot Classic N
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No intake yet.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No intake yet.

    Arm title
    		 Training
    Arm description
    		 Subjects performed aerobic training parallel to the intake of the verum/placebo.
    Arm type
    		 Screening

    Investigational medicinal product name
    Magnesium orotate dihydrate
    Investigational medicinal product code
    Other name
    Magnerot Classic N
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No intake yet.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No intake yet.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The baseline period was added subsequently as a separate period and could not be set as period 1 due to the system structure.
    Number of subjects in period 3
    		No Training Training
    Started
    6
    6
    Completed
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    No Training
    Reporting group description
    		 Subjects performed no training parallel to the intake of the verum/placebo.

    Reporting group title
    Training
    Reporting group description
    		 Subjects performed aerobic training parallel to the intake of the verum/placebo.

    Reporting group values
    		 No Training Training Total
    Number of subjects
    		 6 6 12
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 6 12
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26.67 ( 3.83 ) 24.50 ( 5.32 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 6 6 12
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 77.88 ( 18.69 ) 72.58 ( 14.90 ) -
    BMI
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 24.08 ( 4.45 ) 22.86 ( 4.12 ) -

    End points

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    End points reporting groups
    Reporting group title
    Verum, Placebo + Training
    Reporting group description
    		 4500mg magnesium orotate dihydrate per day for 28 days with training.

    Reporting group title
    Placebo, Verum + Training
    Reporting group description
    		 Placebo for 28 days, with training

    Reporting group title
    Verum, Placebo
    Reporting group description
    		 4500mg magnesium orotate dihydrate per day for 28 days without training.

    Reporting group title
    Placebo, Verum
    Reporting group description
    		 Placebo for 28 days, without training
    Reporting group title
    Verum, Placebo + Training
    Reporting group description
    		 Placebo for 28 days, with training.

    Reporting group title
    Placebo, Verum + Training
    Reporting group description
    		 4500mg magnesium orotate dihydrate per day for 28 days with training.

    Reporting group title
    Verum, Placebo
    Reporting group description
    		 Placebo for 28 days, without training.

    Reporting group title
    Placebo, Verum
    Reporting group description
    		 4500mg magnesium orotate dihydrate per day for 28 days without training.
    Reporting group title
    No Training
    Reporting group description
    		 Subjects performed no training parallel to the intake of the verum/placebo.

    Reporting group title
    Training
    Reporting group description
    		 Subjects performed aerobic training parallel to the intake of the verum/placebo.

    Subject analysis set title
    Verum
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Analysis of period with magnesium orotate dihydrate administration

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Analysis of period with placebo administration

    Primary: Delta VO2max

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    End point title
    		 Delta VO2max
    End point description
    Change of maximal oxygen uptake (VO2max) from start to end of period
    End point type
    Primary
    End point timeframe
    start to end of period; between visit 2 and between 4 and visits 6 and 8 respectively
    End point values
    		 No Training Training Verum Placebo
    Number of subjects analysed
    6
    6
    12
    12
    Units: millilitre(s)/kilogramBW/minute
        arithmetic mean (confidence interval 95%)
    -0.50 (-4.03 to 3.03)
    2.25 (-0.32 to 4.82)
    0.17 (-2.53 to 2.86)
    1.58 (-0.40 to 3.56)
    Statistical analysis title
    		 3-way ANOVA Training v No Training
    Statistical analysis description
    3-way variance analysis with fixed effects for medication and training and random effects for subjects. Subject and medication effects are combined. Cross-over design is considered by using intra-individual differences. Period effect and cross-over effects are checked. All parameters are described with descriptive statistcs (sample size, frequency, relative frequency, maximum, minimum, median, standard deviation, 95% confidence interval). This method was used for all endpoints.
    Comparison groups
    Training v No Training
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0789 [2]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - Linear additive mixed model for explanatory data analysis.
    [2] - 3-way ANOVA
    Statistical analysis title
    		 3-way ANOVA Verum v Placebo
    Statistical analysis description
    3-way variance analysis with fixed effects for medication and training and random effects for subjects. Subject and medication effects are combined. Cross-over design is considered by using intra-individual differences. Period effect and cross-over effects are checked. All parameters are described with descriptive statistcs (sample size, frequency, relative frequency, maximum, minimum, median, standard deviation, 95% confidence interval). This method was used for all endpoints.
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.337 [4]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - Linear additive mixed model for explanatory data analysis. Regarding "number of subjects included": Due to the crossover design the subjects are part of both analyzed groups. Hence, the correct number of subjects included is 12.
    [4] - 3-way ANOVA

    Secondary: Delta AT

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    End point title
    		 Delta AT
    End point description
    Change of oxygen uptake (VO2) at anaerobic threshold (AT)
    End point type
    Secondary
    End point timeframe
    start to end of period; between visit 2 and between 4 and visits 6 and 8 respectively
    End point values
    		 No Training Training Verum Placebo
    Number of subjects analysed
    6
    6
    12
    12
    Units: millilitre(s)/kilogramBW/min
        arithmetic mean (confidence interval 95%)
    -0.33 (-1.81 to 1.14)
    1.00 (-2.74 to 4.74)
    1.00 (-1.48 to 3.48)
    -0.33 (-3.07 to 2.41)
    No statistical analyses for this end point

    Secondary: Delta LT

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    End point title
    		 Delta LT
    End point description
    Change of lactate threshold (LT)
    End point type
    Secondary
    End point timeframe
    start to end of period; between visit 2 and between 4 and visits 6 and 8 respectively
    End point values
    		 No Training Training Verum Placebo
    Number of subjects analysed
    6
    6
    12
    12
    Units: watt/kilogrammBW
        arithmetic mean (confidence interval 95%)
    -0.02 (-0.07 to 0.03)
    0.10 (0.00 to 0.20)
    -0.03 (-0.10 to 0.04)
    0.12 (-0.01 to 0.24)
    No statistical analyses for this end point

    Secondary: Delta Pmax

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    End point title
    		 Delta Pmax
    End point description
    Change of maximal power from start to end of period
    End point type
    Secondary
    End point timeframe
    start to end of period; between visit 2 and between 4 and visits 6 and 8 respectively
    End point values
    		 No Training Training Verum Placebo
    Number of subjects analysed
    6
    6
    12
    12
    Units: watt
        arithmetic mean (confidence interval 95%)
    1.75 (-7.83 to 11.33)
    26.17 (13.08 to 39.25)
    11.17 (-0.79 to 23.12)
    16.75 (5.52 to 27.98)
    No statistical analyses for this end point

    Secondary: FC MSTN

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    End point title
    		 FC MSTN
    End point description
    Fold change of muscular myostatin mRNA, log2-transformed (MSTN gene expression)
    End point type
    Secondary
    End point timeframe
    Start to end of period; between visit 2 and between 4 and visits 6 and 8 respectively
    End point values
    		 No Training Training Verum Placebo
    Number of subjects analysed
    6
    6
    12
    12
    Units: log2 fold change
        arithmetic mean (confidence interval 95%)
    -0.25 (-0.61 to 0.11)
    -0.75 (-1.01 to -0.49)
    -0.63 (-0.93 to -0.34)
    -0.37 (-0.63 to -0.11)
    No statistical analyses for this end point

    Secondary: FC LDHB

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    End point title
    		 FC LDHB
    End point description
    Fold change of muscular lactate dehydrogenase B mRNA, log2-transformed (LDHB gene expression)
    End point type
    Secondary
    End point timeframe
    Start to end of period; between visit 2 and between 4 and visits 6 and 8 respectively
    End point values
    		 No Training Training Verum Placebo
    Number of subjects analysed
    6
    6
    12
    12
    Units: log2 fold change
        arithmetic mean (confidence interval 95%)
    -0.04 (-0.37 to 0.28)
    0.37 (0.13 to 0.61)
    0.20 (-0.05 to 0.46)
    0.12 (-0.14 to 0.39)
    No statistical analyses for this end point

    Secondary: FC TRIM63

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    End point title
    		 FC TRIM63
    End point description
    Fold change of muscular Tripartite Motif Containing 63 / muscle-specific RING finger protein 1 mRNA, log2-transformed (TRIM63 gene expression)
    End point type
    Secondary
    End point timeframe
    Start to end of period; between visit 2 and between 4 and visits 6 and 8 respectively
    End point values
    		 No Training Training Verum Placebo
    Number of subjects analysed
    6
    6
    12
    12
    Units: log2 fold change
        arithmetic mean (confidence interval 95%)
    -0.12 (-0.58 to 0.33)
    -0.48 (-0.85 to -0.11)
    -0.52 (-0.91 to -0.13)
    -0.08 (-0.37 to 0.21)
    No statistical analyses for this end point

    Secondary: FC FBXO32

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    End point title
    		 FC FBXO32
    End point description
    Fold change of period of muscular F-Box Protein 32 / Atrogin-1 mRNA, log2-transformed (FBXO32 gene expression)
    End point type
    Secondary
    End point timeframe
    Start to end of period; between visit 2 and between 4 and visits 6 and 8 respectively
    End point values
    		 No Training Training Verum Placebo
    Number of subjects analysed
    6
    6
    12
    12
    Units: log2 fold change
        arithmetic mean (confidence interval 95%)
    -0.32 (-0.57 to -0.08)
    -0.59 (-1.07 to -0.11)
    -0.66 (-1.09 to -0.23)
    -0.26 (-0.54 to 0.02)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from visit 1 until the end of the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 Reported adverse events during intake of Magnesium orotate dihydrate

    Reporting group title
    Placebo
    Reporting group description
    		 Reported adverse events during intake of placebo

    Serious adverse events
    		 Verum Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Verum Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    3 / 12 (25.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Pulpitis dental
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         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
    08 May 2015
    Investigator change

    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.
    Small number of patients (pilot study);
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