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    Clinical Trial Results:
    The Effects of Normalising Sex Hormone Levels in Obese Hypogonadal Men: A Prospective Randomized Comparator Controlled Parallel Arm Clinical Trial

    Summary
    EudraCT number
    		 2010-021268-13
    Trial protocol
    		 IE  
    Global end of trial date
    01 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2020
    First version publication date
    04 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Letrozole2010-1
    Additional study identifiers
    ISRCTN number
    		 ISRCTN21665331
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College Dublin
    Sponsor organisation address
    Belfield, Dublin, Ireland,
    Public contact
    Rabia Hussain, University College Dublin, +353 017164593, rabia.hussain@ucd.ie
    Scientific contact
    Tomás Ahern, University College Dublin, +353 0878302939, TomasB.Ahern@hse.ie
    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
    01 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the research project is to determine the effect of twelve weeks’ treatment with an aromatase inhibitor (Femara®, 2.5mg weekly) on the change in the serum concentration of the pro-inflammatory cytokine, C Reactive Protein, as measured by the Roche® Cobas immuno-turbidimetric test and compare it to that of twelve weeks’ treatment with a depot intramuscular formulation of testosterone undecanoate (Nebido®, 1g every 6 weeks) and to that of six weeks of no treatment.
    Protection of trial subjects
    Patients were withdrawn from study when safety concerns were expressed by investigator. All research participants who withdraw early from the study were be advised to agree to attend the end of study visit for safety investigations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Apr 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ireland: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    34
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Research participants were be recruited from two centres: St Columcille’s Hospital, Loughlinstown, Co Dublin and St Vincent’s University Hospital, Elm Park, Dublin 4. Men attending these units with a BMI greater than 30kg/m2 and a serum total testosterone concentration measured at less than 8.0mmol/L were screened to be eligible.

    Period 1
    Period 1 title
    Baseline period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Femara
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Letrozole
    Investigational medicinal product code
    Other name
    Femara
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5mg tablet once weekly by oral ingestion for 12 weeks

    Arm title
    		 Nebido
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Testosterone undecanoate
    Investigational medicinal product code
    Other name
    Nebido
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1g injection every 6 weeks by intramuscular administration for 12 weeks

    Number of subjects in period 1
    		Femara Nebido
    Started
    19
    18
    Completed
    19
    18
    Period 2
    Period 2 title
    Outcome period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Femara
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Letrozole
    Investigational medicinal product code
    Other name
    Femara
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5mg tablet once weekly by oral ingestion for 12 weeks

    Arm title
    		 Nebido
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Testosterone undecanoate
    Investigational medicinal product code
    Other name
    Nebido
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1g injection every 6 weeks by intramuscular administration for 12 weeks

    Number of subjects in period 2
    		Femara Nebido
    Started
    19
    18
    Completed
    18
    18
    Not completed
    1
    0
         Unknown
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Femara
    Reporting group description
    		 -

    Reporting group title
    Nebido
    Reporting group description
    		 -

    Reporting group values
    		 Femara Nebido Total
    Number of subjects
    		 19 18 37
    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)
    		 48.0 ± 11.7 49.1 ± 11.0 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 19 18 37
    Type II diabetes
    Units: Subjects
        Yes
    		 9 6 15
        No
    		 10 12 22
    Obstructive sleep apnoea syndrome
    Units: Subjects
        Yes
    		 9 7 16
        No
    		 10 11 21
    Height
    Units: meter
        median (inter-quartile range (Q1-Q3))
    		 1.819 (1.744 to 1.836) 1.772 (1.724 to 1.813) -
    Weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 166.6 (154.4 to 181.6) 173 (156.1 to 188.9) -
    BMI
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    		 53.3 (46.4 to 56.7) 53.6 (48.7 to 59.6) -
    C-reactive protein
    Units: mg/L
        median (inter-quartile range (Q1-Q3))
    		 8.2 (5 to 13.1) 10.3 (4.9 to 13.7) -
    Testosterone
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    		 6.4 (4.7 to 7.7) 6.4 (5.9 to 8) -
    Oestradiol
    Units: pmol/L
        median (inter-quartile range (Q1-Q3))
    		 135 (104 to 161) 154 (132 to 210) -
    Sex hormone-binding globulin
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    		 22.2 (16.3 to 27.4) 26.4 (22.6 to 29.5) -
    Luteinizing hormone
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    		 3.4 (2.8 to 5.6) 4.1 (3.2 to 6.4) -
    Haematocrit
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    		 43.4 (41.35 to 44.15) 45.3 (41.38 to 45.98) -
    Cholesterol
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 4.1 (3.2 to 5.1) 4.8 (4.2 to 5.1) -
    High-density lipoprotein
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 1 (0.9 to 1.25) 1.06 (0.95 to 1.13) -
    Low-density lipoprotein
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 2.21 (1.72 to 3.22) 2.86 (2.38 to 3.43) -
    Prostate-specific antigen
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    		 0.58 (0.28 to 1.19) 0.63 (0.42 to 0.85) -
    Heart rate
    Units: bpm
        median (inter-quartile range (Q1-Q3))
    		 77 (68 to 83) 74 (71 to 80) -
    Systolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 134 (126 to 144) 127 (122 to 137) -
    Diastolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 83 (78 to 94) 82 (76 to 88) -
    Haemoglobin A1C
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    		 6.3 (5.9 to 7.6) 6.1 (6 to 6.3) -
    Glucose
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 6.4 (5.7 to 8.8) 5.2 (4.9 to 5.7) -
    Triglycerides
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 1.31 (1.17 to 1.9) 1.31 (1.08 to 1.96) -
    Homeostatic Model Assessment of Insulin Resistance
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 7.16 (6.087 to 8.981) 5.388 (4.443 to 7.996) -
    Haemoglobin
    Units: g/dL
        median (inter-quartile range (Q1-Q3))
    		 14.7 (13.9 to 15.4) 15 (14.2 to 15.8) -
    Creatinine
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 67 (60 to 75) 68 (63 to 79) -
    Estimated glomerular filtration rate
    Units: mL/min/1.73 m²
        median (inter-quartile range (Q1-Q3))
    		 120.568 (104.668 to 132.521) 117.139 (95.473 to 127.581) -
    Alanine transaminase
    Units: U/L
        median (inter-quartile range (Q1-Q3))
    		 38 (30 to 54) 32 (30 to 36) -
    500 m walk
    Units: sec
        median (inter-quartile range (Q1-Q3))
    		 386 (353 to 418) 382 (348 to 409) -
    Average steps walked during previous 7 days
    Units: steps/day
        median (inter-quartile range (Q1-Q3))
    		 4216 (2523 to 6668) 6000 (3162 to 6883) -

    End points

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    End points reporting groups
    Reporting group title
    Femara
    Reporting group description
    		 -

    Reporting group title
    Nebido
    Reporting group description
    		 -
    Reporting group title
    Femara
    Reporting group description
    		 -

    Reporting group title
    Nebido
    Reporting group description
    		 -

    Primary: Change from baseline in serum concentration of C-reactive protein

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    End point title
    		 Change from baseline in serum concentration of C-reactive protein
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    18
    18
    Units: mg/L
        median (inter-quartile range (Q1-Q3))
    0.2 (-0.5 to 1.7)
    -1.6 (-3.6 to 0.4)
    Statistical analysis title
    		 Difference in medians
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0327
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change from baseline in time to walk 500 metres

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    End point title
    		 Change from baseline in time to walk 500 metres
    End point description
    End point type
    Secondary
    End point timeframe
    18 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    15
    10
    Units: seconds
        arithmetic mean (standard error)
    -18 ± 7
    -14 ± 16
    Statistical analysis title
    		 Difference in means
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8217
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change from baseline in diastolic blood pressure

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    End point title
    		 Change from baseline in diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    18
    18
    Units: mmHg
        arithmetic mean (standard error)
    1 ± 2
    3 ± 2
    Statistical analysis title
    		 Difference in means
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4221
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change from baseline in systolic blood pressure

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    End point title
    		 Change from baseline in systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    18
    18
    Units: mmHg
        arithmetic mean (standard error)
    -2 ± 4
    3 ± 3
    Statistical analysis title
    		 Difference in means
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.363
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change from baseline in HbA1C

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    End point title
    		 Change from baseline in HbA1C
    End point description
    End point type
    Secondary
    End point timeframe
    18 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    18
    18
    Units: percentage
        arithmetic mean (standard error)
    -0.0653 ± 0.1038
    0.0155 ± 0.1125
    Statistical analysis title
    		 Difference in means
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.601
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change from baseline in HOMA-IR

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    End point title
    		 Change from baseline in HOMA-IR
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    13
    14
    Units: score
        median (inter-quartile range (Q1-Q3))
    -0.4 (-0.9 to 0)
    1.3 (0.3 to 2.3)
    Statistical analysis title
    		 Difference in medians
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01448
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change from baseline in HDL

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    End point title
    		 Change from baseline in HDL
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    15
    18
    Units: mmol/L
        arithmetic mean (standard error)
    -0.1 ± 0
    0 ± 0
    Statistical analysis title
    		 Difference in means
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002076
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change from baseline in LDL

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    End point title
    		 Change from baseline in LDL
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    14
    18
    Units: mmol/L
        arithmetic mean (standard error)
    0 ± 0.1
    0.1 ± 0.1
    Statistical analysis title
    		 Difference in means
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4632
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change from baseline in weight

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    End point title
    		 Change from baseline in weight
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Femara Nebido
    Number of subjects analysed
    17
    18
    Units: kg
        median (inter-quartile range (Q1-Q3))
    -0.8 (-2 to 0.8)
    1.3 (-0.2 to 3.3)
    Statistical analysis title
    		 Difference in medians
    Comparison groups
    Femara v Nebido
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03189
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    26 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Femara
    Reporting group description
    		 -

    Reporting group title
    Nebido
    Reporting group description
    		 -

    Serious adverse events
    		 Femara Nebido
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 18 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Hospitalisation
    Additional description: Hospitalisation for three weeks for antibiotic treatment of cellulitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypogonadism
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Femara Nebido
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 19 (15.79%)
    6 / 18 (33.33%)
    Investigations
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Depressed mood
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Hypersomnia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    3
    Paraesthesia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Faeces hard
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Infrequent bowel movements
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 18 (11.11%)
         occurrences all number
    1
    2
    Muscle strain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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