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    Clinical Trial Results:
    An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus.

    Summary
    EudraCT number
    2012-001645-41
    Trial protocol
    DE   HU   SE   ES   GR   EE   CZ   PL  
    Global end of trial date
    31 Mar 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    26 Mar 2016
    First version publication date
    01 Jul 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Minor corrections required.

    Trial information

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    Trial identification
    Sponsor protocol code
    JAK115919
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01777256
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    09 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To estimate the relationship between dose of GSK2586184 and pharmacodynamic effect on expression of selected messenger ribonucleic acid (mRNA) transcripts following 2 weeks of treatment in SLE patients • To estimate the relationship between dose of GSK2586184 and clinical response as assessed by SELENA SLEDAI score following 12 weeks of treatment in SLE patients • To evaluate the safety and tolerability of repeat doses of GSK2586184 in SLE patients.
    Protection of trial subjects
    Not applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Mar 2013
    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
    Argentina: 3
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Peru: 14
    Country: Number of subjects enrolled
    Poland: 9
    Worldwide total number of subjects
    50
    EEA total number of subjects
    32
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants (par) with a clinical diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology classification criteria were enrolled. Enrolled par with clinically active SLE were randomised in a 1:1:1:1:1 ratio to receive twice daily doses of GSK2586184 (50 milligram (mg), 100 mg, 200 mg, 400 mg) or placebo.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GSK2586184 50 mg BID
    Arm description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 50 milligram (mg) of GSK2586184, twice daily (BID) with food for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK2586184
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Either 50mg or 200mg oral tablets taken twice daily with food

    Arm title
    GSK2586184 100 mg BID
    Arm description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 100 mg of GSK2586184, BID with food for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK2586184
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Either 50mg or 200mg oral tablets taken twice daily with food

    Arm title
    GSK2586184 200 mg BID
    Arm description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 200 mg of GSK2586184, BID with food for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK2586184
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Either 50mg or 200mg oral tablets taken twice daily with food

    Arm title
    GSK2586184 400 mg BID
    Arm description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 400 mg of GSK2586184, BID with food for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK2586184
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Either 50mg or 200mg oral tablets taken twice daily with food

    Arm title
    Placebo
    Arm description
    Participants received a combination of 2 film coated tablets of GSK2586184 matching placebo, BID with food for 12 weeks.
    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
    Placebo - Either 50mg or 200mg oral tablets taken twice daily with food

    Number of subjects in period 1
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Started
    9
    10
    10
    10
    11
    Completed
    4
    5
    4
    4
    5
    Not completed
    5
    5
    6
    6
    6
         Protocol deviation
    -
    -
    1
    -
    -
         Physician decision
    -
    -
    -
    1
    -
         Study closed/terminated
    4
    4
    -
    3
    5
         Adverse event, non-fatal
    1
    1
    4
    1
    -
         Consent withdrawn by subject
    -
    -
    1
    1
    -
         Lost to follow-up
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2586184 50 mg BID
    Reporting group description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 50 milligram (mg) of GSK2586184, twice daily (BID) with food for 12 weeks.

    Reporting group title
    GSK2586184 100 mg BID
    Reporting group description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 100 mg of GSK2586184, BID with food for 12 weeks.

    Reporting group title
    GSK2586184 200 mg BID
    Reporting group description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 200 mg of GSK2586184, BID with food for 12 weeks.

    Reporting group title
    GSK2586184 400 mg BID
    Reporting group description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 400 mg of GSK2586184, BID with food for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Participants received a combination of 2 film coated tablets of GSK2586184 matching placebo, BID with food for 12 weeks.

    Reporting group values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo Total
    Number of subjects
    9 10 10 10 11 50
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38 ± 12.55 43.1 ± 11.23 37.3 ± 7.15 47.5 ± 10.99 36.9 ± 10.14 -
    Gender categorical
    Units: Subjects
        Female
    9 10 10 10 11 50
        Male
    0 0 0 0 0 0
    Race
    Units: Subjects
        American Indian or Alaskan Native
    2 2 3 1 4 12
        Asian - Central/South Asian Heritage
    1 0 0 0 0 1
        Asian - East Asian Heritage
    0 0 0 1 0 1
        White - White/Caucasian/European Heritage
    6 6 7 8 7 34
        Mixed Race
    0 2 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    GSK2586184 50 mg BID
    Reporting group description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 50 milligram (mg) of GSK2586184, twice daily (BID) with food for 12 weeks.

    Reporting group title
    GSK2586184 100 mg BID
    Reporting group description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 100 mg of GSK2586184, BID with food for 12 weeks.

    Reporting group title
    GSK2586184 200 mg BID
    Reporting group description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 200 mg of GSK2586184, BID with food for 12 weeks.

    Reporting group title
    GSK2586184 400 mg BID
    Reporting group description
    Participants received a combination of 2 film coated tablets, so that each participant received a total of 400 mg of GSK2586184, BID with food for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Participants received a combination of 2 film coated tablets of GSK2586184 matching placebo, BID with food for 12 weeks.

    Primary: Percentage Inhibition from Baseline of interferon (IFN) Transcriptional Biomarkers at Week 2

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    End point title
    Percentage Inhibition from Baseline of interferon (IFN) Transcriptional Biomarkers at Week 2
    End point description
    Mean reduction (40%) from Baseline of the IFN transcriptional signature biomarker was monitored at Week 2. Percentage (Per) inhibition (=[(Day x–Baseline)/Baseline]*-100), was the Per reduction from baseline (Day1) and evaluated in any pre-designated panels of genes i.e. Addenbrookes 1, Addenbrookes 2, JAK439, PD, Panel Stripping, Flare and Transcription. Analysis was performed using a repeated measures model with covariates of treatment, baseline, Day, Day by baseline and Day by treatment interactions. Only those Par available at the specified time points were analysed (n=X,X,X,X,X). Different Par may have been analysed at different time points, so the overall number of Par analysed reflects everyone in the Intent To Treat (ITT) Population i.e. Par randomised to treatment, received >=1 dose of study medication and had >=1 valid post dose assessment
    End point type
    Primary
    End point timeframe
    Baseline and Week 2
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    8 [1]
    10 [2]
    9 [3]
    9 [4]
    9 [5]
    Units: Percentage
    arithmetic mean (standard deviation)
        Panel1
    1.55 ± 7.621
    0.53 ± 8.048
    0.15 ± 11.338
    4.83 ± 6.315
    -1.21 ± 7.543
        Panel2
    1.1 ± 8.526
    0.64 ± 7.804
    0.38 ± 11.696
    4.48 ± 6.697
    -1.05 ± 7.657
        Panel3
    0.31 ± 6.814
    0.49 ± 5.147
    1.22 ± 12.014
    3.98 ± 5.847
    -0.46 ± 5.36
        Panel4
    -0.48 ± 5.215
    -0.27 ± 4.461
    -1.91 ± 11.685
    2.08 ± 5.586
    -1.02 ± 5.182
        Panel5
    0.73 ± 7.682
    0.29 ± 7.789
    0.16 ± 12.227
    5.29 ± 6.825
    -1.14 ± 7.242
        Panel6
    1.07 ± 6.419
    0.82 ± 6.428
    1.24 ± 10.849
    5.64 ± 6.008
    -0.94 ± 6.425
        Panel7
    0.77 ± 1.835
    -1 ± 2.318
    -1.06 ± 6.948
    0.6 ± 1.503
    -0.3 ± 1.645
    Notes
    [1] - ITT Population
    [2] - ITT Population
    [3] - ITT Population
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    Analysis 1
    Comparison groups
    Placebo v GSK2586184 50 mg BID
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    2.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.31
         upper limit
    9.81
    Notes
    [6] - Panel 1: Placebo vs GSK2586184 50 mg BID at Week 2
    Statistical analysis title
    Analysis 2
    Comparison groups
    Placebo v GSK2586184 100 mg BID
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.19
         upper limit
    8.3
    Notes
    [7] - Panel 1: Placebo vs GSK2586184 100 mg BID at Week 2
    Statistical analysis title
    Analysis 3
    Comparison groups
    Placebo v GSK2586184 200 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [8]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.37
         upper limit
    6.56
    Notes
    [8] - Panel 1: Placebo vs GSK2586184 200 mg BID at Week 2
    Statistical analysis title
    Analysis 4
    Comparison groups
    Placebo v GSK2586184 400 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    5.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.46
         upper limit
    12.25
    Notes
    [9] - Panel 1: Placebo vs GSK2586184 400 mg BID at Week 2
    Statistical analysis title
    Analysis 5
    Comparison groups
    Placebo v GSK2586184 50 mg BID
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    2.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.52
         upper limit
    9.56
    Notes
    [10] - Panel 2: Placebo vs GSK2586184 50 mg BID at Week 2
    Statistical analysis title
    Analysis 6
    Comparison groups
    Placebo v GSK2586184 100 mg BID
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.86
         upper limit
    8.54
    Notes
    [11] - Panel 2: Placebo vs GSK2586184 100 mg BID at Week 2
    Statistical analysis title
    Analysis 7
    Comparison groups
    Placebo v GSK2586184 200 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.95
         upper limit
    6.99
    Notes
    [12] - Panel 2: Placebo vs GSK2586184 200 mg BID at Week 2
    Statistical analysis title
    Analysis 8
    Comparison groups
    Placebo v GSK2586184 400 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [13]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    4.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.55
         upper limit
    12.11
    Notes
    [13] - Panel 2: Placebo vs GSK2586184 400 mg BID at Week 2
    Statistical analysis title
    Analysis 9
    Comparison groups
    Placebo v GSK2586184 50 mg BID
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    superiority [14]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.2
         upper limit
    7.16
    Notes
    [14] - Panel 3: Placebo vs GSK2586184 50 mg BID at Week 2
    Statistical analysis title
    Analysis 10
    Comparison groups
    Placebo v GSK2586184 100 mg BID
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    superiority [15]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.13
         upper limit
    6.65
    Notes
    [15] - Panel 3: Placebo vs GSK2586184 100 mg BID at Week 2
    Statistical analysis title
    Analysis 11
    Comparison groups
    Placebo v GSK2586184 200 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [16]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.06
         upper limit
    6.19
    Notes
    [16] - Panel 3: Placebo vs GSK2586184 200 mg BID at Week 2
    Statistical analysis title
    Analysis 12
    Comparison groups
    Placebo v GSK2586184 400 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [17]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    4.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.99
         upper limit
    10.03
    Notes
    [17] - Panel 3: Placebo vs GSK2586184 400 mg BID at Week 2
    Statistical analysis title
    Analysis 13
    Comparison groups
    Placebo v GSK2586184 50 mg BID
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    superiority [18]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.42
         upper limit
    5.87
    Notes
    [18] - Panel 4: Placebo vs GSK25865184 50 mg BID at Week 2
    Statistical analysis title
    Analysis 14
    Comparison groups
    Placebo v GSK2586184 100 mg BID
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    superiority [19]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.32
         upper limit
    5.46
    Notes
    [19] - Panel 4: Placebo vs GSK2586184 100 mg BID at Week 2
    Statistical analysis title
    Analysis 15
    Comparison groups
    Placebo v GSK2586184 200 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [20]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.41
         upper limit
    2.76
    Notes
    [20] - Panel 4: Placebo vs GSK2586184 200 mg BID at Week 2
    Statistical analysis title
    Analysis 16
    Comparison groups
    Placebo v GSK2586184 400 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [21]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    2.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.01
         upper limit
    8
    Notes
    [21] - Panel 4: Placebo vs GSK2586184 400 mg BID at Week 2
    Statistical analysis title
    Analysis 17
    Comparison groups
    Placebo v GSK2586184 50 mg BID
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    superiority [22]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.53
         upper limit
    9.42
    Notes
    [22] - Panel 5: Placebo vs GSK2586184 50 mg BID at Week 2
    Statistical analysis title
    Analysis 18
    Comparison groups
    Placebo v GSK2586184 100 mg BID
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    superiority [23]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.85
         upper limit
    8.41
    Notes
    [23] - Panel 5: Placebo vs GSK2586184 100 mg BID at Week 2
    Statistical analysis title
    Analysis 19
    Comparison groups
    Placebo v GSK2586184 200 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [24]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.7
         upper limit
    7.04
    Notes
    [24] - Panel 5: Placebo vs GSK2586184 200 mg BID at Week 2
    Statistical analysis title
    Analysis 20
    Comparison groups
    Placebo v GSK2586184 400 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [25]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    5.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.45
         upper limit
    13.06
    Notes
    [25] - Panel 5: Placebo vs GSK2586184 400 mg BID at Week 2
    Statistical analysis title
    Analysis 21
    Comparison groups
    Placebo v GSK2586184 50 mg BID
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    superiority [26]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    2.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.56
         upper limit
    8.61
    Notes
    [26] - Panel 6: Placebo vs GSK2586184 50 mg BID at Week 2
    Statistical analysis title
    Analysis 22
    Comparison groups
    Placebo v GSK2586184 100 mg BID
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    superiority [27]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.71
         upper limit
    7.86
    Notes
    [27] - Panel 6: Placebo vs GSK2586184 100 mg BID at Week 2
    Statistical analysis title
    Analysis 23
    Comparison groups
    Placebo v GSK2586184 200 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [28]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.84
         upper limit
    7.15
    Notes
    [28] - Panel 6: Placebo vs GSK2586184 200 mg BID at Week 2
    Statistical analysis title
    Analysis 24
    Comparison groups
    Placebo v GSK2586184 400 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [29]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    5.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.46
         upper limit
    12.32
    Notes
    [29] - Panel 6: Placebo vs GSK2586184 400 mg BID at Week 2
    Statistical analysis title
    Analysis 25
    Comparison groups
    Placebo v GSK2586184 50 mg BID
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    superiority [30]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.18
         upper limit
    3.45
    Notes
    [30] - Panel 7: Placebo vs GSK2586184 50 mg BID at Week 2
    Statistical analysis title
    Analysis 26
    Comparison groups
    Placebo v GSK2586184 100 mg BID
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    superiority [31]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    2.17
    Notes
    [31] - Panel 7: Placebo vs GSK2586184 100 mg BID at Week 2
    Statistical analysis title
    Analysis 27
    Comparison groups
    Placebo v GSK2586184 200 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [32]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.85
         upper limit
    1.68
    Notes
    [32] - Panel 7: Placebo vs GSK2586184 200 mg BID at Week 2
    Statistical analysis title
    Analysis 28
    Comparison groups
    Placebo v GSK2586184 400 mg BID
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority [33]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.41
         upper limit
    3.09
    Notes
    [33] - Panel 7: Placebo vs GSK2586184 400 mg BID at Week 2

    Primary: Change from Baseline of SELENA SLEDAI score at indicated timepoints up to Week 16.

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    End point title
    Change from Baseline of SELENA SLEDAI score at indicated timepoints up to Week 16. [34]
    End point description
    The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated index for assessing SLE disease activity. It is a weighted index in which signs and symptoms, laboratory tests, and physician’s assessment for each of 9 organ systems are given a weighted score and summed, if present at the time of the visit or in the preceding 10 days. Modified version of SLEDAI is Safety of Estrogen in Lupus National Assessment (SELENA) SLEDAI where the maximum theoretical score for the SELENA SLEDAI was 105 with 0 indicating inactive disease. Baseline value is defined as Day 1 (pre-dose) SELENA SLEDAI score. Only those Par available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different Par may have been analysed at different time points, so the overall number of Par analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 8, 10, 12 and 16
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [35]
    10 [36]
    10 [37]
    10 [38]
    11 [39]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week2, n=9,8,9,9,9
    -2 ± 3.43
    -1 ± 3.02
    0.3 ± 3.46
    -2.4 ± 2.19
    -1.3 ± 3.46
        Week4, n=7,8,7,8,8
    -1.9 ± 4.85
    -1.5 ± 2.33
    -0.6 ± 2.99
    -3.5 ± 3.16
    -2.8 ± 3.69
        Week6, n=7,7,6,8,8
    -3.3 ± 3.3
    -1.9 ± 2.61
    -2 ± 5.66
    -3 ± 3.55
    -2.8 ± 3.2
        Week8, n=6,7,4,7,7
    -4.2 ± 2.86
    -3 ± 2.65
    -3.5 ± 5.74
    -3.4 ± 3.21
    -4 ± 3.83
        Week10, n=5,6,4,6,6
    -3.6 ± 3.29
    -4.2 ± 1.33
    -2 ± 6.93
    -3.7 ± 3.44
    -5.2 ± 3.82
        Week12, n=4,5,4,5,5
    -4.5 ± 4.43
    -6.2 ± 6.1
    -3 ± 6.83
    -4.6 ± 4.98
    -3.6 ± 3.58
        Week16, n=9,10,9,8,10
    -3.7 ± 4.42
    -4.9 ± 4.72
    -3.7 ± 6.08
    -7 ± 3.55
    -3.4 ± 3.66
    Notes
    [35] - ITT Population.
    [36] - ITT Population.
    [37] - ITT Population.
    [38] - ITT Population.
    [39] - ITT Population.
    No statistical analyses for this end point

    Primary: Change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 16

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    End point title
    Change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 16 [40]
    End point description
    Change from Baseline in systolic blood pressure (BP) and diastolic BP is summarised for each post-Baseline assessment up to Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 8, 10, 12 and 16
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [41]
    10 [42]
    10 [43]
    10 [44]
    11 [45]
    Units: Millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        Sitting Systolic BP, Week2, n=8,8,6,8,7
    -1.25 ± 6.944
    -1.13 ± 7.624
    3.5 ± 11.895
    -2.25 ± 7.573
    -0.29 ± 5.09
        Sitting Systolic BP, Week4, n=6,6,7,8,7
    3.33 ± 10.838
    -2.83 ± 11.737
    -0.57 ± 5.318
    -6.75 ± 12.43
    7.14 ± 7.448
        Sitting Systolic BP, Week6, n=6,8,5,8,8
    3.83 ± 8.841
    -2.25 ± 7.421
    5 ± 11.225
    0.5 ± 7.728
    12.63 ± 16.151
        Sitting Systolic BP, Week8, n=7,5,8,8,7
    -3.57 ± 4.65
    -1.4 ± 11.546
    -0.38 ± 10.309
    -4.75 ± 12.556
    4.14 ± 11.067
        Sitting Systolic BP, Week10, n=5,6,3,5,7
    -1.2 ± 11.692
    -1.5 ± 16.159
    2 ± 8.185
    -1.4 ± 18.064
    6.29 ± 15.649
        Sitting Systolic BP, Week12, n=6,5,6,7,6
    -2.5 ± 10.895
    -1.8 ± 9.176
    2.5 ± 8.118
    -2.57 ± 13.477
    2.17 ± 10.265
        Sitting Systolic BP, Week16, n=4,5,2,4,5
    -0.75 ± 9.215
    -2.8 ± 8.758
    7 ± 2.828
    -10.75 ± 19.276
    7.2 ± 14.957
        Supine Systolic BP, Week2, n=1,2,3,1,3
    0 ± 99999
    -10 ± 0
    -9.67 ± 8.963
    5 ± 99999
    11 ± 18.248
        Supine Systolic BP, Week4, n=2,2,1,0,3
    0 ± 7.071
    -15 ± 7.071
    0 ± 99999
    99999 ± 99999
    11.67 ± 25.658
        Supine Systolic BP, Week6, n=1,2,1,1,0
    9 ± 99999
    -10 ± 0
    0 ± 99999
    2 ± 99999
    99999 ± 99999
        Supine Systolic BP, Week8, n=1,2,1,1,2
    5 ± 99999
    -10 ± 14.142
    -10 ± 99999
    0 ± 99999
    7.5 ± 17.678
        Supine Systolic BP, Week10, n=2,2,1,1,1
    10 ± 14.142
    -5 ± 7.071
    0 ± 99999
    0 ± 99999
    10 ± 99999
        Supine Systolic BP, Week12, n=1,2,1,1,1
    5 ± 99999
    -10 ± 0
    -10 ± 99999
    -2 ± 99999
    20 ± 99999
        Supine Systolic BP, Week16, n=1,1,1,1,1
    0 ± 99999
    -10 ± 99999
    0 ± 99999
    2 ± 99999
    18 ± 99999
        Sitting Diastolic BP, Week2, n=8,8,6,8,7
    -0.63 ± 8.667
    0.25 ± 6.944
    -0.33 ± 7.202
    -8.5 ± 10.268
    2.57 ± 4.826
        Sitting Diastolic BP, Week4, n=6,6,7,8,7
    5.17 ± 6.824
    -1.83 ± 8.773
    -0.43 ± 5.94
    -6.63 ± 12.094
    7 ± 8.813
        Sitting Diastolic BP, Week6, n=6,8,5,8,8
    -1.67 ± 3.933
    4 ± 3.817
    -1.6 ± 3.782
    -0.38 ± 8.331
    2.25 ± 8.155
        Sitting Diastolic BP, Week8, n=7,5,8,8,7
    1 ± 11.255
    -2 ± 8.276
    -0.38 ± 4.596
    -2 ± 10.515
    3.43 ± 4.685
        Sitting Diastolic BP, Week10, n=5,6,3,5,7
    -2.8 ± 6.419
    -2.17 ± 12.073
    4.33 ± 3.786
    1 ± 11.662
    6.71 ± 10.812
        Sitting Diastolic BP, Week12, n=6,5,6,7,6
    -2 ± 5.06
    -1.2 ± 3.271
    -2 ± 4.98
    -1 ± 9.539
    1.5 ± 3.507
        Sitting Diastolic BP, Week16, n=4,5,2,4,5
    -2.5 ± 2.646
    -3.6 ± 8.792
    2 ± 7.071
    -0.25 ± 16.681
    11.4 ± 12.422
        Supine Diastolic BP, Week2, n=1,2,3,1,3
    -10 ± 99999
    -5 ± 7.071
    -3.67 ± 5.508
    -5 ± 99999
    5 ± 8.66
        Supine Diastolic BP, Week4, n=2,2,1,0,3
    -5 ± 7.071
    -6 ± 5.657
    -20 ± 99999
    99999 ± 99999
    1.33 ± 12.662
        Supine Diastolic BP, Week6, n=1,2,1,1,0
    0 ± 99999
    -10 ± 2.828
    -10 ± 99999
    -10 ± 99999
    99999 ± 99999
        Supine Diastolic BP, Week8, n=1,2,1,1,2
    0 ± 99999
    -6 ± 5.657
    -10 ± 99999
    5 ± 99999
    5 ± 7.071
        Supine Diastolic BP, Week10, n=2,2,1,1,1
    2.5 ± 10.607
    -11 ± 1.414
    -10 ± 99999
    -15 ± 99999
    10 ± 99999
        Supine Diastolic BP, Week12, n=1,2,1,1,1
    0 ± 99999
    -6 ± 8.485
    -20 ± 99999
    -5 ± 99999
    5 ± 99999
        Supine Diastolic BP, Week16, n=1,1,1,1,1
    -5 ± 99999
    -12 ± 99999
    -10 ± 99999
    0 ± 99999
    8 ± 99999
    Notes
    [41] - ITT Population. “Not available (NA)” data is presented as “99999”
    [42] - ITT Population. “Not available (NA)” data is presented as “99999”
    [43] - ITT Population. “Not available (NA)” data is presented as “99999”
    [44] - ITT Population. “Not available (NA)” data is presented as “99999”
    [45] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in heart rate at the indicated time points up to Week 16

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    End point title
    Change from Baseline in heart rate at the indicated time points up to Week 16 [46]
    End point description
    Change from Baseline in sitting and supine heart rate is summarised for each post-Baseline assessment up to Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 8, 10, 12 and 16
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [47]
    10 [48]
    10 [49]
    10 [50]
    11 [51]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Sitting Heart Rate, Week2, n=8,8,6,8,7
    5.25 ± 6.541
    -2.13 ± 7.357
    -0.5 ± 10.035
    -2.38 ± 9.68
    6.29 ± 13.45
        Sitting Heart Rate, Week4, n=6,6,7,8,7
    2 ± 8.786
    -0.67 ± 12.58
    3.43 ± 11.574
    -2.75 ± 8.924
    3.86 ± 15.869
        Sitting Heart Rate, Week6, n=6,8,5,8,8
    1.17 ± 4.07
    -3.13 ± 9.094
    -0.4 ± 6.58
    -2.38 ± 10.474
    4.88 ± 12.933
        Sitting Heart Rate, Week8, n=7,5,8,8,7
    7.43 ± 10.907
    -5.6 ± 10.139
    -1 ± 7.151
    2 ± 16.318
    3.43 ± 19.372
        Sitting Heart Rate, Week10, n=5,6,3,5,7
    2.2 ± 8.228
    -5.33 ± 7.866
    0.67 ± 5.686
    2.2 ± 6.87
    1.43 ± 17.116
        Sitting Heart Rate, Week12, n=6,5,6,7,6
    1 ± 10.881
    -6 ± 6
    5 ± 9.529
    -2.14 ± 9.668
    -2 ± 19.463
        Sitting Heart Rate, Week16, n=4,5,2,4,5
    -5.5 ± 8.737
    -3.8 ± 3.194
    -3 ± 2.828
    9.5 ± 13.229
    8 ± 19.3
        Supine Heart Rate, Week2, n=1,2,3,1,3
    7 ± 99999
    -1 ± 2.828
    2.67 ± 5.774
    1 ± 99999
    -6.33 ± 6.658
        Supine Heart Rate, Week4, n=2,2,1,0,3
    -2 ± 1.414
    0 ± 1.414
    4 ± 99999
    99999 ± 99999
    -3.33 ± 7.638
        Supine Heart Rate, Week6, n=1,2,1,1,0
    4 ± 99999
    -1.5 ± 0.707
    6 ± 99999
    -8 ± 99999
    99999 ± 99999
        Supine Heart Rate, Week8, n=1,2,1,1,2
    -8 ± 99999
    -0.5 ± 3.536
    12 ± 99999
    -11 ± 99999
    -4 ± 1.414
        Supine Heart Rate, Week10, n=2,2,1,1,1
    -4.5 ± 9.192
    -0.5 ± 0.707
    10 ± 99999
    -8 ± 99999
    -7 ± 99999
        Supine Heart Rate, Week12, n=1,2,1,1,1
    0 ± 99999
    -1 ± 1.414
    7 ± 99999
    -9 ± 99999
    -1 ± 99999
        Supine Heart Rate, Week16, n=1,1,1,1,1
    -8 ± 99999
    -2 ± 99999
    8 ± 99999
    -6 ± 99999
    0 ± 99999
    Notes
    [47] - ITT Population. “Not available (NA)” data is presented as “99999”
    [48] - ITT Population. “Not available (NA)” data is presented as “99999”
    [49] - ITT Population. “Not available (NA)” data is presented as “99999”
    [50] - ITT Population. “Not available (NA)” data is presented as “99999”
    [51] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in temperature at the indicated time points up to Week 16

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    End point title
    Change from Baseline in temperature at the indicated time points up to Week 16 [52]
    End point description
    Change from Baseline in temperature is summarised for each post-Baseline assessment up to Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 8, 10, 12 and 16
    Notes
    [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [53]
    10 [54]
    10 [55]
    10 [56]
    11 [57]
    Units: Celsius
    arithmetic mean (standard deviation)
        Temperature, Week2, n=9,10,9,9,10
    0.04 ± 0.279
    0.26 ± 0.556
    -0.01 ± 0.271
    -0.08 ± 0.299
    0.15 ± 0.331
        Temperature, Week4, n=8,8,8,8,10
    -0.06 ± 0.316
    0.34 ± 0.59
    0.19 ± 0.352
    0.09 ± 0.125
    -0.02 ± 0.326
        Temperature, Week6, n=7,10,6,9,8
    -0.01 ± 0.273
    0.12 ± 0.162
    0.2 ± 0.253
    0.18 ± 0.244
    0.24 ± 0.389
        Temperature, Week8, n=8,7,9,9,9
    0.04 ± 0.119
    0.06 ± 0.611
    0.07 ± 0.212
    0.04 ± 0.159
    0.18 ± 0.319
        Temperature, Week10, n=7,8,4,6,8
    0.04 ± 0.207
    0.11 ± 0.275
    0.23 ± 0.189
    0.07 ± 0.151
    0.18 ± 0.238
        Temperature, Week12, n=7,7,7,8,7
    0.09 ± 0.241
    0.3 ± 0.733
    0.1 ± 0.258
    0.08 ± 0.292
    0.09 ± 0.308
        Temperature, Week16, n=5,6,3,5,6
    -0.1 ± 0.1
    0.2 ± 0.369
    -0.13 ± 0.379
    0.04 ± 0.261
    0.05 ± 0.235
    Notes
    [53] - ITT Population. “Not available (NA)” data is presented as “99999”
    [54] - ITT Population. “Not available (NA)” data is presented as “99999”
    [55] - ITT Population. “Not available (NA)” data is presented as “99999”
    [56] - ITT Population. “Not available (NA)” data is presented as “99999”
    [57] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in albumin, globulin and protein at the indicated time points up to Week 16

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    End point title
    Change from Baseline in albumin, globulin and protein at the indicated time points up to Week 16 [58]
    End point description
    Change from Baseline in the albumin, globulin and protein values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [59]
    10 [60]
    10 [61]
    10 [62]
    11 [63]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Albumin; Week2; n=9,9,9,9,10
    -0.4 ± 1.88
    0.2 ± 2.22
    -0.6 ± 2.19
    0.9 ± 2.2
    -1.2 ± 2.15
        Albumin; Week3; n=1,1,1,0,0
    -2 ± 99999
    -4 ± 99999
    1 ± 99999
    99999 ± 99999
    99999 ± 99999
        Albumin; Week4; n=8,9,8,9,9
    1.3 ± 2.05
    0.4 ± 2.55
    -1 ± 1.36
    1.1 ± 2.09
    -1.4 ± 3.09
        Albumin; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    2 ± 99999
    -3 ± 99999
    2 ± 99999
        Albumin; Week6; n=7,10,6,10,8
    -1 ± 2
    0.7 ± 2.31
    2.3 ± 2.5
    1 ± 3.13
    -0.9 ± 2.85
        Albumin; Week8; n=8,7,9,9,9
    1.3 ± 2.55
    -0.1 ± 2.34
    0.2 ± 1.79
    1.8 ± 4.02
    -2.1 ± 1.9
        Albumin; Week10; n=7,8,4,7,8
    -0.4 ± 2.15
    0.3 ± 2.82
    -0.3 ± 0.96
    1.7 ± 3.73
    -2.1 ± 1.55
        Albumin; Week12; n=7,7,7,8,7
    -0.4 ± 1.51
    0.6 ± 3.21
    -0.4 ± 2.57
    1 ± 3.66
    -2.6 ± 3.1
        Albumin; Week16; n=5,6,3,6,6
    -1.4 ± 2.88
    -1.5 ± 3.33
    -3 ± 1.73
    0.3 ± 3.01
    -2.5 ± 2.74
        Globulin; Week2; n=9,9,9,9,10
    -1.7 ± 3.2
    -0.6 ± 2.55
    0.2 ± 2.28
    -1.6 ± 2.96
    1.1 ± 1.79
        Globulin; Week3; n=1,1,1,0,0
    2 ± 99999
    0 ± 99999
    -6 ± 99999
    99999 ± 99999
    99999 ± 99999
        Globulin; Week4; n=8,9,8,9,9
    -2.1 ± 3.44
    -1.1 ± 3.18
    -1.8 ± 3.06
    -2.6 ± 1.67
    0.3 ± 2.92
        Globulin; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -0.7 ± 99999
    -3 ± 99999
    3 ± 99999
        Globulin; Week6; n=7,10,6,10,8
    -1 ± 1.83
    -0.3 ± 2.11
    -1.5 ± 3.33
    -3.4 ± 3.24
    1.5 ± 2
        Globulin; Week8; n=8,7,9,9,9
    -1.6 ± 3.78
    -1.7 ± 1.7
    -2.6 ± 3.13
    -2.6 ± 2.3
    -0.7 ± 2.29
        Globulin; Week10; n=7,8,4,7,8
    -2.1 ± 2.79
    -0.5 ± 2.27
    -0.8 ± 1.26
    -3.1 ± 1.46
    0.1 ± 1.64
        Globulin; Week12; n=7,7,7,8,7
    -0.3 ± 2.29
    -0.6 ± 3.46
    -0.7 ± 5.15
    -1.5 ± 3.02
    -0.4 ± 1.62
        Globulin; Week16; n=5,6,3,6,6
    -0.6 ± 1.67
    0.3 ± 2.34
    -0.7 ± 1.15
    -2 ± 4.1
    0.8 ± 2.23
        Protein; Week2; n=9,9,9,9,10
    -2.1 ± 3.95
    -0.3 ± 3.81
    -0.3 ± 3.81
    -0.7 ± 4.82
    -0.1 ± 3.14
        Protein; Week3; n=1,1,1,0,0
    0 ± 99999
    -4 ± 99999
    -5 ± 99999
    99999 ± 99999
    99999 ± 99999
        Protein; Week4; n=8,9,8,9,9
    -0.9 ± 2.9
    -0.7 ± 4.44
    -1.9 ± 2.23
    -1.4 ± 3.4
    -1.1 ± 3.52
        Protein; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -5 ± 99999
    -6 ± 99999
    5 ± 99999
        Protein; Week6; n=7,10,6,10,8
    -2 ± 3.46
    0.4 ± 2.8
    0.8 ± 2.93
    -2.4 ± 5.8
    0.6 ± 2.83
        Protein; Week8; n=8,7,9,9,9
    -0.4 ± 3.29
    -1.9 ± 2.54
    -2.3 ± 3.84
    -0.8 ± 5.21
    -2.8 ± 3.42
        Protein; Week10; n=7,8,4,7,8
    -2.6 ± 4.47
    -0.3 ± 3.69
    -1 ± 1.15
    -1.4 ± 4.39
    -2 ± 2.45
        Protein; Week12; n=7,7,7,8,7
    -0.7 ± 3.68
    0 ± 3.42
    -1.1 ± 3.53
    -0.5 ± 4
    -3 ± 3.32
        Protein; Week16; n=5,6,3,6,6
    -2 ± 4.36
    -1.2 ± 3.25
    -3.7 ± 1.53
    -1.7 ± 4.5
    -1.7 ± 3.44
    Notes
    [59] - ITT Population. “Not available (NA)” data is presented as “99999”
    [60] - ITT Population. “Not available (NA)” data is presented as “99999”
    [61] - ITT Population. “Not available (NA)” data is presented as “99999”
    [62] - ITT Population. “Not available (NA)” data is presented as “99999”
    [63] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase at the indicated time points up to Week 16

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    End point title
    Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase at the indicated time points up to Week 16 [64]
    End point description
    Change from Baseline in the alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase (CK), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LDH) values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [64] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [65]
    10 [66]
    10 [67]
    10 [68]
    11 [69]
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALP; Week2; n=9,9,9,9,10
    -4.2 ± 6.2
    1.7 ± 16.53
    -5.8 ± 13.64
    -4.1 ± 5.64
    -3.7 ± 9.33
        ALP; Week3; n=1,1,1,0,0
    5 ± 99999
    -10 ± 99999
    -59 ± 99999
    99999 ± 99999
    99999 ± 99999
        ALP; Week4; n=8,9,8,9,9
    -0.9 ± 7.47
    -4.4 ± 6.52
    24.6 ± 102.06
    -3 ± 11.64
    0.3 ± 20.46
        ALP; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    27.7 ± 122.66
    12 ± 99999
    4 ± 99999
        ALP; Week6; n=7,10,7,10,8
    -3.1 ± 7.27
    -5.1 ± 4.95
    -4.4 ± 35.58
    -6.9 ± 10.76
    -2 ± 10.94
        ALP; Week8; n=9,7,9,9,9
    -5.3 ± 7.89
    -8.1 ± 5.87
    -13 ± 26
    -5.9 ± 7.06
    -3.3 ± 10.7
        ALP; Week10; n=7,8,4,7,8
    -5.3 ± 12.62
    -7.8 ± 7.83
    -16.3 ± 9.29
    -12.4 ± 10.66
    0.6 ± 13.32
        ALP; Week12; n=7,7,7,8,7
    -2.7 ± 9.07
    -6.4 ± 12.99
    -19.6 ± 24.23
    -10.4 ± 8.75
    -3.6 ± 8.14
        ALP; Week16; n=5,6,3,6,6
    1.2 ± 6.42
    -9.8 ± 9.83
    -8.3 ± 2.52
    -9.2 ± 16.75
    11.7 ± 37.75
        ALT; Week2; n=9,9,9,9,10
    10.4 ± 28.1
    24.1 ± 65.25
    35.3 ± 68.85
    10.7 ± 23.49
    1.4 ± 4.06
        ALT; Week3; n=1,1,1,0,0
    5 ± 99999
    -2 ± 99999
    5 ± 99999
    99999 ± 99999
    99999 ± 99999
        ALT; Week4; n=8,9,8,9,9
    0 ± 5.63
    1.8 ± 13.71
    67.3 ± 156.91
    7.7 ± 17.15
    1.1 ± 6.83
        ALT; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    40 ± 67.18
    17 ± 99999
    0 ± 99999
        ALT; Week6; n=7,10,7,10,8
    56.1 ± 149.97
    1 ± 4.67
    9.3 ± 27.37
    27.37 ± 4.36
    0.3 ± 4.65
        ALT; Week8; n=9,7,9,9,9
    -0.4 ± 4.98
    1.3 ± 9.95
    -2.3 ± 13.02
    0.8 ± 3.11
    1 ± 5.63
        ALT; Week10; n=7,8,4,7,8
    4.3 ± 13.31
    -2.4 ± 6.99
    1.8 ± 4.27
    1.3 ± 3.9
    -1.9 ± 4.94
        ALT; Week12; n=7,7,7,8,7
    9.6 ± 24.79
    -1.6 ± 6.16
    -5.3 ± 11.87
    4 ± 5.32
    -0.9 ± 3.85
        ALT; Week16; n=5,6,3,6,6
    2 ± 6.44
    3.5 ± 14.45
    2.3 ± 3.79
    -1.2 ± 5.31
    -0.7 ± 3.67
        AST; Week2; n=9,9,9,9,10
    9.7 ± 21.6
    37.6 ± 106.14
    37.7 ± 61.72
    14.8 ± 23.69
    2 ± 3.02
        AST; Week3; n=1,1,1,0,0
    6 ± 99999
    2 ± 99999
    -24 ± 99999
    99999 ± 99999
    99999 ± 99999
        AST; Week4; n=8,9,8,9,9
    -2.8 ± 5.85
    -0.1 ± 3.14
    25.9 ± 68.92
    5 ± 3.04
    0.8 ± 4.74
        AST; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    -4.3 ± 16.92
    -1 ± 99999
    0 ± 99999
        AST; Week6; n=7,10,7,10,8
    25.6 ± 66.39
    1.4 ± 4.2
    5 ± 23.47
    2.5 ± 7.49
    -0.5 ± 2
        AST; Week8; n=9,7,9,9,9
    1 ± 6.71
    2.7 ± 7.48
    -3.2 ± 10.8
    4 ± 4.66
    0.3 ± 4.12
        AST; Week10; n=7,8,4,7,8
    4.4 ± 7.61
    -0.9 ± 5.22
    2.5 ± 5
    4.9 ± 3.29
    -0.6 ± 4.57
        AST; Week12; n=7,7,7,8,7
    8 ± 17.95
    1.1 ± 5.79
    -2 ± 11.55
    8.5 ± 7.03
    0 ± 2.31
        AST; Week16; n=5,6,3,6,6
    1.6 ± 6.66
    0.3 ± 9.52
    2.3 ± 3.06
    -0.2 ± 3.25
    0.7 ± 2.58
        CK; Week2; n=9,9,9,9,10
    7.4 ± 10.51
    287.9 ± 809.45
    38.9 ± 53.16
    41.9 ± 31.62
    0.3 ± 6.58
        CK; Week3; n=1,1,1,0,0
    0 ± 99999
    -27 ± 99999
    -30 ± 99999
    99999 ± 99999
    99999 ± 99999
        CK; Week4; n=8,9,8,9,9
    2.6 ± 15.18
    25.1 ± 15.14
    19.3 ± 26.12
    55.9 ± 54.49
    4.7 ± 13.72
        CK; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    83 ± 154.15
    -19 ± 99999
    -5 ± 99999
        CK; Week6; n=7,10,7,10,8
    21.3 ± 30.6
    16.8 ± 17.16
    26.3 ± 37.3
    59.9 ± 125.28
    7.6 ± 22.19
        CK; Week8; n=9,7,9,9,9
    12.5 ± 17.03
    27.6 ± 26.79
    21.4 ± 53.68
    68.4 ± 57.07
    4.9 ± 13.36
        CK; Week10; n=7,8,4,7,8
    18.7 ± 20.25
    34.5 ± 31
    53.3 ± 45.68
    81.1 ± 63.2
    9.6 ± 34.85
        CK; Week12; n=7,7,7,8,7
    21.7 ± 24.56
    28.9 ± 20.36
    12.9 ± 50.7
    173.6 ± 265.21
    24.9 ± 52.2
        CK; Week16; n=5,6,3,6,6
    25.6 ± 39.6
    15.7 ± 10.52
    -4.3 ± 19.14
    18.5 ± 25.56
    -1.8 ± 18.45
        GGT; Week2; n=9,9,9,9,10
    1 ± 4.74
    15.7 ± 45.96
    5.9 ± 18.1
    0.2 ± 4.92
    -0.6 ± 7.26
        GGT; Week3; n=1,1,1,0,0
    0 ± 99999
    -2 ± 99999
    19 ± 99999
    99999 ± 99999
    99999 ± 99999
        GGT; Week4; n=8,9,8,9,9
    0.5 ± 4.14
    4.6 ± 25.5
    82.8 ± 197.06
    6.4 ± 25.04
    4 ± 16.12
        GGT; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    -25 ± 99999
    42 ± 99999
    -2 ± 99999
        GGT; Week6; n=7,10,7,10,8
    5 ± 14.05
    1.2 ± 12.74
    1.2 ± 20.68
    3.1 ± 8.17
    -0.1 ± 7.3
        GGT; Week8; n=9,7,9,9,9
    -1.5 ± 8.67
    -0.3 ± 11.25
    7.2 ± 29.11
    0.9 ± 5.62
    -0.7 ± 6.26
        GGT; Week10; n=7,8,4,7,8
    -0.3 ± 3.73
    -4.1 ± 8.53
    0.8 ± 6.18
    -2.6 ± 2.76
    -1.9 ± 6.38
        GGT; Week12; n=7,7,7,8,7
    3.4 ± 13.2
    -4.3 ± 8.86
    -5.3 ± 16.5
    -1.5 ± 3.93
    -2.6 ± 4.79
        GGT; Week16; n=5,6,3,6,6
    0.8 ± 3.96
    -2.5 ± 5.09
    2 ± 5.2
    -1.3 ± 4.27
    6.3 ± 20.55
        LDH; Week2; n=9,9,9,9,10
    7.7 ± 21.75
    61.3 ± 148.63
    73.1 ± 70.39
    49.3 ± 62.86
    5.9 ± 20.62
        LDH; Week3; n=1,1,1,0,0
    18 ± 99999
    6 ± 99999
    -2 ± 99999
    99999 ± 99999
    99999 ± 99999
        LDH; Week4; n=8,9,8,9,9
    -17.6 ± 55.64
    11.6 ± 12.85
    80.5 ± 160.09
    31.8 ± 32.28
    -7.7 ± 17.93
        LDH; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    45 ± 82.02
    43 ± 99999
    -1 ± 99999
        LDH; Week6; n=7,10,7,10,8
    18.7 ± 49.19
    10.1 ± 20.43
    21.3 ± 31.78
    36.8 ± 36.43
    -5.4 ± 15.68
        LDH; Week8; n=9,7,9,9,9
    -11.8 ± 36.81
    3.7 ± 18.59
    14.8 ± 21.62
    40.4 ± 25.95
    -1.6 ± 20.43
        LDH; Week10; n=7,8,4,7,8
    -3.7 ± 25.92
    22.4 ± 25.05
    23.8 ± 22.91
    41.3 ± 31.37
    -1.1 ± 11.92
        LDH; Week12; n=7,7,7,8,7
    0.6 ± 27.16
    18.4 ± 16.92
    9.7 ± 32.91
    46 ± 34.33
    3.9 ± 22.3
        LDH; Week16; n=5,6,3,6,6
    -2.2 ± 28.59
    9.3 ± 18.91
    4.3 ± 14.05
    17.7 ± 18.11
    -1.5 ± 30.33
    Notes
    [65] - ITT Population. “Not available (NA)” data is presented as “99999”
    [66] - ITT Population. “Not available (NA)” data is presented as “99999”
    [67] - ITT Population. “Not available (NA)” data is presented as “99999”
    [68] - ITT Population. “Not available (NA)” data is presented as “99999”
    [69] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in anion gap, calcium, cholesterol, chloride, carbon dioxide, glucose, HDL cholesterol, potassium, LDL cholesterol, magnesium, phosphate, sodium, triglycerides, urea, VLDL cholesterol at the indicated time points up to Week 16.

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    End point title
    Change from Baseline in anion gap, calcium, cholesterol, chloride, carbon dioxide, glucose, HDL cholesterol, potassium, LDL cholesterol, magnesium, phosphate, sodium, triglycerides, urea, VLDL cholesterol at the indicated time points up to Week 16. [70]
    End point description
    Change from Baseline in the anion gap, calcium, ionised calcium, cholesterol, chloride, carbon dioxide, glucose, high density lipoprotein (HDL) cholesterol (fasted and not fasted), potassium, low density lipoprotein (LDL) cholesterol (fasted and not fasted), magnesium, phosphate, sodium, triglycerides (fasted and not fasted), urea and very low density lipoprotein (VLDL) cholesterol values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (n=X,X,X,X,X). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [71]
    10 [72]
    10 [73]
    10 [74]
    11 [75]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Anion Gap; Week2; n=9,9,9,9,10
    -1.8 ± 2.49
    -0.8 ± 2.39
    -1 ± 3.71
    -0.1 ± 2.37
    -1.1 ± 3.48
        Anion Gap; Week3; n=1,1,1,0,0
    -3 ± 99999
    -3 ± 99999
    -5 ± 99999
    99999 ± 99999
    99999 ± 99999
        Anion Gap; Week4; n=8,9,8,9,9
    0 ± 3.55
    -0.8 ± 3.15
    -0.6 ± 4.57
    -1 ± 4.06
    -0.7 ± 2.69
        Anion Gap; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -9 ± 99999
    -3 ± 99999
    -2 ± 99999
        Anion Gap; Week6; n=6,10,6,9,7
    0 ± 1.67
    -1 ± 3.09
    -1.7 ± 2.66
    -1.7 ± 2.5
    0 ± 1
        Anion Gap; Week8; n=8,7,8,9,9
    -0.5 ± 2.56
    -0.9 ± 3.93
    -0.5 ± 3.93
    -0.3 ± 3.87
    -1.4 ± 1.51
        Anion Gap; Week10; n=7,8,4,7,8
    0 ± 2.94
    -1.3 ± 3.62
    -1.3 ± 2.5
    0 ± 2.08
    -1 ± 1.51
        Anion Gap; Week12; n=6,7,7,8,7
    2.3 ± 2.5
    -0.9 ± 3.08
    -1.3 ± 4.54
    -0.3 ± 2.82
    -2.4 ± 3.1
        Anion Gap; Week16; n=5,6,3,6,6
    -0.8 ± 2.77
    0.8 ± 3.19
    -2.3 ± 3.06
    -0.3 ± 2.88
    -0.7 ± 3.5
        Calcium; Week2; n=9,9,9,9,10
    -0.036 ± 0.0654
    -0.011 ± 0.0842
    -0.029 ± 0.0985
    -0.034 ± 0.0814
    -0.03 ± 0.1111
        Calcium; Week3; n=1,1,1,0,0
    -0.12 ± 99999
    -0.06 ± 99999
    0.01 ± 99999
    99999 ± 99999
    99999 ± 99999
        Calcium; Week4; n=8,9,8,9,9
    -0.001 ± 0.0517
    -0.007 ± 0.0667
    -0.01 ± 0.0404
    -0.02 ± 0.061
    -0.006 ± 0.0843
        Calcium; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    0.08 ± 99999
    0.19 ± 99999
    0.11 ± 99999
        Calcium; Week6; n=7,10,7,10,8
    -0.033 ± 0.0596
    0.023 ± 0.0952
    0.043 ± 0.1108
    -0.02 ± 0.0833
    -0.049 ± 0.1166
        Calcium; Week8; n=9,7,9,9,9
    -0.051 ± 0.1109
    -0.02 ± 0.0728
    0.028 ± 0.0992
    0.002 ± 0.0856
    -0.059 ± 0.1125
        Calcium; Week10; n=7,8,4,7,8
    -0.053 ± 0.0692
    -0.032 ± 0.0794
    0 ± 0.0606
    -0.013 ± 0.0685
    -0.046 ± 0.0825
        Calcium; Week12; n=7,7,7,8,7
    -0.053 ± 0.0783
    -0.023 ± 0.105
    0.003 ± 0.0665
    -0.055 ± 0.0644
    -0.027 ± 0.072
        Calcium; Week16; n=5,6,3,6,6
    -0.02 ± 0.1288
    -0.065 ± 0.0779
    -0.03 ± 0.0755
    -0.04 ± 0.0654
    -0.027 ± 0.1046
        Calcium ionised; Week2; n=9,9,9,9,10
    0.003 ± 0.032
    0.001 ± 0.0448
    -0.011 ± 0.0183
    -0.011 ± 0.0306
    -0.012 ± 0.0326
        Calcium ionised; Week3; n=1,1,1,0,0
    -0.05 ± 99999
    0.01 ± 99999
    0.04 ± 99999
    99999 ± 99999
    99999 ± 99999
        Calcium ionised; Week4; n=8,9,8,9,9
    0.009 ± 0.0314
    -0.002 ± 0.0268
    0.011 ± 0.0217
    0.001 ± 0.0392
    0.003 ± 0.0274
        Calcium ionised; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.08 ± 99999
    0.14 ± 99999
    0 ± 99999
        Calcium ionised; Week6; n=6,10,6,9,7
    0.007 ± 0.0356
    0.004 ± 0.0357
    0.013 ± 0.0327
    0.01 ± 0.0456
    -0.023 ± 0.0446
        Calcium ionised; Week8; n=8,7,8,9,9
    -0.019 ± 0.0491
    0.009 ± 0.0302
    0.03 ± 0.0283
    0.009 ± 0.0293
    -0.003 ± 0.0433
        Calcium ionised; Week10; n=7,8,4,7,8
    0.003 ± 0.0359
    -0.01 ± 0.0351
    0.01 ± 0.0216
    0.006 ± 0.0315
    -0.001 ± 0.0356
        Calcium ionised; Week12; n=7,7,7,8,7
    -0.016 ± 0.0506
    -0.013 ± 0.0427
    0.011 ± 0.0334
    -0.021 ± 0.0348
    0.013 ± 0.039
        Calcium ionised; Week16; n=5,6,3,6,6
    0.012 ± 0.0396
    -0.018 ± 0.0382
    0.017 ± 0.0379
    -0.007 ± 0.0398
    0.007 ± 0.0372
        Cholesterol; Week2; n=9,9,9,9,10
    -0.126 ± 0.5514
    0.167 ± 0.4644
    -0.039 ± 0.4517
    0.316 ± 0.6995
    0.079 ± 0.3626
        Cholesterol; Week3; n=1,1,1,0,0
    -0.56 ± 99999
    -0.15 ± 99999
    1.51 ± 99999
    99999 ± 99999
    99999 ± 99999
        Cholesterol; Week4; n=8,9,8,9,9
    0.197 ± 0.8224
    0.197 ± 0.7258
    0.519 ± 0.9386
    0.322 ± 0.6854
    -0.023 ± 0.3443
        Cholesterol; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.98 ± 99999
    -0.55 ± 99999
    0.92 ± 99999
        Cholesterol; Week6; n=7,10,6,10,8
    -0.023 ± 0.7105
    0.325 ± 0.5219
    0.472 ± 0.8739
    0.559 ± 0.7808
    -0.103 ± 0.5727
        Cholesterol; Week8; n=8,7,9,9,9
    0.146 ± 0.5702
    -0.039 ± 0.3315
    0.466 ± 0.5557
    0.688 ± 0.8384
    -0.171 ± 0.3699
        Cholesterol; Week10; n=7,8,4,7,8
    -0.061 ± 0.5494
    0.26 ± 0.5641
    0.195 ± 0.3747
    0.551 ± 0.6929
    -0.549 ± 0.2554
        Cholesterol; Week12; n=7,7,7,8,7
    0.173 ± 0.5702
    0.147 ± 0.384
    0.119 ± 0.3293
    0.601 ± 0.5253
    -0.176 ± 0.348
        Cholesterol; Week16; n=5,6,3,6,6
    -0.472 ± 0.4219
    0.04 ± 0.3043
    0.133 ± 0.0569
    0.223 ± 0.4871
    -0.26 ± 0.3636
        Chloride; Week2; n=9,9,9,9,10
    0.3 ± 2.6
    1 ± 1.73
    0.1 ± 3.22
    -1.3 ± 2.12
    0.1 ± 2.42
        Chloride; Week3; n=1,1,1,0,0
    3 ± 99999
    -1 ± 99999
    -3 ± 99999
    99999 ± 99999
    99999 ± 99999
        Chloride; Week4; n=8,9,8,9,9
    99999 ± 99999
    0.7 ± 1.94
    -0.9 ± 2.3
    -0.4 ± 2.4
    0.7 ± 1.73
        Chloride; Week5; n=0,0,1,1,1
    -1.3 ± 1.39
    99999 ± 99999
    -1 ± 99999
    -3 ± 99999
    -6 ± 99999
        Chloride; Week6; n=7,10,6,10,8
    -0.3 ± 1.11
    -0.8 ± 2.53
    -0.3 ± 1.51
    -0.3 ± 2.06
    0.3 ± 1.67
        Chloride; Week8; n=8,7,9,9,9
    -0.5 ± 2.33
    1.6 ± 2.15
    0.1 ± 1.96
    -1.1 ± 3.06
    0.6 ± 1.67
        Chloride; Week10; n=7,8,4,7,8
    0.9 ± 2.41
    0.9 ± 2.42
    0.3 ± 1.71
    -0.7 ± 1.25
    0.9 ± 2.1
        Chloride; Week12; n=7,7,7,8,7
    0.3 ± 2.14
    1.4 ± 2.76
    0.3 ± 1.98
    -0.5 ± 2.88
    0.6 ± 1.13
        Chloride; Week16; n=5,6,3,6,6
    -0.4 ± 2.19
    1.5 ± 2.35
    -0.7 ± 2.08
    -1.5 ± 2.66
    1.2 ± 1.33
        Carbon Dioxide; Week2; n=9,9,9,9,10
    0 ± 1.8
    -1 ± 1.32
    -0.4 ± 3
    -0.1 ± 1.62
    1.1 ± 2.38
        Carbon Dioxide; Week3; n=1,1,1,0,0
    -1 ± 99999
    3 ± 99999
    5 ± 99999
    99999 ± 99999
    99999 ± 99999
        Carbon Dioxide; Week4; n=8,9,8,9,9
    -0.4 ± 2.77
    -1.3 ± 2.45
    0.4 ± 3.29
    0.2 ± 1.64
    0.9 ± 2.03
        Carbon Dioxide; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    7 ± 99999
    4 ± 99999
    4 ± 99999
        Carbon Dioxide; Week6; n=7,10,6,10,8
    -0.9 ± 2.19
    0.5 ± 2.17
    0.3 ± 1.51
    0.9 ± 2.69
    0.4 ± 1.6
        Carbon Dioxide; Week8; n=8,7,9,9,9
    0.3 ± 1.98
    -1 ± 2.45
    -1.1 ± 3.59
    -0.1 ± 2.71
    0.9 ± 2.26
        Carbon Dioxide; Week10; n=7,8,4,7,8
    -1.6 ± 2.88
    -0.1 ± 1.81
    0.3 ± 2.99
    0.6 ± 2.15
    0.5 ± 1.77
        Carbon Dioxide; Week12; n=7,7,7,8,7
    -2.1 ± 2.34
    -1.3 ± 1.38
    -0.6 ± 3.64
    0.1 ± 2.42
    1.7 ± 2.56
        Carbon Dioxide; Week16; n=5,6,3,6,6
    -0.2 ± 0.84
    -1.8 ± 1.83
    1.7 ± 1.53
    0.8 ± 2.23
    0 ± 3.69
        Glucose; Week2; n=9,9,9,9,10
    0.2 ± 0.304
    0.04 ± 0.384
    0.27 ± 1.302
    0.03 ± 0.779
    0.07 ± 0.368
        Glucose; Week3; n=1,1,1,0,0
    1.7 ± 99999
    -0.1 ± 99999
    -1.3 ± 99999
    99999 ± 99999
    99999 ± 99999
        Glucose; Week4; n=8,9,8,9,9
    0.11 ± 0.348
    0.11 ± 0.276
    -0.14 ± 0.403
    0.12 ± 0.851
    0.32 ± 0.338
        Glucose; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -0.5 ± 99999
    0.7 ± 99999
    0.4 ± 99999
        Glucose; Week6; n=7,10,6,10,8
    0.46 ± 0.506
    0.09 ± 0.428
    0.53 ± 1.813
    -0.08 ± 1.191
    0.69 ± 1.106
        Glucose; Week8; n=8,7,9,9,9
    0.06 ± 0.444
    -0.01 ± 0.186
    0.26 ± 0.646
    0.11 ± 0.796
    0 ± 0.403
        Glucose; Week10; n=7,8,4,7,8
    0.21 ± 0.334
    0.03 ± 0.271
    0 ± 0.356
    -0.2 ± 0.889
    0.05 ± 0.487
        Glucose; Week12; n=7,7,7,8,7
    0.16 ± 0.613
    0.16 ± 0.424
    -0.31 ± 0.414
    -0.19 ± 0.559
    -0.03 ± 0.386
        Glucose; Week16; n=5,6,3,6,6
    0.12 ± 0.383
    0.13 ± 0.207
    -0.07 ± 0.289
    1.48 ± 4.014
    -0.02 ± 0.271
        HDL Cholesterol, Fasted; Week2; n=0,1,0,0,1
    99999 ± 99999
    -0.3 ± 99999
    99999 ± 99999
    99999 ± 99999
    0.25 ± 99999
        HDL Cholesterol, Fasted; Week3; n=1,1,0,0,0
    -0.18 ± 99999
    -0.27 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        HDL Cholesterol, Fasted; Week4; n=1,1,2,0,1
    0.66 ± 99999
    0.4 ± 99999
    0.225 ± 0.0354
    99999 ± 99999
    -0.09 ± 99999
        HDL Cholesterol, Fasted; Week6; n=0,1,0,1,0
    99999 ± 99999
    0.1 ± 99999
    99999 ± 99999
    0.08 ± 99999
    99999 ± 99999
        HDL Cholesterol, Fasted; Week8; n=0,0,3,01
    99999 ± 99999
    99999 ± 99999
    -0.013 ± 0.3664
    99999 ± 99999
    -0.08 ± 99999
        HDL Cholesterol, Fasted; Week10; n=2,1,0,0,0
    0.125 ± 0.0354
    -0.2 ± 99999
    99999 ± 99999
    99999 ± 99999
    0.03 ± 99999
        HDL Cholesterol, Fasted; Week12; n=5,6,4,6,5
    0.06 ± 0.1925
    0.06 ± 0.1637
    0.098 ± 0.3063
    0.487 ± 0.3847
    -0.158 ± 0.177
        HDL Cholesterol, Not fasted; Week2; n=9,8,9,9,9
    -0.013 ± 0.1655
    0.145 ± 0.1305
    -0.24 ± 0.3226
    0.107 ± 0.4241
    0.046 ± 0.2051
        HDL Cholesterol, Not fasted; Week3; n=0,0,1,0,0
    99999 ± 99999
    99999 ± 99999
    -0.09 ± 99999
    99999 ± 99999
    99999 ± 99999
        HDL Cholesterol, Not fasted; Week4; n=7,8,6,9,8
    -0.029 ± 0.1046
    0.16 ± 0.1336
    -0.145 ± 0.125
    0.294 ± 0.2932
    0.017 ± 0.1951
        HDL Cholesterol, Not fasted; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.05 ± 99999
    0.05 ± 99999
    0.06 ± 99999
        HDL Cholesterol, Not fasted; Week6; n=7,9,6,9,8
    -0.05 ± 0.1751
    0.159 ± 0.309
    0.073 ± 0.207
    0.322 ± 0.2712
    0.04 ± 0.3704
        HDL Cholesterol, Not fasted; Week8; n=8,7,6,8,8
    0.066 ± 0.0639
    0.11 ± 0.2728
    0.033 ± 0.2309
    0.543 ± 0.4174
    -0.05 ± 0.2594
        HDL Cholesterol, Not fasted; Week10; n=5,7,4,7,7
    -0.138 ± 0.1397
    0.136 ± 0.0969
    0.058 ± 0.2804
    0.464 ± 0.2531
    -0.151 ± 0.2769
        HDL Cholesterol, Not fasted; Week12; n=2,1,4,2,2
    -0.165 ± 0.1909
    -0.1 ± 99999
    0.12 ± 0.1581
    0.175 ± 0.0212
    0.045 ± 0.1344
        HDL Cholesterol, Not fasted; Week16; n=5,6,3,6,6
    -0.278 ± 0.2805
    -0.003 ± 0.2211
    -0.2 ± 0.2931
    0.137 ± 0.1875
    -0.103 ± 0.2808
        Potassium; Week2; n=9,9,9,9,10
    -0.18 ± 0.299
    0.01 ± 0.196
    -0.13 ± 0.312
    -0.18 ± 0.367
    0.1 ± 0.447
        Potassium; Week3; n=1,1,1,0,0
    0 ± 99999
    0.2 ± 99999
    0.2 ± 99999
    99999 ± 99999
    99999 ± 99999
        Potassium; Week4; n=8,9,8,9,9
    -0.06 ± 0.141
    0.07 ± 0.461
    -0.15 ± 0.421
    -0.16 ± 0.34
    0.13 ± 0.367
        Potassium; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -0.4 ± 99999
    0 ± 99999
    0.2 ± 99999
        Potassium; Week6; n=7,10,6,10,8
    0.03 ± 0.214
    0.15 ± 0.403
    0.03 ± 0.197
    -0.18 ± 0.371
    0.13 ± 0.392
        Potassium; Week8; n=8,7,9,9,9
    -0.06 ± 0.338
    0.03 ± 0.315
    0 ± 0.418
    -0.06 ± 0.283
    -0.08 ± 0.399
        Potassium; Week10; n=7,8,4,7,8
    -0.26 ± 0.223
    0.05 ± 0.382
    -0.03 ± 0.222
    -0.14 ± 0.42
    0.04 ± 0.207
        Potassium; Week12; n=7,7,7,8,7
    -0.06 ± 0.113
    -0.04 ± 0.369
    0.04 ± 0.341
    -0.11 ± 0.383
    -0.09 ± 0.334
        Potassium; Week16; n=5,6,3,6,6
    -0.2 ± 0.292
    -0.08 ± 0.371
    0.07 ± 0.321
    -0.12 ± 0.286
    0 ± 0.363
        LDL Cholesterol, Fasted; Week2; n=0,1,0,0,1
    99999 ± 99999
    -0.38 ± 99999
    99999 ± 99999
    99999 ± 99999
    0.4 ± 99999
        LDL Cholesterol, Fasted; Week3; n=1,1,0,0,0
    -0.62 ± 99999
    -0.34 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        LDL Cholesterol, Fasted; Week4; n=1,1,2,0,1
    1.5 ± 99999
    1.3 ± 99999
    0.52 ± 1.3576
    99999 ± 99999
    0.07 ± 99999
        LDL Cholesterol, Fasted; Week6; n=0,1,0,1,0
    99999 ± 99999
    -0.21 ± 99999
    99999 ± 99999
    -1 ± 99999
    99999 ± 99999
        LDL Cholesterol, Fasted; Week8; n=0,0,3,01
    99999 ± 99999
    99999 ± 99999
    0.37 ± 0.2946
    99999 ± 99999
    -0.35 ± 99999
        LDL Cholesterol, Fasted; Week10; n=2,1,0,0,0
    0.01 ± 0.396
    0.14 ± 99999
    99999 ± 99999
    99999 ± 99999
    -0.18 ± 99999
        LDL Cholesterol, Fasted; Week12; n=4,5,4,6,5
    0.147 ± 0.287
    0 ± 0.3272
    0.105 ± 0.2464
    0.187 ± 0.283
    0.096 ± 0.3396
        LDL Cholesterol, Not fasted; Week2; n=9,7,9,9,9
    -0.271 ± 0.6127
    0.157 ± 0.5447
    -0.212 ± 0.3942
    0.144 ± 0.6862
    -0.016 ± 0.2168
        LDL Cholesterol, Not fasted; Week3; n=0,0,1,0,0
    99999 ± 99999
    99999 ± 99999
    0.19 ± 99999
    99999 ± 99999
    99999 ± 99999
        LDL Cholesterol, Not fasted; Week4; n=7,7,6,9,8
    -0.104 ± 0.4535
    -0.089 ± 0.3488
    -0.03 ± 0.3504
    0.086 ± 0.6037
    -0.023 ± 0.5208
        LDL Cholesterol, Not fasted; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.1 ± 99999
    -0.62 ± 99999
    0.55 ± 99999
        LDL Cholesterol, Not fasted; Week6; n=7,8,6,9,8
    -0.301 ± 0.6443
    0.349 ± 0.578
    0.052 ± 0.5242
    0.25 ± 0.5119
    -0.101 ± 0.428
        LDL Cholesterol, Not fasted; Week8; n=8,6,6,8,8
    0.143 ± 0.635
    0.085 ± 0.6563
    0.102 ± 0.4613
    0.166 ± 0.663
    0.091 ± 0.3331
        LDL Cholesterol, Not fasted; Week10; n=5,6,4,7,7
    -0.492 ± 0.2993
    0.385 ± 0.6471
    -0.198 ± 0.3826
    0.121 ± 0.6339
    -0.424 ± 0.2717
        LDL Cholesterol, Not fasted; Week12; n=2,1,4,2,2
    -0.105 ± 0.8839
    0.43 ± 99999
    -0.253 ± 0.3269
    0.54 ± 0.3111
    0.105 ± 0.0919
        LDL Cholesterol, Not fasted; Week16; n=5,5,3,6,6
    -0.48 ± 0.6055
    0.294 ± 0.6993
    -0.267 ± 0.2479
    -0.055 ± 0.542
    -0.082 ± 0.3476
        Magnesium; Week2; n=9,9,9,9,10
    -0.02 ± 0.0548
    0.023 ± 0.0904
    0.011 ± 0.0766
    0.019 ± 0.0417
    -0.003 ± 0.046
        Magnesium; Week3; n=1,1,1,0,0
    0.07 ± 99999
    0.13 ± 99999
    0.14 ± 99999
    99999 ± 99999
    99999 ± 99999
        Magnesium; Week4; n=8,9,8,9,9
    0.015 ± 0.0207
    0.006 ± 0.0841
    0.025 ± 0.0573
    0.004 ± 0.0557
    -0.013 ± 0.0433
        Magnesium; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.08 ± 99999
    0 ± 99999
    0.05 ± 99999
        Magnesium; Week6; n=7,10,6,10,8
    -0.016 ± 0.0493
    0.009 ± 0.0745
    0.03 ± 0.0978
    0.007 ± 0.0675
    0.004 ± 0.0555
        Magnesium; Week8; n=8,7,9,9,9
    0.001 ± 0.0391
    0.013 ± 0.0909
    0.023 ± 0.063
    0 ± 0.0524
    -0.019 ± 0.0523
        Magnesium; Week10; n=7,8,4,7,8
    -0.021 ± 0.0641
    0.023 ± 0.1057
    -0.06 ± 0.0572
    -0.013 ± 0.0468
    -0.009 ± 0.0562
        Magnesium; Week12; n=7,7,7,8,7
    -0.007 ± 0.0509
    0.013 ± 0.0789
    -0.016 ± 0.0808
    -0.005 ± 0.0396
    -0.019 ± 0.0521
        Magnesium; Week16; n=5,6,3,6,6
    -0.024 ± 0.0152
    0.032 ± 0.1005
    -0.05 ± 0.11
    -0.023 ± 0.0509
    -0.018 ± 0.0571
        Phosphate; Week2; n=9,9,9,9,10
    -0.073 ± 0.1103
    -0.032 ± 0.2049
    -0.148 ± 0.1866
    -0.114 ± 0.2266
    0.009 ± 0.193
        Phosphate; Week3; n=1,1,1,0,0
    -0.03 ± 99999
    0.03 ± 99999
    0.1 ± 99999
    99999 ± 99999
    99999 ± 99999
        Phosphate; Week4; n=8,9,8,9,9
    -0.045 ± 0.1683
    -0.043 ± 0.114
    -0.134 ± 0.1987
    -0.197 ± 0.1091
    -0.074 ± 0.1664
        Phosphate; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.05 ± 99999
    -0.02 ± 99999
    0.22 ± 99999
        Phosphate; Week6; n=7,10,6,10,8
    0.004 ± 0.0704
    0.014 ± 0.1047
    0.095 ± 0.119
    -0.12 ± 0.1595
    -0.028 ± 0.2064
        Phosphate; Week8; n=8,7,9,9,9
    -0.032 ± 0.3227
    0.026 ± 0.136
    0.059 ± 0.1365
    -0.09 ± 0.1179
    -0.1 ± 0.2302
        Phosphate; Week10; n=7,8,4,7,8
    -0.051 ± 0.1788
    -0.054 ± 0.2326
    0.085 ± 0.2089
    -0.144 ± 0.1929
    -0.039 ± 0.1174
        Phosphate; Week12; n=7,7,7,8,7
    -0.116 ± 0.2435
    -0.131 ± 0.2291
    0.071 ± 0.1065
    -0.105 ± 0.1775
    0.026 ± 0.1439
        Phosphate; Week16; n=5,6,3,6,6
    0.008 ± 0.1232
    -0.118 ± 0.1614
    -0.01 ± 0.1473
    -0.133 ± 0.2058
    0.023 ± 0.0816
        Sodium; Week2; n=9,9,9,9,10
    -1.1 ± 1.83
    -0.9 ± 1.45
    -1.3 ± 2.74
    -1.4 ± 1.01
    0.1 ± 1.6
        Sodium; Week3; n=1,1,1,0,0
    -1 ± 99999
    -1 ± 99999
    -3 ± 99999
    99999 ± 99999
    99999 ± 99999
        Sodium; Week4; n=8,9,8,9,9
    -1.6 ± 2
    -1.6 ± 1.13
    -1 ± 2.39
    -1.2 ± 2.22
    0.7 ± 2.24
        Sodium; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -3 ± 99999
    -2 ± 99999
    -4 ± 99999
        Sodium; Week6; n=7,10,6,10,8
    -0.7 ± 1.25
    -1.4 ± 1.71
    -1.7 ± 1.63
    -0.7 ± 1.57
    0.5 ± 2.39
        Sodium; Week8; n=8,7,9,9,9
    -0.6 ± 2.26
    -0.4 ± 2.07
    -1.1 ± 2.76
    -1.6 ± 2.74
    0 ± 1.73
        Sodium; Week10; n=7,8,4,7,8
    -0.4 ± 2.44
    -0.5 ± 1.07
    -0.5 ± 3
    -0.1 ± 1.46
    0.4 ± 1.69
        Sodium; Week12; n=7,7,7,8,7
    -0.4 ± 1.13
    -0.9 ± 1.57
    -1.6 ± 2.99
    -0.6 ± 1.85
    0 ± 1.29
        Sodium; Week16; n=5,6,3,6,6
    -1 ± 2
    0.3 ± 1.86
    -1.3 ± 3.21
    -1.2 ± 1.72
    0.7 ± 1.51
        Triglycerides, Fasted; Week2; n=0,1,0,0,1
    99999 ± 99999
    2.68 ± 99999
    99999 ± 99999
    99999 ± 99999
    0.06 ± 99999
        Triglycerides, Fasted; Week3; n=1,1,0,0,0
    0.51 ± 99999
    1.01 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        Triglycerides, Fasted; Week4; n=1,1,2,0,1
    -1.25 ± 99999
    0.2 ± 99999
    0.55 ± 0.495
    99999 ± 99999
    0.46 ± 99999
        Triglycerides, Fasted; Week6; n=0,1,0,1,0
    99999 ± 99999
    0 ± 99999
    99999 ± 99999
    0.16 ± 99999
    99999 ± 99999
        Triglycerides, Fasted; Week8; n=0,0,3,01
    99999 ± 99999
    99999 ± 99999
    0.29 ± 0.27
    99999 ± 99999
    -0.45 ± 99999
        Triglycerides, Fasted; Week10; n=2,1,0,0,0
    0.44 ± 0.6788
    0.56 ± 99999
    99999 ± 99999
    99999 ± 99999
    -0.53 ± 99999
        Triglycerides, Fasted; Week12; n=5,6,4,6,5
    0.474 ± 1.4676
    -0.252 ± 0.6544
    -0.072 ± 0.4272
    -0.232 ± 0.5087
    -0.394 ± 0.4215
        Triglycerides, Not Fasted; Week2; n=9,8,9,9,9
    0.142 ± 0.6915
    -0.358 ± 0.783
    0.224 ± 0.6196
    -0.118 ± 0.397
    0.146 ± 0.3789
        Triglycerides, Not Fasted; Week3; n=0,0,1,0,0
    99999 ± 99999
    99999 ± 99999
    1.61 ± 99999
    99999 ± 99999
    99999 ± 99999
        Triglycerides, Not Fasted; Week4; n=7,8,6,9,8
    -0.116 ± 0.533
    -0.208 ± 0.7373
    0.218 ± 0.3916
    -0.388 ± 0.3914
    0.099 ± 0.3549
        Triglycerides, Not Fasted; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.36 ± 99999
    0.05 ± 99999
    -0.1 ± 99999
        Triglycerides, Not Fasted; Week6; n=7,9,6,9,8
    0.316 ± 0.9129
    -0.239 ± 0.4658
    0.145 ± 0.2891
    0.05 ± 0.7227
    0.105 ± 0.3932
        Triglycerides, Not Fasted; Week8; n=8,7,6,8,8
    -0.182 ± 0.7551
    -0.299 ± 0.737
    0.093 ± 0.2452
    -0.314 ± 0.3539
    -0.02 ± 0.2491
        Triglycerides, Not Fasted; Week10; n=5,7,4,7,7
    0.354 ± 0.441
    -0.38 ± 0.6995
    -0.03 ± 0.0622
    -0.259 ± 0.4313
    0.199 ± 0.4482
        Triglycerides, Not Fasted; Week12; n=2,1,4,2,2
    -0.065 ± 0.1344
    0.04 ± 99999
    -0.03 ± 0.1842
    -0.555 ± 0.7566
    -0.015 ± 0.3748
        Triglycerides, Not Fasted; Week16; n=5,6,3,6,6
    0.082 ± 0.7262
    -0.235 ± 0.8101
    0.257 ± 0.3683
    -0.107 ± 0.4525
    0.2 ± 0.2739
        Urea; Week2; n=9,9,9,9,10
    0.6 ± 1.017
    0.7 ± 1.595
    -0.28 ± 1.28
    -0.08 ± 0.736
    -0.1 ± 1.357
        Urea; Week3; n=1,1,1,0,0
    -0.4 ± 99999
    1.2 ± 99999
    2.4 ± 99999
    99999 ± 99999
    99999 ± 99999
        Urea; Week4; n=8,9,8,9,9
    0.56 ± 1.581
    -0.53 ± 0.957
    -0.33 ± 1.243
    0.21 ± 1.014
    0.08 ± 1.352
        Urea; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    1 ± 99999
    -1.6 ± 99999
    -0.1 ± 99999
        Urea; Week6; n=7,10,6,10,8
    0.09 ± 1.224
    -0.05 ± 1.178
    0.32 ± 0.9
    0.14 ± 1.372
    0.56 ± 0.877
        Urea; Week8; n=8,7,9,9,9
    -0.3 ± 1.331
    -1 ± 1.021
    0.09 ± 1.447
    0.37 ± 0.866
    0.16 ± 1.014
        Urea; Week10; n=7,8,4,7,8
    0 ± 1.954
    -0.93 ± 1.077
    1.03 ± 1.615
    0.39 ± 1.804
    -0.06 ± 1.158
        Urea; Week12; n=7,7,7,8,7
    -0.51 ± 1.548
    -0.47 ± 1.889
    -0.11 ± 1.199
    0.41 ± 1.988
    0.29 ± 0.501
        Urea; Week16; n=5,6,3,6,6
    -0.32 ± 1.069
    -0.68 ± 2.282
    -0.17 ± 0.666
    -0.03 ± 1.546
    -0.18 ± 1.085
        VLDL Cholesterol; Week2; n=9,8,9,9,10
    -0.014 ± 0.3899
    0.16 ± 0.4416
    0.081 ± 0.2732
    -0.008 ± 0.2493
    0.009 ± 0.0681
        VLDL Cholesterol; Week3; n=1,1,1,0,0
    0.24 ± 99999
    0.46 ± 99999
    0.75 ± 99999
    99999 ± 99999
    99999 ± 99999
        VLDL Cholesterol; Week4; n=8,8,8,9,9
    -0.18 ± 0.2344
    0.065 ± 0.2066
    0.136 ± 0.1591
    -0.13 ± 0.1935
    0.01 ± 0.1916
        VLDL Cholesterol; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.17 ± 99999
    0.02 ± 99999
    0.12 ± 99999
        VLDL Cholesterol; Week6; n=7,9,6,10,8
    0.073 ± 0.4708
    -0.004 ± 0.0879
    0.007 ± 0.1586
    0.071 ± 0.3474
    -0.011 ± 0.176
        VLDL Cholesterol; Week8; n=8,6,9,9,9
    -0.151 ± 0.4333
    0.003 ± 0.1986
    0.024 ± 0.1483
    -0.126 ± 0.1764
    -0.104 ± 0.1613
        VLDL Cholesterol; Week10; n=7,7,4,7,8
    0.11 ± 0.2424
    0.01 ± 0.1751
    -0.098 ± 0.1531
    -0.064 ± 0.2046
    -0.014 ± 0.2629
        VLDL Cholesterol; Week12; n=6,6,7,8,7
    -0.075 ± 0.0914
    0.018 ± 0.1486
    0.031 ± 0.1247
    -0.138 ± 0.251
    -0.116 ± 0.2032
        VLDL Cholesterol; Week16; n=5,5,3,6,6
    -0.05 ± 0.2547
    0.038 ± 0.1659
    0.027 ± 0.2801
    0.012 ± 0.2164
    -0.012 ± 0.1447
    Notes
    [71] - ITT Population. “Not available (NA)” data is presented as “99999”
    [72] - ITT Population. “Not available (NA)” data is presented as “99999”
    [73] - ITT Population. “Not available (NA)” data is presented as “99999”
    [74] - ITT Population. “Not available (NA)” data is presented as “99999”
    [75] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in bilirubin, creatinine, iron binding capacity, iron and uric acid at the indicated time points up to Week 16

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    End point title
    Change from Baseline in bilirubin, creatinine, iron binding capacity, iron and uric acid at the indicated time points up to Week 16 [76]
    End point description
    Change from Baseline in the bilirubin, direct and indirect bilirubin, creatinine, total iron binding capacity (TIBC), unsaturated iron binding capacity (UIBC), iron and uric acid values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [76] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [77]
    10 [78]
    10 [79]
    10 [80]
    11 [81]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Direct Bilirubin; Week2; n=9,9,9,9,10
    -0.1 ± 1.17
    0.2 ± 0.83
    -0.1 ± 0.93
    -0.1 ± 0.33
    -0.1 ± 0.74
        Direct Bilirubin; Week3; n=1,1,1,0,0
    0 ± 99999
    -1 ± 99999
    1 ± 99999
    99999 ± 99999
    99999 ± 99999
        Direct Bilirubin; Week4; n=8,9,8,9,9
    0.1 ± 0.99
    0.6 ± 0.88
    0.6 ± 1.19
    0.4 ± 0.53
    0.1 ± 0.33
        Direct Bilirubin; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    2 ± 99999
    1 ± 99999
    0 ± 99999
        Direct Bilirubin; Week6; n=7,10,6,10,8
    0.3 ± 0.95
    -0.1 ± 1.1
    0.8 ± 1.17
    0 ± 0.47
    -0.5 ± 0.93
        Direct Bilirubin; Week8; n=8,7,9,9,9
    0.3 ± 1.04
    0.6 ± 1.13
    0.2 ± 1.3
    0 ± 0.87
    0.1 ± 0.33
        Direct Bilirubin; Week10; n=7,8,4,7,8
    0.3 ± 0.76
    0.3 ± 0.71
    0.8 ± 0.96
    0.6 ± 0.53
    -0.4 ± 0.74
        Direct Bilirubin; Week12; n=7,7,7,8,7
    0.4 ± 0.79
    0.4 ± 0.79
    0.4 ± 0.98
    -0.1 ± 0.83
    0 ± 0
        Direct Bilirubin; Week16; n=5,6,3,6,6
    -0.4 ± 0.89
    0.3 ± 0.82
    1 ± 1.73
    0.2 ± 0.41
    0 ± 0.63
        Bilirubin; Week2; n=9,9,9,9,10
    0.8 ± 1.99
    0.8 ± 2.44
    -0.4 ± 1.42
    0.6 ± 1.94
    -1.1 ± 2.47
        Bilirubin; Week3; n=1,1,1,0,0
    0 ± 99999
    -2 ± 99999
    6 ± 99999
    99999 ± 99999
    99999 ± 99999
        Bilirubin; Week4; n=8,9,8,9,9
    0.5 ± 2.27
    1.9 ± 2.52
    2.9 ± 4.16
    1.6 ± 1.33
    -1.6 ± 1.33
        Bilirubin; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    4.3 ± 2.52
    0 ± 99999
    0 ± 99999
        Bilirubin; Week6; n=7,10,7,10,8
    1.9 ± 3.02
    -0.2 ± 2.15
    2.9 ± 3.29
    0.3 ± 1.57
    -1.9 ± 2.8
        Bilirubin; Week8; n=8,7,9,9,9
    1.4 ± 2.01
    -0.7 ± 3.4
    0.9 ± 4.34
    0.4 ± 1.13
    -1.8 ± 1.72
        Bilirubin; Week10; n=7,8,4,7,8
    0.4 ± 2.7
    0 ± 3.02
    1.8 ± 4.57
    1.4 ± 1.99
    -2.4 ± 1.77
        Bilirubin; Week12; n=7,7,7,8,7
    0.3 ± 2.63
    0.6 ± 3.64
    2 ± 3.92
    0.1 ± 2.47
    -2.1 ± 1.77
        Bilirubin; Week16; n=5,6,3,6,6
    -0.4 ± 2.7
    0.2 ± 2.79
    4 ± 6.93
    1 ± 2.1
    -2.3 ± 2.07
        Indirect Bilirubin; Week2; n=9,9,9,9,10
    0.9 ± 1.83
    0.6 ± 2.24
    -0.3 ± 0.87
    0.7 ± 1.66
    -1.2 ± 2.2
        Indirect Bilirubin; Week3; n=1,1,1,0,0
    0 ± 99999
    -1 ± 99999
    5 ± 99999
    99999 ± 99999
    99999 ± 99999
        Indirect Bilirubin; Week4; n=8,9,8,9,9
    0.4 ± 2.13
    1.3 ± 2.35
    2.3 ± 3.65
    1.1 ± 1.05
    -1.4 ± 1.42
        Indirect Bilirubin; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    5 ± 99999
    -1 ± 99999
    0 ± 99999
        Indirect Bilirubin; Week6; n=7,10,6,10,8
    1.6 ± 2.57
    -0.1 ± 2.18
    1.5 ± 2.59
    0.3 ± 1.34
    -1.4 ± 2.83
        Indirect Bilirubin; Week8; n=8,7,9,9,9
    1.4 ± 2.07
    -1.3 ± 3.04
    0.7 ± 3.57
    0.4 ± 0.73
    -1.9 ± 1.69
        Indirect Bilirubin; Week10; n=7,8,4,7,8
    0.1 ± 2.85
    -0.3 ± 3.11
    1 ± 3.92
    0.9 ± 1.57
    -2 ± 1.77
        Indirect Bilirubin; Week12; n=7,7,7,8,7
    -0.1 ± 2.48
    0.1 ± 3.34
    1.6 ± 3.41
    0.3 ± 1.83
    -2.1 ± 1.77
        Indirect Bilirubin; Week16; n=5,6,3,6,6
    0 ± 2.92
    -0.2 ± 2.93
    3 ± 5.2
    0.8 ± 1.72
    -2.3 ± 1.86
        Creatinine; Week2; n=9,9,9,9,10
    2.31 ± 9.124
    1.79 ± 3.958
    3.34 ± 5.611
    6.09 ± 6.748
    -0.53 ± 4.592
        Creatinine; Week3; n=1,1,1,0,0
    8.5 ± 99999
    -3.4 ± 99999
    3.5 ± 99999
    99999 ± 99999
    99999 ± 99999
        Creatinine; Week4; n=8,9,8,9,9
    2.4 ± 5.475
    1.34 ± 6.522
    1.71 ± 5.713
    5.72 ± 5.253
    -2.76 ± 3.749
        Creatinine; Week5; n=0,0,3,1,1
    99999 ± 99999
    99999 ± 99999
    9.8 ± 99999
    2.8 ± 99999
    3.1 ± 99999
        Creatinine; Week6; n=6,9,7,9,8
    0.67 ± 5.167
    1.22 ± 3.868
    2.17 ± 3.472
    5.87 ± 7.206
    -2.66 ± 2.67
        Creatinine; Week8; n=9,7,9,9,9
    4.66 ± 4.364
    6.19 ± 6.258
    3.49 ± 7.516
    8.14 ± 6.011
    -2.99 ± 4.281
        Creatinine; Week10; n=7,8,4,7,8
    2.3 ± 4.974
    3.03 ± 6.911
    5.3 ± 3.997
    10.19 ± 5.328
    -0.8 ± 4.798
        Creatinine; Week12; n=7,7,7,8,7
    -0.29 ± 3.402
    1.49 ± 6.839
    2.26 ± 7.047
    5.97 ± 6.331
    -3.3 ± 2.796
        Creatinine; Week16; n=5,6,3,6,6
    -0.26 ± 3.259
    0.5 ± 4.944
    1.33 ± 3.781
    -0.03 ± 5.32
    -4.62 ± 3.779
        TIBC; Week2; n=9,9,9,9,10
    -1.6 ± 4.33
    1.2 ± 2.99
    1 ± 4.5
    3.8 ± 4.74
    -1.8 ± 6
        TIBC; Week3; n=1,1,1,0,0
    5 ± 99999
    -8 ± 99999
    0 ± 99999
    99999 ± 99999
    99999 ± 99999
        TIBC; Week4; n=8,9,8,9,9
    1.1 ± 5.46
    2.7 ± 4.66
    4 ± 6.5
    3.4 ± 4.67
    -1 ± 4.66
        TIBC; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -4 ± 99999
    3 ± 99999
    3 ± 99999
        TIBC; Week6; n=7,10,6,10,8
    0.3 ± 2.21
    0.5 ± 5.66
    4 ± 2.76
    3.9 ± 8.2
    1 ± 4.81
        TIBC; Week8; n=8,7,9,9,8
    1.3 ± 6.8
    -0.7 ± 5.06
    2.9 ± 5.09
    4.2 ± 9.82
    -1.9 ± 8.89
        TIBC; Week10; n=7,8,4,7,8
    0.1 ± 4.06
    2 ± 4.14
    0.8 ± 5.68
    7 ± 8.94
    -2 ± 6.19
        TIBC; Week12; n=7,7,7,8,7
    1.1 ± 5.27
    3.4 ± 3.99
    2.3 ± 6.6
    7.1 ± 9.78
    -2.3 ± 3.9
        TIBC; Week16; n=5,6,3,6,6
    -1.2 ± 2.86
    3.7 ± 4.32
    0.3 ± 5.86
    3.7 ± 6.31
    -4.2 ± 6.97
        UIBC; Week2; n=9,9,9,9,10
    -3.2 ± 9.24
    -2.4 ± 11.39
    0.4 ± 9.46
    3 ± 9.8
    -1.2 ± 9.13
        UIBC; Week3; n=1,1,1,0,0
    5 ± 99999
    -13 ± 99999
    -31 ± 99999
    99999 ± 99999
    99999 ± 99999
        UIBC; Week4; n=8,9,8,9,9
    3.8 ± 7.25
    -1.6 ± 10.09
    0.5 ± 10.98
    1.3 ± 6.4
    0.4 ± 7.23
        UIBC; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -4 ± 99999
    12 ± 99999
    12 ± 99999
        UIBC; Week6; n=7,10,6,10,8
    -3.1 ± 8.07
    -0.8 ± 5.31
    6 ± 8.15
    4.5 ± 11.31
    5.6 ± 8.05
        UIBC; Week8; n=8,7,9,9,9
    3.3 ± 8.21
    1.3 ± 8.85
    4.3 ± 5.96
    5.4 ± 9.96
    -0.4 ± 11.08
        UIBC; Week10; n=7,8,4,7,8
    0.7 ± 8.01
    4.8 ± 7.92
    -1.3 ± 9.74
    3.6 ± 10.18
    0.5 ± 9.1
        UIBC; Week12; n=7,7,7,8,7
    1 ± 6
    4.7 ± 6.78
    1.4 ± 10.81
    5.8 ± 7.65
    2.1 ± 5.01
        UIBC; Week16; n=5,6,3,6,6
    2 ± 6
    3.8 ± 7.19
    0 ± 7.55
    3.8 ± 10.03
    -2.2 ± 5.78
        Iron; Week2; n=9,9,9,9,10
    1.7 ± 6.32
    3.7 ± 11.43
    0.6 ± 9.03
    0.8 ± 9.02
    -0.6 ± 7.09
        Iron; Week3; n=1,1,1,0,0
    0 ± 99999
    5 ± 99999
    31 ± 99999
    99999 ± 99999
    99999 ± 99999
        Iron; Week4; n=8,9,8,9,9
    -2.6 ± 3.38
    4.2 ± 11.04
    3.5 ± 7.98
    2.1 ± 7.29
    -1.4 ± 4.13
        Iron; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0 ± 99999
    -9 ± 99999
    -9 ± 99999
        Iron; Week6; n=7,10,6,10,8
    3.4 ± 9.47
    1.3 ± 2.16
    -2 ± 6.45
    -0.6 ± 6.02
    -4.6 ± 6.8
        Iron; Week8; n=8,7,9,9,9
    -2 ± 7.45
    -2 ± 6.06
    -1.4 ± 4.8
    -1.2 ± 6.14
    -1.6 ± 3.91
        Iron; Week10; n=7,8,4,7,8
    -0.6 ± 4.96
    -2.8 ± 4.8
    2 ± 9.2
    3.4 ± 4.89
    -2.5 ± 5.13
        Iron; Week12; n=7,7,7,8,7
    0.1 ± 6.41
    -1.3 ± 6.18
    0.9 ± 9.99
    1.4 ± 11.15
    -4.4 ± 3.36
        Iron; Week16; n=5,6,3,6,6
    -3.2 ± 6.06
    -0.2 ± 5.34
    0.3 ± 4.16
    -0.2 ± 4.36
    -2 ± 2.9
        Uric acid; Week2; n=9,9,9,9,10
    -5.7 ± 34.67
    5.8 ± 50.46
    -14.4 ± 24.81
    -13.4 ± 14.48
    2.2 ± 35.59
        Uric acid; Week3; n=1,1,1,0,0
    -8 ± 99999
    37 ± 99999
    -73 ± 99999
    99999 ± 99999
    99999 ± 99999
        Uric acid; Week4; n=8,9,8,9,9
    -4.6 ± 49.4
    0.4 ± 57.21
    -16.8 ± 26.38
    -15.9 ± 32.94
    -7.2 ± 31.58
        Uric acid; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -14 ± 99999
    -45 ± 99999
    9 ± 99999
        Uric acid; Week6; n=7,10,6,10,8
    -11.3 ± 29.83
    1.7 ± 54.57
    -14.5 ± 16.84
    -15.8 ± 25.33
    -2.1 ± 30.02
        Uric acid; Week8; n=8,7,9,9,9
    2.4 ± 30.83
    -2 ± 62.41
    -16.2 ± 40.28
    -6.1 ± 46.93
    0.7 ± 35.19
        Uric acid; Week10; n=7,8,4,7,8
    -4.7 ± 35.92
    -5.1 ± 53.14
    -8.8 ± 33.18
    -14.9 ± 41.09
    -1.9 ± 29.46
        Uric acid; Week12; n=7,7,7,8,7
    -14.9 ± 19.07
    2.3 ± 75.78
    -23.3 ± 28.6
    -12.3 ± 36.1
    -7.1 ± 18.25
        Uric acid; Week16; n=5,6,3,6,6
    -13 ± 31.1
    -9.5 ± 60.18
    -13 ± 19.47
    -23.7 ± 28.89
    -4.7 ± 25.45
    Notes
    [77] - ITT Population. “Not available (NA)” data is presented as “99999”
    [78] - ITT Population. “Not available (NA)” data is presented as “99999”
    [79] - ITT Population. “Not available (NA)” data is presented as “99999”
    [80] - ITT Population. “Not available (NA)” data is presented as “99999”
    [81] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in albumin/globulin, BUN/creatinine and transferrin saturation at the indicated time points up to Week 16

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    End point title
    Change from Baseline in albumin/globulin, BUN/creatinine and transferrin saturation at the indicated time points up to Week 16 [82]
    End point description
    Change from baseline in the albumin/globulin, blood urea nitrogen (BUN)/creatinine and transferrin saturation values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [82] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [83]
    10 [84]
    10 [85]
    10 [86]
    11 [87]
    Units: Ratio
    arithmetic mean (standard deviation)
        Albumin/Globulin; Week2; n=9,9,9,9,10
    0.07 ± 0.173
    0.03 ± 0.122
    -0.04 ± 0.133
    0.09 ± 0.117
    -0.12 ± 0.132
        Albumin/Globulin; Week3; n=1,1,1,0,0
    -0.1 ± 99999
    -0.1 ± 99999
    0.4 ± 99999
    99999 ± 99999
    99999 ± 99999
        Albumin/Globulin; Week4; n=8,9,8,9,9
    0.13 ± 0.149
    0.07 ± 0.166
    0.05 ± 0.207
    0.17 ± 0.087
    -0.06 ± 0.194
        Albumin/Globulin; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.5 ± 99999
    0 ± 99999
    -0.1 ± 99999
        Albumin/Globulin; Week6; n=7,10,6,10,8
    0.01 ± 0.107
    0.03 ± 0.142
    0.15 ± 0.266
    0.21 ± 0.129
    -0.11 ± 0.196
        Albumin/Globulin; Week8; n=8,7,9,9,9
    0.09 ± 0.189
    0.11 ± 0.146
    0.12 ± 0.164
    0.18 ± 0.139
    -0.02 ± 0.139
        Albumin/Globulin; Week10; n=7,8,4,7,8
    0.11 ± 0.168
    0.05 ± 0.193
    0.03 ± 0.096
    0.21 ± 0.107
    -0.1 ± 0.131
        Albumin/Globulin; Week12; n=7,7,7,8,7
    0.03 ± 0.125
    0.09 ± 0.297
    0.03 ± 0.309
    0.1 ± 0.227
    -0.04 ± 0.151
        Albumin/Globulin; Week16; n=5,6,3,6,6
    -0.04 ± 0.055
    -0.05 ± 0.176
    -0.07 ± 0.153
    0.07 ± 0.25
    -0.13 ± 0.186
        BUN/Creatinine; Week2; n=9,9,9,9,10
    8.8 ± 18.91
    8.9 ± 27.81
    -9.1 ± 22.05
    -7.4 ± 15.45
    0.3 ± 21.19
        BUN/Creatinine; Week3; n=1,1,1,0,0
    -15 ± 99999
    21 ± 99999
    40 ± 99999
    99999 ± 99999
    99999 ± 99999
        BUN/Creatinine; Week4; n=8,9,8,9,9
    4 ± 19.27
    -10.2 ± 22.94
    -7.3 ± 20.95
    -3.7 ± 15.7
    7.8 ± 23.2
        BUN/Creatinine; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    1 ± 99999
    -36 ± 99999
    -4 ± 99999
        BUN/Creatinine; Week6; n=6,9,6,9,8
    -0.7 ± 16.49
    -1 ± 17.48
    2 ± 15.05
    -5.8 ± 20.52
    15.4 ± 14.92
        BUN/Creatinine; Week8; n=8,7,9,9,9
    -11.8 ± 21.42
    -23.9 ± 21.14
    -4 ± 16.48
    -5.2 ± 12.78
    8.7 ± 19.92
        BUN/Creatinine; Week10; n=7,8,4,7,8
    -2.6 ± 29.07
    -17.8 ± 22.25
    9.8 ± 22.9
    -7.4 ± 34.32
    3 ± 20.73
        BUN/Creatinine; Week12; n=7,7,7,8,7
    -8.7 ± 23.14
    -9.3 ± 35.49
    -4.3 ± 16.2
    -1 ± 28.24
    10.9 ± 7.6
        BUN/Creatinine; Week16; n=5,6,3,6,6
    -5.2 ± 15.99
    -11.8 ± 43.73
    -5.7 ± 6.66
    0.2 ± 33.39
    6.8 ± 25.88
        Transferrin saturation; Week2; n=9,9,9,9,10
    0.036 ± 0.1093
    0.05 ± 0.1577
    0.002 ± 0.1242
    0.004 ± 0.1599
    0 ± 0.1036
        Transferrin saturation; Week3; n=1,1,1,0,0
    0 ± 99999
    0.13 ± 99999
    0.46 ± 99999
    99999 ± 99999
    99999 ± 99999
        Transferrin saturation; Week4; n=8,9,8,9,9
    -0.05 ± 0.0763
    0.04 ± 0.1459
    0.043 ± 0.1172
    0.018 ± 0.111
    -0.024 ± 0.0641
        Transferrin saturation; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    0.01 ± 99999
    -0.17 ± 99999
    -0.2 ± 99999
        Transferrin saturation; Week6; n=7,10,6,10,8
    0.049 ± 0.1297
    0.016 ± 0.0317
    -0.033 ± 0.0905
    -0.011 ± 0.1343
    -0.08 ± 0.1251
        Transferrin saturation; Week8; n=8,7,9,9,8
    -0.039 ± 0.1246
    -0.029 ± 0.0888
    -0.03 ± 0.0758
    -0.031 ± 0.1046
    -0.026 ± 0.0847
        Transferrin saturation; Week10; n=7,8,4,7,8
    -0.01 ± 0.0906
    -0.048 ± 0.0742
    0.045 ± 0.1392
    0.031 ± 0.084
    -0.036 ± 0.0868
        Transferrin saturation; Week12; n=7,7,7,8,7
    -0.007 ± 0.1013
    -0.024 ± 0.0856
    0.01 ± 0.1502
    -0.013 ± 0.1659
    -0.071 ± 0.0549
        Transferrin saturation; Week16; n=5,6,3,6,6
    -0.054 ± 0.1095
    -0.01 ± 0.078
    0.017 ± 0.0723
    -0.015 ± 0.0922
    -0.028 ± 0.044
    Notes
    [83] - ITT Population. “Not available (NA)” data is presented as “99999”
    [84] - ITT Population. “Not available (NA)” data is presented as “99999”
    [85] - ITT Population. “Not available (NA)” data is presented as “99999”
    [86] - ITT Population. “Not available (NA)” data is presented as “99999”
    [87] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in creatinine clearance at the indicated time points up to Week 16

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    End point title
    Change from Baseline in creatinine clearance at the indicated time points up to Week 16 [88]
    End point description
    Change from Baseline in the Creatinine Clearance values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [88] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [89]
    10 [90]
    10 [91]
    10 [92]
    11 [93]
    Units: Milliliter per minute (mL/min)
    arithmetic mean (standard deviation)
        Creatinine clearance; Week2; n=9,9,9,9,10
    -1.8 ± 27.86
    -5.6 ± 9.34
    -5.9 ± 11.89
    -13.2 ± 16.84
    1.7 ± 8.03
        Creatinine clearance; Week3; n=1,1,0,0,0
    -13 ± 99999
    4 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        Creatinine clearance; Week4; n=8,9,8,9,9
    -7.1 ± 16.25
    -3.2 ± 11.2
    -6.8 ± 13.66
    -13.2 ± 13.55
    7.7 ± 10.78
        Creatinine clearance; Week5; n=0,0,1,1,1
    99999 ± 99999
    99999 ± 99999
    -36 ± 99999
    -13 ± 99999
    -5 ± 99999
        Creatinine clearance; Week6; n=0,3,1,2,0
    99999 ± 99999
    3.7 ± 1.53
    5 ± 99999
    -9.5 ± 99999
    99999 ± 99999
        Creatinine clearance; Week8; n=8,7,8,9,9
    -10.6 ± 11.19
    -12.1 ± 14.58
    -10.9 ± 17.21
    -18.3 ± 18.83
    10.1 ± 13.91
        Creatinine clearance; Week10; n=2,2,1,1,2
    -10 ± 14.14
    7.5 ± 4.95
    -6 ± 99999
    -29 ± 99999
    -10.5 ± 10.61
        Creatinine clearance; Week12; n=7,7,7,8,7
    -2.1 ± 17.03
    -3 ± 14.41
    -3 ± 23.79
    -14.6 ± 18.07
    9.6 ± 10.28
        Creatinine clearance; Week16; n=5,6,3,6,6
    -3.6 ± 17.81
    -1 ± 10.53
    -1 ± 3.46
    -1.7 ± 10.61
    14.8 ± 14.8
    Notes
    [89] - ITT Population. “Not available (NA)” data is presented as “99999”
    [90] - ITT Population. “Not available (NA)” data is presented as “99999”
    [91] - ITT Population. “Not available (NA)” data is presented as “99999”
    [92] - ITT Population. “Not available (NA)” data is presented as “99999”
    [93] - ITT Population. “Not available (NA)” data is presented as “99999”
    No statistical analyses for this end point

    Primary: Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils SG, platelets and leukocytes at the indicated time points up to Week 16

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    End point title
    Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils SG, platelets and leukocytes at the indicated time points up to Week 16 [94]
    End point description
    Change from Baseline in the basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented (SG), platelets and leukocytes values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [94] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [95]
    10 [96]
    10 [97]
    10 [98]
    11 [99]
    Units: Billions per liter
    arithmetic mean (standard deviation)
        Basophils, Week1, n=9,10,9,10,11
    -0.002 ± 0.0335
    0.002 ± 0.0114
    -0.004 ± 0.0219
    0.004 ± 0.0178
    -0.003 ± 0.0195
        Basophils, Week2, n=9,9,10,9,9
    0.001 ± 0.0271
    -0.004 ± 0.0133
    -0.008 ± 0.014
    0.004 ± 0.0088
    -0.003 ± 0.0122
        Basophils, Week3, n=9,7,9,6,7
    -0.002 ± 0.0468
    0 ± 0.0141
    0.004 ± 0.03
    0.01 ± 0.0261
    0.001 ± 0.0135
        Basophils, Week4, n=6,9,9,9,9
    0 ± 0.0469
    0.002 ± 0.013
    -0.001 ± 0.0176
    0.002 ± 0.0164
    -0.007 ± 0.01
        Basophils, Week5, n=7,6,6,9,7
    -0.011 ± 0.0449
    0.012 ± 0.0147
    0.002 ± 0.0354
    0 ± 0.015
    -0.004 ± 0.019
        Basophils, Week6, n=7,10,6,10,7
    -0.023 ± 0.0399
    0.003 ± 0.0106
    -0.013 ± 0.0137
    0 ± 0.0082
    -0.006 ± 0.0127
        Basophils, Week8, n=8,7,9,9,9
    -0.011 ± 0.0458
    0.001 ± 0.0146
    0.019 ± 0.047
    0.003 ± 0.015
    -0.002 ± 0.0164
        Basophils, Week10, n=7,8,4,7,8
    -0.011 ± 0.0324
    0 ± 0.0076
    -0.018 ± 0.0096
    0.001 ± 0.0069
    0.001 ± 0.0083
        Basophils, Week12, n=7,7,7,8,7
    -0.014 ± 0.0264
    0.006 ± 0.0215
    -0.01 ± 0.0058
    -0.005 ± 0.0093
    -0.001 ± 0.0285
        Basophils, Week16, n=5,6,3,6,6
    -0.006 ± 0.0207
    -0.003 ± 0.0121
    -0.007 ± 0.0115
    0.008 ± 0.0214
    -0.005 ± 0.0105
        Eosinophils, Week1, n=9,10,9,10,11
    0.006 ± 0.0515
    -0.027 ± 0.0707
    -0.051 ± 0.1523
    0.035 ± 0.0665
    -0.003 ± 0.0631
        Eosinophils, Week2, n=9,9,10,9,9
    0.137 ± 0.2082
    -0.023 ± 0.1009
    0.003 ± 0.2005
    0.03 ± 0.0705
    -0.003 ± 0.0332
        Eosinophils, Week3, n=9,7,9,6,7
    0.072 ± 0.1225
    -0.02 ± 0.1071
    -0.05 ± 0.1396
    0.023 ± 0.0288
    0.064 ± 0.0981
        Eosinophils, Week4, n=6,9,9,9,9
    -0.002 ± 0.0523
    -0.044 ± 0.0879
    -0.027 ± 0.1622
    -0.027 ± 0.0534
    -0.009 ± 0.0267
        Eosinophils, Week5, n=7,6,6,9,7
    0.019 ± 0.0752
    -0.035 ± 0.1009
    0.008 ± 0.0449
    -0.017 ± 0.0585
    -0.014 ± 0.0162
        Eosinophils, Week6, n=7,10,6,10,7
    -0.017 ± 0.0499
    -0.05 ± 0.101
    -0.023 ± 0.0186
    -0.028 ± 0.0711
    -0.011 ± 0.0212
        Eosinophils, Week8, n=8,7,9,9,9
    0.016 ± 0.0437
    -0.04 ± 0.0935
    -0.029 ± 0.1039
    -0.017 ± 0.043
    0 ± 0.0265
        Eosinophils, Week10, n=7,8,4,7,8
    0.039 ± 0.0917
    0.001 ± 0.126
    -0.033 ± 0.0299
    -0.019 ± 0.1125
    0.008 ± 0.0459
        Eosinophils, Week12, n=7,7,7,8,7
    0.021 ± 0.0767
    -0.009 ± 0.126
    -0.014 ± 0.0351
    -0.008 ± 0.0504
    0.047 ± 0.0682
        Eosinophils, Week16, n=5,6,3,6,6
    0.002 ± 0.0295
    -0.048 ± 0.1034
    0.053 ± 0.1274
    -0.052 ± 0.0773
    0.032 ± 0.0504
        Lymphocytes, Week1, n=9,10,9,10,11
    0.763 ± 1.5656
    0.115 ± 0.701
    -0.127 ± 0.4761
    0.148 ± 0.5696
    -0.1 ± 0.41
        Lymphocytes, Week2, n=9,9,10,9,9
    0.407 ± 1.0582
    0.043 ± 0.2932
    -0.36 ± 0.3286
    -0.258 ± 0.7151
    -0.086 ± 0.3673
        Lymphocytes, Week3, n=9,7,9,6,7
    0.754 ± 1.2905
    0.151 ± 0.2727
    0.139 ± 0.6525
    0.173 ± 0.5052
    0.193 ± 0.6479
        Lymphocytes, Week4, n=6,9,9,9,9
    0.813 ± 1.4774
    0.033 ± 0.292
    0.308 ± 0.8582
    -0.151 ± 0.4103
    -0.02 ± 0.5295
        Lymphocytes, Week5, n=7,6,6,9,7
    0.286 ± 0.5651
    0.142 ± 0.1136
    0.332 ± 1.2818
    -0.017 ± 0.5348
    0.054 ± 0.5757
        Lymphocytes, Week6, n=7,10,6,10,7
    0.246 ± 0.4796
    -0.136 ± 0.2762
    0.297 ± 0.832
    -0.059 ± 0.5509
    -0.183 ± 0.4596
        Lymphocytes, Week8, n=8,7,9,9,9
    0.519 ± 1.2726
    0.131 ± 0.93
    0.227 ± 0.8526
    0 ± 0.6471
    -0.084 ± 0.3248
        Lymphocytes, Week10, n=7,8,4,7,8
    0.127 ± 0.3555
    0.128 ± 0.4077
    -0.19 ± 0.1206
    -0.161 ± 0.4008
    -0.011 ± 0.5503
        Lymphocytes, Week12, n=7,7,7,8,7
    -0.06 ± 0.3709
    -0.05 ± 0.0887
    0.221 ± 0.5321
    -0.328 ± 0.4631
    0.081 ± 0.6077
        Lymphocytes, Week16, n=5,6,3,6,6
    0.064 ± 0.4868
    0.163 ± 0.5223
    0.117 ± 0.0833
    0.01 ± 0.6658
    0.075 ± 0.4366
        Monocytes, Week1, n=9,10,9,10,11
    -0.066 ± 0.349
    -0.006 ± 0.1543
    0.056 ± 0.2089
    0.02 ± 0.1585
    -0.055 ± 0.1408
        Monocytes, Week2, n=9,9,10,9,9
    -0.149 ± 0.4253
    0.042 ± 0.1965
    -0.034 ± 0.1685
    -0.116 ± 0.1068
    -0.009 ± 0.1291
        Monocytes, Week3, n=9,7,9,6,7
    -0.153 ± 0.3728
    0.024 ± 0.139
    0.163 ± 0.2259
    -0.02 ± 0.1682
    -0.017 ± 0.0673
        Monocytes, Week4, n=6,9,9,9,9
    -0.165 ± 0.4373
    0.038 ± 0.1776
    0.167 ± 0.5101
    -0.043 ± 0.2149
    -0.038 ± 0.1102
        Monocytes, Week5, n=7,6,6,9,7
    0.006 ± 0.1131
    0.058 ± 0.1425
    0.062 ± 0.1843
    -0.02 ± 0.1912
    -0.001 ± 0.1272
        Monocytes, Week6, n=7,10,6,10,7
    -0.074 ± 0.1254
    -0.057 ± 0.1542
    0.038 ± 0.1209
    -0.117 ± 0.1517
    -0.076 ± 0.0783
        Monocytes, Week8, n=8,7,9,9,9
    -0.129 ± 0.3993
    0.041 ± 0.1325
    0.008 ± 0.1173
    -0.047 ± 0.0843
    -0.013 ± 0.091
        Monocytes, Week10, n=7,8,4,7,8
    0.01 ± 0.0995
    -0.006 ± 0.1413
    -0.015 ± 0.1234
    -0.08 ± 0.1743
    -0.054 ± 0.0803
        Monocytes, Week12, n=7,7,7,8,7
    -0.004 ± 0.119
    0.006 ± 0.1001
    0.094 ± 0.2385
    -0.049 ± 0.1195
    -0.036 ± 0.0675
        Monocytes, Week16, n=5,6,3,6,6
    -0.004 ± 0.0378
    -0.047 ± 0.1565
    -0.01 ± 0.0964
    -0.14 ± 0.1296
    0.043 ± 0.1293
        Neutrophils, Week1, n=9,10,9,10,11
    -0.192 ± 1.4294
    1.638 ± 3.9206
    1.422 ± 0.8979
    0.092 ± 2.6648
    0.439 ± 1.5593
        Neutrophils, Week2, n=9,9,10,9,9
    -1.231 ± 1.6188
    0.247 ± 1.7058
    0.14 ± 0.8193
    -1.291 ± 2.8048
    -0.023 ± 0.512
        Neutrophils, Week3, n=9,7,9,6,7
    0.069 ± 1.3707
    0.327 ± 2.4038
    0.912 ± 1.4991
    -2.055 ± 2.4167
    0.206 ± 1.6235
        Neutrophils, Week4, n=6,9,9,9,9
    -0.033 ± 1.6415
    0.052 ± 1.8589
    0.606 ± 0.6448
    -1.423 ± 2.1838
    -0.241 ± 0.8247
        Neutrophils, Week5, n=7,6,6,9,7
    -0.153 ± 1.3439
    0.09 ± 2.0247
    1.387 ± 2.6017
    -1.407 ± 3.1341
    0.893 ± 0.7082
        Neutrophils, Week6, n=7,9,6,10,7
    -0.054 ± 1.6672
    -0.031 ± 2.3978
    0.927 ± 2.0966
    -0.445 ± 2.4812
    0.151 ± 1.2003
        Neutrophils, Week8, n=8,7,9,9,9
    -0.629 ± 1.6773
    -0.216 ± 2.159
    0.46 ± 1.1872
    -1.619 ± 3.3418
    -0.177 ± 0.7237
        Neutrophils, Week10, n=7,8,4,7,8
    -1.124 ± 1.257
    0.189 ± 1.5403
    0.798 ± 0.9581
    -1.474 ± 4.2315
    -0.356 ± 1.144
        Neutrophils, Week12, n=7,7,7,8,7
    -0.087 ± 1.3356
    0.196 ± 0.8878
    0.164 ± 1.1213
    -1.576 ± 3.7465
    -0.563 ± 0.4907
        Neutrophils, Week16, n=5,6,3,6,6
    -1.25 ± 1.8168
    -0.693 ± 1.52
    0.233 ± 0.9611
    -0.938 ± 2.3948
    0.332 ± 0.4296
        Neutrophils SG, Week1, n=9,10,9,10,11
    -0.192 ± 1.4294
    1.638 ± 3.9206
    1.422 ± 0.8979
    0.092 ± 2.6648
    0.439 ± 1.5593
        Neutrophils SG, Week2, n=9,9,10,9,9
    -1.231 ± 1.6188
    0.247 ± 1.7058
    0.14 ± 0.8193
    -1.291 ± 2.8048
    -0.023 ± 0.512
        Neutrophils SG, Week3, n=9,7,9,6,7
    0.069 ± 1.3707
    0.327 ± 2.4038
    0.912 ± 1.4991
    -2.055 ± 2.4167
    0.206 ± 1.6235
        Neutrophils SG, Week4, n=6,9,9,9,9
    -0.033 ± 1.6415
    0.052 ± 1.8589
    0.606 ± 0.6448
    -1.423 ± 2.1838
    -0.241 ± 0.8247
        Neutrophils SG, Week5, n=7,6,6,9,7
    -0.153 ± 1.3439
    0.09 ± 2.0247
    1.387 ± 2.6017
    -1.407 ± 3.1341
    0.893 ± 0.7082
        Neutrophils SG, Week6, n=7,10,6,10,7
    -0.054 ± 1.6672
    0.119 ± 2.31
    0.927 ± 2.0966
    -0.445 ± 2.4812
    0.151 ± 1.2003
        Neutrophils SG, Week8, n=8,7,9,9,9
    -0.629 ± 1.6773
    -0.216 ± 2.159
    0.46 ± 1.1872
    -1.619 ± 3.3418
    -0.177 ± 0.7237
        Neutrophils SG, Week10, n=7,8,4,7,8
    -1.124 ± 1.257
    0.189 ± 1.5403
    0.798 ± 0.9581
    -1.474 ± 4.2315
    -0.356 ± 1.144
        Neutrophils SG, Week12, n=7,7,7,8,7
    -0.087 ± 1.3356
    0.196 ± 0.8878
    0.164 ± 1.1213
    -1.576 ± 3.7465
    -0.563 ± 0.4907
        Neutrophils SG, Week16, n=5,6,3,6,6
    -1.25 ± 1.8168
    -0.693 ± 1.52
    0.233 ± 0.9611
    -0.938 ± 2.3948
    0.332 ± 0.4296
        Platelets, Week1, n=9,10,9,10,11
    -2.3 ± 24.32
    -4.7 ± 30.15
    13.8 ± 41.28
    23.8 ± 26.09
    10.6 ± 21.81
        Platelets, Week2, n=9,9,10,9,9
    -31.3 ± 48.71
    -48.4 ± 50.31
    -45.2 ± 44.47
    -32.2 ± 33.25
    2.6 ± 17.08
        Platelets, Week3, n=9,7,9,6,7
    2.4 ± 25.74
    -36.7 ± 39.77
    0 ± 29.29
    -39.2 ± 58.51
    16.9 ± 29.04
        Platelets, Week4, n=6,9,9,9,9
    -10.8 ± 22.74
    -32.2 ± 45.34
    -0.1 ± 47.01
    -19.1 ± 17.52
    18.9 ± 30.53
        Platelets, Week5, n=7,6,7,9,7
    3.1 ± 30.99
    -35.7 ± 57.01
    12.1 ± 66.55
    -15.6 ± 38.46
    41.4 ± 35.64
        Platelets, Week6, n=7,10,5,10,8
    7.7 ± 38.77
    -18.9 ± 36.06
    -9.6 ± 20.48
    1.8 ± 43.42
    29 ± 36.18
        Platelets, Week8, n=8,7,9,9,9
    -11.3 ± 51.49
    -33 ± 29.68
    -6.9 ± 34.56
    -1.9 ± 65.75
    15.8 ± 28.31
        Platelets, Week10, n=7,8,4,7,8
    2.4 ± 25.1
    -19.5 ± 30.8
    -16.5 ± 23.95
    -12.4 ± 67.01
    24.4 ± 42.88
        Platelets, Week12, n=7,7,7,8,7
    13.6 ± 26.69
    -29.7 ± 57.09
    -3 ± 19.08
    -14.4 ± 43.84
    25.1 ± 34.12
        Platelets, Week16, n=5,6,3,6,6
    7.8 ± 31.88
    -35.2 ± 40.04
    9 ± 16.52
    10.8 ± 54.17
    16.5 ± 23.71
        Leukocytes, Week1, n=9,10,9,10,11
    0.53 ± 2.076
    1.73 ± 3.604
    1.3 ± 0.763
    0.3 ± 2.489
    0.29 ± 1.575
        Leukocytes, Week2, n=9,9,10,9,9
    -0.81 ± 1.548
    0.3 ± 1.938
    -0.27 ± 1.033
    -1.62 ± 2.984
    -0.12 ± 0.634
        Leukocytes, Week3, n=9,7,9,6,7
    0.77 ± 1.942
    0.47 ± 2.404
    1.16 ± 1.998
    -1.88 ± 2.283
    0.44 ± 1.212
        Leukocytes, Week4, n=6,9,9,9,9
    0.62 ± 1.321
    0.06 ± 1.902
    1.03 ± 1.464
    -1.62 ± 2.411
    -0.31 ± 1.029
        Leukocytes, Week5, n=7,6,6,9,7
    0.17 ± 0.75
    0.27 ± 2.201
    1.78 ± 3.843
    -1.46 ± 2.985
    0.93 ± 0.986
        Leukocytes, Week6, n=7,10,6,10,7
    0.1 ± 1.398
    -0.15 ± 2.314
    1.25 ± 1.712
    -0.65 ± 2.911
    -0.11 ± 1.295
        Leukocytes, Week8, n=8,7,9,9,9
    -0.2 ± 1.098
    -0.09 ± 2.126
    0.7 ± 1.795
    -1.68 ± 3.515
    -0.28 ± 1.003
        Leukocytes, Week10, n=7,8,4,7,8
    -0.94 ± 0.964
    0.31 ± 1.49
    0.53 ± 1.097
    -1.73 ± 4.375
    -0.41 ± 1.331
        Leukocytes, Week12, n=7,7,7,8,7
    -0.14 ± 1.33
    0.16 ± 0.913
    0.44 ± 1.533
    -1.95 ± 3.777
    -0.47 ± 0.73
        Leukocytes, Week16, n=5,6,3,6,6
    -1.2 ± 1.678
    -0.65 ± 1.15
    0.4 ± 1.153
    -1.1 ± 2.45
    0.5 ± 0.839
    Notes
    [95] - ITT Population
    [96] - ITT Population
    [97] - ITT Population
    [98] - ITT Population
    [99] - ITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, neutrophils SG/leukocytes and EDW at the indicated time points up to Week 16

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    End point title
    Change from Baseline in basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, neutrophils SG/leukocytes and EDW at the indicated time points up to Week 16 [100]
    End point description
    Change from Baseline in the basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, neutrophils segmented (SG)/leukocytes and erythrocyte distribution width (EDW) values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (n=X,X,X,X,X). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [100] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [101]
    10 [102]
    10 [103]
    10 [104]
    11 [105]
    Units: Percentage
    arithmetic mean (standard deviation)
        Basophils/Leukocytes, Week1, n=9,10,9,10,11
    -0.02 ± 0.367
    -0.03 ± 0.149
    -0.08 ± 0.441
    -0.01 ± 0.242
    -0.09 ± 0.266
        Basophils/Leukocytes, Week2, n=9,9,10,9,9
    0.12 ± 0.373
    -0.09 ± 0.145
    -0.14 ± 0.272
    0.07 ± 0.173
    -0.12 ± 0.244
        Basophils/Leukocytes, Week3, n=9,7,9,6,7
    -0.04 ± 0.416
    -0.04 ± 0.251
    0.18 ± 0.595
    0.18 ± 0.431
    0.01 ± 0.277
        Basophils/Leukocytes, Week4, n=6,9,9,9,9
    0.02 ± 0.462
    -0.02 ± 0.244
    -0.07 ± 0.357
    0.03 ± 0.26
    -0.12 ± 0.179
        Basophils/Leukocytes, Week5, n=7,6,6,9,7
    -0.11 ± 0.449
    0.18 ± 0.248
    -0.13 ± 0.344
    -0.03 ± 0.229
    -0.14 ± 0.288
        Basophils/Leukocytes, Week6, n=7,10,6,10,7
    -0.24 ± 0.387
    0.05 ± 0.196
    -0.28 ± 0.299
    -0.03 ± 0.106
    -0.09 ± 0.234
        Basophils/Leukocytes, Week8, n=8,7,9,9,9
    -0.09 ± 0.455
    0.03 ± 0.214
    0.4 ± 0.941
    0.11 ± 0.203
    -0.07 ± 0.296
        Basophils/Leukocytes, Week10, n=7,8,4,7,8
    -0.07 ± 0.35
    -0.01 ± 0.21
    -0.35 ± 0.173
    0.06 ± 0.172
    0.03 ± 0.139
        Basophils/Leukocytes, Week12, n=7,7,7,8,7
    -0.17 ± 0.243
    0.03 ± 0.298
    -0.17 ± 0.138
    -0.05 ± 0.214
    -0.06 ± 0.369
        Basophils/Leukocytes, Week16, n=5,6,3,6,6
    0 ± 0.308
    -0.08 ± 0.172
    -0.1 ± 0.3
    0.12 ± 0.279
    -0.1 ± 0.228
        Eosinophils/Leukocytes, Week1, n=9,10,9,10,11
    0.11 ± 1.054
    -0.69 ± 1.501
    -2.21 ± 5.829
    0.49 ± 0.716
    0.1 ± 1.052
        Eosinophils/Leukocytes, Week2, n=9,9,10,9,9
    2.1 ± 2.264
    -0.39 ± 1.394
    -0.64 ± 7.039
    1.29 ± 2.389
    -0.07 ± 0.515
        Eosinophils/Leukocytes, Week3, n=9,7,9,6,7
    0.61 ± 1.114
    -0.73 ± 1.947
    -2.08 ± 5.652
    0.87 ± 0.437
    1.59 ± 2.26
        Eosinophils/Leukocytes, Week4, n=6,9,9,9,9
    -0.37 ± 0.958
    -0.89 ± 1.578
    -1.7 ± 5.803
    -0.04 ± 0.642
    -0.07 ± 0.57
        Eosinophils/Leukocytes, Week5, n=7,6,6,9,7
    0.2 ± 1.405
    -0.73 ± 1.188
    0.15 ± 0.997
    0.12 ± 0.574
    -0.24 ± 0.31
        Eosinophils/Leukocytes, Week6, n=7,10,6,10,7
    -0.43 ± 1.048
    -0.86 ± 1.581
    -0.58 ± 0.496
    -0.16 ± 0.662
    -0.04 ± 0.42
        Eosinophils/Leukocytes, Week8, n=8,7,9,9,9
    0.1 ± 0.678
    -0.74 ± 1.259
    -1.2 ± 3.844
    0.29 ± 0.695
    0.12 ± 0.67
        Eosinophils/Leukocytes, Week10, n=7,8,4,7,8
    0.87 ± 2.131
    -0.19 ± 2.307
    -0.8 ± 0.757
    0.51 ± 2.343
    0.46 ± 1.234
        Eosinophils/Leukocytes, Week12, n=7,7,7,8,7
    0.06 ± 1.212
    -0.34 ± 2.167
    -0.37 ± 0.848
    0.75 ± 1.449
    1.14 ± 1.408
        Eosinophils/Leukocytes, Week16, n=5,6,3,6,6
    0.24 ± 0.77
    -0.87 ± 1.742
    1.33 ± 2.829
    -0.55 ± 0.718
    0.53 ± 0.763
        Lymphocytes/Leukocytes, Week1, n=9,10,9,10,11
    7.37 ± 10.9
    -2.44 ± 11.9
    -7.27 ± 7.597
    -0.18 ± 8.646
    -1.85 ± 7.021
        Lymphocytes/Leukocytes, Week2, n=9,9,10,9,9
    5.57 ± 11.455
    -0.09 ± 5.623
    -6.49 ± 6.821
    1.56 ± 9.714
    -1.49 ± 6.214
        Lymphocytes/Leukocytes, Week3, n=9,7,9,6,7
    6.17 ± 12.256
    0.64 ± 8.374
    -2.63 ± 7.333
    9.45 ± 6.77
    3.99 ± 14.729
        Lymphocytes/Leukocytes, Week4, n=6,9,9,9,9
    8.02 ± 12.199
    0.27 ± 8.848
    -1.2 ± 5.79
    4.68 ± 8.387
    -0.31 ± 6.648
        Lymphocytes/Leukocytes, Week5, n=7,6,6,9,7
    1.93 ± 9.353
    1.87 ± 7.289
    -3.7 ± 8.298
    6.59 ± 10.764
    -2.39 ± 4.963
        Lymphocytes/Leukocytes, Week6, n=7,10,6,10,7
    4.07 ± 10.43
    -0.84 ± 7.714
    0.73 ± 15.625
    1.79 ± 5.275
    -2.81 ± 8.409
        Lymphocytes/Leukocytes, Week8, n=8,7,9,9,9
    6.49 ± 13.921
    0.89 ± 10.618
    -0.08 ± 11.076
    7.33 ± 12.026
    -0.62 ± 3.987
        Lymphocytes/Leukocytes, Week10, n=7,8,4,7,8
    4.69 ± 8.153
    0.04 ± 7.789
    -6.05 ± 4.08
    3.69 ± 10.497
    0.77 ± 7.583
        Lymphocytes/Leukocytes, Week12, n=7,7,7,8,7
    -0.41 ± 6.828
    -1.86 ± 3.134
    3.1 ± 9.892
    2.74 ± 11.547
    2.83 ± 9.272
        Lymphocytes/Leukocytes, Week16, n=5,6,3,6,6
    4.58 ± 10.518
    4.75 ± 11.131
    0.67 ± 5.311
    3.5 ± 10.198
    -1.2 ± 4.572
        Monocytes/Leukocytes, Week1, n=9,10,9,10,11
    -0.23 ± 4.618
    -1.44 ± 1.851
    -0.26 ± 4.954
    -0.1 ± 3.053
    -0.86 ± 2.037
        Monocytes/Leukocytes, Week2, n=9,9,10,9,9
    -0.78 ± 4.229
    -0.01 ± 2.606
    -0.66 ± 3.168
    -0.78 ± 2.485
    -0.12 ± 2.164
        Monocytes/Leukocytes, Week3, n=9,7,9,6,7
    -1.96 ± 4.246
    -0.19 ± 2.83
    1.66 ± 5.079
    0.63 ± 3.533
    -0.51 ± 1.142
        Monocytes/Leukocytes, Week4, n=6,9,9,9,9
    -2.05 ± 4.077
    0.12 ± 2.8
    0.34 ± 3.968
    0.8 ± 5.071
    -0.51 ± 1.722
        Monocytes/Leukocytes, Week5, n=7,6,6,9,7
    -0.27 ± 2.188
    0.72 ± 1.309
    0.37 ± 4.712
    0.68 ± 4.668
    -0.87 ± 1.863
        Monocytes/Leukocytes, Week6, n=7,10,6,10,7
    -1 ± 1.69
    -0.51 ± 2.682
    -0.97 ± 4.149
    -1.82 ± 2.439
    -1.13 ± 0.972
        Monocytes/Leukocytes, Week8, n=8,7,9,9,9
    -1.24 ± 2.856
    1.34 ± 4.065
    -0.17 ± 2.401
    0.69 ± 2.816
    0.29 ± 1.642
        Monocytes/Leukocytes, Week10, n=7,8,4,7,8
    0.59 ± 1.416
    -0.65 ± 2.519
    -0.98 ± 3.645
    0.03 ± 3.539
    -0.45 ± 1.448
        Monocytes/Leukocytes, Week12, n=7,7,7,8,7
    0.04 ± 2.326
    -0.2 ± 1.882
    1.34 ± 3.38
    0.95 ± 3.746
    -0.04 ± 0.986
        Monocytes/Leukocytes, Week16, n=5,6,3,6,6
    0.94 ± 1.358
    -0.43 ± 2.207
    -0.83 ± 0.569
    -1.62 ± 2.091
    0.3 ± 1.74
        Neutrophils/Leukocytes, Week1, n=8,10,9,10,11
    -6.89 ± 10.974
    4.6 ± 14.042
    9.81 ± 9.751
    -0.2 ± 11.49
    2.71 ± 8.625
        Neutrophils/Leukocytes, Week2, n=8,9,10,9,9
    -6.95 ± 10.766
    0.58 ± 7.422
    7.93 ± 8.472
    -2.13 ± 10.553
    1.8 ± 8.24
        Neutrophils/Leukocytes, Week3, n=8,7,9,6,7
    -4.61 ± 12.278
    0.31 ± 11.97
    2.88 ± 10.999
    -11.13 ± 8.861
    -5.07 ± 16.55
        Neutrophils/Leukocytes, Week4, n=5,9,9,9,9
    -6.88 ± 11.033
    0.52 ± 12.138
    2.62 ± 9.988
    -5.47 ± 9.665
    1.01 ± 7.743
        Neutrophils/Leukocytes, Week5, n=6,6,6,9,7
    -1.67 ± 11.661
    -2.03 ± 7.169
    3.32 ± 12.056
    -7.36 ± 13.85
    3.64 ± 5.422
        Neutrophils/Leukocytes, Week6, n=6,10,6,10,7
    -2.7 ± 13
    2.16 ± 9.334
    1.1 ± 16.691
    0.22 ± 5.022
    4.07 ± 8.798
        Neutrophils/Leukocytes, Week8, n=7,7,9,9,9
    -5.21 ± 13.064
    -1.51 ± 13.268
    1.04 ± 10.843
    -8.42 ± 13.702
    0.28 ± 5.261
        Neutrophils/Leukocytes, Week10, n=6,8,4,7,8
    -5.93 ± 11.454
    0.81 ± 11.653
    8.18 ± 5.705
    -4.29 ± 12.505
    -0.81 ± 8.921
        Neutrophils/Leukocytes, Week12, n=6,7,7,8,7
    0.68 ± 7.055
    2.37 ± 5.459
    -3.9 ± 10.99
    -4.39 ± 14.892
    -3.87 ± 8.832
        Neutrophils/Leukocytes, Week16, n=4,6,3,6,6
    -5.38 ± 13.405
    -3.37 ± 12.751
    -1.07 ± 4.007
    -1.45 ± 11.237
    0.47 ± 5.895
        Neutrophils SG/Leukocytes, Week1, n=9,10,9,10,11
    -7.22 ± 10.314
    4.6 ± 14.042
    9.81 ± 9.751
    -0.2 ± 11.49
    2.71 ± 8.625
        Neutrophils SG/Leukocytes, Week2, n=9,9,10,9,9
    -6.98 ± 10.071
    0.58 ± 7.422
    7.93 ± 8.472
    -2.13 ± 10.553
    1.8 ± 8.24
        Neutrophils SG/Leukocytes, Week3, n=9,7,9,6,7
    -4.78 ± 11.496
    0.31 ± 11.97
    2.88 ± 10.999
    -11.13 ± 8.861
    -5.07 ± 16.55
        Neutrophils SG/Leukocytes, Week4, n=6,9,9,9,9
    -5.62 ± 10.342
    0.52 ± 12.138
    2.62 ± 9.988
    -5.47 ± 9.665
    1.01 ± 7.743
        Neutrophils SG/Leukocytes, Week5, n=7,6,6,9,7
    -1.74 ± 10.647
    -2.03 ± 7.169
    3.32 ± 12.056
    -7.36 ± 13.85
    3.64 ± 5.422
        Neutrophils SG/Leukocytes, Week6, n=7,10,6,10,7
    -2.4 ± 11.894
    2.16 ± 9.334
    1.1 ± 16.691
    0.22 ± 5.022
    4.07 ± 8.798
        Neutrophils SG/Leukocytes, Week8, n=8,7,9,9,9
    -5.26 ± 12.096
    -1.51 ± 13.268
    1.04 ± 10.843
    -8.42 ± 13.702
    0.28 ± 5.261
        Neutrophils SG/Leukocytes, Week10, n=7,8,4,7,8
    -6.07 ± 10.462
    0.81 ± 11.653
    8.18 ± 5.705
    -4.29 ± 12.505
    -0.81 ± 8.921
        Neutrophils SG/Leukocytes, Week12, n=7,7,7,8,7
    0.49 ± 6.462
    2.37 ± 5.459
    -3.9 ± 10.99
    -4.39 ± 14.892
    -3.87 ± 8.832
        Neutrophils SG/Leukocytes, Week16, n=5,6,3,6,6
    -5.76 ± 11.641
    -3.37 ± 12.751
    -1.07 ± 4.007
    -1.45 ± 11.237
    0.47 ± 5.895
        EDW, Week1, n=9,10,9,10,11
    0.07 ± 0.447
    0.03 ± 0.523
    -0.26 ± 0.75
    -0.25 ± 0.472
    -0.17 ± 0.427
        EDW, Week2, n=9,9,10,9,9
    0.28 ± 0.387
    0.22 ± 0.545
    0.08 ± 0.594
    -0.33 ± 0.654
    0.08 ± 0.672
        EDW, Week3, n=9,7,9,7,7
    0.14 ± 0.691
    0.37 ± 0.206
    0.44 ± 0.918
    -0.2 ± 0.936
    0.1 ± 0.847
        EDW, Week4, n=6,9,9,9,9
    0.85 ± 0.864
    0.1 ± 0.51
    0.54 ± 0.644
    -0.08 ± 1.099
    0.31 ± 1.288
        EDW, Week5, n=7,6,6,9,7
    0.59 ± 0.96
    0.43 ± 0.833
    1.2 ± 1.131
    0.39 ± 1.237
    0.41 ± 1.489
        EDW, Week6, n=7,10,6,10,8
    0.43 ± 1.268
    0.06 ± 0.744
    0.55 ± 1.544
    0.46 ± 0.987
    -0.02 ± 1.635
        EDW, Week8, n=8,7,9,9,9
    0.31 ± 1.169
    0.01 ± 0.773
    1.02 ± 1.498
    0.77 ± 0.97
    0.37 ± 1.907
        EDW, Week10, n=7,8,4,7,8
    0.23 ± 0.945
    0.06 ± 1.187
    0.5 ± 1.538
    0.91 ± 1.129
    0.91 ± 2.906
        EDW, Week12, n=7,7,7,8,7
    0.51 ± 1.794
    0.11 ± 1.275
    0.51 ± 1.235
    0.94 ± 1.25
    1.57 ± 2.715
        EDW, Week16, n=5,6,3,6,6
    0.7 ± 1.377
    0.57 ± 1.341
    0.5 ± 0.265
    0.52 ± 1.16
    1.72 ± 3.98
    Notes
    [101] - ITT Population
    [102] - ITT Population
    [103] - ITT Population
    [104] - ITT Population
    [105] - ITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in erythrocytes and reticulocytes at the indicated time points up to Week 16

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    End point title
    Change from Baseline in erythrocytes and reticulocytes at the indicated time points up to Week 16 [106]
    End point description
    Change from Baseline in the erythrocyte and reticulocyte values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [106] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [107]
    10 [108]
    10 [109]
    10 [110]
    11 [111]
    Units: Trillion per liter
    arithmetic mean (standard deviation)
        Erythrocytes, Week1, n=9,10,9,10,11
    -0.07 ± 0.187
    -0.08 ± 0.162
    0.01 ± 0.226
    -0.06 ± 0.178
    -0.13 ± 0.127
        Erythrocytes, Week2, n=9,9,10,9,9
    -0.1 ± 0.166
    0.02 ± 0.277
    0.07 ± 0.226
    -0.07 ± 0.2
    -0.14 ± 0.088
        Erythrocytes, Week3, n=9,7,9,7,7
    -0.12 ± 0.172
    0.03 ± 0.263
    0.04 ± 0.201
    -0.04 ± 0.27
    -0.13 ± 0.221
        Erythrocytes, Week4, n=6,9,9,9,9
    -0.05 ± 0.207
    -0.07 ± 0.2
    0.04 ± 0.151
    -0.13 ± 0.283
    -0.09 ± 0.22
        Erythrocytes, Week5, n=7,6,7,9,7
    -0.27 ± 0.17
    0 ± 0.29
    0 ± 0.141
    -0.19 ± 0.176
    -0.07 ± 0.198
        Erythrocytes, Week6, n=7,10,6,10,8
    -0.17 ± 0.25
    0.08 ± 0.377
    0.08 ± 0.279
    -0.08 ± 0.204
    0.05 ± 0.12
        Erythrocytes, Week8, n=8,7,9,9,9
    0.04 ± 0.302
    -0.06 ± 0.151
    -0.06 ± 0.207
    -0.09 ± 0.341
    -0.04 ± 0.219
        Erythrocytes, Week10, n=7,8,4,7,8
    -0.13 ± 0.214
    -0.03 ± 0.296
    -0.05 ± 0.129
    -0.21 ± 0.146
    0.04 ± 0.256
        Erythrocytes, Week12, n=7,7,7,8,7
    -0.11 ± 0.227
    -0.01 ± 0.204
    0.01 ± 0.107
    -0.04 ± 0.311
    -0.04 ± 0.331
        Erythrocytes, Week16, n=5,6,3,6,6
    -0.02 ± 0.327
    -0.1 ± 0.21
    -0.17 ± 0.058
    -0.03 ± 0.32
    0.03 ± 0.28
        Reticulocytes, Week1, n=9,10,9,10,11
    0.01023 ± 0.013577
    -0.00241 ± 0.016591
    0.00822 ± 0.014942
    0.00233 ± 0.01305
    -0.00318 ± 0.015587
        Reticulocytes, Week2, n=9,9,10,9,9
    0.01356 ± 0.014036
    -0.00686 ± 0.020924
    -0.0008 ± 0.014329
    -0.0026 ± 0.017417
    -0.00031 ± 0.024158
        Reticulocytes, Week3, n=9,7,9,7,7
    0.02272 ± 0.022383
    0.00693 ± 0.032031
    0.01006 ± 0.011791
    0.00519 ± 0.022769
    -0.00409 ± 0.022753
        Reticulocytes, Week4, n=6,9,9,9,9
    0.01822 ± 0.008272
    0.00904 ± 0.039946
    0.00202 ± 0.018841
    0.00278 ± 0.020853
    0.00083 ± 0.025744
        Reticulocytes, Week5, n=7,6,7,9,7
    0.01267 ± 0.015672
    0.00122 ± 0.015623
    0.01227 ± 0.019674
    0.00874 ± 0.022087
    0.00009 ± 0.031287
        Reticulocytes, Week6, n=7,10,6,10,8
    0.00827 ± 0.018538
    0.00131 ± 0.020422
    -0.00193 ± 0.01615
    0.00872 ± 0.019709
    -0.00243 ± 0.023781
        Reticulocytes, Week8, n=8,7,9,9,9
    0.00609 ± 0.01307
    0.00561 ± 0.02537
    0.01772 ± 0.026266
    0.01912 ± 0.046264
    0.00214 ± 0.025027
        Reticulocytes, Week10, n=7,8,4,7,8
    0.01343 ± 0.005743
    -0.00155 ± 0.024259
    -0.00227 ± 0.010259
    0.01686 ± 0.027415
    0.00125 ± 0.035393
        Reticulocytes, Week12, n=7,7,7,8,7
    0.00839 ± 0.01347
    0.00454 ± 0.019287
    0.00017 ± 0.011061
    0.00011 ± 0.025521
    0.00859 ± 0.009494
        Reticulocytes, Week16, n=5,6,3,6,6
    0.00778 ± 0.01031
    -0.00515 ± 0.012694
    0.00853 ± 0.013776
    0.00412 ± 0.023629
    0.00195 ± 0.008808
    Notes
    [107] - ITT Population
    [108] - ITT Population
    [109] - ITT Population
    [110] - ITT Population
    [111] - ITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in hemoglobin and EMCHC at the indicated time points up to Week 16

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    End point title
    Change from Baseline in hemoglobin and EMCHC at the indicated time points up to Week 16 [112]
    End point description
    Change from Baseline in the hemoglobin and erythrocyte mean corpuscular hemoglobin concentration (EMCHC) values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [112] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [113]
    10 [114]
    10 [115]
    10 [116]
    11 [117]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Hemoglobin, Week1, n=9,10,9,10,11
    -2.4 ± 5.61
    -2.5 ± 4.14
    0.2 ± 6.46
    -0.7 ± 6.07
    -4.3 ± 4.47
        Hemoglobin, Week2, n=9,9,10,9,9
    -2.6 ± 4.42
    -0.3 ± 7.48
    1.6 ± 6.47
    -1 ± 6.52
    -5.2 ± 3.38
        Hemoglobin, Week3, n=9,7,9,7,7
    -3.6 ± 4.75
    0.9 ± 5.46
    1 ± 5.63
    -0.9 ± 6.67
    -5.1 ± 6.15
        Hemoglobin, Week4, n=6,9,9,9,9
    -1.8 ± 7.14
    -1.6 ± 6.56
    1.8 ± 4.74
    -3.1 ± 8.91
    -4.7 ± 7.16
        Hemoglobin, Week5, n=7,6,7,9,7
    -8.6 ± 3.99
    -0.5 ± 7.97
    2.1 ± 4.45
    -3.9 ± 7.15
    -5.1 ± 7.22
        Hemoglobin, Week6, n=7,10,6,10,8
    -6.3 ± 5.68
    2.4 ± 11.46
    3.8 ± 7
    -1.7 ± 6.85
    -2.4 ± 6.72
        Hemoglobin, Week8, n=8,7,9,9,9
    0.3 ± 8.94
    -3.1 ± 5.24
    -0.1 ± 5.82
    -3.3 ± 9.33
    -5.9 ± 7.54
        Hemoglobin, Week10, n=7,8,4,7,8
    -4.9 ± 5.21
    -2.1 ± 9
    1.5 ± 3.7
    -3.6 ± 7.37
    -4.1 ± 7.74
        Hemoglobin, Week12, n=7,7,7,8,7
    -6 ± 6.58
    -3.7 ± 5.35
    1.4 ± 1.72
    -2.1 ± 8.72
    -7.7 ± 5.22
        Hemoglobin, Week16, n=5,6,3,6,6
    -6.6 ± 7.67
    -6.2 ± 6.11
    -3 ± 1.73
    -4.2 ± 4.31
    -4.7 ± 8.12
        EMCHC, Week1, n=9,10,9,10,11
    -4.6 ± 6.52
    -3.9 ± 5.7
    2.4 ± 4.93
    1.4 ± 6.79
    -0.5 ± 6.33
        EMCHC, Week2, n=9,9,10,9,9
    -2.8 ± 7.28
    -3.3 ± 5.57
    3.8 ± 3.99
    4 ± 5.59
    0.1 ± 5.13
        EMCHC, Week3, n=9,7,9,7,7
    1.3 ± 4.64
    -2.4 ± 5.91
    2.3 ± 6.52
    2.9 ± 11.63
    -2.9 ± 4.63
        EMCHC, Week4, n=6,9,9,9,9
    -1.7 ± 5.89
    1.8 ± 7.53
    2.1 ± 6.39
    6.4 ± 7.99
    -0.4 ± 5.32
        EMCHC, Week5, n=7,6,7,9,7
    -3.1 ± 7.9
    -3.3 ± 5.85
    1.4 ± 3.41
    3.9 ± 7.99
    -3.1 ± 9.23
        EMCHC, Week6, n=7,10,6,10,8
    -4.1 ± 9.82
    -0.8 ± 6.66
    3 ± 4.24
    1.8 ± 10.21
    -3.1 ± 10.72
        EMCHC, Week8, n=8,7,9,9,9
    0.4 ± 5.63
    -1.9 ± 6.04
    2.3 ± 6.2
    1.7 ± 10.69
    -1.6 ± 9.74
        EMCHC, Week10, n=7,8,4,7,8
    0.6 ± 6.8
    1.4 ± 5.26
    2.3 ± 4.19
    4.3 ± 8.56
    -2.9 ± 7.75
        EMCHC, Week12, n=7,7,7,8,7
    -3.7 ± 11.79
    -0.9 ± 4.22
    3.1 ± 7.88
    3.4 ± 7.42
    -6 ± 8.33
        EMCHC, Week16, n=5,6,3,6,6
    -6.6 ± 9.96
    0.3 ± 7.26
    5 ± 5.57
    -3.2 ± 13.35
    1.8 ± 15.66
    Notes
    [113] - ITT Population
    [114] - ITT Population
    [115] - ITT Population
    [116] - ITT Population
    [117] - ITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in EMCH at the indicated time points up to Week 16

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    End point title
    Change from Baseline in EMCH at the indicated time points up to Week 16 [118]
    End point description
    Change from Baseline in the hemoglobin and erythrocyte mean corpuscular hemoglobin (EMCH) values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [118] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [119]
    10 [120]
    10 [121]
    10 [122]
    11 [123]
    Units: Picograms
    arithmetic mean (standard deviation)
        EMCH, Week1, n=9,10,9,10,11
    -0.17 ± 0.45
    -0.22 ± 0.563
    0.13 ± 0.316
    0.25 ± 0.517
    -0.13 ± 0.529
        EMCH, Week2, n=9,9,10,9,9
    0.01 ± 0.22
    -0.38 ± 0.58
    0.09 ± 0.348
    0.1 ± 0.532
    -0.18 ± 0.62
        EMCH, Week3, n=9,7,9,7,7
    0.16 ± 0.553
    -0.11 ± 0.626
    -0.04 ± 0.43
    -0.03 ± 1.029
    -0.66 ± 0.75
        EMCH, Week4, n=6,9,9,9,9
    0.03 ± 0.869
    0 ± 0.458
    0.1 ± 0.65
    0.14 ± 0.609
    -0.49 ± 1.177
        EMCH, Week5, n=7,6,7,9,7
    -0.16 ± 0.447
    -0.1 ± 0.4
    0.5 ± 0.216
    0.49 ± 0.747
    -0.79 ± 1.442
        EMCH, Week6, n=7,10,6,10,8
    -0.23 ± 0.655
    -0.34 ± 0.847
    0.23 ± 0.367
    0.15 ± 0.72
    -1 ± 1.504
        EMCH, Week8, n=8,7,9,9,9
    -0.12 ± 0.907
    -0.46 ± 0.791
    0.28 ± 0.455
    -0.17 ± 1.428
    -1.19 ± 1.691
        EMCH, Week10, n=7,8,4,7,8
    -0.33 ± 0.668
    -0.35 ± 0.548
    0.52 ± 0.126
    0.54 ± 1.229
    -1.37 ± 1.972
        EMCH, Week12, n=7,7,7,8,7
    -0.56 ± 0.774
    -0.84 ± 0.914
    0.26 ± 0.675
    -0.15 ± 1.323
    -1.79 ± 2.323
        EMCH, Week16, n=5,6,3,6,6
    -1.18 ± 1.178
    -0.9 ± 0.957
    0.3 ± 0.5
    -0.88 ± 1.731
    -1.43 ± 2.868
    Notes
    [119] - ITT Population.
    [120] - ITT Population.
    [121] - ITT Population.
    [122] - ITT Population.
    [123] - ITT Population.
    No statistical analyses for this end point

    Primary: Change from Baseline in EMCV and MPV at the indicated time points up to Week 16

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    End point title
    Change from Baseline in EMCV and MPV at the indicated time points up to Week 16 [124]
    End point description
    Change from Baseline in the erythrocyte mean corpuscular volume (EMCV) and mean platelet volume (MPV) values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [124] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [125]
    10 [126]
    10 [127]
    10 [128]
    11 [129]
    Units: Femtoliters
    arithmetic mean (standard deviation)
        EMCV, Week1, n=9,10,9,10,11
    0.4 ± 1.42
    0.6 ± 1.9
    -0.6 ± 1.13
    0.2 ± 1.32
    -0.3 ± 1.68
        EMCV, Week2, n=9,9,10,9,9
    0.6 ± 1.74
    -0.3 ± 1.66
    -0.7 ± 0.95
    -1 ± 1.41
    -0.4 ± 2.7
        EMCV, Week3, n=9,7,9,7,7
    -0.1 ± 1.69
    0.7 ± 1.7
    -0.7 ± 1.66
    -0.9 ± 1.21
    -1 ± 2.24
        EMCV, Week4, n=6,9,9,9,9
    0.3 ± 2.8
    -0.3 ± 2.45
    -0.3 ± 1.73
    -1.7 ± 1.41
    -1.1 ± 2.98
        EMCV, Week5, n=7,6,7,9,7
    0 ± 1
    0.8 ± 2.64
    1.1 ± 0.9
    0.1 ± 1.96
    -1.6 ± 3.41
        EMCV, Week6, n=7,10,6,10,8
    0.3 ± 1.98
    -0.8 ± 2.25
    0.2 ± 2.14
    -0.1 ± 2.08
    -2.1 ± 4.22
        EMCV, Week8, n=8,7,9,9,9
    -0.6 ± 2.83
    -1 ± 2.52
    0.2 ± 2.28
    -1.2 ± 1.99
    -3.1 ± 4.01
        EMCV, Week10, n=7,8,4,7,8
    -1.6 ± 2.44
    -1.5 ± 1.85
    1 ± 0.82
    0.4 ± 2.3
    -3.5 ± 5.15
        EMCV, Week12, n=7,7,7,8,7
    -0.9 ± 4.45
    -2.4 ± 2.15
    -0.3 ± 1.7
    -1.6 ± 2.39
    -3.7 ± 6.34
        EMCV, Week16, n=5,6,3,6,6
    -2.2 ± 5.45
    -3 ± 2.83
    0 ± 0
    -1.7 ± 2.16
    -5.3 ± 6.28
        MPV, Week1, n=9,10,9,10,11
    0.12 ± 0.273
    -0.04 ± 0.45
    0.06 ± 0.317
    -0.37 ± 0.696
    -0.16 ± 0.32
        MPV, Week2, n=9,9,10,9,9
    0.1 ± 0.24
    -0.02 ± 0.556
    0.31 ± 0.626
    -0.22 ± 0.821
    -0.08 ± 0.509
        MPV, Week3, n=9,7,9,7,7
    -0.09 ± 0.352
    -0.01 ± 0.631
    -0.17 ± 0.76
    -0.45 ± 0.829
    -0.17 ± 0.335
        MPV, Week4, n=6,9,9,9,9
    -0.08 ± 0.248
    -0.02 ± 0.572
    -0.24 ± 0.675
    -0.24 ± 0.805
    -0.02 ± 0.421
        MPV, Week5, n=7,6,7,9,7
    -0.1 ± 0.416
    0.12 ± 0.595
    -0.1 ± 0.258
    -0.49 ± 0.772
    -0.07 ± 0.616
        MPV, Week6, n=7,10,6,10,8
    0.2 ± 0.648
    -0.14 ± 0.731
    -0.17 ± 0.388
    -0.56 ± 0.76
    -0.09 ± 0.569
        MPV, Week8, n=8,7,9,9,9
    -0.17 ± 0.396
    -0.06 ± 0.704
    -0.13 ± 0.557
    -0.39 ± 1.029
    -0.12 ± 0.663
        MPV, Week10, n=7,8,4,7,8
    -0.16 ± 0.447
    -0.1 ± 0.374
    0.05 ± 0.48
    -0.46 ± 0.832
    0.01 ± 0.579
        MPV, Week12, n=7,7,7,8,7
    -0.07 ± 0.736
    0.2 ± 0.569
    0.01 ± 0.689
    -0.24 ± 0.778
    -0.03 ± 0.789
        MPV, Week16, n=5,6,3,6,6
    0.1 ± 0.566
    -0.08 ± 0.631
    -0.7 ± 0.52
    -0.38 ± 1.003
    0 ± 0.559
    Notes
    [125] - ITT Population
    [126] - ITT Population
    [127] - ITT Population
    [128] - ITT Population
    [129] - ITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in hematocrit and reticulocytes/erythrocytes at the indicated time points up to Week 16

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    End point title
    Change from Baseline in hematocrit and reticulocytes/erythrocytes at the indicated time points up to Week 16 [130]
    End point description
    Change from Baseline in the hematocrit and reticulocytes/erythrocytes values are summarised for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). Different participants may have been analysed at different time points, so the overall number of participants analysed reflects everyone in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [130] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [131]
    10 [132]
    10 [133]
    10 [134]
    11 [135]
    Units: Fraction of 1
    arithmetic mean (standard deviation)
        Hematocrit, Week1, n=9,10,9,10,11
    -0.0023 ± 0.01869
    -0.0029 ± 0.01554
    -0.0028 ± 0.02198
    -0.0037 ± 0.01824
    -0.0128 ± 0.01308
        Hematocrit, Week2, n=9,9,10,9,9
    -0.0059 ± 0.01841
    0.0036 ± 0.02677
    -0.0001 ± 0.01959
    -0.0086 ± 0.0199
    -0.0154 ± 0.01507
        Hematocrit, Week3, n=9,7,9,7,7
    -0.0127 ± 0.01796
    0.0067 ± 0.02298
    -0.0003 ± 0.01761
    -0.0061 ± 0.02975
    -0.0124 ± 0.02204
        Hematocrit, Week4, n=6,9,9,9,9
    -0.0037 ± 0.01691
    -0.0067 ± 0.02438
    0.0027 ± 0.01525
    -0.0172 ± 0.02486
    -0.0136 ± 0.02166
        Hematocrit, Week5, n=7,6,7,9,7
    -0.0241 ± 0.01661
    0.0038 ± 0.0312
    0.0037 ± 0.0151
    -0.0168 ± 0.02156
    -0.0127 ± 0.01685
        Hematocrit, Week6, n=7,10,6,10,8
    -0.0147 ± 0.02043
    0.0069 ± 0.03471
    0.0082 ± 0.01863
    -0.0088 ± 0.01862
    -0.0038 ± 0.01552
        Hematocrit, Week8, n=8,7,9,9,9
    -0.0008 ± 0.0306
    -0.0074 ± 0.01758
    -0.0034 ± 0.01955
    -0.0124 ± 0.03152
    -0.0168 ± 0.02049
        Hematocrit, Week10, n=7,8,4,7,8
    -0.0173 ± 0.01505
    -0.008 ± 0.03033
    0.0015 ± 0.005
    -0.016 ± 0.01893
    -0.0106 ± 0.01983
        Hematocrit, Week12, n=7,7,7,8,7
    -0.0151 ± 0.02123
    -0.0099 ± 0.01541
    -0.0007 ± 0.01132
    -0.011 ± 0.02818
    -0.0181 ± 0.02038
        Hematocrit, Week16, n=5,6,3,6,6
    -0.0126 ± 0.0167
    -0.0195 ± 0.0195
    -0.0163 ± 0.00379
    -0.0087 ± 0.02391
    -0.019 ± 0.01455
        Reticulocytes/Erythrocytes, Week1, n=9,10,9,10,11
    0.0026 ± 0.00305
    -0.0004 ± 0.0042
    0.002 ± 0.00339
    0.0009 ± 0.00311
    -0.0004 ± 0.0037
        Reticulocytes/Erythrocytes, Week2, n=9,9,10,9,9
    0.0036 ± 0.00357
    -0.0018 ± 0.00502
    -0.0002 ± 0.00346
    -0.0001 ± 0.00392
    0.0002 ± 0.0054
        Reticulocytes/Erythrocytes, Week3, n=9,7,9,7,7
    0.0059 ± 0.00629
    0.002 ± 0.00777
    0.0023 ± 0.0025
    0.0016 ± 0.0055
    -0.0003 ± 0.00559
        Reticulocytes/Erythrocytes, Week4, n=6,9,9,9,9
    0.0045 ± 0.00243
    0.0024 ± 0.00961
    0.0002 ± 0.00471
    0.0014 ± 0.00654
    0.0007 ± 0.0061
        Reticulocytes/Erythrocytes, Week5, n=7,6,7,9,7
    0.0037 ± 0.00407
    0.0003 ± 0.00446
    0.0027 ± 0.00461
    0.0031 ± 0.00613
    0.0006 ± 0.00728
        Reticulocytes/Erythrocytes, Week6, n=7,10,6,10,8
    0.0021 ± 0.00418
    -0.0001 ± 0.00461
    -0.0007 ± 0.00413
    0.0025 ± 0.00495
    -0.0006 ± 0.00545
        Reticulocytes/Erythrocytes, Week8, n=8,7,9,9,9
    0.0013 ± 0.00337
    0.0017 ± 0.00556
    0.0042 ± 0.00608
    0.0049 ± 0.00957
    0.0008 ± 0.00533
        Reticulocytes/Erythrocytes, Week10, n=7,8,4,7,8
    0.0036 ± 0.00151
    -0.0002 ± 0.00557
    -0.0005 ± 0.00238
    0.0047 ± 0.00582
    0.0004 ± 0.00821
        Reticulocytes/Erythrocytes, Week12, n=7,7,7,8,7
    0.0023 ± 0.00304
    0.0009 ± 0.00418
    -0.0001 ± 0.00219
    0.0004 ± 0.0059
    0.002 ± 0.00294
        Reticulocytes/Erythrocytes, Week16, n=5,6,3,6,6
    0.002 ± 0.00173
    -0.0007 ± 0.00258
    0.0023 ± 0.00306
    0.0013 ± 0.0048
    0.0003 ± 0.00197
    Notes
    [131] - ITT Population
    [132] - ITT Population
    [133] - ITT Population
    [134] - ITT Population
    [135] - ITT Population
    No statistical analyses for this end point

    Primary: Number of participants with urinalysis data at the indicated time points up to Week 16

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    End point title
    Number of participants with urinalysis data at the indicated time points up to Week 16 [136]
    End point description
    Number of participants with negative and positives (trace, +, ++ and +++) data for urine glucose (UGLU), urine ketones (UKET) and urine occult blood (UOB) are summarised for each post-Baseline assesment until Week 16. Urinalysis was performed by dipstick method. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analysed (represented by n=X,X,X,X,X in category titles). A value of 99999 indicates no participants were analyzed therefore there is no data for this time point.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16
    Notes
    [136] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistics for this endpoint.
    End point values
    GSK2586184 50 mg BID GSK2586184 100 mg BID GSK2586184 200 mg BID GSK2586184 400 mg BID Placebo
    Number of subjects analysed
    9 [137]
    10 [138]
    10 [139]
    10 [140]
    11 [141]
    Units: Participants
        UGLU, Negative, Baseline, n=9,10,10,10,11
    9
    10
    10
    10
    11
        UGLU, Positive, Baseline, n=9,10,10,10,11
    0
    0
    0
    0
    0
        UGLU, Negative, Week2, n=9,9,9,9,10
    9
    9
    9
    9
    10
        UGLU, Positive, Week2, n=9,9,9,9,10
    0
    0
    0
    0
    0
        UGLU, Negative, Week3, n=1,1,0,0,0
    1
    1
    99999
    99999
    99999
        UGLU, Positive, Week3, n=1,1,0,0,0
    0
    0
    99999
    99999
    99999
        UGLU, Negative, Week4, n=8,9,8,8,9
    8
    9
    8
    8
    9
        UGLU, Positive, Week4, n=8,9,8,8,9
    0
    0
    0
    0
    0
        UGLU, Negative, Week5, n=0,0,0,0,2
    99999
    99999
    99999
    99999
    2
        UGLU, Positive, Week5, n=0,0,0,0,2
    99999
    99999
    99999
    99999
    0
        UGLU, Negative, Week6, n=7,10,6,9,8
    7
    10
    6
    9
    8
        UGLU, Positive, Week6, n=7,10,6,9,8
    0
    0
    0
    0
    0
        UGLU, Negative, Week8, n=8,7,9,9,9
    8
    7
    9
    9
    9
        UGLU, Positive, Week8, n=8,7,9,9,9
    0
    0
    0
    0
    0
        UGLU, Negative, Week10, n=7,8,4,7,8
    7
    8
    4
    7
    8
        UGLU, Positive, Week10, n=7,8,4,7,8
    0
    0
    0
    0
    0
        UGLU, Negative, Week12, n=7,7,7,8,7
    7
    7
    7
    8
    7
        UGLU, Positive, Week12, n=7,7,7,8,7
    0
    0
    0
    0
    0
        UGLU, Negative, Week16, n=5,6,3,6,6
    5
    6
    3
    5
    6
        UGLU, Positive, Week16, n=5,6,3,6,6
    0
    0
    0
    1
    0
        UKET, Negative, Baseline, n=9,10,10,10,11
    9
    10
    10
    10
    11
        UKET, Positive, Baseline, n=9,10,10,10,11
    0
    0
    0
    0
    0
        UKET, Negative, Week2, n=9,9,9,9,10
    9
    9
    6
    7
    10
        UKET, Positive, Week2, n=9,9,9,9,10
    0
    0
    3
    2
    0
        UKET, Negative, Week3, n=1,1,0,0,0
    0
    1
    99999
    99999
    99999
        UKET, Positive, Week3, n=1,1,0,0,0
    1
    0
    99999
    99999
    99999
        UKET, Negative, Week4, n=8,9,8,8,9
    8
    9
    6
    7
    9
        UKET, Positive, Week4, n=8,9,8,8,9
    0
    0
    2
    1
    0
        UKET, Negative, Week5, n=0,0,0,0,2
    99999
    99999
    99999
    99999
    2
        UKET, Positive, Week5, n=0,0,0,0,2
    99999
    99999
    99999
    99999
    0
        UKET, Negative, Week6, n=7,10,6,9,8
    6
    9
    5
    6
    8
        UKET, Positive, Week6, n=7,10,6,9,8
    1
    1
    1
    3
    0
        UKET, Negative, Week8, n=8,7,9,9,9
    8
    7
    8
    9
    9
        UKET, Positive, Week8, n=8,7,9,9,9
    0
    0
    1
    0
    0
        UKET, Negative, Week10, n=7,8,4,7,8
    7
    8
    3
    7
    8
        UKET, Positive, Week10, n=7,8,4,7,8
    0
    0
    1
    0
    0
        UKET, Negativ