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    Clinical Trial Results:
    A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression

    Summary
    EudraCT number
    		 2013-004903-37
    Trial protocol
    		 IT   BG   Outside EU/EEA   HU   DE   GB   FR  
    Global end of trial date
    19 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2017
    First version publication date
    14 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1050326
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02046369
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 D1050326: D1050326
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    ONE BRIDGE PLAZA NORTH, SUITE 510,, Fort Lee, United States, 07024
    Public contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., 01 (1) 201-592-2050, clinicaltrialsdisclosure@sunovion.com
    Scientific contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., 01 (1) 201-592-2050, clinicaltrialsdisclosure@sunovion.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this research study is to evaluate the safety and effectiveness of lurasidone (20 mg/day to 80 mg/day) compared to a placebo for use in children and adolescent subjects with bipolar I depression
    Protection of trial subjects
    The study was conducted according to the protocol, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), ICH guidelines, and the ethical principles that have their origin in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 153
    Country: Number of subjects enrolled
    Ukraine: 66
    Country: Number of subjects enrolled
    Russian Federation: 42
    Country: Number of subjects enrolled
    Mexico: 33
    Country: Number of subjects enrolled
    Bulgaria: 17
    Country: Number of subjects enrolled
    Colombia: 14
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 7
    Country: Number of subjects enrolled
    Philippines: 2
    Worldwide total number of subjects
    350
    EEA total number of subjects
    33
    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)
    44
    Adolescents (12-17 years)
    306
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 MALE AND FEMALE SUBJECTS 10 TO 17, INCLUSIVE,WITH DSM-5 PRIMARY DIAGNOSIS OF BIPOLAR 1 DISORDER, MOST RECENT EPISODE DEPRESSED, AND CONFIRMATION OF THE DIAGNOSIS BY MEANS OF THE SCHEDULE FOR AFFECTIVE DISORDERS AND SCHIZOPHRENIA FOR SCHOOL-AGE CHILDREN.

    Pre-assignment
    Screening details
    		 continued from above: THE CURRENT EPISODE OF MAJOR DEPRESSION ASSOVIATED WITH BIPOLAR 1 DISORDER MUST HAVE BEEN CONFIRMED BY THE INVESTIGATOR AND NOTED IN THE SOURCE RECORDS. SUBJECTS MUST ALSO HAVE HAD CHILDREN’S DEPRESSION RATING SCALE SCORE OF ≥ 45 AT SCREENING AND BASELINE; YOUNG MANIA RATING SCALE SCORE OF ≤ 15 AT SCREENING AND BASELINE

    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
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Luradisone
    Arm description
    		 Luradisone 20- 80 mg administered once daily Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    lurasidone
    Investigational medicinal product code
    Other name
    Latuda
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg - 80mg flexible dosing once daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo administered once daily Placebo: Placebo Comparator once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    placebo dosed once daily

    Number of subjects in period 1
    		Luradisone Placebo
    Started
    176
    174
    Completed
    162
    156
    Not completed
    14
    18
         Consent withdrawn by subject
    3
    6
         non compliance
    1
    -
         Adverse event, non-fatal
    3
    3
         never received study drug
    -
    1
         Lost to follow-up
    3
    3
         Lack of efficacy
    3
    3
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Luradisone
    Reporting group description
    		 Luradisone 20- 80 mg administered once daily Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered once daily Placebo: Placebo Comparator once daily

    Reporting group values
    		 Luradisone Placebo Total
    Number of subjects
    		 176 174 350
    Age Categorical
    Units: Participants
        <=18 years
    		 175 172 347
        Between 18 and 65 years
    		 0 0 0
        >=65 years
    		 0 0 0
        Not recorded
    		 1 2 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.2 ± 2.18 14.3 ± 2.01 -
    Gender categorical
    Units: Subjects
        Female
    		 87 83 170
        Male
    		 88 89 177
        not recorded
    		 1 2 3
    Sex: Female, Male
    Units: Subjects
        Female
    		 87 83 170
        Male
    		 88 89 177
        not recorded
    		 1 2 3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 175 172 347
        Unknown or Not Reported
    		 0 0 0
        not recorded
    		 1 2 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 2
        Asian
    		 7 4 11
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 16 20 36
        White
    		 135 125 260
        More than one race
    		 15 23 38
        Unknown or Not Reported
    		 0 0 0
        not recorded
    		 1 2 3
    Region of Enrollment
    Units: Subjects
        Colombia
    		 7 7 14
        Puerto Rico
    		 0 0 0
        South Korea
    		 4 3 7
        Hungary
    		 5 5 10
        United States
    		 75 75 150
        Philippines
    		 2 0 2
        Ukraine
    		 33 33 66
        Poland
    		 2 3 5
        Mexico
    		 16 17 33
        Bulgaria
    		 9 8 17
        France
    		 1 0 1
        Russian Federation
    		 21 21 42
        not recorded
    		 1 2 3
    Bipolar I disorder history
    Units: Subjects
        Without rapid cycling (0-3 cycles past 12 months
    		 149 147 296
        Without rapid cycling(4-7 cycles past 12 months
    		 26 24 50
        With 8 or more cycles within past 12 months
    		 0 1 1
        not recorded
    		 1 2 3
    Psychiatric History
    Units: years
        arithmetic mean (standard deviation)
    		 12.44 ± 2.79 12.17 ± 2.68 -

    End points

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    End points reporting groups
    Reporting group title
    Luradisone
    Reporting group description
    		 Luradisone 20- 80 mg administered once daily Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered once daily Placebo: Placebo Comparator once daily

    Primary: Change in the Children's Depression Rating Scale, Revised (CDRS-R) total score as compared to placebo from Double-Blind Baseline to Week 6 (Day 43) baseline

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    End point title
    		 Change in the Children's Depression Rating Scale, Revised (CDRS-R) total score as compared to placebo from Double-Blind Baseline to Week 6 (Day 43) baseline
    End point description
    CDRS-R total score: changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
    End point type
    Primary
    End point timeframe
    baseline
    End point values
    		 Luradisone Placebo
    Number of subjects analysed
    173
    170
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    59.2 ± 8.24
    58.6 ± 8.26
        week 6
    -21 ± 1.06
    -15.3 ± 1.08
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    A mean difference in change from Baseline in CDRS-R total score of 5.0 units was assumed for the lurasidone 20-80 mg/day arm over the placebo arm, and a common standard deviation of 14.2 units (effect size=0.35), a sample size of 145 subjects per treatment arm was calculated to yield a power of 85%. With an expected attrition rate of 15%, approximately 170 subjects per treatment arm (340 in total) were to be randomized in a 1:1 ratio .
    Comparison groups
    Luradisone v Placebo
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 LS mean differnece (SE)
    Parameter type
    		 LS mean differnce (SE)
    Point estimate
    -5.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 -3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.39

    Secondary: Change from Baseline in Pediatric Anxiety Rating Scale (PARS) score as compared to placebo.

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    End point title
    		 Change from Baseline in Pediatric Anxiety Rating Scale (PARS) score as compared to placebo.
    End point description
    PARS score: changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    		 Luradisone Placebo
    Number of subjects analysed
    173
    170
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    10.9 ± 7.72
    11.5 ± 7.6
        week 6
    -3.4 ± 0.44
    -2.3 ± 0.45
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
    Comparison groups
    Luradisone v Placebo
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0385
    Method
    		 LS mean differnece (SE)
    Parameter type
    		 LS mean differnce (SE)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.54

    Secondary: Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) score as compared to placebo.

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    End point title
    		 Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) score as compared to placebo.
    End point description
    PQ-LES-Q percentage maximum possible score: changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    		 Luradisone Placebo
    Number of subjects analysed
    173
    169
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    49.6 ± 15.49
    49.7 ± 17.31
        week 6
    11.8 ± 1.1
    7.9 ± 1.13
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
    Comparison groups
    Luradisone v Placebo
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0044
    Method
    		 LS mean differnece (SE)
    Parameter type
    		 LS mean differnce (SE)
    Point estimate
    3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 6.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.35

    Secondary: Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) score as compared to placebo.

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    End point title
    		 Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) score as compared to placebo.
    End point description
    CGAS Score: changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    		 Luradisone Placebo
    Number of subjects analysed
    173
    170
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    48.8 ± 8.73
    49.5 ± 6.99
        week 6
    14 ± 0.96
    9.3 ± 0.99
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
    Comparison groups
    Luradisone v Placebo
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 LS mean differnece (SE)
    Parameter type
    		 LS mean differnce (SE)
    Point estimate
    4.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.4
         upper limit
    		 7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.19

    Secondary: Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) score as compared to placebo.

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    End point title
    		 Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) score as compared to placebo.
    End point description
    ADHD-RS total score: changes from baseline over time -ANCOVA LS Mean and SE for change from baseline are based on ANCOVA
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    		 Luradisone Placebo
    Number of subjects analysed
    173
    167
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    11.8 ± 10.85
    12.3 ± 11.62
        week 6
    -2.6 ± 7.26
    -2 ± 7.61
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
    Comparison groups
    Luradisone v Placebo
    Number of subjects included in analysis
    340
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3715
    Method
    		 ANCOVA
    Parameter type
    		 LS mean differnce (SE)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.77

    Secondary: Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score

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    End point title
    		 Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score
    End point description
    Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    		 Luradisone Placebo
    Number of subjects analysed
    173
    170
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    4.6 ± 0.65
    4.5 ± 0.57
        week 6
    -1.49 ± 0.085
    -1.05 ± 0.087
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Luradisone v Placebo
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 LS mean differnece (SE)
    Parameter type
    		 LS mean differnce (SE)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.66
         upper limit
    		 -0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.112
    Notes
    [1] - LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind st
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Luradisone
    Reporting group description
    		 Luradisone 20- 80 mg administered once daily Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered once daily Placebo: Placebo Comparator once daily

    Serious adverse events
    		 Luradisone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 175 (1.14%)
    4 / 172 (2.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    humerus fracture
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    abortion spontaneous
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar I disorder
         subjects affected / exposed
    1 / 175 (0.57%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    depression
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    psychotic disorder
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Luradisone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    112 / 175 (64.00%)
    75 / 172 (43.60%)
    Investigations
    weight increased
         subjects affected / exposed
    12 / 175 (6.86%)
    3 / 172 (1.74%)
         occurrences all number
    12
    3
    Nervous system disorders
    headache
         subjects affected / exposed
    25 / 175 (14.29%)
    26 / 172 (15.12%)
         occurrences all number
    30
    38
    somnolence
         subjects affected / exposed
    16 / 175 (9.14%)
    8 / 172 (4.65%)
         occurrences all number
    20
    9
    dizziness
         subjects affected / exposed
    10 / 175 (5.71%)
    8 / 172 (4.65%)
         occurrences all number
    12
    8
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    28 / 175 (16.00%)
    10 / 172 (5.81%)
         occurrences all number
    35
    13
    vomiting
         subjects affected / exposed
    11 / 175 (6.29%)
    6 / 172 (3.49%)
         occurrences all number
    15
    8
    Psychiatric disorders
    insomnia
         subjects affected / exposed
    9 / 175 (5.14%)
    4 / 172 (2.33%)
         occurrences all number
    9
    4
    Infections and infestations
    nasopharyngitis
         subjects affected / exposed
    7 / 175 (4.00%)
    10 / 172 (5.81%)
         occurrences all number
    7
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2014
    AMENDMENT 2 INCLUDED THE FOLLOWING CHANGES: • Revise the description of select scales used in the protocol. • Clarify ADHD medication usage. • Clarify stimulant usage status in respect to the statistical analysis. • Update of Appendix G, Protocol Exclusion Criterion #7 CDRS-R Reference Chart.
    19 Mar 2014
    AMENDMENT 1 INCLUDED THE FOLLOWING CHANGES: • Removal of the YMRS assessment from the follow-up visit. • Update of Appendix G, Protocol Exclusion Criterion #7 CDRS-R Reference Chart.
    29 Apr 2014
    AMENDMENT 3 INCLUDED THE FOLLOWING CHANGES: •Clarify the criteria for hospitalization and discharge. •Clarify ADHD medication usage. •Clarify age inclusion criterion. •Clarify diagnosis exclusion criterion. •Clarify suicidal ideation exclusion criterion. •Clarify Type 2 diabetes exclusion criterion.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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