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    Clinical Trial Results:
    A THREE YEAR, PROSPECTIVE, OPEN-LABEL, STUDY TO EVALUATE CLINICAL EFFICACY, SAFETY AND TOLERABILITY OF ATORVASTATIN IN CHILDREN AND ADOLESCENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

    Summary
    EudraCT number
    		 2008-006130-95
    Trial protocol
    		 ES   HU   BE   IT   DE   GR   SK   Outside EU/EEA  
    Global end of trial date
    08 Oct 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 May 2016
    First version publication date
    25 Jun 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Reporting periods and duplicate Adverse Events in their data.

    Trial information

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    Trial identification
    Sponsor protocol code
    A2581173
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00827606
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 00 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 00 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000073-PIP01-07
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize long-term (three year) descriptive growth development (i.e., height, weight, body mass index, Tanner Stage) in pediatric subjects with heterozygous familial hypercholesterolemia (HeFH) receiving atorvastatin treatment. To characterize long-term, three year descriptive efficacy (low-density lipoprotein cholesterol [LDL-C], total cholesterol [TC], triglycerides [TG], high-density lipoprotein [HDL], very low-density lipoprotein [VLDL], apolipoprotein A-1 [Apo A-1], apolipoprotein B [Apo B]), tolerability and safety in pediatric subjects with HeFH receiving atorvastatin treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2009
    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
    Switzerland: 8
    Country: Number of subjects enrolled
    Norway: 25
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Slovakia: 16
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Belgium: 16
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Greece: 40
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Canada: 27
    Country: Number of subjects enrolled
    United States: 50
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Turkey: 18
    Worldwide total number of subjects
    271
    EEA total number of subjects
    162
    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)
    177
    Adolescents (12-17 years)
    94
    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
    		 -

    Pre-assignment
    Screening details
    		 The study started on 30 March 2009 and ended on 08 October 2013 in Belgium, Canada, Switzerland, Germany, Spain, Greece, Hungry, Italy, Norway, Poland , Russian Federation, Slovakia, Turkey, United States.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atorvastatin (5-80 mg): Tanner_Stage 1
    Arm description
    		 Subjects aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (PO), through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 millimoles per liter [mmol/L]) was not attained.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Initial dose of 5 mg/day of atorvastatin was administered PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day)

    Arm title
    		 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Arm description
    		 Subjects aged greater than or equal to (≥) 10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Initial dose of 10 mg/day of atorvastatin was administered PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day).

    Number of subjects in period 1
    		Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Started
    139
    132
    Completed
    112
    94
    Not completed
    27
    38
         Consent withdrawn by subject
    7
    6
         Adverse events
    4
    2
         Protocol violation
    4
    3
         Not specified
    5
    13
         Pregnancy
    -
    1
         Lost to follow-up
    3
    1
         LDL below 2.59 mmol/L
    4
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atorvastatin (5-80 mg): Tanner_Stage 1
    Reporting group description
    		 Subjects aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (PO), through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 millimoles per liter [mmol/L]) was not attained.

    Reporting group title
    Atorvastatin (10-80 mg): Tanner_Stage 2+
    Reporting group description
    		 Subjects aged greater than or equal to (≥) 10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Reporting group values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+ Total
    Number of subjects
    		 139 132 271
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.5 ( 1.86 ) 12 ( 1.68 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 79 125
        Male
    		 93 53 146

    End points

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    End points reporting groups
    Reporting group title
    Atorvastatin (5-80 mg): Tanner_Stage 1
    Reporting group description
    		 Subjects aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (PO), through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 millimoles per liter [mmol/L]) was not attained.

    Reporting group title
    Atorvastatin (10-80 mg): Tanner_Stage 2+
    Reporting group description
    		 Subjects aged greater than or equal to (≥) 10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Subject analysis set title
    Atorvastatin (10-80 mg): Baseline Tanner_Stage 4
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged ≥10 to 15 years, at Tanner_Stage 4 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Subject analysis set title
    Atorvastatin (10-80 mg): Baseline Tanner_Stage 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged ≥10 to 15 years, at Tanner_Stage 3 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Subject analysis set title
    Atorvastatin (10-80 mg): Baseline Tanner_Stage 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged ≥10 to 15 years, at Tanner_Stage 2 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Subject analysis set title
    Atorvastatin (10-80 mg): Baseline Tanner_Stage 5
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged ≥10 to 15 years, at Tanner_Stage 5 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Subject analysis set title
    Atorvastatin (5-80 mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Subjects aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Primary: Low Density Lipoprotein Cholesterol (LDL-C; millimoles per liter [mmol/L]) During the Study

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    End point title
    		 Low Density Lipoprotein Cholesterol (LDL-C; millimoles per liter [mmol/L]) During the Study [1]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. Full analysis set (FAS); n (number) equals (=) number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
    Notes
    [1] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    139
    132
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline (n=139,132)
    6.304 ( 1.313 )
    5.921 ( 1.1646 )
        Month 1 (n=131,130)
    4.087 ( 1.0264 )
    3.675 ( 0.8749 )
        Change at Month 1 (n=131,130)
    -2.214 ( 0.7568 )
    -2.233 ( 0.8009 )
        Month 2 (n=132,122)
    3.719 ( 0.8346 )
    3.437 ( 0.7438 )
        Change at Month 2 (n=132,122)
    -2.586 ( 0.9297 )
    -2.554 ( 0.9155 )
        Month 3 (n=126,117)
    3.503 ( 0.7566 )
    3.27 ( 0.6533 )
        Change at Month 3 (n=126,117)
    -2.798 ( 1.0251 )
    -2.795 ( 1.0835 )
        Month 6 (n=127,115)
    3.366 ( 0.5787 )
    3.347 ( 0.5953 )
        Change at Month 6 (n=127,115)
    -2.968 ( 1.1096 )
    -2.732 ( 1.066 )
        Month 12 (n=121,109)
    3.409 ( 0.7395 )
    3.196 ( 0.6565 )
        Change at Month 12 (n=121,109)
    -2.966 ( 1.0987 )
    -2.838 ( 1.145 )
        Month 18 (n=116,101)
    3.309 ( 0.5933 )
    3.261 ( 0.5288 )
        Change at Month 18 (n=116,101)
    -3.105 ( 1.1558 )
    -2.835 ( 1.2128 )
        Month 24 (n=111,96)
    3.316 ( 0.6803 )
    3.189 ( 0.6537 )
        Change at Month 24 (n=111,96)
    -3.088 ( 1.2026 )
    -2.933 ( 1.2292 )
        Month 30 (n=112,94)
    3.335 ( 0.649 )
    3.142 ( 0.6916 )
        Change at Month 30 (n=112,94)
    -3.09 ( 1.2402 )
    -3.008 ( 1.1489 )
        Month 36/ET (n=123,117)
    3.45 ( 0.7372 )
    3.457 ( 0.8808 )
        Change at Month 36/ET (n=123,117)
    -2.855 ( 1.2625 )
    -2.468 ( 1.327 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in LDL-C

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    End point title
    		 Percent Change from Baseline in LDL-C [2]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)
    Notes
    [2] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    132
    130
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=131,130)
    -34.995 ( 9.73 )
    -37.516 ( 10.0245 )
        Month 2 (n=132,122)
    -40.371 ( 9.6468 )
    -41.939 ( 10.4816 )
        Month 3 (n=126,117)
    -43.568 ( 10.2149 )
    -44.887 ( 12.753 )
        Month 6 (n=127,115)
    -45.647 ( 9.6969 )
    -43.697 ( 11.1836 )
        Month 12 (n=121,109)
    -45.53 ( 10.5112 )
    -45.727 ( 13.5336 )
        Month 18 (n=116,101)
    -47.101 ( 10.5592 )
    -44.818 ( 13.2623 )
        Month 24 (n=111,96)
    -46.944 ( 11.949 )
    -46.417 ( 13.8658 )
        Month 30 (n=112,94)
    -46.631 ( 12.0206 )
    -47.734 ( 12.6696 )
        Month 36/ET (n=123,117)
    -43.785 ( 13.5585 )
    -39.863 ( 17.5411 )
    No statistical analyses for this end point

    Primary: High-Density Lipoprotein Cholesterol (HDL-C; mmol/L) During the Study

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    End point title
    		 High-Density Lipoprotein Cholesterol (HDL-C; mmol/L) During the Study [3]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [3] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    139
    132
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline (n=139,132)
    1.349 ( 0.2732 )
    1.277 ( 0.2546 )
        Month 1 (n=131,130)
    1.36 ( 0.2717 )
    1.292 ( 0.265 )
        Change at Month 1 (n=131,130)
    0.01 ( 0.1685 )
    0.016 ( 0.174 )
        Month 2 (n=132,122)
    1.364 ( 0.2805 )
    1.297 ( 0.2625 )
        Change at Month 2 (n=132,122)
    0.014 ( 0.2238 )
    0.025 ( 0.16 )
        Month 3 (n=126,117)
    1.371 ( 0.2768 )
    1.274 ( 0.2606 )
        Change at Month 3 (n=126,117)
    0.015 ( 0.1943 )
    0.011 ( 0.1837 )
        Month 6 (n=127,115)
    1.337 ( 0.2834 )
    1.268 ( 0.2311 )
        Change at Month 6 (n=127,115)
    -0.011 ( 0.1848 )
    0.01 ( 0.1833 )
        Month 12 (n=121,109)
    1.328 ( 0.2885 )
    1.241 ( 0.2429 )
        Change at Month 12 (n=121,109)
    -0.012 ( 0.1945 )
    -0.023 ( 0.1727 )
        Month 18 (n=116,102)
    1.367 ( 0.3003 )
    1.234 ( 0.2349 )
        Change at Month 18 (n=116,102)
    0.024 ( 0.1923 )
    -0.027 ( 0.1744 )
        Month 24 (n=111,96)
    1.385 ( 0.2729 )
    1.266 ( 0.2443 )
        Change at Month 24 (n=111,96)
    0.027 ( 0.2043 )
    0.007 ( 0.191 )
        Month 30 (n=112,94)
    1.38 ( 0.2942 )
    1.265 ( 0.2487 )
        Change at Month 30 (n=112,94)
    0.032 ( 0.1997 )
    0.006 ( 0.215 )
        Month 36/ET (n=123,117)
    1.335 ( 0.2918 )
    1.278 ( 0.2516 )
        Change at Month 36/ET (n=123,117)
    -0.024 ( 0.1949 )
    0.005 ( 0.1975 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in HDL-C

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    End point title
    		 Percent Change from Baseline in HDL-C [4]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [4] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    132
    130
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=131,130)
    1.526 ( 12.7845 )
    2.192 ( 14.0769 )
        Month 2 (n=132,122)
    2.195 ( 15.6882 )
    2.544 ( 12.7802 )
        Month 3 (n=126,117)
    1.929 ( 14.7329 )
    1.674 ( 14.9525 )
        Month 6 (n=127,115)
    -0.016 ( 14.8853 )
    1.877 ( 14.9113 )
        Month 12 (n=121,109)
    -0.069 ( 15.2821 )
    -1.023 ( 14.1983 )
        Month 18 (n=116,102)
    2.472 ( 14.8939 )
    -1.165 ( 14.3783 )
        Month 24 (n=111,96)
    3.014 ( 14.9559 )
    1.737 ( 15.6924 )
        Month 30 (n=112,94)
    3.345 ( 15.508 )
    1.868 ( 17.2633 )
        Month 36/ET (n=123,117)
    -1.125 ( 14.7816 )
    1.602 ( 15.4895 )
    No statistical analyses for this end point

    Primary: Total Cholesterol (mmol/L) During the Study

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    End point title
    		 Total Cholesterol (mmol/L) During the Study [5]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [5] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    139
    132
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline (n=139,132)
    8.056 ( 1.3356 )
    7.647 ( 1.225 )
        Month 1 (n=134,131)
    5.785 ( 1.0497 )
    5.352 ( 0.9345 )
        Change at Month 1 (n=134,131)
    -2.266 ( 0.7957 )
    -2.297 ( 0.8516 )
        Month 2 (n=132,124)
    5.435 ( 0.8629 )
    5.061 ( 0.7865 )
        Change at Month 2 (n=132,124)
    -2.62 ( 0.9581 )
    -2.654 ( 0.9707 )
        Month 3 (n=127,118)
    5.195 ( 0.8 )
    4.883 ( 0.7034 )
        Change at Month 3 (n=127,118)
    -2.869 ( 1.0904 )
    -2.883 ( 1.1363 )
        Month 6 (n=127,115)
    5.019 ( 0.638 )
    4.982 ( 0.662 )
        Change at Month 6 (n=127,115)
    -3.063 ( 1.1687 )
    -2.809 ( 1.1133 )
        Month 12 (n=121,109)
    5.081 ( 0.747 )
    4.799 ( 0.7176 )
        Change at Month 12 (n=121,109)
    -3.04 ( 1.1353 )
    -2.945 ( 1.2112 )
        Month 18 (n=116,101)
    4.989 ( 0.6512 )
    4.845 ( 0.5401 )
        Change at Month 18 (n=116,101)
    -3.168 ( 1.199 )
    -2.965 ( 1.2667 )
        Month 24 (n=111,96)
    5.032 ( 0.7111 )
    4.817 ( 0.7413 )
        Change at Month 24 (n=111,96)
    -3.123 ( 1.2039 )
    -3.009 ( 1.2871 )
        Month 30 (n=112,95)
    5.075 ( 0.6951 )
    4.795 ( 0.8256 )
        Change at Month 30 (n=112,95)
    -3.096 ( 1.2999 )
    -3.048 ( 1.2716 )
        Month 36/ET (n=123,117)
    5.134 ( 0.7863 )
    5.099 ( 0.9318 )
        Change at Month 36/ET (n=123,117)
    -2.923 ( 1.3256 )
    -2.543 ( 1.3669 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Total Cholesterol

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    End point title
    		 Percent Change from Baseline in Total Cholesterol [6]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [6] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    134
    131
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=134,131)
    -27.879 ( 8.2639 )
    -29.653 ( 8.5987 )
        Month 2 (n=132,124)
    -31.9 ( 8.5025 )
    -33.726 ( 9.2319 )
        Month 3 (n=127,118)
    -34.784 ( 9.4141 )
    -36.126 ( 11.0136 )
        Month 6 (n=127,115)
    -36.889 ( 9.2297 )
    35.055 ( 10.0273 )
        Month 12 (n=121,109)
    -36.541 ( 9.2486 )
    -36.943 ( 11.9418 )
        Month 18 (n=116,101)
    -37.772 ( 9.7325 )
    -36.634 ( 11.4572 )
        Month 24 (n=111,96)
    -37.287 ( 9.9578 )
    -37.317 ( 12.2461 )
        Month 30 (n=112,95)
    -36.662 ( 11.2064 )
    -37.856 ( 12.5116 )
        Month 36/ET (n=123,117)
    -35.063 ( 12.0345 )
    -32.013 ( 14.5 )
    No statistical analyses for this end point

    Primary: Trigylcerides (mmol/L) During the Study

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    End point title
    		 Trigylcerides (mmol/L) During the Study [7]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [7] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    139
    132
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline (n=139,132)
    0.88 ( 0.4343 )
    0.98 ( 0.4986 )
        Month 1 (n=134,131)
    0.759 ( 0.3958 )
    0.815 ( 0.3848 )
        Change at Month 1 (n=134,131)
    -0.121 ( 0.3895 )
    -0.166 ( 0.5024 )
        Month 2 (n=132,124)
    0.772 ( 0.3837 )
    0.741 ( 0.3382 )
        Change at Month 2 (n=132,124)
    -0.103 ( 0.3652 )
    -0.246 ( 0.4825 )
        Month 3 (n=127,118)
    0.699 ( 0.2916 )
    0.748 ( 0.3357 )
        Change at Month 3 (n=127,118)
    -0.166 ( 0.3937 )
    -0.237 ( 0.4466 )
        Month 6 (n=127,115)
    0.691 ( 0.3602 )
    0.801 ( 0.3848 )
        Change at Month 6 (n=127,115)
    -0.183 ( 0.4305 )
    -0.188 ( 0.488 )
        Month 12 (n=121,109)
    -0.747 ( 0.3901 )
    0.789 ( 0.405 )
        Change at Month 12 (n=121,109)
    -0.136 ( 0.406 )
    -0.181 ( 0.5255 )
        Month 18 (n=116,102)
    0.687 ( 0.3435 )
    0.765 ( 0.3438 )
        Change at Month 18 (n=116,102)
    -0.19 ( 0.3665 )
    -0.219 ( 0.4623 )
        Month 24 (n=111,96)
    0.725 ( 0.3676 )
    0.79 ( 0.3651 )
        Change at Month 24 (n=111,96)
    -0.133 ( 0.4112 )
    -0.179 ( 0.4956 )
        Month 30 (n=112,95)
    0.788 ( 0.3454 )
    0.781 ( 0.4167 )
        Change at Month 30 (n=112,95)
    -0.082 ( 0.3898 )
    -0.187 ( 0.5728 )
        Month 36/ET (n=123,117)
    0.764 ( 0.422 )
    0.794 ( 0.3894 )
        Change at Month 36/ET (n=123,117)
    -0.092 ( 0.4615 )
    -0.171 ( 0.5216 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Trigylcerides

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    End point title
    		 Percent Change from Baseline in Trigylcerides [8]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [8] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    134
    131
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=134,131)
    -5.95 ( 39.0995 )
    -5.927 ( 51.1811 )
        Month 2 (n=132,124)
    -3.26 ( 42.5136 )
    -14.832 ( 40.4952 )
        Month 3 (n=127,118)
    -8.76 ( 41.1184 )
    -14.415 ( 39.9951 )
        Month 6 (n=127,115)
    -11.817 ( 41.9879 )
    -9.097 ( 43.035 )
        Month 12 (n=121,109)
    -7.981 ( 40.4511 )
    -7.95 ( 48.7238 )
        Month 18 (n=116,102)
    -13.113 ( 39.399 )
    -12.443 ( 37.3822 )
        Month 24 (n=111,96)
    -6.697 ( 38.7027 )
    -7.328 ( 45.3694 )
        Month 30 (n=112,95)
    0.657 ( 43.3886 )
    -4.935 ( 63.1887 )
        Month 36/ET (n=123,117)
    -0.703 ( 50.6333 )
    -7.759 ( 45.6372 )
    No statistical analyses for this end point

    Primary: Very Low-Density Lipoprotein (VLDL; mmol/L) During the Study

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    End point title
    		 Very Low-Density Lipoprotein (VLDL; mmol/L) During the Study [9]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [9] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    139
    132
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline (n=139,132)
    0.403 ( 0.1993 )
    0.449 ( 0.2288 )
        Month 1 (n=134,131)
    0.348 ( 0.1823 )
    0.374 ( 0.177 )
        Change at Month 1 (n=134,131)
    -0.056 ( 0.1793 )
    -0.076 ( 0.2307 )
        Month 2 (n=132,124)
    0.354 ( 0.1757 )
    0.34 ( 0.1541 )
        Change at Month 2 (n=132,124)
    -0.047 ( 0.1672 )
    -0.113 ( 0.2215 )
        Month 3 (n=127,118)
    0.32 ( 0.1333 )
    0.344 ( 0.1548 )
        Change at Month 3 (n=127,118)
    -0.076 ( 0.1805 )
    -0.108 ( 0.2044 )
        Month 6 (n=127,115)
    0.317 ( 0.1652 )
    0.367 ( 0.1767 )
        Change at Month 6 (n=127,115)
    -0.084 ( 0.1977 )
    -0.086 ( 0.224 )
        Month 12 (n=121,109)
    0.343 ( 0.1786 )
    0.362 ( 0.1862 )
        Change at Month 12 (n=121,109)
    -0.062 ( 0.1872 )
    -0.082 ( 0.2421 )
        Month 18 (n=116,101)
    0.315 ( 0.1571 )
    0.349 ( 0.1571 )
        Change at Month 18 (n=116,101)
    -0.087 ( 0.168 )
    -0.102 ( 0.2126 )
        Month 24 (n=111,96)
    0.332 ( 0.168 )
    0.363 ( 0.168 )
        Change at Month 24 (n=111,96)
    -0.061 ( 0.1887 )
    -0.081 ( 0.2285 )
        Month 30 (n=112,95)
    0.361 ( 0.1581 )
    0.358 ( 0.1914 )
        Change at Month 30 (n=112,95)
    -0.038 ( 0.1781 )
    -0.086 ( 0.2621 )
        Month 36/ET (n=123,117)
    0.35 ( 0.193 )
    0.364 ( 0.1782 )
        Change at Month 36/ET (n=123,117)
    -0.042 ( 0.2112 )
    -0.079 ( 0.2385 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in VLDL

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    End point title
    		 Percent Change from Baseline in VLDL [10]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [10] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    134
    131
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=134,131)
    -6.06 ( 39.33 )
    -5.805 ( 51.7264 )
        Month 2 (n=132,124)
    -3.097 ( 42.3626 )
    -14.694 ( 40.171 )
        Month 3 (n=127,118)
    -8.711 ( 41.2631 )
    -14.263 ( 39.7239 )
        Month 6 (n=127,115)
    -11.591 ( 42.4219 )
    -9.158 ( 43.1397 )
        Month 12 (n=121,109)
    -7.739 ( 40.7579 )
    -7.827 ( 48.9819 )
        Month 18 (n=116,101)
    -12.911 ( 39.7908 )
    -12.768 ( 37.4142 )
        Month 24 (n=111,96)
    -6.654 ( 38.7945 )
    -6.92 ( 46.3317 )
        Month 30 (n=112,95)
    0.627 ( 43.6239 )
    -4.751 ( 64.2502 )
        Month 36/ET (n=123,117)
    -0.52 ( 51.3422 )
    -7.842 ( 45.464 )
    No statistical analyses for this end point

    Primary: Apolipoprotein A-1 (Apo A-1; grams per liter [g/L]) During the Study

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    End point title
    		 Apolipoprotein A-1 (Apo A-1; grams per liter [g/L]) During the Study [11]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [11] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    138
    132
    Units: g/L
    arithmetic mean (standard deviation)
        Baseline (n=138,132)
    1.396 ( 0.1839 )
    1.308 ( 0.2006 )
        Month 1 (n=132,130)
    1.419 ( 0.2233 )
    1.337 ( 0.1927 )
        Change at Month 1 (n=132,130)
    0.025 ( 0.1639 )
    0.032 ( 0.1506 )
        Month 2 (n=131,123)
    1.411 ( 0.1952 )
    1.334 ( 0.195 )
        Change at Month 2 (n=131,123)
    0.016 ( 0.1519 )
    0.025 ( 0.1355 )
        Month 3 (n=126,117)
    1.405 ( 0.1914 )
    1.306 ( 0.1919 )
        Change at Month 3 (n=126,117)
    0.005 ( 0.1713 )
    0.006 ( 0.1557 )
        Month 6 (n=123,110)
    1.386 ( 0.2081 )
    1.329 ( 0.1894 )
        Change at Month 6 (n=123,110)
    -0.007 ( 0.1609 )
    0.026 ( 0.1818 )
        Month 12 (n=120,108)
    1.347 ( 0.1893 )
    1.271 ( 0.1798 )
        Change at Month 12 (n=120,108)
    -0.041 ( 0.1574 )
    -0.028 ( 0.1586 )
        Month 18 (n=114,100)
    1.339 ( 0.1972 )
    1.266 ( 0.1676 )
        Change at Month 18 (n=114,100)
    -0.049 ( 0.1558 )
    -0.038 ( 0.1643 )
        Month 24 (n=113,95)
    1.364 ( 0.1929 )
    1.275 ( 0.1736 )
        Change at Month 24 (n=113,95)
    -0.032 ( 0.1749 )
    -0.027 ( 0.1799 )
        Month 30 (n=112,95)
    1.357 ( 0.2247 )
    1.268 ( 0.1848 )
        Change at Month 30 (n=112,95)
    -0.04 ( 0.1857 )
    -0.036 ( 0.1861 )
        Month 36/ET (n=125,118)
    1.327 ( 0.2081 )
    1.272 ( 0.1664 )
        Change at Month 36/ET (n=125,118)
    -0.073 ( 0.1725 )
    -0.04 ( 0.1676 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Apolipoprotein (Apo A-1)

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    End point title
    		 Percent Change from Baseline in Apolipoprotein (Apo A-1) [12]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [12] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    132
    130
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=132,130)
    2.229 ( 12.4001 )
    3.301 ( 12.2009 )
        Month 2 (n=131,123)
    1.701 ( 11.0364 )
    2.499 ( 10.7656 )
        Month 3 (n=126,117)
    1.041 ( 12.4204 )
    1.192 ( 12.164 )
        Month 6 (n=123,110)
    -0.069 ( 12.1109 )
    3.011 ( 14.1347 )
        Month 12 (n=120,108)
    -2.365 ( 11.5882 )
    -1.37 ( 12.3901 )
        Month 18 (n=114,100)
    -3.042 ( 11.2219 )
    -1.98 ( 12.217 )
        Month 24 (n=113,95)
    -1.611 ( 12.4618 )
    -0.961 ( 13.9868 )
        Month 30 (n=112,95)
    -2.342 ( 13.3357 )
    -1.695 ( 14.2732 )
        Month 36/ET (n=125,118)
    -4.804 ( 12.0443 )
    -1.954 ( 12.7229 )
    No statistical analyses for this end point

    Primary: Apolipoprotein B (Apo B; g/L) During the Study

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    End point title
    		 Apolipoprotein B (Apo B; g/L) During the Study [13]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [13] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    138
    132
    Units: g/L
    arithmetic mean (standard deviation)
        Baseline (n=138,132)
    1.454 ( 0.289 )
    1.381 ( 0.2619 )
        Month 1 (n=132,130)
    1.062 ( 0.2423 )
    0.967 ( 0.2257 )
        Change at Month 1 (n=132,130)
    -0.395 ( 0.1599 )
    -0.415 ( 0.1691 )
        Month 2 (n=131,123)
    0.98 ( 0.1929 )
    0.916 ( 0.1813 )
        Change at Month 2 (n=131,123)
    -0.471 ( 0.1825 )
    -0.484 ( 0.1858 )
        Month 3 (n=126,117)
    0.93 ( 0.1836 )
    0.89 ( 0.1707 )
        Change at Month 3 (n=126,117)
    -0.522 ( 0.2152 )
    -0.518 ( 0.2184 )
        Month 6 (n=123,110)
    0.919 ( 0.1557 )
    0.91 ( 0.1683 )
        Change at Month 6 (n=123,110)
    -0.535 ( 0.2092 )
    -0.503 ( 0.2086 )
        Month 12 (n=120,108)
    0.918 ( 0.1816 )
    0.871 ( 0.1493 )
        Change at Month 12 (n=120,108)
    -0.548 ( 0.2131 )
    -0.53 ( 0.2194 )
        Month 18 (n=114,100)
    0.893 ( 0.1546 )
    0.882 ( 0.1293 )
        Change at Month 18 (n=114,100)
    -0.578 ( 0.2343 )
    -0.533 ( 0.2463 )
        Month 24 (n=113,95)
    0.918 ( 0.1719 )
    0.884 ( 0.1575 )
        Change at Month 24 (n=113,95)
    -0.551 ( 0.2353 )
    -0.535 ( 0.2344 )
        Month 30 (n=112,95)
    0.91 ( 0.1723 )
    0.885 ( 0.1717 )
        Change at Month 30 (n=112,95)
    -0.56 ( 0.2664 )
    -0.533 ( 0.2467 )
        Month 36/ET (n=125,118)
    0.926 ( 0.186 )
    0.924 ( 0.2173 )
        Change at Month 36/ET (n=125,118)
    -0.52 ( 0.273 )
    -0.45 ( 0.2748 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Apolipoprotein B (Apo B)

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    End point title
    		 Percent Change from Baseline in Apolipoprotein B (Apo B) [14]
    End point description
    Assessments were performed in the fasting state (minimum 10-hour fast). FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [14] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    132
    130
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=132,130)
    -26.933 ( 9.555 )
    -29.851 ( 10.3544 )
        Month 2 (n=131,123)
    -31.867 ( 9.2821 )
    -33.959 ( 9.9478 )
        Month 3 (n=126,117)
    -35.163 ( 10.568 )
    -35.849 ( 11.6832 )
        Month 6 (n=123,110)
    -35.9 ( 9.3398 )
    -34.74 ( 10.7982 )
        Month 12 (n=120,108)
    -36.624 ( 9.7413 )
    -36.842 ( 11.6106 )
        Month 18 (n=114,100)
    -38.158 ( 10.4084 )
    -36.211 ( 12.7805 )
        Month 24 (n=113,95)
    -36.426 ( 11.4333 )
    -36.677 ( 12.1824 )
        Month 30 (n=112,95)
    -36.668 ( 12.8783 )
    -36.453 ( 13.6888 )
        Month 36/ET (n=125,118)
    -34.507 ( 14.074 )
    -31.362 ( 16.477 )
    No statistical analyses for this end point

    Primary: Number of Subjects with Shift from Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage

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    End point title
    		 Number of Subjects with Shift from Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage [15] [16]
    End point description
    Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit. FAS; n=number of subjects assessed for the specific parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 6, 12, 18, 24, 30, and 36/ET
    Notes
    [15] - 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: Only descriptive data was planned to be reported for this endpoint.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for prespecified reporting groups of interest as Tanner Stage 2, 3, 4, 5 separately instead of Tanner_Stage 2+ (combined).
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 Atorvastatin (10-80 mg): Baseline Tanner_Stage 2 Atorvastatin (10-80 mg): Baseline Tanner_Stage 5
    Number of subjects analysed
    127
    31
    25
    52
    18
    Units: subjects
        Tanner_Stage 1, Month 6 (n=126,48,25,27,15)
    107
    0
    0
    0
    0
        Tanner_Stage 2 , Month 6 (n=126,48,25,27,15)
    14
    0
    0
    34
    0
         Tanner_Stage 3, Month 6 (n=126,48,25,27,15)
    5
    0
    14
    10
    0
         Tanner_Stage 4, Month 6 (n=126,48,25,27,15)
    0
    25
    11
    4
    1
         Tanner_Stage 5, Month 6 (n=126,48,25,27,15)
    0
    2
    0
    0
    14
         Tanner_Stage 1, Month 12 (n=121,43,23,26,15)
    85
    0
    0
    0
    0
        Tanner_Stage 2, Month 12 (n=121,43,23,26,15)
    25
    0
    0
    17
    0
         Tanner_Stage 3, Month 12 (n=121,43,23,26,15)
    10
    0
    11
    21
    0
        Tanner_Stage 4, Month 12 (n=121,43,23,26,15)
    1
    22
    10
    5
    1
         Tanner_Stage 5, Month 12 (n=121,43,23,26,15)
    0
    4
    2
    0
    14
        Tanner_Stage 1, Month 18 (n=115,41, 21,25,14)
    63
    0
    0
    0
    0
         Tanner_Stage 2, Month 18 (n=115,41, 21,25,14)
    31
    0
    0
    15
    0
         Tanner_Stage 3, Month 18 (n=115,41, 21,25,14)
    18
    0
    6
    16
    0
         Tanner_Stage 4, Month 18 (n=115,41, 21,25,14)
    3
    18
    11
    9
    1
        Tanner_Stage 5, Month 18 (n=115,41, 21,25,14)
    0
    7
    4
    1
    13
        Tanner_Stage 1, Month 24 (n=113,38,19,22,14)
    51
    0
    0
    0
    0
        Tanner_Stage 2, Month 24 (n=113,38,19,22,14)
    33
    0
    0
    9
    0
        Tanner_Stage 3, Month 24 (n=113,38,19,22,14)
    20
    0
    2
    14
    0
        Tanner_Stage 4, Month 24 (n=113,38,19,22,14)
    9
    13
    13
    12
    1
        Tanner_Stage 5, Month 24 (n=113,38,19,22,14)
    0
    9
    4
    3
    13
        Tanner_Stage 1, Month 30 (n=111,38,19,23,14)
    39
    0
    0
    0
    0
        Tanner_Stage 2, Month 30 (n=111,38,19,23,14)
    32
    0
    0
    3
    0
        Tanner_Stage 3, Month 30 (n=111,38,19,23,14)
    26
    0
    1
    11
    0
        Tanner_Stage 4, Month 30 (n=111,38,19,23,14)
    14
    11
    9
    18
    1
        Tanner_Stage 5, Month 30 (n=111,38,19,23,14)
    0
    12
    9
    6
    13
        Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18)
    41
    0
    0
    0
    0
        Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18)
    31
    0
    0
    6
    0
        Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18)
    25
    0
    2
    10
    0
        Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18)
    25
    12
    13
    24
    0
        Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18)
    5
    19
    10
    12
    18
    No statistical analyses for this end point

    Primary: Height (centimeters [cm]) During the Study: Males

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    End point title
    		 Height (centimeters [cm]) During the Study: Males [17]
    End point description
    Investigator assessment of height changes during the study. Change from baseline was also determined. FAS; only male subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [17] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    146
    Units: cm
    arithmetic mean (standard deviation)
        Baseline (n=146)
    144.36 ( 16.004 )
        Month 1 (n=141)
    145.21 ( 16.114 )
        Change at Month 1 (n=141)
    0.68 ( 0.964 )
        Month 2 (n=138)
    145.93 ( 16.302 )
        Change at Month 2 (n=138)
    1.27 ( 0.964 )
        Month 3 (n=133)
    146 ( 16.139 )
        Change at Month 3 (n=133)
    1.72 ( 1.172 )
        Month 6 (n=129)
    147.17 ( 16.033 )
        Change at Month 6 (n=129)
    3.24 ( 1.485 )
        Month 12 (n=123)
    150.75 ( 16.321 )
        Change at Month 12 (n=123)
    6.67 ( 2.385 )
        Month 18 (n=119)
    153.26 ( 16.388 )
        Change at Month 18 (n=119)
    9.31 ( 2.978 )
        Month 24 (n=114)
    156.03 ( 16.001 )
        Change at Month 24 (n=114)
    12.11 ( 3.63 )
        Month 30 (n=114)
    158.78 ( 15.77 )
        Change at Month 30 (n=114)
    14.86 ( 4.403 )
        Month 36/ET (n=134)
    160.59 ( 15.602 )
        Change at Month 36/ET (n=134)
    15.53 ( 6.801 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Height: Males

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    End point title
    		 Percent Change from Baseline in Height: Males [18]
    End point description
    Investigator assessment of height changes during the study. FAS; only male subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [18] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    141
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=141)
    0.47 ( 0.689 )
        Month 2 (n=138)
    0.88 ( 0.652 )
        Month 3 (n=133)
    1.19 ( 0.777 )
        Month 6 (n=129)
    2.25 ( 0.987 )
        Month 12 (n=123)
    4.66 ( 1.606 )
        Month 18 (n=119)
    6.53 ( 2.021 )
        Month 24 (n=114)
    8.53 ( 2.607 )
        Month 30 (n=114)
    10.49 ( 3.26 )
        Month 36/ET (n=134)
    10.97 ( 5.01 )
    No statistical analyses for this end point

    Primary: Height (cm) During the Study: Females

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    End point title
    		 Height (cm) During the Study: Females [19]
    End point description
    Investigator assessment of height changes during the study. Change from baseline was also determined. FAS; only female subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [19] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    125
    Units: cm
    arithmetic mean (standard deviation)
        Baseline (n=125)
    145.28 ( 14.108 )
        Month 1 (n=124)
    146.06 ( 14.045 )
        Change at Month 1 (n=124)
    0.71 ( 1.378 )
        Month 2 (n=119)
    146.57 ( 13.919 )
        Change at Month 2 (n=119)
    1.19 ( 1.7 )
        Month 3 (n=115)
    146.81 ( 13.838 )
        Change at Month 3 (n=115)
    1.68 ( 1.278 )
        Month 6 (n=113)
    147.87 ( 13.619 )
        Change at Month 6 (n=113)
    2.77 ( 1.72 )
        Month 12 (n=107)
    150.84 ( 12.968 )
        Change at Month 12 (n=107)
    5.5 ( 2.992 )
        Month 18 (n=99)
    152.77 ( 12.648 )
        Change at Month 18 (n=99)
    7.41 ( 4.043 )
        Month 24 (n=95)
    154.79 ( 11.913 )
        Change at Month 24 (n=95)
    9.61 ( 5.12 )
        Month 30 (n=93)
    156.43 ( 11.288 )
        Change at Month 30 (n=93)
    11.23 ( 6.118 )
        Month 36/ET (n=121)
    156.52 ( 11.032 )
        Change at Month 36/ET (n=121)
    11.23 ( 7.551 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Height: Females

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    End point title
    		 Percent Change from Baseline in Height: Females [20]
    End point description
    Investigator assessment of height changes during the study. FAS; only female subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [20] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    124
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=124)
    0.51 ( 1.004 )
        Month 2 (n=119)
    0.84 ( 1.22 )
        Month 3 (n=115)
    1.2 ( 0.925 )
        Month 6 (n=113)
    1.98 ( 1.291 )
        Month 12 (n=107)
    3.93 ( 2.262 )
        Month 18 (n=99)
    5.3 ( 3.036 )
        Month 24 (n=95)
    6.93 ( 3.933 )
        Month 30 (n=93)
    8.13 ( 4.74 )
        Month 36/ET (n=121)
    8.14 ( 5.789 )
    No statistical analyses for this end point

    Primary: Weight (kilograms [kg]) During the Study: Males

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    End point title
    		 Weight (kilograms [kg]) During the Study: Males [21]
    End point description
    Investigator assessment of weight changes during the study. Change from baseline was also determined. FAS; only male subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [21] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    146
    Units: kg
    arithmetic mean (standard deviation)
        Baseline (n=146)
    40.79 ( 14.079 )
        Month 1 (n=141)
    41.18 ( 14.287 )
        Change at Month 1 (n=141)
    0.36 ( 1.203 )
        Month 2 (n=138)
    41.83 ( 14.467 )
        Change at Month 2 (n=138)
    0.8 ( 1.422 )
        Month 3 (n=133)
    41.68 ( 14.266 )
        Change at Month 3 (n=133)
    1.08 ( 1.907 )
        Month 6 (n=129)
    42.47 ( 14.564 )
        Change at Month 6 (n=129)
    2 ( 2.528 )
        Month 12 (n=123)
    45.29 ( 15.526 )
        Change at Month 12 (n=123)
    4.65 ( 3.822 )
        Month 18 (n=119)
    47.53 ( 16.164 )
        Change at Month 18 (n=119)
    7.02 ( 4.432 )
        Month 24 (n=114)
    49.77 ( 16.401 )
        Change at Month 24 (n=114)
    9.27 ( 5.079 )
        Month 30 (n=114)
    52.12 ( 17.1 )
        Change at Month 30 (n=114)
    11.61 ( 6.032 )
        Month 36/ET (n=134)
    53.5 ( 16.787 )
        Change at Month 36/ET (n=134)
    12.35 ( 6.771 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Weight: Males

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    End point title
    		 Percent Change from Baseline in Weight: Males [22]
    End point description
    Investigator assessment of weight changes during the study. FAS; only male subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [22] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    141
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=141)
    0.94 ( 2.739 )
        Month 2 (n=138)
    2.04 ( 3.262 )
        Month 3 (n=133)
    2.73 ( 4.317 )
        Month 6 (n=129)
    5.09 ( 5.559 )
        Month 12 (n=123)
    11.85 ( 8.172 )
        Month 18 (n=119)
    18.03 ( 9.629 )
        Month 24 (n=114)
    24.28 ( 11.696 )
        Month 30 (n=114)
    30.46 ( 14.058 )
        Month 36/ET (n=134)
    32.54 ( 17.409 )
    No statistical analyses for this end point

    Primary: Weight (kg) During the Study: Females

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    End point title
    		 Weight (kg) During the Study: Females [23]
    End point description
    Investigator assessment of weight changes during the study. Change from baseline was also determined. FAS; only female subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [23] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    125
    Units: kg
    arithmetic mean (standard deviation)
        Baseline (n=125)
    42.14 ( 14.038 )
        Month 1 (n=125)
    42.5 ( 14.007 )
        Change at Month 1 (n=125)
    0.36 ( 0.924 )
        Month 2 (n=120)
    42.86 ( 14.209 )
        Change at Month 2 (n=120)
    0.67 ( 1.338 )
        Month 3 (n=115)
    43.34 ( 14.753 )
        Change at Month 3 (n=115)
    1.24 ( 1.819 )
        Month 6 (n=113)
    44.26 ( 15.027 )
        Change at Month 6 (n=113)
    2.1 ( 2.409 )
        Month 12 (n=107)
    46.61 ( 15.158 )
        Change at Month 12 (n=107)
    4.41 ( 3.317 )
        Month 18 (n=99)
    48.32 ( 14.67 )
        Change at Month 18 (n=99)
    6.24 ( 4.291 )
        Month 24 (n=95)
    50.13 ( 14.731 )
        Change at Month 24 (n=95)
    8.55 ( 5.038 )
        Month 30 (n=93)
    51.73 ( 14.681 )
        Change at Month 30 (n=93)
    10.02 ( 6.127 )
        Month 36/ET (n=121)
    51.55 ( 14.498 )
        Change at Month 36/ET (n=121)
    9.77 ( 7.047 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Weight: Females

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    End point title
    		 Percent Change from Baseline in Weight: Females [24]
    End point description
    Investigator assessment of weight changes during the study. FAS; only female subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [24] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    125
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=125)
    0.97 ( 2.303 )
        Month 2 (n=120)
    1.85 ( 3.206 )
        Month 3 (n=115)
    3.16 ( 4.149 )
        Month 6 (n=113)
    5.37 ( 5.529 )
        Month 12 (n=107)
    11.65 ( 8.391 )
        Month 18 (n=99)
    16.79 ( 11.315 )
        Month 24 (n=95)
    23.43 ( 14.333 )
        Month 30 (n=93)
    27.83 ( 17.507 )
        Month 36/ET (n=121)
    27.26 ( 21.389 )
    No statistical analyses for this end point

    Primary: Body Mass Index (BMI in kg per square meter [kg/m^2]) During the Study: Males

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    End point title
    		 Body Mass Index (BMI in kg per square meter [kg/m^2]) During the Study: Males [25]
    End point description
    Investigator assessment of BMI changes during the study. Change from baseline was also determined. FAS; only male subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [25] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    146
    Units: kg/m^2
    arithmetic mean (standard deviation)
        Baseline (n=146)
    18.97 ( 3.664 )
        Month 1 (n=141)
    18.94 ( 3.751 )
        Change at Month 1 (n=141)
    0.01 ( 0.577 )
        Month 2 (n=138)
    19.06 ( 3.755 )
        Change at Month 2 (n=138)
    0.06 ( 0.658 )
        Month 3 (n=133)
    18.99 ( 3.745 )
        Change at Month 3 (n=133)
    0.07 ( 0.89 )
        Month 6 (n=129)
    19.04 ( 3.881 )
        Change at Month 6 (n=129)
    0.1 ( 1.218 )
        Month 12 (n=123)
    19.34 ( 3.922 )
        Change at Month 12 (n=123)
    0.37 ( 1.541 )
        Month 18 (n=119)
    19.65 ( 4.053 )
        Change at Month 18 (n=119)
    0.73 ( 1.625 )
        Month 24 (n=114)
    19.91 ( 4.098 )
        Change at Month 24 (n=114)
    0.99 ( 1.745 )
        Month 30 (n=114)
    20.18 ( 4.4 )
        Change at Month 30 (n=114)
    1.25 ( 2.099 )
        Month 36/ET (n=134)
    20.28 ( 4.137 )
        Change at Month 36/ET (n=134)
    1.33 ( 1.958 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in BMI: Males

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    End point title
    		 Percent Change from Baseline in BMI: Males [26]
    End point description
    Investigator assessment of BMI changes during the study. FAS; only male subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [26] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    141
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=141)
    0.03 ( 2.953 )
        Month 2 (n=138)
    0.31 ( 3.405 )
        Month 3 (n=133)
    0.39 ( 4.496 )
        Month 6 (n=129)
    0.55 ( 5.673 )
        Month 12 (n=123)
    2.1 ( 7.065 )
        Month 18 (n=119)
    3.98 ( 7.533 )
        Month 24 (n=114)
    5.45 ( 8.306 )
        Month 30 (n=114)
    6.8 ( 9.737 )
        Month 36/ET (n=134)
    7.31 ( 9.29 )
    No statistical analyses for this end point

    Primary: BMI (kg/m^2) During the Study: Females

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    End point title
    		 BMI (kg/m^2) During the Study: Females [27]
    End point description
    Investigator assessment of BMI changes during the study. Change from baseline was also determined. FAS; only female subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [27] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    125
    Units: kg/m^2
    arithmetic mean (standard deviation)
        Baseline (n=125)
    19.44 ( 3.994 )
        Month 1 (n=124)
    19.45 ( 3.973 )
        Change at Month 1 (n=124)
    -0.02 ( 0.582 )
        Month 2 (n=119)
    19.47 ( 3.94 )
        Change at Month 2 (n=119)
    0 ( 0.756 )
        Month 3 (n=115)
    19.54 ( 4.171 )
        Change at Month 3 (n=115)
    0.13 ( 0.861 )
        Month 6 (n=113)
    19.68 ( 4.288 )
        Change at Month 6 (n=113)
    0.24 ( 1.004 )
        Month 12 (n=107)
    19.98 ( 4.257 )
        Change at Month 12 (n=107)
    0.6 ( 1.305 )
        Month 18 (n=99)
    20.24 ( 3.99 )
        Change at Month 18 (n=99)
    0.92 ( 1.432 )
        Month 24 (n=95)
    20.5 ( 3.976 )
        Change at Month 24 (n=95)
    1.38 ( 1.624 )
        Month 30 (n=93)
    20.75 ( 4.014 )
        Change at Month 30 (n=93)
    1.59 ( 1.931 )
        Month 36/ET (n=121)
    20.71 ( 4.217 )
        Change at Month 36/ET (n=121)
    1.46 ( 1.948 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in BMI: Females

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    End point title
    		 Percent Change from Baseline in BMI: Females [28]
    End point description
    Investigator assessment of BMI changes during the study. FAS; only female subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [28] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    124
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=124)
    -0.06 ( 3.058 )
        Month 2 (n=119)
    0.16 ( 3.777 )
        Month 3 (n=115)
    0.73 ( 4.314 )
        Month 6 (n=113)
    1.26 ( 4.992 )
        Month 12 (n=107)
    3.33 ( 6.765 )
        Month 18 (n=99)
    5.14 ( 7.578 )
        Month 24 (n=95)
    7.68 ( 8.661 )
        Month 30 (n=93)
    8.89 ( 9.916 )
        Month 36/ET (n=121)
    8.06 ( 10.147 )
    No statistical analyses for this end point

    Primary: Age (years) During the Study: Males

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    End point title
    		 Age (years) During the Study: Males [29]
    End point description
    Investigator assessment of age during the study. Change from baseline was also determined. FAS; only male subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [29] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    146
    Units: years
    arithmetic mean (standard deviation)
        Baseline (n=146)
    9.94 ( 2.489 )
        Month 1 (n=141)
    10.05 ( 2.553 )
        Change at Month 1 (n=141)
    0.11 ( 0.309 )
        Month 2 (n=138)
    10.14 ( 2.583 )
        Change at Month 2 (n=138)
    0.18 ( 0.387 )
        Month 3 (n=133)
    10.21 ( 2.567 )
        Change at Month 3 (n=133)
    0.29 ( 0.457 )
        Month 6 (n=129)
    10.43 ( 2.552 )
        Change at Month 6 (n=129)
    0.55 ( 0.499 )
        Month 12 (n=123)
    10.96 ( 2.543 )
        Change at Month 12 (n=123)
    1.02 ( 0.155 )
        Month 18 (n=119)
    11.47 ( 2.544 )
        Change at Month 18 (n=119)
    1.54 ( 0.501 )
        Month 24 (n=114)
    11.93 ( 2.534 )
        Change at Month 24 (n=114)
    2.02 ( 0.132 )
        Month 30 (n=114)
    12.46 ( 2.553 )
        Change at Month 30 (n=114)
    2.54 ( 0.5 )
        Month 36/ET (n=134)
    12.69 ( 2.587 )
        Change at Month 36/ET (n=134)
    2.67 ( 0.899 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Age: Males

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    End point title
    		 Percent Change from Baseline in Age: Males [30]
    End point description
    Investigator assessment of age during the study. FAS; only male subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [30] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    141
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=141)
    1.09 ( 3.327 )
        Month 2 (n=138)
    1.86 ( 4.184 )
        Month 3 (n=133)
    3.16 ( 5.175 )
        Month 6 (n=129)
    6.06 ( 5.956 )
        Month 12 (n=123)
    11.13 ( 3.878 )
        Month 18 (n=119)
    16.82 ( 7.732 )
        Month 24 (n=114)
    21.92 ( 6.623 )
        Month 30 (n=114)
    27.67 ( 9.855 )
        Month 36/ET (n=134)
    28.9 ( 13.486 )
    No statistical analyses for this end point

    Primary: Age (years) During the Study: Females

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    End point title
    		 Age (years) During the Study: Females [31]
    End point description
    Investigator assessment of age during the study. Change from baseline was also determined. FAS; only female subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [31] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    125
    Units: years
    arithmetic mean (standard deviation)
        Baseline (n=125)
    10.55 ( 2.421 )
        Month 1 (n=125)
    10.66 ( 2.436 )
        Change at Month 1 (n=125)
    0.11 ( 0.317 )
        Month 2 (n=120)
    10.78 ( 2.43 )
        Change at Month 2 (n=120)
    0.2 ( 0.402 )
        Month 3 (n=115)
    10.75 ( 2.449 )
        Change at Month 3 (n=115)
    0.28 ( 0.45 )
        Month 6 (n=113)
    10.99 ( 2.477 )
        Change at Month 6 (n=113)
    0.52 ( 0.502 )
        Month 12 (n=107)
    11.5 ( 2.416 )
        Change at Month 12 (n=107)
    0.99 ( 0.097 )
        Month 18 (n=99)
    12.02 ( 2.503 )
        Change at Month 18 (n=99)
    1.52 ( 0.502 )
        Month 24 (n=95)
    12.42 ( 2.482 )
        Change at Month 24 (n=95)
    1.98 ( 0.144 )
        Month 30 (n=93)
    12.99 ( 2.564 )
        Change at Month 30 (n=93)
    2.52 ( 0.502 )
        Month 36/ET (n=121)
    13.07 ( 2.547 )
        Change at Month 36/ET (n=121)
    2.54 ( 0.94 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Age: Females

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    End point title
    		 Percent Change from Baseline in Age: Females [32]
    End point description
    Investigator assessment of age during the study. FAS; only female subjects were included in the analysis. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
    Notes
    [32] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg)
    Number of subjects analysed
    125
    Units: percent change
    arithmetic mean (standard deviation)
        Month 1 (n=125)
    1.1 ( 3.169 )
        Month 2 (n=120)
    2 ( 4.128 )
        Month 3 (n=115)
    2.74 ( 4.549 )
        Month 6 (n=113)
    5.18 ( 5.221 )
        Month 12 (n=107)
    10 ( 2.811 )
        Month 18 (n=99)
    15.2 ( 6.006 )
        Month 24 (n=95)
    20.08 ( 5.298 )
        Month 30 (n=93)
    25.35 ( 7.415 )
        Month 36/ET (n=121)
    25.73 ( 12.168 )
    No statistical analyses for this end point

    Primary: Flow-Mediated Dilatation (FMD) During the Study

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    End point title
    		 Flow-Mediated Dilatation (FMD) During the Study [33]
    End point description
    Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined. FMD Set: all subjects enrolled in the FMD study who had at least baseline FMD measurements. n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Baseline, Months 6, 12, 18, 24, 30 and 36/ET
    Notes
    [33] - 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    37
    36
    Units: % FMD
    arithmetic mean (standard deviation)
        Baseline (n=37,36)
    5.523 ( 3.2062 )
    6.651 ( 4.4926 )
        Month 6 (n=27,23)
    5.749 ( 2.5047 )
    6.52 ( 4.0763 )
        Change at Month 6 (n=27,23)
    -0.063 ( 3.4768 )
    -0.759 ( 4.8732 )
        Month 12 (n=32,29)
    4.732 ( 1.8477 )
    6.363 ( 8.037 )
        Change at Month 12 (n=32,29)
    -0.952 ( 3.6796 )
    -0.778 ( 9.4743 )
        Month 18 (n=33,28)
    4.942 ( 2.674 )
    4.668 ( 3.8874 )
        Change at Month 18 (n=33,28)
    -0.762 ( 3.7374 )
    -2.556 ( 6.3123 )
        Month 24 (n=33,28)
    4.538 ( 2.4239 )
    5.679 ( 4.3224 )
        Change at Month 24 (n=33,28)
    -1.166 ( 3.2524 )
    -1.545 ( 7.2325 )
        Month 30 (n=33,28)
    5.571 ( 2.7198 )
    5.191 ( 2.512 )
        Change at Month 30 (n=33,28)
    -0.134 ( 3.3399 )
    -2.033 ( 5.8591 )
        Month 36/ET (n=34,33)
    4.987 ( 2.254 )
    5.36 ( 2.9873 )
        Change at Month 36/ET (n=34,33)
    -0.55 ( 3.6625 )
    -1.563 ( 4.8355 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in FMD

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    End point title
    		 Percent Change from Baseline in FMD [34]
    End point description
    Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. FMD Set; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Primary
    End point timeframe
    Months 6, 12, 18, 24, 30 and 36/ET
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    34
    33
    Units: percent change
    arithmetic mean (standard deviation)
        Month 6 (n=27,23)
    14.867 ( 67.6028 )
    -0.205 ( 60.7192 )
        Month 12 (n=32,29)
    -3.88 ( 56.191 )
    15.444 ( 207.6932 )
        Month 18 (n=33,28)
    -4.598 ( 68.0267 )
    -24.387 ( 81.5683 )
        Month 24 (n=33,28)
    -9.992 ( 57.3868 )
    3.85 ( 102.2001 )
        Month 30 (n=33,28)
    7 ( 63.0894 )
    -18.804 ( 42.2259 )
        Month 36/ET (n=34,33)
    0.648 ( 62.5814 )
    -7.506 ( 61.2361 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Overall Expected Maturation and Development Consistent with Expectations as Assessed by the Investigator

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    End point title
    		 Percentage of Subjects With Overall Expected Maturation and Development Consistent with Expectations as Assessed by the Investigator
    End point description
    FAS; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    139
    132
    Units: Percentage of subjects
    number (not applicable)
        Baseline (n=139,132)
    99.3
    100
        Month 1 (n=118,113)
    100
    100
        Month 2 (n=116,109)
    100
    100
        Month 3 (n=130,118)
    100
    100
        Month 6 (n=127,115)
    100
    99.1
        Month 12 (n=121,109)
    100
    99.1
        Month 18 (n=115,102)
    100
    100
        Month 24 (n=113,95)
    100
    100
        Month 30 (n=111,94)
    100
    98.9
        Month 36/Early Termination (n=128,127)
    99.2
    99.2
    No statistical analyses for this end point

    Secondary: Percentage of subjects by Study Drug Compliance Category

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    End point title
    		 Percentage of subjects by Study Drug Compliance Category
    End point description
    Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%. Safety Analysis Set: all subjects who received at least 1 dose of study drug; n=number of subjects assessed for the specified parameter at a given visit.
    End point type
    Secondary
    End point timeframe
    Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)
    End point values
    		 Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
    Number of subjects analysed
    135
    132
    Units: percentage of subjects
    number (not applicable)
        Month 1, <80% (n=135,132)
    3
    6.8
        Month 1, 80%-120% (n=135,132)
    97
    93.2
        Month 1, >120% (n=135,132)
    0
    0
        Month 2, <80% (n=132,126)
    6.8
    7.9
        Month 2, 80%-120% (n=132,126)
    92.4
    92.1
        Month 2, >120% (n=132,126)
    0.8
    0
        Month 3, <80% (n=130,118)
    3.8
    7.6
        Month 3, 80%-120% (n=130,118)
    95.4
    92.4
        Month 3, >120% (n=130,118)
    0.8
    0
        Month 6, <80% (n=127,115)
    7.9
    9.6
        Month 6, 80%-120% (n=127,115)
    92.1
    90.4
        Month 6, >120% (n=127,115)
    0
    0
        Month 12, <80% (n=121,109)
    7.4
    7.3
        Month 12, 80%-120% (n=121,109)
    92.6
    92.7
        Month 12, >120% (n=121,109)
    0
    0
        Month 18, <80% (n=116,102)
    4.3
    5.9
        Month 18, 80%-120% (n=116,102)
    94
    94.1
        Month 18, >120% (n=116,102)
    1.7
    0
        Month 24, <80% (n=113,95)
    8.8
    9.5
        Month 24, 80%-120% (n=113,95)
    91.2
    89.5
        Month 24, >120% (n=113,95)
    0
    1.1
        Month 30, <80% (n=112,94)
    8
    6.4
        Month 30, 80%-120% (n=112,94)
    92
    92.6
        Month 30, >120% (n=112,94)
    0
    1.1
        Month 36/ET, <80% (n=129,129)
    11.6
    16.3
        Month 36/ET, 80%-120% (n=129,129)
    86.8
    83.7
        Month 36/ET, >120% (n=129,129)
    1.6
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up through Month 36
    Adverse event reporting additional description
    The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Atorvastatin (10-80 mg): Tanner_Stage 2+
    Reporting group description
    		 Subjects aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Reporting group title
    Atorvastatin (5-80 mg): Tanner_Stage 1
    Reporting group description
    		 Subjects aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.

    Serious adverse events
    		 Atorvastatin (10-80 mg): Tanner_Stage 2+ Atorvastatin (5-80 mg): Tanner_Stage 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 132 (5.30%)
    14 / 139 (10.07%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ewing's sarcoma
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intravascular papillary endothelial hyperplasia
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 132 (0.76%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Feeling abnormal
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 132 (0.76%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendix disorder
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular appendage torsion
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 132 (0.00%)
    2 / 139 (1.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Atorvastatin (10-80 mg): Tanner_Stage 2+ Atorvastatin (5-80 mg): Tanner_Stage 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 132 (65.15%)
    93 / 139 (66.91%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    9 / 132 (6.82%)
    3 / 139 (2.16%)
         occurrences all number
    10
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 132 (18.94%)
    25 / 139 (17.99%)
         occurrences all number
    53
    41
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    13 / 132 (9.85%)
    15 / 139 (10.79%)
         occurrences all number
    20
    21
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    10 / 132 (7.58%)
    21 / 139 (15.11%)
         occurrences all number
    13
    23
    Abdominal pain upper
         subjects affected / exposed
    3 / 132 (2.27%)
    7 / 139 (5.04%)
         occurrences all number
    3
    10
    Diarrhoea
         subjects affected / exposed
    9 / 132 (6.82%)
    8 / 139 (5.76%)
         occurrences all number
    10
    9
    Nausea
         subjects affected / exposed
    8 / 132 (6.06%)
    3 / 139 (2.16%)
         occurrences all number
    13
    8
    Vomiting
         subjects affected / exposed
    7 / 132 (5.30%)
    15 / 139 (10.79%)
         occurrences all number
    11
    17
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 132 (8.33%)
    14 / 139 (10.07%)
         occurrences all number
    18
    28
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    10 / 132 (7.58%)
    4 / 139 (2.88%)
         occurrences all number
    10
    4
    Pain in extremity
         subjects affected / exposed
    5 / 132 (3.79%)
    14 / 139 (10.07%)
         occurrences all number
    5
    26
    Arthralgia
         subjects affected / exposed
    5 / 132 (3.79%)
    10 / 139 (7.19%)
         occurrences all number
    8
    15
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 132 (0.76%)
    9 / 139 (6.47%)
         occurrences all number
    1
    11
    Ear infection
         subjects affected / exposed
    6 / 132 (4.55%)
    9 / 139 (6.47%)
         occurrences all number
    6
    11
    Influenza
         subjects affected / exposed
    14 / 132 (10.61%)
    13 / 139 (9.35%)
         occurrences all number
    17
    15
    Gastroenteritis
         subjects affected / exposed
    12 / 132 (9.09%)
    17 / 139 (12.23%)
         occurrences all number
    15
    24
    Pharyngitis
         subjects affected / exposed
    8 / 132 (6.06%)
    9 / 139 (6.47%)
         occurrences all number
    15
    9
    Nasopharyngitis
         subjects affected / exposed
    26 / 132 (19.70%)
    26 / 139 (18.71%)
         occurrences all number
    50
    48
    Rhinitis
         subjects affected / exposed
    9 / 132 (6.82%)
    13 / 139 (9.35%)
         occurrences all number
    9
    24
    Respiratory tract infection
         subjects affected / exposed
    0 / 132 (0.00%)
    7 / 139 (5.04%)
         occurrences all number
    0
    8
    Tonsillitis
         subjects affected / exposed
    6 / 132 (4.55%)
    10 / 139 (7.19%)
         occurrences all number
    7
    10
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 132 (7.58%)
    20 / 139 (14.39%)
         occurrences all number
    13
    27
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 132 (2.27%)
    13 / 139 (9.35%)
         occurrences all number
    4
    13

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

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

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