Atorvastatin Three Year Pediatric Study

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00827606
• Collaborator: (none)
• Enrollment: 272
• Locations: 40
• Arm: 1
• Duration (Months): 55
• Patients Per Site: 6.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin treatment.

Condition or Disease	Intervention/Treatment	Phase
Familial Hypercholesterolemia	Drug: atorvastatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 272 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atorvastatin All subjects will be treated with atorvastatin	Drug: atorvastatin; Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)

Outcome Measures

Primary Outcome Measures

1. Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])]

   Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

2. Percent Change From Baseline in LDL-C [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)]

   Assessments were performed in the fasting state (minimum 10-hour fast).

3. High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

   Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

4. Percent Change From Baseline in HDL-C [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

   Assessments were performed in the fasting state (minimum 10-hour fast).

5. Total Cholesterol (mMol/L) During the Study [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

   Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

6. Percent Change From Baseline in Total Cholesterol [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

   Assessments were performed in the fasting state (minimum 10-hour fast).

7. Trigylcerides (mMol/L) During the Study [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

   Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

8. Percent Change From Baseline in Trigylcerides [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

   Assessments were performed in the fasting state (minimum 10-hour fast).

9. Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

   Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

10. Percent Change From Baseline in VLDL [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Assessments were performed in the fasting state (minimum 10-hour fast).

11. Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

12. Percent Change From Baseline in Apo A-1 [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Assessments were performed in the fasting state (minimum 10-hour fast).

13. Apoliprotein B (Apo B; g/L) During the Study [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

14. Percent Change From Baseline in Apo B [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Assessments were performed in the fasting state (minimum 10-hour fast).

15. Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage [Baseline, Months 6, 12, 18, 24, 30, and 36/ET]

    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.

16. Height (Centimeters [cm]) During the Study: Males [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of height changes during the study. Change from baseline was also determined.

17. Percent Change From Baseline in Height: Males [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of height changes during the study.

18. Height (cm) During the Study: Females [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of height changes during the study. Change from baseline was also determined.

19. Percent Change From Baseline in Height: Females [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of height changes during the study.

20. Weight (Kilograms [kg]) During the Study: Males [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of weight changes during the study. Change from baseline was also determined.

21. Percent Change From Baseline in Weight: Males [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of weight changes during the study.

22. Weight (kg) During the Study: Females [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of weight changes during the study. Change from baseline was also determined.

23. Percent Change From Baseline in Weight: Females [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of weight changes during the study.

24. Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of BMI changes during the study. Change from baseline was also determined.

25. Percent Change From Baseline in BMI: Males [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of BMI changes during the study.

26. BMI (kg/m^2) During the Study: Females [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of BMI changes during the study. Change from baseline was also determined.

27. Percent Change From Baseline in BMI: Females [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of BMI changes during the study.

28. Age (Years) During the Study: Males [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of age during the study. Change from baseline was also determined.

29. Percent Change From Baseline in Age: Males [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of age during the study.

30. Age (Years) During the Study: Females [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of age during the study. Change from baseline was also determined.

31. Percent Change From Baseline in Age: Females [Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

    Investigator assessment of age during the study.

32. Flow-Mediated Dilatation (FMD) During the Study [Baseline, Months 6, 12, 18, 24, 30 and 36/ET]

    Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.

33. Percent Change From Baseline in FMD [Months 6, 12, 18, 24, 30 and 36/ET]

    Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.

Secondary Outcome Measures

1. Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator [Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)]

2. Percentage of Participants by Study Drug Compliance Category [Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)]

   Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l

Exclusion Criteria:

• Active liver disease or hepatic dysfunction, or persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN).

Female of childbearing potential who is not using adequate contraceptive measures or any female who is pregnant or breastfeeding. Any female who becomes pregnant during study participation will be immediately discontinued from treatment and counseled appropriately about the in utero exposure.

Known hypersensitivities to HMG-CoA reductase inhibitors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016
2	Children's National Medical Center	Washington	District of Columbia	United States	20010
3	University of Florida	Gainesville	Florida	United States	32608
4	Johns Hopkins University	Baltimore	Maryland	United States	21287
5	Johns Hopkins	Baltimore	Maryland	United States	21287
6	MEDPACE Clinical Pharmacology Unit	Cincinnati	Ohio	United States	45212
7	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
8	Cliniques Universitaires Saint-Luc / Pediatrie generale	Bruxelles		Belgium	1200
9	Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases	Leuven		Belgium	3000
10	Clinique des maladies lipidiques de Quebec Inc	Sainte-Foy,	Quebec	Canada	G1V 4M6
11	Clinique des Maladies Lipidiques de Quebec	Quebec		Canada	G1V 4M6
12	Charite Campus Virchow-Klinikum	Berlin		Germany	13353
13	Augenaerztliche Gemeinschaftspraxis	Freiburg		Germany	79098
14	1st Pediatrics Clinic , University of Athens, Agia Sofia Hospital	Athens		Greece	115 27
15	Semmelweis Medical University	Budapest		Hungary	H-1094
16	Fejer Megyei Szent Gyorgy Korhaz	Szekesfehervar		Hungary	8003
17	Dipartimento di Medicina Clinica e delle Patologie Emergenti-University Hospital of Palermo	Palermo		Italy	90127
18	Dipartimento di Clinica e Terapia Medica, Università degli Studi di Roma La Sapienza	Roma		Italy	00161
19	Rikshospitalet Lipidklinikken	Oslo		Norway	0027
20	Poradnia Chorob Metabolicznych	Bydgoszcz		Poland	85-667
21	Klinika Chorob Metabolicznych	Warszawa		Poland	04-730
22	Hospital de la Concepcion	San German		Puerto Rico	683
23	Moscow State Healthcare Institution 'Morozovskaya Children's City Clinical Hospital'	Moscow		Russian Federation	119049
24	Saint-Petersburg State Pediatric Medical Academy	Saint-Petersburg		Russian Federation	194100
25	Saint-Petersburg State Healthcare Institution "Children's Polyclinic #35"	Saint-Petersburg		Russian Federation	196084
26	Autonomous Non-Profit Organization Medical Center 21 Century	St Petersburg		Russian Federation	194044
27	Metabolicka ambulancia, 2. Detská klinika Lekárskej fakulty Univerzity Komenského	Bratislava		Slovakia	833 40
28	Detska fakultna nemocnica Kosice-old	Kosice		Slovakia	040 01
29	Detska fakultna nemocnica Kosice	Kosice		Slovakia	040 11
30	Lipmet, s.r.o.	Poprad		Slovakia	05801
31	Fakultna nemocnica Trencin	Trencin		Slovakia	911 71
32	Hospital General Universitario de Elche	Elche	Alicante	Spain	03202
33	Hospital de Merida	Merida	Badajoz	Spain	6800
34	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
35	Hospital Santa Creu I Sant Pau	Barcelona		Spain	08041
36	Hospital Sant Joan de Deu	Esplugues de Llobregat		Spain	08950
37	Dr. med. Jean-Marc Nuoffer	Ch-3010 Bern		Switzerland
38	Hacettepe University Medical Faculty. Department of Pediatrics. Nutrition and Metabolism Unit	Ankara		Turkey	06100
39	Gazi University, Medical Faculty	Ankara		Turkey	6500
40	Ege University Medical Faculty	Izmir		Turkey	35100

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00827606
• Other Study ID Numbers: A2581173; 2008-006130-95
• First Posted: Jan 23, 2009
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: pediatric heterozygous familial hypercholesterolemia
• Additional relevant MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Atorvastatin

Study Results

Participant Flow

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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 low-density lipoprotein cholesterol (LDL-C) (<3.35 millimoles per liter [mmol/L]) was not attained.	Participants 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.
Period Title: Overall Study
STARTED	139	132
COMPLETED	112	94
NOT COMPLETED	27	38

Baseline Characteristics

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+	Total
Arm/Group Description	Participants 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.	Participants 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.	Total of all reporting groups
Overall Participants	139	132	271
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.5 (1.86)	12.0 (1.68)	10.2 (2.48)
Sex: Female, Male (Count of Participants)
Female	46 33.1%	79 59.8%	125 46.1%
Male	93 66.9%	53 40.2%	146 53.9%

Outcome Measures

1. Primary Outcome

Title	Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
Description	Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])

Outcome Measure Data

Analysis Population Description

FAS; n (number) equals (=) number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	139	132
Baseline (n=139,132)	6.304 (1.3130)	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)	3.270 (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 (1.0660)
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 (1.1450)
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 (0.6490)	3.142 (0.6916)
Change at Month 30 (n=112,94)	-3.090 (1.2402)	-3.008 (1.1489)
Month 36/ET (n=123,117)	3.450 (0.7372)	3.457 (0.8808)
Change at Month 36/ET (n=123,117)	-2.855 (1.2625)	-2.468 (1.3270)

2. Primary Outcome

Title	Percent Change From Baseline in LDL-C
Description	Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	132	130
Month 1 (n=131,130)	-34.995 (9.7300)	-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 (12.7530)
Month 6 (n=127,115)	-45.647 (9.6969)	-43.697 (11.1836)
Month 12 (n=121,109)	-45.530 (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 (11.9490)	-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)

3. Primary Outcome

Title	High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study
Description	Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	139	132
Baseline (n=139,132)	1.349 (0.2732)	1.277 (0.2546)
Month 1 (n=131,130)	1.360 (0.2717)	1.292 (0.2650)
Change at Month 1 (n=131,130)	0.010 (0.1685)	0.016 (0.1740)
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 (0.1600)
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)	0.010 (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 (0.1910)
Month 30 (n=112,94)	1.380 (0.2942)	1.265 (0.2487)
Change at Month 30 (n=112,94)	0.032 (0.1997)	0.006 (0.2150)
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)

4. Primary Outcome

Title	Percent Change From Baseline in HDL-C
Description	Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	132	130
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 (15.5080)	1.868 (17.2633)
Month 36/ET (n=123,117)	-1.125 (14.7816)	1.602 (15.4895)

5. Primary Outcome

Title	Total Cholesterol (mMol/L) During the Study
Description	Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	139	132
Baseline (n=139,132)	8.056 (1.3356)	7.647 (1.2250)
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)	-2.620 (0.9581)	-2.654 (0.9707)
Month 3 (n=127,118)	5.195 (0.8000)	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 (0.6380)	4.982 (0.6620)
Change at Month 6 (n=127,115)	-3.063 (1.1687)	-2.809 (1.1133)
Month 12 (n=121,109)	5.081 (0.7470)	4.799 (0.7176)
Change at Month 12 (n=121,109)	-3.040 (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 (1.1990)	-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)

6. Primary Outcome

Title	Percent Change From Baseline in Total Cholesterol
Description	Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	134	131
Month 1 (n=134,131)	-27.879 (8.2639)	-29.653 (8.5987)
Month 2 (n=132,124)	-31.900 (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 (14.5000)

7. Primary Outcome

Title	Trigylcerides (mMol/L) During the Study
Description	Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	139	132
Baseline (n=139,132)	0.880 (0.4343)	0.980 (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 (0.4880)
Month 12 (n=121,109)	-0.747 (0.3901)	0.789 (0.4050)
Change at Month 12 (n=121,109)	-0.136 (0.4060)	-0.181 (0.5255)
Month 18 (n=116,102)	0.687 (0.3435)	0.765 (0.3438)
Change at Month 18 (n=116,102)	-0.190 (0.3665)	-0.219 (0.4623)
Month 24 (n=111,96)	0.725 (0.3676)	0.790 (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 (0.4220)	0.794 (0.3894)
Change at Month 36/ET (n=123,117)	-0.092 (0.4615)	-0.171 (0.5216)

8. Primary Outcome

Title	Percent Change From Baseline in Trigylcerides
Description	Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	134	131
Month 1 (n=134,131)	-5.950 (39.0995)	-5.927 (51.1811)
Month 2 (n=132,124)	-3.260 (42.5136)	-14.832 (40.4952)
Month 3 (n=127,118)	-8.760 (41.1184)	-14.415 (39.9951)
Month 6 (n=127,115)	-11.817 (41.9879)	-9.097 (43.0350)
Month 12 (n=121,109)	-7.981 (40.4511)	-7.950 (48.7238)
Month 18 (n=116,102)	-13.113 (39.3990)	-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)

9. Primary Outcome

Title	Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study
Description	Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	139	132
Baseline (n=139,132)	0.403 (0.1993)	0.449 (0.2288)
Month 1 (n=134,131)	0.348 (0.1823)	0.374 (0.1770)
Change at Month 1 (n=134,131)	-0.056 (0.1793)	-0.076 (0.2307)
Month 2 (n=132,124)	0.354 (0.1757)	0.340 (0.1541)
Change at Month 2 (n=132,124)	-0.047 (0.1672)	-0.113 (0.2215)
Month 3 (n=127,118)	0.320 (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 (0.2240)
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 (0.1680)	-0.102 (0.2126)
Month 24 (n=111,96)	0.332 (0.1680)	0.363 (0.1680)
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)	0.350 (0.1930)	0.364 (0.1782)
Change at Month 36/ET (n=123,117)	-0.042 (0.2112)	-0.079 (0.2385)

10. Primary Outcome

Title	Percent Change From Baseline in VLDL
Description	Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	134	131
Month 1 (n=134,131)	-6.060 (39.3300)	-5.805 (51.7264)
Month 2 (n=132,124)	-3.097 (42.3626)	-14.694 (40.1710)
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)	-6.920 (46.3317)
Month 30 (n=112,95)	0.627 (43.6239)	-4.751 (64.2502)
Month 36/ET (n=123,117)	-0.520 (51.3422)	-7.842 (45.4640)

11. Primary Outcome

Title	Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study
Description	Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	138	132
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 (0.1950)
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)	-0.040 (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)	-0.040 (0.1676)

12. Primary Outcome

Title	Percent Change From Baseline in Apo A-1
Description	Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	132	130
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 (12.1640)
Month 6 (n=123,110)	-0.069 (12.1109)	3.011 (14.1347)
Month 12 (n=120,108)	-2.365 (11.5882)	-1.370 (12.3901)
Month 18 (n=114,100)	-3.042 (11.2219)	-1.980 (12.2170)
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)

13. Primary Outcome

Title	Apoliprotein B (Apo B; g/L) During the Study
Description	Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	138	132
Baseline (n=138,132)	1.454 (0.2890)	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)	0.980 (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)	0.930 (0.1836)	0.890 (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)	0.910 (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)	-0.530 (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)	0.910 (0.1723)	0.885 (0.1717)
Change at Month 30 (n=112,95)	-0.560 (0.2664)	-0.533 (0.2467)
Month 36/ET (n=125,118)	0.926 (0.1860)	0.924 (0.2173)
Change at Month 36/ET (n=125,118)	-0.520 (0.2730)	-0.450 (0.2748)

14. Primary Outcome

Title	Percent Change From Baseline in Apo B
Description	Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	132	130
Month 1 (n=132,130)	-26.933 (9.5550)	-29.851 (10.3544)
Month 2 (n=131,123)	-31.867 (9.2821)	-33.959 (9.9478)
Month 3 (n=126,117)	-35.163 (10.5680)	-35.849 (11.6832)
Month 6 (n=123,110)	-35.900 (9.3398)	-34.740 (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 (14.0740)	-31.362 (16.4770)

15. Primary Outcome

Title	Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage
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.
Time Frame	Baseline, Months 6, 12, 18, 24, 30, and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specific parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Baseline Tanner_Stage 1	Atorvastatin (10-80 mg): Baseline Tanner_Stage 2	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5
Arm/Group Description	Participants 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.	Participants 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.	Participants 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.	Participants 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.	Participants 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.
Measure Participants	127	52	25	31	18
Tanner_Stage 1, Month 6 (n=126,48,25,27,15)	107 77%	0 0%	0 0%	0 NaN	0 NaN
Tanner_Stage 2 , Month 6 (n=126,48,25,27,15)	14 10.1%	34 25.8%	0 0%	0 NaN	0 NaN
Tanner_Stage 3, Month 6 (n=126,48,25,27,15)	5 3.6%	10 7.6%	14 5.2%	0 NaN	0 NaN
Tanner_Stage 4, Month 6 (n=126,48,25,27,15)	0 0%	4 3%	11 4.1%	25 NaN	1 NaN
Tanner_Stage 5, Month 6 (n=126,48,25,27,15)	0 0%	0 0%	0 0%	2 NaN	14 NaN
Tanner_Stage 1, Month 12 (n=121,43,23,26,15)	85 61.2%	0 0%	0 0%	0 NaN	0 NaN
Tanner_Stage 2, Month 12 (n=121,43,23,26,15)	25 18%	17 12.9%	0 0%	0 NaN	0 NaN
Tanner_Stage 3, Month 12 (n=121,43,23,26,15)	10 7.2%	21 15.9%	11 4.1%	0 NaN	0 NaN
Tanner_Stage 4, Month 12 (n=121,43,23,26,15)	1 0.7%	5 3.8%	10 3.7%	22 NaN	1 NaN
Tanner_Stage 5, Month 12 (n=121,43,23,26,15)	0 0%	0 0%	2 0.7%	4 NaN	14 NaN
Tanner_Stage 1, Month 18 (n=115,41, 21,25,14)	63 45.3%	0 0%	0 0%	0 NaN	0 NaN
Tanner_Stage 2, Month 18 (n=115,41, 21,25,14)	31 22.3%	15 11.4%	0 0%	0 NaN	0 NaN
Tanner_Stage 3, Month 18 (n=115,41, 21,25,14)	18 12.9%	16 12.1%	6 2.2%	0 NaN	0 NaN
Tanner_Stage 4, Month 18 (n=115,41, 21,25,14)	3 2.2%	9 6.8%	11 4.1%	18 NaN	1 NaN
Tanner_Stage 5, Month 18 (n=115,41, 21,25,14)	0 0%	1 0.8%	4 1.5%	7 NaN	13 NaN
Tanner_Stage 1, Month 24 (n=113,38,19,22,14)	51 36.7%	0 0%	0 0%	0 NaN	0 NaN
Tanner_Stage 2, Month 24 (n=113,38,19,22,14)	33 23.7%	9 6.8%	0 0%	0 NaN	0 NaN
Tanner_Stage 3, Month 24 (n=113,38,19,22,14)	20 14.4%	14 10.6%	2 0.7%	0 NaN	0 NaN
Tanner_Stage 4, Month 24 (n=113,38,19,22,14)	9 6.5%	12 9.1%	13 4.8%	13 NaN	1 NaN
Tanner_Stage 5, Month 24 (n=113,38,19,22,14)	0 0%	3 2.3%	4 1.5%	9 NaN	13 NaN
Tanner_Stage 1, Month 30 (n=111,38,19,23,14)	39 28.1%	0 0%	0 0%	0 NaN	0 NaN
Tanner_Stage 2, Month 30 (n=111,38,19,23,14)	32 23%	3 2.3%	0 0%	0 NaN	0 NaN
Tanner_Stage 3, Month 30 (n=111,38,19,23,14)	26 18.7%	11 8.3%	1 0.4%	0 NaN	0 NaN
Tanner_Stage 4, Month 30 (n=111,38,19,23,14)	14 10.1%	18 13.6%	9 3.3%	11 NaN	1 NaN
Tanner_Stage 5, Month 30 (n=111,38,19,23,14)	0 0%	6 4.5%	9 3.3%	12 NaN	13 NaN
Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18)	41 29.5%	0 0%	0 0%	0 NaN	0 NaN
Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18)	31 22.3%	6 4.5%	0 0%	0 NaN	0 NaN
Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18)	25 18%	10 7.6%	2 0.7%	0 NaN	0 NaN
Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18)	25 18%	24 18.2%	13 4.8%	12 NaN	0 NaN
Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18)	5 3.6%	12 9.1%	10 3.7%	19 NaN	18 NaN

16. Primary Outcome

Title	Height (Centimeters [cm]) During the Study: Males
Description	Investigator assessment of height changes during the study. Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	146
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)	146.00 (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 (3.630)
Month 30 (n=114)	158.78 (15.770)
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)

17. Primary Outcome

Title	Percent Change From Baseline in Height: Males
Description	Investigator assessment of height changes during the study.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	141
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 (3.260)
Month 36/ET (n=134)	10.97 (5.010)

18. Primary Outcome

Title	Height (cm) During the Study: Females
Description	Investigator assessment of height changes during the study. Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	125
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 (1.700)
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 (1.720)
Month 12 (n=107)	150.84 (12.968)
Change at Month 12 (n=107)	5.50 (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 (5.120)
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)

19. Primary Outcome

Title	Percent Change From Baseline in Height: Females
Description	Investigator assessment of height changes during the study.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	124
Month 1 (n=124)	0.51 (1.004)
Month 2 (n=119)	0.84 (1.220)
Month 3 (n=115)	1.20 (0.925)
Month 6 (n=113)	1.98 (1.291)
Month 12 (n=107)	3.93 (2.262)
Month 18 (n=99)	5.30 (3.036)
Month 24 (n=95)	6.93 (3.933)
Month 30 (n=93)	8.13 (4.740)
Month 36/ET (n=121)	8.14 (5.789)

20. Primary Outcome

Title	Weight (Kilograms [kg]) During the Study: Males
Description	Investigator assessment of weight changes during the study. Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	146
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)	0.80 (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)	2.00 (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 (17.100)
Change at Month 30 (n=114)	11.61 (6.032)
Month 36/ET (n=134)	53.50 (16.787)
Change at Month 36/ET (n=134)	12.35 (6.771)

21. Primary Outcome

Title	Percent Change From Baseline in Weight: Males
Description	Investigator assessment of weight changes during the study.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	141
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)

22. Primary Outcome

Title	Weight (kg) During the Study: Females
Description	Investigator assessment of weight changes during the study. Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	125
Baseline (n=125)	42.14 (14.038)
Month 1 (n=125)	42.50 (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)	2.10 (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 (14.670)
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)

23. Primary Outcome

Title	Percent Change From Baseline in Weight: Females
Description	Investigator assessment of weight changes during the study.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	125
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)

24. Primary Outcome

Title	Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males
Description	Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	146
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 (0.890)
Month 6 (n=129)	19.04 (3.881)
Change at Month 6 (n=129)	0.10 (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 (4.400)
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)

25. Primary Outcome

Title	Percent Change From Baseline in BMI: Males
Description	Investigator assessment of BMI changes during the study.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	141
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)	2.10 (7.065)
Month 18 (n=119)	3.98 (7.533)
Month 24 (n=114)	5.45 (8.306)
Month 30 (n=114)	6.80 (9.737)
Month 36/ET (n=134)	7.31 (9.290)

26. Primary Outcome

Title	BMI (kg/m^2) During the Study: Females
Description	Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	125
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 (3.940)
Change at Month 2 (n=119)	0.00 (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)	0.60 (1.305)
Month 18 (n=99)	20.24 (3.990)
Change at Month 18 (n=99)	0.92 (1.432)
Month 24 (n=95)	20.50 (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)

27. Primary Outcome

Title	Percent Change From Baseline in BMI: Females
Description	Investigator assessment of BMI changes during the study.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	124
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)

28. Primary Outcome

Title	Age (Years) During the Study: Males
Description	Investigator assessment of age during the study. Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	146
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 (0.500)
Month 36/ET (n=134)	12.69 (2.587)
Change at Month 36/ET (n=134)	2.67 (0.899)

29. Primary Outcome

Title	Percent Change From Baseline in Age: Males
Description	Investigator assessment of age during the study.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	141
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)	28.90 (13.486)

30. Primary Outcome

Title	Age (Years) During the Study: Females
Description	Investigator assessment of age during the study. Change from baseline was also determined.
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	125
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 (2.430)
Change at Month 2 (n=120)	0.20 (0.402)
Month 3 (n=115)	10.75 (2.449)
Change at Month 3 (n=115)	0.28 (0.450)
Month 6 (n=113)	10.99 (2.477)
Change at Month 6 (n=113)	0.52 (0.502)
Month 12 (n=107)	11.50 (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 (0.940)

31. Primary Outcome

Title	Percent Change From Baseline in Age: Females
Description	Investigator assessment of age during the study.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg)
Arm/Group Description	Participants 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. Participants 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.
Measure Participants	125
Month 1 (n=125)	1.10 (3.169)
Month 2 (n=120)	2.00 (4.128)
Month 3 (n=115)	2.74 (4.549)
Month 6 (n=113)	5.18 (5.221)
Month 12 (n=107)	10.00 (2.811)
Month 18 (n=99)	15.20 (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)

32. Secondary Outcome

Title	Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
Time Frame	Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	139	132
Baseline (n=139,132)	99.3 71.4%	100.0 75.8%
Month 1 (n=118,113)	100.0 71.9%	100.0 75.8%
Month 2 (n=116,109)	100.0 71.9%	100.0 75.8%
Month 3 (n=130,118)	100.0 71.9%	100.0 75.8%
Month 6 (n=127,115)	100.0 71.9%	99.1 75.1%
Month 12 (n=121,109)	100.0 71.9%	99.1 75.1%
Month 18 (n=115,102)	100.0 71.9%	100.0 75.8%
Month 24 (n=113,95)	100.0 71.9%	100.0 75.8%
Month 30 (n=111,94)	100.0 71.9%	98.9 74.9%
Month 36/Early Termination (n=128,127)	99.2 71.4%	99.2 75.2%

33. Primary Outcome

Title	Flow-Mediated Dilatation (FMD) During the Study
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.
Time Frame	Baseline, Months 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FMD Set: all participants enrolled in the FMD study who had at least baseline FMD measurements. n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	37	36
Baseline (n=37,36)	5.523 (3.2062)	6.651 (4.4926)
Month 6 (n=27,23)	5.749 (2.5047)	6.520 (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 (8.0370)
Change at Month 12 (n=32,29)	-0.952 (3.6796)	-0.778 (9.4743)
Month 18 (n=33,28)	4.942 (2.6740)	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 (2.5120)
Change at Month 30 (n=33,28)	-0.134 (3.3399)	-2.033 (5.8591)
Month 36/ET (n=34,33)	4.987 (2.2540)	5.360 (2.9873)
Change at Month 36/ET (n=34,33)	-0.550 (3.6625)	-1.563 (4.8355)

34. Primary Outcome

Title	Percent Change From Baseline in FMD
Description	Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
Time Frame	Months 6, 12, 18, 24, 30 and 36/ET

Outcome Measure Data

Analysis Population Description

FMD Set; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	34	33
Month 6 (n=27,23)	14.867 (67.6028)	-0.205 (60.7192)
Month 12 (n=32,29)	-3.880 (56.1910)	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)	3.850 (102.2001)
Month 30 (n=33,28)	7.000 (63.0894)	-18.804 (42.2259)
Month 36/ET (n=34,33)	0.648 (62.5814)	-7.506 (61.2361)

35. Secondary Outcome

Title	Percentage of Participants by Study Drug Compliance Category
Description	Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.
Time Frame	Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set: all participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1	Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.	Participants 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.
Measure Participants	135	132
Month 1, <80% (n=135,132)	3.0 2.2%	6.8 5.2%
Month 1, 80%-120% (n=135,132)	97.0 69.8%	93.2 70.6%
Month 1, >120% (n=135,132)	0 0%	0 0%
Month 2, <80% (n=132,126)	6.8 4.9%	7.9 6%
Month 2, 80%-120% (n=132,126)	92.4 66.5%	92.1 69.8%
Month 2, >120% (n=132,126)	0.8 0.6%	0 0%
Month 3, <80% (n=130,118)	3.8 2.7%	7.6 5.8%
Month 3, 80%-120% (n=130,118)	95.4 68.6%	92.4 70%
Month 3, >120% (n=130,118)	0.8 0.6%	0 0%
Month 6, <80% (n=127,115)	7.9 5.7%	9.6 7.3%
Month 6, 80%-120% (n=127,115)	92.1 66.3%	90.4 68.5%
Month 6, >120% (n=127,115)	0 0%	0 0%
Month 12, <80% (n=121,109)	7.4 5.3%	7.3 5.5%
Month 12, 80%-120% (n=121,109)	92.6 66.6%	92.7 70.2%
Month 12, >120% (n=121,109)	0 0%	0 0%
Month 18, <80% (n=116,102)	4.3 3.1%	5.9 4.5%
Month 18, 80%-120% (n=116,102)	94.0 67.6%	94.1 71.3%
Month 18, >120% (n=116,102)	1.7 1.2%	0 0%
Month 24, <80% (n=113,95)	8.8 6.3%	9.5 7.2%
Month 24, 80%-120% (n=113,95)	91.2 65.6%	89.5 67.8%
Month 24, >120% (n=113,95)	0 0%	1.1 0.8%
Month 30, <80% (n=112,94)	8.0 5.8%	6.4 4.8%
Month 30, 80%-120% (n=112,94)	92.0 66.2%	92.6 70.2%
Month 30, >120% (n=112,94)	0 0%	1.1 0.8%
Month 36/ET, <80% (n=129,129)	11.6 8.3%	16.3 12.3%
Month 36/ET, 80%-120% (n=129,129)	86.8 62.4%	83.7 63.4%
Month 36/ET, >120% (n=129,129)	1.6 1.2%	0 0%

Adverse Events

Time Frame	Baseline up through Month 36
Adverse Event Reporting 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Atorvastatin (5-80 mg): Tanner_Stage 1		Atorvastatin (10-80 mg): Tanner_Stage 2+
Arm/Group Description	Participants 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.		Participants 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.
All Cause Mortality
	Atorvastatin (5-80 mg): Tanner_Stage 1		Atorvastatin (10-80 mg): Tanner_Stage 2+
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Atorvastatin (5-80 mg): Tanner_Stage 1		Atorvastatin (10-80 mg): Tanner_Stage 2+
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/139 (10.1%)		7/132 (5.3%)
Gastrointestinal disorders
Abdominal pain	1/139 (0.7%)		1/132 (0.8%)
Appendix disorder	1/139 (0.7%)		0/132 (0%)
Haemorrhoids	1/139 (0.7%)		0/132 (0%)
Vomiting	0/139 (0%)		1/132 (0.8%)
General disorders
Feeling abnormal	1/139 (0.7%)		0/132 (0%)
Infections and infestations
Appendicitis	2/139 (1.4%)		0/132 (0%)
Viral infection	1/139 (0.7%)		0/132 (0%)
Injury, poisoning and procedural complications
Concussion	1/139 (0.7%)		0/132 (0%)
Limb injury	0/139 (0%)		1/132 (0.8%)
Lumbar vertebral fracture	0/139 (0%)		1/132 (0.8%)
Thoracic vertebral fracture	0/139 (0%)		1/132 (0.8%)
Ulna fracture	1/139 (0.7%)		0/132 (0%)
Metabolism and nutrition disorders
Obesity	0/139 (0%)		1/132 (0.8%)
Type I diabetes mellitus	0/139 (0%)		1/132 (0.8%)
Musculoskeletal and connective tissue disorders
Myositis	1/139 (0.7%)		0/132 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewing's sarcoma	1/139 (0.7%)		0/132 (0%)
Intravascular papillary endothelial hyperplasia	1/139 (0.7%)		0/132 (0%)
Nervous system disorders
Syncope	1/139 (0.7%)		1/132 (0.8%)
Psychiatric disorders
Bipolar disorder	1/139 (0.7%)		0/132 (0%)
Suicide attempt	0/139 (0%)		1/132 (0.8%)
Reproductive system and breast disorders
Testsicular appendage torsion	1/139 (0.7%)		0/132 (0%)
Other (Not Including Serious) Adverse Events
	Atorvastatin (5-80 mg): Tanner_Stage 1		Atorvastatin (10-80 mg): Tanner_Stage 2+
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	93/139 (66.9%)		86/132 (65.2%)
Gastrointestinal disorders
Abdominal pain	21/139 (15.1%)		10/132 (7.6%)
Abdominal pain upper	7/139 (5%)		3/132 (2.3%)
Diarrhoea	8/139 (5.8%)		9/132 (6.8%)
Nausea	3/139 (2.2%)		8/132 (6.1%)
Vomiting	15/139 (10.8%)		7/132 (5.3%)
General disorders
Pyrexia	15/139 (10.8%)		13/132 (9.8%)
Infections and infestations
Nasopharyngitis	26/139 (18.7%)		26/132 (19.7%)
Bronchitis	9/139 (6.5%)		1/132 (0.8%)
Ear infection	9/139 (6.5%)		6/132 (4.5%)
Gastroenteritis	17/139 (12.2%)		12/132 (9.1%)
Influenza	13/139 (9.4%)		14/132 (10.6%)
Pharyngitis	9/139 (6.5%)		8/132 (6.1%)
Respiratory tract infection	7/139 (5%)		0/132 (0%)
Rhinitis	13/139 (9.4%)		9/132 (6.8%)
Tonsillitis	10/139 (7.2%)		6/132 (4.5%)
Upper respiratory tract infection	20/139 (14.4%)		10/132 (7.6%)
Viral upper respiratory tract infection	13/139 (9.4%)		3/132 (2.3%)
Investigations
Blood creatine phosphokinase increased	3/139 (2.2%)		9/132 (6.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	10/139 (7.2%)		5/132 (3.8%)
Myalgia	4/139 (2.9%)		10/132 (7.6%)
Pain in extremity	14/139 (10.1%)		5/132 (3.8%)
Nervous system disorders
Headache	25/139 (18%)		25/132 (18.9%)
Respiratory, thoracic and mediastinal disorders
Cough	14/139 (10.1%)		11/132 (8.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.