Trial Outcomes & Findings for Atorvastatin Three Year Pediatric Study (NCT NCT00827606)

NCT ID: NCT00827606

Last Updated: 2021-02-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 272 participants
• Primary outcome timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
• Results posted on: 2021-02-21

Participant Flow

Participant milestones

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.
Overall Study STARTED	139	132
Overall Study COMPLETED	112	94
Overall Study NOT COMPLETED	27	38

Reasons for withdrawal

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.
Overall Study Protocol Violation	4	3
Overall Study Lost to Follow-up	3	1
Overall Study Withdrawal by Subject	7	6
Overall Study Pregnancy	0	1
Overall Study Other	5	13
Overall Study LDL below 2.59 mmol/L	4	12
Overall Study Adverse Event	4	2

Baseline Characteristics

Atorvastatin Three Year Pediatric Study

Baseline characteristics by cohort

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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 n=271 Participants Total of all reporting groups
Age, Continuous	8.5 years STANDARD_DEVIATION 1.86 • n=93 Participants	12.0 years STANDARD_DEVIATION 1.68 • n=4 Participants	10.2 years STANDARD_DEVIATION 2.48 • n=27 Participants
Sex: Female, Male Female	46 Participants n=93 Participants	79 Participants n=4 Participants	125 Participants n=27 Participants
Sex: Female, Male Male	93 Participants n=93 Participants	53 Participants n=4 Participants	146 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Baseline (n=139,132)	6.304 mMol/L Standard Deviation 1.3130	5.921 mMol/L Standard Deviation 1.1646	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 1 (n=131,130)	4.087 mMol/L Standard Deviation 1.0264	3.675 mMol/L Standard Deviation 0.8749	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 1 (n=131,130)	-2.214 mMol/L Standard Deviation 0.7568	-2.233 mMol/L Standard Deviation 0.8009	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 2 (n=132,122)	3.719 mMol/L Standard Deviation 0.8346	3.437 mMol/L Standard Deviation 0.7438	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 2 (n=132,122)	-2.586 mMol/L Standard Deviation 0.9297	-2.554 mMol/L Standard Deviation 0.9155	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 3 (n=126,117)	3.503 mMol/L Standard Deviation 0.7566	3.270 mMol/L Standard Deviation 0.6533	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 3 (n=126,117)	-2.798 mMol/L Standard Deviation 1.0251	-2.795 mMol/L Standard Deviation 1.0835	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 6 (n=127,115)	3.366 mMol/L Standard Deviation 0.5787	3.347 mMol/L Standard Deviation 0.5953	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 6 (n=127,115)	-2.968 mMol/L Standard Deviation 1.1096	-2.732 mMol/L Standard Deviation 1.0660	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 12 (n=121,109)	3.409 mMol/L Standard Deviation 0.7395	3.196 mMol/L Standard Deviation 0.6565	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 12 (n=121,109)	-2.966 mMol/L Standard Deviation 1.0987	-2.838 mMol/L Standard Deviation 1.1450	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 18 (n=116,101)	3.309 mMol/L Standard Deviation 0.5933	3.261 mMol/L Standard Deviation 0.5288	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 18 (n=116,101)	-3.105 mMol/L Standard Deviation 1.1558	-2.835 mMol/L Standard Deviation 1.2128	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 24 (n=111,96)	3.316 mMol/L Standard Deviation 0.6803	3.189 mMol/L Standard Deviation 0.6537	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 24 (n=111,96)	-3.088 mMol/L Standard Deviation 1.2026	-2.933 mMol/L Standard Deviation 1.2292	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 30 (n=112,94)	3.335 mMol/L Standard Deviation 0.6490	3.142 mMol/L Standard Deviation 0.6916	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 30 (n=112,94)	-3.090 mMol/L Standard Deviation 1.2402	-3.008 mMol/L Standard Deviation 1.1489	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Month 36/ET (n=123,117)	3.450 mMol/L Standard Deviation 0.7372	3.457 mMol/L Standard Deviation 0.8808	—	—	—
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study Change at Month 36/ET (n=123,117)	-2.855 mMol/L Standard Deviation 1.2625	-2.468 mMol/L Standard Deviation 1.3270	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=132 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=130 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in LDL-C Month 1 (n=131,130)	-34.995 percent change Standard Deviation 9.7300	-37.516 percent change Standard Deviation 10.0245	—	—	—
Percent Change From Baseline in LDL-C Month 2 (n=132,122)	-40.371 percent change Standard Deviation 9.6468	-41.939 percent change Standard Deviation 10.4816	—	—	—
Percent Change From Baseline in LDL-C Month 3 (n=126,117)	-43.568 percent change Standard Deviation 10.2149	-44.887 percent change Standard Deviation 12.7530	—	—	—
Percent Change From Baseline in LDL-C Month 6 (n=127,115)	-45.647 percent change Standard Deviation 9.6969	-43.697 percent change Standard Deviation 11.1836	—	—	—
Percent Change From Baseline in LDL-C Month 12 (n=121,109)	-45.530 percent change Standard Deviation 10.5112	-45.727 percent change Standard Deviation 13.5336	—	—	—
Percent Change From Baseline in LDL-C Month 18 (n=116,101)	-47.101 percent change Standard Deviation 10.5592	-44.818 percent change Standard Deviation 13.2623	—	—	—
Percent Change From Baseline in LDL-C Month 24 (n=111,96)	-46.944 percent change Standard Deviation 11.9490	-46.417 percent change Standard Deviation 13.8658	—	—	—
Percent Change From Baseline in LDL-C Month 30 (n=112,94)	-46.631 percent change Standard Deviation 12.0206	-47.734 percent change Standard Deviation 12.6696	—	—	—
Percent Change From Baseline in LDL-C Month 36/ET (n=123,117)	-43.785 percent change Standard Deviation 13.5585	-39.863 percent change Standard Deviation 17.5411	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Baseline (n=139,132)	1.349 mMol/L Standard Deviation 0.2732	1.277 mMol/L Standard Deviation 0.2546	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 1 (n=131,130)	1.360 mMol/L Standard Deviation 0.2717	1.292 mMol/L Standard Deviation 0.2650	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 1 (n=131,130)	0.010 mMol/L Standard Deviation 0.1685	0.016 mMol/L Standard Deviation 0.1740	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 2 (n=132,122)	1.364 mMol/L Standard Deviation 0.2805	1.297 mMol/L Standard Deviation 0.2625	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 2 (n=132,122)	0.014 mMol/L Standard Deviation 0.2238	0.025 mMol/L Standard Deviation 0.1600	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 3 (n=126,117)	1.371 mMol/L Standard Deviation 0.2768	1.274 mMol/L Standard Deviation 0.2606	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 3 (n=126,117)	0.015 mMol/L Standard Deviation 0.1943	0.011 mMol/L Standard Deviation 0.1837	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 6 (n=127,115)	1.337 mMol/L Standard Deviation 0.2834	1.268 mMol/L Standard Deviation 0.2311	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 6 (n=127,115)	-0.011 mMol/L Standard Deviation 0.1848	0.010 mMol/L Standard Deviation 0.1833	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 12 (n=121,109)	1.328 mMol/L Standard Deviation 0.2885	1.241 mMol/L Standard Deviation 0.2429	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 12 (n=121,109)	-0.012 mMol/L Standard Deviation 0.1945	-0.023 mMol/L Standard Deviation 0.1727	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 18 (n=116,102)	1.367 mMol/L Standard Deviation 0.3003	1.234 mMol/L Standard Deviation 0.2349	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 18 (n=116,102)	0.024 mMol/L Standard Deviation 0.1923	-0.027 mMol/L Standard Deviation 0.1744	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 24 (n=111,96)	1.385 mMol/L Standard Deviation 0.2729	1.266 mMol/L Standard Deviation 0.2443	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 24 (n=111,96)	0.027 mMol/L Standard Deviation 0.2043	0.007 mMol/L Standard Deviation 0.1910	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 30 (n=112,94)	1.380 mMol/L Standard Deviation 0.2942	1.265 mMol/L Standard Deviation 0.2487	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 30 (n=112,94)	0.032 mMol/L Standard Deviation 0.1997	0.006 mMol/L Standard Deviation 0.2150	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Month 36/ET (n=123,117)	1.335 mMol/L Standard Deviation 0.2918	1.278 mMol/L Standard Deviation 0.2516	—	—	—
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study Change at Month 36/ET (n=123,117)	-0.024 mMol/L Standard Deviation 0.1949	0.005 mMol/L Standard Deviation 0.1975	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=132 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=130 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in HDL-C Month 1 (n=131,130)	1.526 percent change Standard Deviation 12.7845	2.192 percent change Standard Deviation 14.0769	—	—	—
Percent Change From Baseline in HDL-C Month 2 (n=132,122)	2.195 percent change Standard Deviation 15.6882	2.544 percent change Standard Deviation 12.7802	—	—	—
Percent Change From Baseline in HDL-C Month 3 (n=126,117)	1.929 percent change Standard Deviation 14.7329	1.674 percent change Standard Deviation 14.9525	—	—	—
Percent Change From Baseline in HDL-C Month 6 (n=127,115)	-0.016 percent change Standard Deviation 14.8853	1.877 percent change Standard Deviation 14.9113	—	—	—
Percent Change From Baseline in HDL-C Month 12 (n=121,109)	-0.069 percent change Standard Deviation 15.2821	-1.023 percent change Standard Deviation 14.1983	—	—	—
Percent Change From Baseline in HDL-C Month 18 (n=116,102)	2.472 percent change Standard Deviation 14.8939	-1.165 percent change Standard Deviation 14.3783	—	—	—
Percent Change From Baseline in HDL-C Month 24 (n=111,96)	3.014 percent change Standard Deviation 14.9559	1.737 percent change Standard Deviation 15.6924	—	—	—
Percent Change From Baseline in HDL-C Month 30 (n=112,94)	3.345 percent change Standard Deviation 15.5080	1.868 percent change Standard Deviation 17.2633	—	—	—
Percent Change From Baseline in HDL-C Month 36/ET (n=123,117)	-1.125 percent change Standard Deviation 14.7816	1.602 percent change Standard Deviation 15.4895	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Total Cholesterol (mMol/L) During the Study Baseline (n=139,132)	8.056 mMol/L Standard Deviation 1.3356	7.647 mMol/L Standard Deviation 1.2250	—	—	—
Total Cholesterol (mMol/L) During the Study Month 1 (n=134,131)	5.785 mMol/L Standard Deviation 1.0497	5.352 mMol/L Standard Deviation 0.9345	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 1 (n=134,131)	-2.266 mMol/L Standard Deviation 0.7957	-2.297 mMol/L Standard Deviation 0.8516	—	—	—
Total Cholesterol (mMol/L) During the Study Month 2 (n=132,124)	5.435 mMol/L Standard Deviation 0.8629	5.061 mMol/L Standard Deviation 0.7865	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 2 (n=132,124)	-2.620 mMol/L Standard Deviation 0.9581	-2.654 mMol/L Standard Deviation 0.9707	—	—	—
Total Cholesterol (mMol/L) During the Study Month 3 (n=127,118)	5.195 mMol/L Standard Deviation 0.8000	4.883 mMol/L Standard Deviation 0.7034	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 3 (n=127,118)	-2.869 mMol/L Standard Deviation 1.0904	-2.883 mMol/L Standard Deviation 1.1363	—	—	—
Total Cholesterol (mMol/L) During the Study Month 6 (n=127,115)	5.019 mMol/L Standard Deviation 0.6380	4.982 mMol/L Standard Deviation 0.6620	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 6 (n=127,115)	-3.063 mMol/L Standard Deviation 1.1687	-2.809 mMol/L Standard Deviation 1.1133	—	—	—
Total Cholesterol (mMol/L) During the Study Month 12 (n=121,109)	5.081 mMol/L Standard Deviation 0.7470	4.799 mMol/L Standard Deviation 0.7176	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 12 (n=121,109)	-3.040 mMol/L Standard Deviation 1.1353	-2.945 mMol/L Standard Deviation 1.2112	—	—	—
Total Cholesterol (mMol/L) During the Study Month 18 (n=116,101)	4.989 mMol/L Standard Deviation 0.6512	4.845 mMol/L Standard Deviation 0.5401	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 18 (n=116,101)	-3.168 mMol/L Standard Deviation 1.1990	-2.965 mMol/L Standard Deviation 1.2667	—	—	—
Total Cholesterol (mMol/L) During the Study Month 24 (n=111,96)	5.032 mMol/L Standard Deviation 0.7111	4.817 mMol/L Standard Deviation 0.7413	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 24 (n=111,96)	-3.123 mMol/L Standard Deviation 1.2039	-3.009 mMol/L Standard Deviation 1.2871	—	—	—
Total Cholesterol (mMol/L) During the Study Month 30 (n=112,95)	5.075 mMol/L Standard Deviation 0.6951	4.795 mMol/L Standard Deviation 0.8256	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 30 (n=112,95)	-3.096 mMol/L Standard Deviation 1.2999	-3.048 mMol/L Standard Deviation 1.2716	—	—	—
Total Cholesterol (mMol/L) During the Study Month 36/ET (n=123,117)	5.134 mMol/L Standard Deviation 0.7863	5.099 mMol/L Standard Deviation 0.9318	—	—	—
Total Cholesterol (mMol/L) During the Study Change at Month 36/ET (n=123,117)	-2.923 mMol/L Standard Deviation 1.3256	-2.543 mMol/L Standard Deviation 1.3669	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=134 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=131 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Total Cholesterol Month 1 (n=134,131)	-27.879 percent change Standard Deviation 8.2639	-29.653 percent change Standard Deviation 8.5987	—	—	—
Percent Change From Baseline in Total Cholesterol Month 2 (n=132,124)	-31.900 percent change Standard Deviation 8.5025	-33.726 percent change Standard Deviation 9.2319	—	—	—
Percent Change From Baseline in Total Cholesterol Month 3 (n=127,118)	-34.784 percent change Standard Deviation 9.4141	-36.126 percent change Standard Deviation 11.0136	—	—	—
Percent Change From Baseline in Total Cholesterol Month 6 (n=127,115)	-36.889 percent change Standard Deviation 9.2297	-35.055 percent change Standard Deviation 10.0273	—	—	—
Percent Change From Baseline in Total Cholesterol Month 12 (n=121,109)	-36.541 percent change Standard Deviation 9.2486	-36.943 percent change Standard Deviation 11.9418	—	—	—
Percent Change From Baseline in Total Cholesterol Month 18 (n=116,101)	-37.772 percent change Standard Deviation 9.7325	-36.634 percent change Standard Deviation 11.4572	—	—	—
Percent Change From Baseline in Total Cholesterol Month 24 (n=111,96)	-37.287 percent change Standard Deviation 9.9578	-37.317 percent change Standard Deviation 12.2461	—	—	—
Percent Change From Baseline in Total Cholesterol Month 30 (n=112,95)	-36.662 percent change Standard Deviation 11.2064	-37.856 percent change Standard Deviation 12.5116	—	—	—
Percent Change From Baseline in Total Cholesterol Month 36/ET (n=123,117)	-35.063 percent change Standard Deviation 12.0345	-32.013 percent change Standard Deviation 14.5000	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Trigylcerides (mMol/L) During the Study Baseline (n=139,132)	0.880 mMol/L Standard Deviation 0.4343	0.980 mMol/L Standard Deviation 0.4986	—	—	—
Trigylcerides (mMol/L) During the Study Month 1 (n=134,131)	0.759 mMol/L Standard Deviation 0.3958	0.815 mMol/L Standard Deviation 0.3848	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 1 (n=134,131)	-0.121 mMol/L Standard Deviation 0.3895	-0.166 mMol/L Standard Deviation 0.5024	—	—	—
Trigylcerides (mMol/L) During the Study Month 2 (n=132,124)	0.772 mMol/L Standard Deviation 0.3837	0.741 mMol/L Standard Deviation 0.3382	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 2 (n=132,124)	-0.103 mMol/L Standard Deviation 0.3652	-0.246 mMol/L Standard Deviation 0.4825	—	—	—
Trigylcerides (mMol/L) During the Study Month 3 (n=127,118)	0.699 mMol/L Standard Deviation 0.2916	0.748 mMol/L Standard Deviation 0.3357	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 3 (n=127,118)	-0.166 mMol/L Standard Deviation 0.3937	-0.237 mMol/L Standard Deviation 0.4466	—	—	—
Trigylcerides (mMol/L) During the Study Month 6 (n=127,115)	0.691 mMol/L Standard Deviation 0.3602	0.801 mMol/L Standard Deviation 0.3848	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 6 (n=127,115)	-0.183 mMol/L Standard Deviation 0.4305	-0.188 mMol/L Standard Deviation 0.4880	—	—	—
Trigylcerides (mMol/L) During the Study Month 12 (n=121,109)	-0.747 mMol/L Standard Deviation 0.3901	0.789 mMol/L Standard Deviation 0.4050	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 12 (n=121,109)	-0.136 mMol/L Standard Deviation 0.4060	-0.181 mMol/L Standard Deviation 0.5255	—	—	—
Trigylcerides (mMol/L) During the Study Month 18 (n=116,102)	0.687 mMol/L Standard Deviation 0.3435	0.765 mMol/L Standard Deviation 0.3438	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 18 (n=116,102)	-0.190 mMol/L Standard Deviation 0.3665	-0.219 mMol/L Standard Deviation 0.4623	—	—	—
Trigylcerides (mMol/L) During the Study Month 24 (n=111,96)	0.725 mMol/L Standard Deviation 0.3676	0.790 mMol/L Standard Deviation 0.3651	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 24 (n=111,96)	-0.133 mMol/L Standard Deviation 0.4112	-0.179 mMol/L Standard Deviation 0.4956	—	—	—
Trigylcerides (mMol/L) During the Study Month 30 (n=112,95)	0.788 mMol/L Standard Deviation 0.3454	0.781 mMol/L Standard Deviation 0.4167	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 30 (n=112,95)	-0.082 mMol/L Standard Deviation 0.3898	-0.187 mMol/L Standard Deviation 0.5728	—	—	—
Trigylcerides (mMol/L) During the Study Month 36/ET (n=123,117)	0.764 mMol/L Standard Deviation 0.4220	0.794 mMol/L Standard Deviation 0.3894	—	—	—
Trigylcerides (mMol/L) During the Study Change at Month 36/ET (n=123,117)	-0.092 mMol/L Standard Deviation 0.4615	-0.171 mMol/L Standard Deviation 0.5216	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=134 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=131 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Trigylcerides Month 1 (n=134,131)	-5.950 percent change Standard Deviation 39.0995	-5.927 percent change Standard Deviation 51.1811	—	—	—
Percent Change From Baseline in Trigylcerides Month 2 (n=132,124)	-3.260 percent change Standard Deviation 42.5136	-14.832 percent change Standard Deviation 40.4952	—	—	—
Percent Change From Baseline in Trigylcerides Month 3 (n=127,118)	-8.760 percent change Standard Deviation 41.1184	-14.415 percent change Standard Deviation 39.9951	—	—	—
Percent Change From Baseline in Trigylcerides Month 6 (n=127,115)	-11.817 percent change Standard Deviation 41.9879	-9.097 percent change Standard Deviation 43.0350	—	—	—
Percent Change From Baseline in Trigylcerides Month 12 (n=121,109)	-7.981 percent change Standard Deviation 40.4511	-7.950 percent change Standard Deviation 48.7238	—	—	—
Percent Change From Baseline in Trigylcerides Month 18 (n=116,102)	-13.113 percent change Standard Deviation 39.3990	-12.443 percent change Standard Deviation 37.3822	—	—	—
Percent Change From Baseline in Trigylcerides Month 24 (n=111,96)	-6.697 percent change Standard Deviation 38.7027	-7.328 percent change Standard Deviation 45.3694	—	—	—
Percent Change From Baseline in Trigylcerides Month 30 (n=112,95)	0.657 percent change Standard Deviation 43.3886	-4.935 percent change Standard Deviation 63.1887	—	—	—
Percent Change From Baseline in Trigylcerides Month 36/ET (n=123,117)	-0.703 percent change Standard Deviation 50.6333	-7.759 percent change Standard Deviation 45.6372	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 2 (n=132,124)	0.354 mMol/L Standard Deviation 0.1757	0.340 mMol/L Standard Deviation 0.1541	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 2 (n=132,124)	-0.047 mMol/L Standard Deviation 0.1672	-0.113 mMol/L Standard Deviation 0.2215	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 3 (n=127,118)	0.320 mMol/L Standard Deviation 0.1333	0.344 mMol/L Standard Deviation 0.1548	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 3 (n=127,118)	-0.076 mMol/L Standard Deviation 0.1805	-0.108 mMol/L Standard Deviation 0.2044	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 6 (n=127,115)	0.317 mMol/L Standard Deviation 0.1652	0.367 mMol/L Standard Deviation 0.1767	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 6 (n=127,115)	-0.084 mMol/L Standard Deviation 0.1977	-0.086 mMol/L Standard Deviation 0.2240	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 12 (n=121,109)	0.343 mMol/L Standard Deviation 0.1786	0.362 mMol/L Standard Deviation 0.1862	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 12 (n=121,109)	-0.062 mMol/L Standard Deviation 0.1872	-0.082 mMol/L Standard Deviation 0.2421	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 18 (n=116,101)	0.315 mMol/L Standard Deviation 0.1571	0.349 mMol/L Standard Deviation 0.1571	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 18 (n=116,101)	-0.087 mMol/L Standard Deviation 0.1680	-0.102 mMol/L Standard Deviation 0.2126	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 24 (n=111,96)	0.332 mMol/L Standard Deviation 0.1680	0.363 mMol/L Standard Deviation 0.1680	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 24 (n=111,96)	-0.061 mMol/L Standard Deviation 0.1887	-0.081 mMol/L Standard Deviation 0.2285	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 30 (n=112,95)	0.361 mMol/L Standard Deviation 0.1581	0.358 mMol/L Standard Deviation 0.1914	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 30 (n=112,95)	-0.038 mMol/L Standard Deviation 0.1781	-0.086 mMol/L Standard Deviation 0.2621	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 36/ET (n=123,117)	0.350 mMol/L Standard Deviation 0.1930	0.364 mMol/L Standard Deviation 0.1782	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 36/ET (n=123,117)	-0.042 mMol/L Standard Deviation 0.2112	-0.079 mMol/L Standard Deviation 0.2385	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Baseline (n=139,132)	0.403 mMol/L Standard Deviation 0.1993	0.449 mMol/L Standard Deviation 0.2288	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Month 1 (n=134,131)	0.348 mMol/L Standard Deviation 0.1823	0.374 mMol/L Standard Deviation 0.1770	—	—	—
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study Change at Month 1 (n=134,131)	-0.056 mMol/L Standard Deviation 0.1793	-0.076 mMol/L Standard Deviation 0.2307	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=134 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=131 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in VLDL Month 1 (n=134,131)	-6.060 percent change Standard Deviation 39.3300	-5.805 percent change Standard Deviation 51.7264	—	—	—
Percent Change From Baseline in VLDL Month 2 (n=132,124)	-3.097 percent change Standard Deviation 42.3626	-14.694 percent change Standard Deviation 40.1710	—	—	—
Percent Change From Baseline in VLDL Month 3 (n=127,118)	-8.711 percent change Standard Deviation 41.2631	-14.263 percent change Standard Deviation 39.7239	—	—	—
Percent Change From Baseline in VLDL Month 6 (n=127,115)	-11.591 percent change Standard Deviation 42.4219	-9.158 percent change Standard Deviation 43.1397	—	—	—
Percent Change From Baseline in VLDL Month 12 (n=121,109)	-7.739 percent change Standard Deviation 40.7579	-7.827 percent change Standard Deviation 48.9819	—	—	—
Percent Change From Baseline in VLDL Month 18 (n=116,101)	-12.911 percent change Standard Deviation 39.7908	-12.768 percent change Standard Deviation 37.4142	—	—	—
Percent Change From Baseline in VLDL Month 24 (n=111,96)	-6.654 percent change Standard Deviation 38.7945	-6.920 percent change Standard Deviation 46.3317	—	—	—
Percent Change From Baseline in VLDL Month 30 (n=112,95)	0.627 percent change Standard Deviation 43.6239	-4.751 percent change Standard Deviation 64.2502	—	—	—
Percent Change From Baseline in VLDL Month 36/ET (n=123,117)	-0.520 percent change Standard Deviation 51.3422	-7.842 percent change Standard Deviation 45.4640	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=138 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Baseline (n=138,132)	1.396 g/L Standard Deviation 0.1839	1.308 g/L Standard Deviation 0.2006	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 1 (n=132,130)	1.419 g/L Standard Deviation 0.2233	1.337 g/L Standard Deviation 0.1927	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 1 (n=132,130)	0.025 g/L Standard Deviation 0.1639	0.032 g/L Standard Deviation 0.1506	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 2 (n=131,123)	1.411 g/L Standard Deviation 0.1952	1.334 g/L Standard Deviation 0.1950	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 2 (n=131,123)	0.016 g/L Standard Deviation 0.1519	0.025 g/L Standard Deviation 0.1355	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 3 (n=126,117)	1.405 g/L Standard Deviation 0.1914	1.306 g/L Standard Deviation 0.1919	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 3 (n=126,117)	0.005 g/L Standard Deviation 0.1713	0.006 g/L Standard Deviation 0.1557	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 6 (n=123,110)	1.386 g/L Standard Deviation 0.2081	1.329 g/L Standard Deviation 0.1894	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 6 (n=123,110)	-0.007 g/L Standard Deviation 0.1609	0.026 g/L Standard Deviation 0.1818	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 12 (n=120,108)	1.347 g/L Standard Deviation 0.1893	1.271 g/L Standard Deviation 0.1798	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 12 (n=120,108)	-0.041 g/L Standard Deviation 0.1574	-0.028 g/L Standard Deviation 0.1586	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 18 (n=114,100)	1.339 g/L Standard Deviation 0.1972	1.266 g/L Standard Deviation 0.1676	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 18 (n=114,100)	-0.049 g/L Standard Deviation 0.1558	-0.038 g/L Standard Deviation 0.1643	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 24 (n=113,95)	1.364 g/L Standard Deviation 0.1929	1.275 g/L Standard Deviation 0.1736	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 24 (n=113,95)	-0.032 g/L Standard Deviation 0.1749	-0.027 g/L Standard Deviation 0.1799	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 30 (n=112,95)	1.357 g/L Standard Deviation 0.2247	1.268 g/L Standard Deviation 0.1848	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 30 (n=112,95)	-0.040 g/L Standard Deviation 0.1857	-0.036 g/L Standard Deviation 0.1861	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Month 36/ET (n=125,118)	1.327 g/L Standard Deviation 0.2081	1.272 g/L Standard Deviation 0.1664	—	—	—
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study Change at Month 36/ET (n=125,118)	-0.073 g/L Standard Deviation 0.1725	-0.040 g/L Standard Deviation 0.1676	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=132 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=130 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Apo A-1 Month 1 (n=132,130)	2.229 percent change Standard Deviation 12.4001	3.301 percent change Standard Deviation 12.2009	—	—	—
Percent Change From Baseline in Apo A-1 Month 2 (n=131,123)	1.701 percent change Standard Deviation 11.0364	2.499 percent change Standard Deviation 10.7656	—	—	—
Percent Change From Baseline in Apo A-1 Month 3 (n=126,117)	1.041 percent change Standard Deviation 12.4204	1.192 percent change Standard Deviation 12.1640	—	—	—
Percent Change From Baseline in Apo A-1 Month 6 (n=123,110)	-0.069 percent change Standard Deviation 12.1109	3.011 percent change Standard Deviation 14.1347	—	—	—
Percent Change From Baseline in Apo A-1 Month 12 (n=120,108)	-2.365 percent change Standard Deviation 11.5882	-1.370 percent change Standard Deviation 12.3901	—	—	—
Percent Change From Baseline in Apo A-1 Month 18 (n=114,100)	-3.042 percent change Standard Deviation 11.2219	-1.980 percent change Standard Deviation 12.2170	—	—	—
Percent Change From Baseline in Apo A-1 Month 24 (n=113,95)	-1.611 percent change Standard Deviation 12.4618	-0.961 percent change Standard Deviation 13.9868	—	—	—
Percent Change From Baseline in Apo A-1 Month 30 (n=112,95)	-2.342 percent change Standard Deviation 13.3357	-1.695 percent change Standard Deviation 14.2732	—	—	—
Percent Change From Baseline in Apo A-1 Month 36/ET (n=125,118)	-4.804 percent change Standard Deviation 12.0443	-1.954 percent change Standard Deviation 12.7229	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=138 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Apoliprotein B (Apo B; g/L) During the Study Baseline (n=138,132)	1.454 g/L Standard Deviation 0.2890	1.381 g/L Standard Deviation 0.2619	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 1 (n=132,130)	1.062 g/L Standard Deviation 0.2423	0.967 g/L Standard Deviation 0.2257	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 1 (n=132,130)	-0.395 g/L Standard Deviation 0.1599	-0.415 g/L Standard Deviation 0.1691	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 2 (n=131,123)	0.980 g/L Standard Deviation 0.1929	0.916 g/L Standard Deviation 0.1813	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 2 (n=131,123)	-0.471 g/L Standard Deviation 0.1825	-0.484 g/L Standard Deviation 0.1858	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 3 (n=126,117)	0.930 g/L Standard Deviation 0.1836	0.890 g/L Standard Deviation 0.1707	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 3 (n=126,117)	-0.522 g/L Standard Deviation 0.2152	-0.518 g/L Standard Deviation 0.2184	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 6 (n=123,110)	0.919 g/L Standard Deviation 0.1557	0.910 g/L Standard Deviation 0.1683	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 6 (n=123,110)	-0.535 g/L Standard Deviation 0.2092	-0.503 g/L Standard Deviation 0.2086	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 12 (n=120,108)	0.918 g/L Standard Deviation 0.1816	0.871 g/L Standard Deviation 0.1493	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 12 (n=120,108)	-0.548 g/L Standard Deviation 0.2131	-0.530 g/L Standard Deviation 0.2194	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 18 (n=114,100)	0.893 g/L Standard Deviation 0.1546	0.882 g/L Standard Deviation 0.1293	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 18 (n=114,100)	-0.578 g/L Standard Deviation 0.2343	-0.533 g/L Standard Deviation 0.2463	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 24 (n=113,95)	0.918 g/L Standard Deviation 0.1719	0.884 g/L Standard Deviation 0.1575	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 24 (n=113,95)	-0.551 g/L Standard Deviation 0.2353	-0.535 g/L Standard Deviation 0.2344	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 30 (n=112,95)	0.910 g/L Standard Deviation 0.1723	0.885 g/L Standard Deviation 0.1717	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 30 (n=112,95)	-0.560 g/L Standard Deviation 0.2664	-0.533 g/L Standard Deviation 0.2467	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Month 36/ET (n=125,118)	0.926 g/L Standard Deviation 0.1860	0.924 g/L Standard Deviation 0.2173	—	—	—
Apoliprotein B (Apo B; g/L) During the Study Change at Month 36/ET (n=125,118)	-0.520 g/L Standard Deviation 0.2730	-0.450 g/L Standard Deviation 0.2748	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=132 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=130 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Apo B Month 1 (n=132,130)	-26.933 percent change Standard Deviation 9.5550	-29.851 percent change Standard Deviation 10.3544	—	—	—
Percent Change From Baseline in Apo B Month 2 (n=131,123)	-31.867 percent change Standard Deviation 9.2821	-33.959 percent change Standard Deviation 9.9478	—	—	—
Percent Change From Baseline in Apo B Month 3 (n=126,117)	-35.163 percent change Standard Deviation 10.5680	-35.849 percent change Standard Deviation 11.6832	—	—	—
Percent Change From Baseline in Apo B Month 6 (n=123,110)	-35.900 percent change Standard Deviation 9.3398	-34.740 percent change Standard Deviation 10.7982	—	—	—
Percent Change From Baseline in Apo B Month 12 (n=120,108)	-36.624 percent change Standard Deviation 9.7413	-36.842 percent change Standard Deviation 11.6106	—	—	—
Percent Change From Baseline in Apo B Month 18 (n=114,100)	-38.158 percent change Standard Deviation 10.4084	-36.211 percent change Standard Deviation 12.7805	—	—	—
Percent Change From Baseline in Apo B Month 24 (n=113,95)	-36.426 percent change Standard Deviation 11.4333	-36.677 percent change Standard Deviation 12.1824	—	—	—
Percent Change From Baseline in Apo B Month 30 (n=112,95)	-36.668 percent change Standard Deviation 12.8783	-36.453 percent change Standard Deviation 13.6888	—	—	—
Percent Change From Baseline in Apo B Month 36/ET (n=125,118)	-34.507 percent change Standard Deviation 14.0740	-31.362 percent change Standard Deviation 16.4770	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 6, 12, 18, 24, 30, and 36/ET

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

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.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=127 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=52 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 n=25 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 n=31 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 n=18 Participants 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.
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 1, Month 6 (n=126,48,25,27,15)	107 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 2 , Month 6 (n=126,48,25,27,15)	14 participants	34 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 3, Month 6 (n=126,48,25,27,15)	5 participants	10 participants	14 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 4, Month 6 (n=126,48,25,27,15)	0 participants	4 participants	11 participants	25 participants	1 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 5, Month 6 (n=126,48,25,27,15)	0 participants	0 participants	0 participants	2 participants	14 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 1, Month 12 (n=121,43,23,26,15)	85 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 2, Month 12 (n=121,43,23,26,15)	25 participants	17 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 3, Month 12 (n=121,43,23,26,15)	10 participants	21 participants	11 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 4, Month 12 (n=121,43,23,26,15)	1 participants	5 participants	10 participants	22 participants	1 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 5, Month 12 (n=121,43,23,26,15)	0 participants	0 participants	2 participants	4 participants	14 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 1, Month 18 (n=115,41, 21,25,14)	63 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 2, Month 18 (n=115,41, 21,25,14)	31 participants	15 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 3, Month 18 (n=115,41, 21,25,14)	18 participants	16 participants	6 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 4, Month 18 (n=115,41, 21,25,14)	3 participants	9 participants	11 participants	18 participants	1 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 5, Month 18 (n=115,41, 21,25,14)	0 participants	1 participants	4 participants	7 participants	13 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 1, Month 24 (n=113,38,19,22,14)	51 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 2, Month 24 (n=113,38,19,22,14)	33 participants	9 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 3, Month 24 (n=113,38,19,22,14)	20 participants	14 participants	2 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 4, Month 24 (n=113,38,19,22,14)	9 participants	12 participants	13 participants	13 participants	1 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 5, Month 24 (n=113,38,19,22,14)	0 participants	3 participants	4 participants	9 participants	13 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 1, Month 30 (n=111,38,19,23,14)	39 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 2, Month 30 (n=111,38,19,23,14)	32 participants	3 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 3, Month 30 (n=111,38,19,23,14)	26 participants	11 participants	1 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 4, Month 30 (n=111,38,19,23,14)	14 participants	18 participants	9 participants	11 participants	1 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 5, Month 30 (n=111,38,19,23,14)	0 participants	6 participants	9 participants	12 participants	13 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18)	41 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18)	31 participants	6 participants	0 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18)	25 participants	10 participants	2 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18)	25 participants	24 participants	13 participants	12 participants	0 participants
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18)	5 participants	12 participants	10 participants	19 participants	18 participants

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=146 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Height (Centimeters [cm]) During the Study: Males Baseline (n=146)	144.36 cm Standard Deviation 16.004	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 1 (n=141)	145.21 cm Standard Deviation 16.114	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 1 (n=141)	0.68 cm Standard Deviation 0.964	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 2 (n=138)	145.93 cm Standard Deviation 16.302	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 2 (n=138)	1.27 cm Standard Deviation 0.964	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 3 (n=133)	146.00 cm Standard Deviation 16.139	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 3 (n=133)	1.72 cm Standard Deviation 1.172	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 6 (n=129)	147.17 cm Standard Deviation 16.033	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 6 (n=129)	3.24 cm Standard Deviation 1.485	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 12 (n=123)	150.75 cm Standard Deviation 16.321	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 12 (n=123)	6.67 cm Standard Deviation 2.385	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 18 (n=119)	153.26 cm Standard Deviation 16.388	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 18 (n=119)	9.31 cm Standard Deviation 2.978	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 24 (n=114)	156.03 cm Standard Deviation 16.001	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 24 (n=114)	12.11 cm Standard Deviation 3.630	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 30 (n=114)	158.78 cm Standard Deviation 15.770	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 30 (n=114)	14.86 cm Standard Deviation 4.403	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Month 36/ET (n=134)	160.59 cm Standard Deviation 15.602	—	—	—	—
Height (Centimeters [cm]) During the Study: Males Change at Month 36/ET (n=134)	15.53 cm Standard Deviation 6.801	—	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

Investigator assessment of height changes during the study.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=141 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Height: Males Month 1 (n=141)	0.47 percent change Standard Deviation 0.689	—	—	—	—
Percent Change From Baseline in Height: Males Month 2 (n=138)	0.88 percent change Standard Deviation 0.652	—	—	—	—
Percent Change From Baseline in Height: Males Month 3 (n=133)	1.19 percent change Standard Deviation 0.777	—	—	—	—
Percent Change From Baseline in Height: Males Month 6 (n=129)	2.25 percent change Standard Deviation 0.987	—	—	—	—
Percent Change From Baseline in Height: Males Month 12 (n=123)	4.66 percent change Standard Deviation 1.606	—	—	—	—
Percent Change From Baseline in Height: Males Month 18 (n=119)	6.53 percent change Standard Deviation 2.021	—	—	—	—
Percent Change From Baseline in Height: Males Month 24 (n=114)	8.53 percent change Standard Deviation 2.607	—	—	—	—
Percent Change From Baseline in Height: Males Month 30 (n=114)	10.49 percent change Standard Deviation 3.260	—	—	—	—
Percent Change From Baseline in Height: Males Month 36/ET (n=134)	10.97 percent change Standard Deviation 5.010	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=125 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Height (cm) During the Study: Females Baseline (n=125)	145.28 cm Standard Deviation 14.108	—	—	—	—
Height (cm) During the Study: Females Month 1 (n=124)	146.06 cm Standard Deviation 14.045	—	—	—	—
Height (cm) During the Study: Females Change at Month 1 (n=124)	0.71 cm Standard Deviation 1.378	—	—	—	—
Height (cm) During the Study: Females Month 2 (n=119)	146.57 cm Standard Deviation 13.919	—	—	—	—
Height (cm) During the Study: Females Change at Month 2 (n=119)	1.19 cm Standard Deviation 1.700	—	—	—	—
Height (cm) During the Study: Females Month 3 (n=115)	146.81 cm Standard Deviation 13.838	—	—	—	—
Height (cm) During the Study: Females Change at Month 3 (n=115)	1.68 cm Standard Deviation 1.278	—	—	—	—
Height (cm) During the Study: Females Month 6 (n=113)	147.87 cm Standard Deviation 13.619	—	—	—	—
Height (cm) During the Study: Females Change at Month 6 (n=113)	2.77 cm Standard Deviation 1.720	—	—	—	—
Height (cm) During the Study: Females Month 12 (n=107)	150.84 cm Standard Deviation 12.968	—	—	—	—
Height (cm) During the Study: Females Change at Month 12 (n=107)	5.50 cm Standard Deviation 2.992	—	—	—	—
Height (cm) During the Study: Females Month 18 (n=99)	152.77 cm Standard Deviation 12.648	—	—	—	—
Height (cm) During the Study: Females Change at Month 18 (n=99)	7.41 cm Standard Deviation 4.043	—	—	—	—
Height (cm) During the Study: Females Month 24 (n=95)	154.79 cm Standard Deviation 11.913	—	—	—	—
Height (cm) During the Study: Females Change at Month 24 (n=95)	9.61 cm Standard Deviation 5.120	—	—	—	—
Height (cm) During the Study: Females Month 30 (n=93)	156.43 cm Standard Deviation 11.288	—	—	—	—
Height (cm) During the Study: Females Change at Month 30 (n=93)	11.23 cm Standard Deviation 6.118	—	—	—	—
Height (cm) During the Study: Females Month 36/ET (n=121)	156.52 cm Standard Deviation 11.032	—	—	—	—
Height (cm) During the Study: Females Change at Month 36/ET (n=121)	11.23 cm Standard Deviation 7.551	—	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

Investigator assessment of height changes during the study.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=124 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Height: Females Month 1 (n=124)	0.51 percent change Standard Deviation 1.004	—	—	—	—
Percent Change From Baseline in Height: Females Month 2 (n=119)	0.84 percent change Standard Deviation 1.220	—	—	—	—
Percent Change From Baseline in Height: Females Month 3 (n=115)	1.20 percent change Standard Deviation 0.925	—	—	—	—
Percent Change From Baseline in Height: Females Month 6 (n=113)	1.98 percent change Standard Deviation 1.291	—	—	—	—
Percent Change From Baseline in Height: Females Month 12 (n=107)	3.93 percent change Standard Deviation 2.262	—	—	—	—
Percent Change From Baseline in Height: Females Month 18 (n=99)	5.30 percent change Standard Deviation 3.036	—	—	—	—
Percent Change From Baseline in Height: Females Month 24 (n=95)	6.93 percent change Standard Deviation 3.933	—	—	—	—
Percent Change From Baseline in Height: Females Month 30 (n=93)	8.13 percent change Standard Deviation 4.740	—	—	—	—
Percent Change From Baseline in Height: Females Month 36/ET (n=121)	8.14 percent change Standard Deviation 5.789	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=146 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Weight (Kilograms [kg]) During the Study: Males Baseline (n=146)	40.79 kg Standard Deviation 14.079	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 1 (n=141)	41.18 kg Standard Deviation 14.287	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 1 (n=141)	0.36 kg Standard Deviation 1.203	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 2 (n=138)	41.83 kg Standard Deviation 14.467	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 2 (n=138)	0.80 kg Standard Deviation 1.422	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 3 (n=133)	41.68 kg Standard Deviation 14.266	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 3 (n=133)	1.08 kg Standard Deviation 1.907	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 6 (n=129)	42.47 kg Standard Deviation 14.564	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 6 (n=129)	2.00 kg Standard Deviation 2.528	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 12 (n=123)	45.29 kg Standard Deviation 15.526	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 12 (n=123)	4.65 kg Standard Deviation 3.822	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 18 (n=119)	47.53 kg Standard Deviation 16.164	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 18 (n=119)	7.02 kg Standard Deviation 4.432	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 24 (n=114)	49.77 kg Standard Deviation 16.401	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 24 (n=114)	9.27 kg Standard Deviation 5.079	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 30 (n=114)	52.12 kg Standard Deviation 17.100	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 30 (n=114)	11.61 kg Standard Deviation 6.032	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Month 36/ET (n=134)	53.50 kg Standard Deviation 16.787	—	—	—	—
Weight (Kilograms [kg]) During the Study: Males Change at Month 36/ET (n=134)	12.35 kg Standard Deviation 6.771	—	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

Investigator assessment of weight changes during the study.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=141 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Weight: Males Month 1 (n=141)	0.94 percent change Standard Deviation 2.739	—	—	—	—
Percent Change From Baseline in Weight: Males Month 2 (n=138)	2.04 percent change Standard Deviation 3.262	—	—	—	—
Percent Change From Baseline in Weight: Males Month 3 (n=133)	2.73 percent change Standard Deviation 4.317	—	—	—	—
Percent Change From Baseline in Weight: Males Month 6 (n=129)	5.09 percent change Standard Deviation 5.559	—	—	—	—
Percent Change From Baseline in Weight: Males Month 12 (n=123)	11.85 percent change Standard Deviation 8.172	—	—	—	—
Percent Change From Baseline in Weight: Males Month 18 (n=119)	18.03 percent change Standard Deviation 9.629	—	—	—	—
Percent Change From Baseline in Weight: Males Month 24 (n=114)	24.28 percent change Standard Deviation 11.696	—	—	—	—
Percent Change From Baseline in Weight: Males Month 30 (n=114)	30.46 percent change Standard Deviation 14.058	—	—	—	—
Percent Change From Baseline in Weight: Males Month 36/ET (n=134)	32.54 percent change Standard Deviation 17.409	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=125 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Weight (kg) During the Study: Females Baseline (n=125)	42.14 kg Standard Deviation 14.038	—	—	—	—
Weight (kg) During the Study: Females Month 1 (n=125)	42.50 kg Standard Deviation 14.007	—	—	—	—
Weight (kg) During the Study: Females Change at Month 1 (n=125)	0.36 kg Standard Deviation 0.924	—	—	—	—
Weight (kg) During the Study: Females Month 2 (n=120)	42.86 kg Standard Deviation 14.209	—	—	—	—
Weight (kg) During the Study: Females Change at Month 2 (n=120)	0.67 kg Standard Deviation 1.338	—	—	—	—
Weight (kg) During the Study: Females Month 3 (n=115)	43.34 kg Standard Deviation 14.753	—	—	—	—
Weight (kg) During the Study: Females Change at Month 3 (n=115)	1.24 kg Standard Deviation 1.819	—	—	—	—
Weight (kg) During the Study: Females Month 6 (n=113)	44.26 kg Standard Deviation 15.027	—	—	—	—
Weight (kg) During the Study: Females Change at Month 6 (n=113)	2.10 kg Standard Deviation 2.409	—	—	—	—
Weight (kg) During the Study: Females Month 12 (n=107)	46.61 kg Standard Deviation 15.158	—	—	—	—
Weight (kg) During the Study: Females Change at Month 12 (n=107)	4.41 kg Standard Deviation 3.317	—	—	—	—
Weight (kg) During the Study: Females Month 18 (n=99)	48.32 kg Standard Deviation 14.670	—	—	—	—
Weight (kg) During the Study: Females Change at Month 18 (n=99)	6.24 kg Standard Deviation 4.291	—	—	—	—
Weight (kg) During the Study: Females Month 24 (n=95)	50.13 kg Standard Deviation 14.731	—	—	—	—
Weight (kg) During the Study: Females Change at Month 24 (n=95)	8.55 kg Standard Deviation 5.038	—	—	—	—
Weight (kg) During the Study: Females Month 30 (n=93)	51.73 kg Standard Deviation 14.681	—	—	—	—
Weight (kg) During the Study: Females Change at Month 30 (n=93)	10.02 kg Standard Deviation 6.127	—	—	—	—
Weight (kg) During the Study: Females Month 36/ET (n=121)	51.55 kg Standard Deviation 14.498	—	—	—	—
Weight (kg) During the Study: Females Change at Month 36/ET (n=121)	9.77 kg Standard Deviation 7.047	—	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

Investigator assessment of weight changes during the study.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=125 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Weight: Females Month 1 (n=125)	0.97 percent change Standard Deviation 2.303	—	—	—	—
Percent Change From Baseline in Weight: Females Month 2 (n=120)	1.85 percent change Standard Deviation 3.206	—	—	—	—
Percent Change From Baseline in Weight: Females Month 3 (n=115)	3.16 percent change Standard Deviation 4.149	—	—	—	—
Percent Change From Baseline in Weight: Females Month 6 (n=113)	5.37 percent change Standard Deviation 5.529	—	—	—	—
Percent Change From Baseline in Weight: Females Month 12 (n=107)	11.65 percent change Standard Deviation 8.391	—	—	—	—
Percent Change From Baseline in Weight: Females Month 18 (n=99)	16.79 percent change Standard Deviation 11.315	—	—	—	—
Percent Change From Baseline in Weight: Females Month 24 (n=95)	23.43 percent change Standard Deviation 14.333	—	—	—	—
Percent Change From Baseline in Weight: Females Month 30 (n=93)	27.83 percent change Standard Deviation 17.507	—	—	—	—
Percent Change From Baseline in Weight: Females Month 36/ET (n=121)	27.26 percent change Standard Deviation 21.389	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=146 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Baseline (n=146)	18.97 kg/m^2 Standard Deviation 3.664	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 1 (n=141)	18.94 kg/m^2 Standard Deviation 3.751	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 1 (n=141)	0.01 kg/m^2 Standard Deviation 0.577	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 2 (n=138)	19.06 kg/m^2 Standard Deviation 3.755	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 2 (n=138)	0.06 kg/m^2 Standard Deviation 0.658	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 3 (n=133)	18.99 kg/m^2 Standard Deviation 3.745	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 3 (n=133)	0.07 kg/m^2 Standard Deviation 0.890	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 6 (n=129)	19.04 kg/m^2 Standard Deviation 3.881	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 6 (n=129)	0.10 kg/m^2 Standard Deviation 1.218	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 12 (n=123)	19.34 kg/m^2 Standard Deviation 3.922	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 12 (n=123)	0.37 kg/m^2 Standard Deviation 1.541	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 18 (n=119)	19.65 kg/m^2 Standard Deviation 4.053	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 18 (n=119)	0.73 kg/m^2 Standard Deviation 1.625	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 24 (n=114)	19.91 kg/m^2 Standard Deviation 4.098	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 24 (n=114)	0.99 kg/m^2 Standard Deviation 1.745	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 30 (n=114)	20.18 kg/m^2 Standard Deviation 4.400	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 30 (n=114)	1.25 kg/m^2 Standard Deviation 2.099	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Month 36/ET (n=134)	20.28 kg/m^2 Standard Deviation 4.137	—	—	—	—
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males Change at Month 36/ET (n=134)	1.33 kg/m^2 Standard Deviation 1.958	—	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

Investigator assessment of BMI changes during the study.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=141 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in BMI: Males Month 30 (n=114)	6.80 percent change Standard Deviation 9.737	—	—	—	—
Percent Change From Baseline in BMI: Males Month 36/ET (n=134)	7.31 percent change Standard Deviation 9.290	—	—	—	—
Percent Change From Baseline in BMI: Males Month 1 (n=141)	0.03 percent change Standard Deviation 2.953	—	—	—	—
Percent Change From Baseline in BMI: Males Month 2 (n=138)	0.31 percent change Standard Deviation 3.405	—	—	—	—
Percent Change From Baseline in BMI: Males Month 3 (n=133)	0.39 percent change Standard Deviation 4.496	—	—	—	—
Percent Change From Baseline in BMI: Males Month 6 (n=129)	0.55 percent change Standard Deviation 5.673	—	—	—	—
Percent Change From Baseline in BMI: Males Month 12 (n=123)	2.10 percent change Standard Deviation 7.065	—	—	—	—
Percent Change From Baseline in BMI: Males Month 18 (n=119)	3.98 percent change Standard Deviation 7.533	—	—	—	—
Percent Change From Baseline in BMI: Males Month 24 (n=114)	5.45 percent change Standard Deviation 8.306	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=125 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
BMI (kg/m^2) During the Study: Females Baseline (n=125)	19.44 kg/m^2 Standard Deviation 3.994	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 1 (n=124)	19.45 kg/m^2 Standard Deviation 3.973	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 1 (n=124)	-0.02 kg/m^2 Standard Deviation 0.582	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 2 (n=119)	19.47 kg/m^2 Standard Deviation 3.940	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 2 (n=119)	0.00 kg/m^2 Standard Deviation 0.756	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 3 (n=115)	19.54 kg/m^2 Standard Deviation 4.171	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 3 (n=115)	0.13 kg/m^2 Standard Deviation 0.861	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 6 (n=113)	19.68 kg/m^2 Standard Deviation 4.288	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 6 (n=113)	0.24 kg/m^2 Standard Deviation 1.004	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 12 (n=107)	19.98 kg/m^2 Standard Deviation 4.257	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 12 (n=107)	0.60 kg/m^2 Standard Deviation 1.305	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 18 (n=99)	20.24 kg/m^2 Standard Deviation 3.990	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 18 (n=99)	0.92 kg/m^2 Standard Deviation 1.432	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 24 (n=95)	20.50 kg/m^2 Standard Deviation 3.976	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 24 (n=95)	1.38 kg/m^2 Standard Deviation 1.624	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 30 (n=93)	20.75 kg/m^2 Standard Deviation 4.014	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 30 (n=93)	1.59 kg/m^2 Standard Deviation 1.931	—	—	—	—
BMI (kg/m^2) During the Study: Females Month 36/ET (n=121)	20.71 kg/m^2 Standard Deviation 4.217	—	—	—	—
BMI (kg/m^2) During the Study: Females Change at Month 36/ET (n=121)	1.46 kg/m^2 Standard Deviation 1.948	—	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

Investigator assessment of BMI changes during the study.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=124 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in BMI: Females Month 1 (n=124)	-0.06 percent change Standard Deviation 3.058	—	—	—	—
Percent Change From Baseline in BMI: Females Month 2 (n=119)	0.16 percent change Standard Deviation 3.777	—	—	—	—
Percent Change From Baseline in BMI: Females Month 3 (n=115)	0.73 percent change Standard Deviation 4.314	—	—	—	—
Percent Change From Baseline in BMI: Females Month 6 (n=113)	1.26 percent change Standard Deviation 4.992	—	—	—	—
Percent Change From Baseline in BMI: Females Month 12 (n=107)	3.33 percent change Standard Deviation 6.765	—	—	—	—
Percent Change From Baseline in BMI: Females Month 18 (n=99)	5.14 percent change Standard Deviation 7.578	—	—	—	—
Percent Change From Baseline in BMI: Females Month 24 (n=95)	7.68 percent change Standard Deviation 8.661	—	—	—	—
Percent Change From Baseline in BMI: Females Month 30 (n=93)	8.89 percent change Standard Deviation 9.916	—	—	—	—
Percent Change From Baseline in BMI: Females Month 36/ET (n=121)	8.06 percent change Standard Deviation 10.147	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=146 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Age (Years) During the Study: Males Baseline (n=146)	9.94 years Standard Deviation 2.489	—	—	—	—
Age (Years) During the Study: Males Month 1 (n=141)	10.05 years Standard Deviation 2.553	—	—	—	—
Age (Years) During the Study: Males Change at Month 1 (n=141)	0.11 years Standard Deviation 0.309	—	—	—	—
Age (Years) During the Study: Males Month 2 (n=138)	10.14 years Standard Deviation 2.583	—	—	—	—
Age (Years) During the Study: Males Change at Month 2 (n=138)	0.18 years Standard Deviation 0.387	—	—	—	—
Age (Years) During the Study: Males Month 3 (n=133)	10.21 years Standard Deviation 2.567	—	—	—	—
Age (Years) During the Study: Males Change at Month 3 (n=133)	0.29 years Standard Deviation 0.457	—	—	—	—
Age (Years) During the Study: Males Month 6 (n=129)	10.43 years Standard Deviation 2.552	—	—	—	—
Age (Years) During the Study: Males Change at Month 6 (n=129)	0.55 years Standard Deviation 0.499	—	—	—	—
Age (Years) During the Study: Males Month 12 (n=123)	10.96 years Standard Deviation 2.543	—	—	—	—
Age (Years) During the Study: Males Change at Month 12 (n=123)	1.02 years Standard Deviation 0.155	—	—	—	—
Age (Years) During the Study: Males Month 18 (n=119)	11.47 years Standard Deviation 2.544	—	—	—	—
Age (Years) During the Study: Males Change at Month 18 (n=119)	1.54 years Standard Deviation 0.501	—	—	—	—
Age (Years) During the Study: Males Month 24 (n=114)	11.93 years Standard Deviation 2.534	—	—	—	—
Age (Years) During the Study: Males Change at Month 24 (n=114)	2.02 years Standard Deviation 0.132	—	—	—	—
Age (Years) During the Study: Males Month 30 (n=114)	12.46 years Standard Deviation 2.553	—	—	—	—
Age (Years) During the Study: Males Change at Month 30 (n=114)	2.54 years Standard Deviation 0.500	—	—	—	—
Age (Years) During the Study: Males Month 36/ET (n=134)	12.69 years Standard Deviation 2.587	—	—	—	—
Age (Years) During the Study: Males Change at Month 36/ET (n=134)	2.67 years Standard Deviation 0.899	—	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

Investigator assessment of age during the study.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=141 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Age: Males Month 1 (n=141)	1.09 percent change Standard Deviation 3.327	—	—	—	—
Percent Change From Baseline in Age: Males Month 2 (n=138)	1.86 percent change Standard Deviation 4.184	—	—	—	—
Percent Change From Baseline in Age: Males Month 3 (n=133)	3.16 percent change Standard Deviation 5.175	—	—	—	—
Percent Change From Baseline in Age: Males Month 6 (n=129)	6.06 percent change Standard Deviation 5.956	—	—	—	—
Percent Change From Baseline in Age: Males Month 12 (n=123)	11.13 percent change Standard Deviation 3.878	—	—	—	—
Percent Change From Baseline in Age: Males Month 18 (n=119)	16.82 percent change Standard Deviation 7.732	—	—	—	—
Percent Change From Baseline in Age: Males Month 24 (n=114)	21.92 percent change Standard Deviation 6.623	—	—	—	—
Percent Change From Baseline in Age: Males Month 30 (n=114)	27.67 percent change Standard Deviation 9.855	—	—	—	—
Percent Change From Baseline in Age: Males Month 36/ET (n=134)	28.90 percent change Standard Deviation 13.486	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=125 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Age (Years) During the Study: Females Baseline (n=125)	10.55 years Standard Deviation 2.421	—	—	—	—
Age (Years) During the Study: Females Month 1 (n=125)	10.66 years Standard Deviation 2.436	—	—	—	—
Age (Years) During the Study: Females Change at Month 1 (n=125)	0.11 years Standard Deviation 0.317	—	—	—	—
Age (Years) During the Study: Females Month 2 (n=120)	10.78 years Standard Deviation 2.430	—	—	—	—
Age (Years) During the Study: Females Change at Month 2 (n=120)	0.20 years Standard Deviation 0.402	—	—	—	—
Age (Years) During the Study: Females Month 3 (n=115)	10.75 years Standard Deviation 2.449	—	—	—	—
Age (Years) During the Study: Females Change at Month 3 (n=115)	0.28 years Standard Deviation 0.450	—	—	—	—
Age (Years) During the Study: Females Month 6 (n=113)	10.99 years Standard Deviation 2.477	—	—	—	—
Age (Years) During the Study: Females Change at Month 6 (n=113)	0.52 years Standard Deviation 0.502	—	—	—	—
Age (Years) During the Study: Females Month 12 (n=107)	11.50 years Standard Deviation 2.416	—	—	—	—
Age (Years) During the Study: Females Change at Month 12 (n=107)	0.99 years Standard Deviation 0.097	—	—	—	—
Age (Years) During the Study: Females Month 18 (n=99)	12.02 years Standard Deviation 2.503	—	—	—	—
Age (Years) During the Study: Females Change at Month 18 (n=99)	1.52 years Standard Deviation 0.502	—	—	—	—
Age (Years) During the Study: Females Month 24 (n=95)	12.42 years Standard Deviation 2.482	—	—	—	—
Age (Years) During the Study: Females Change at Month 24 (n=95)	1.98 years Standard Deviation 0.144	—	—	—	—
Age (Years) During the Study: Females Month 30 (n=93)	12.99 years Standard Deviation 2.564	—	—	—	—
Age (Years) During the Study: Females Change at Month 30 (n=93)	2.52 years Standard Deviation 0.502	—	—	—	—
Age (Years) During the Study: Females Month 36/ET (n=121)	13.07 years Standard Deviation 2.547	—	—	—	—
Age (Years) During the Study: Females Change at Month 36/ET (n=121)	2.54 years Standard Deviation 0.940	—	—	—	—

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

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

Investigator assessment of age during the study.

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=125 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in Age: Females Month 1 (n=125)	1.10 percent change Standard Deviation 3.169	—	—	—	—
Percent Change From Baseline in Age: Females Month 2 (n=120)	2.00 percent change Standard Deviation 4.128	—	—	—	—
Percent Change From Baseline in Age: Females Month 3 (n=115)	2.74 percent change Standard Deviation 4.549	—	—	—	—
Percent Change From Baseline in Age: Females Month 6 (n=113)	5.18 percent change Standard Deviation 5.221	—	—	—	—
Percent Change From Baseline in Age: Females Month 12 (n=107)	10.00 percent change Standard Deviation 2.811	—	—	—	—
Percent Change From Baseline in Age: Females Month 18 (n=99)	15.20 percent change Standard Deviation 6.006	—	—	—	—
Percent Change From Baseline in Age: Females Month 24 (n=95)	20.08 percent change Standard Deviation 5.298	—	—	—	—
Percent Change From Baseline in Age: Females Month 30 (n=93)	25.35 percent change Standard Deviation 7.415	—	—	—	—
Percent Change From Baseline in Age: Females Month 36/ET (n=121)	25.73 percent change Standard Deviation 12.168	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Months 6, 12, 18, 24, 30 and 36/ET

Population: 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.

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=37 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=36 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Flow-Mediated Dilatation (FMD) During the Study Baseline (n=37,36)	5.523 % FMD Standard Deviation 3.2062	6.651 % FMD Standard Deviation 4.4926	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Month 6 (n=27,23)	5.749 % FMD Standard Deviation 2.5047	6.520 % FMD Standard Deviation 4.0763	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Change at Month 6 (n=27,23)	-0.063 % FMD Standard Deviation 3.4768	-0.759 % FMD Standard Deviation 4.8732	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Month 12 (n=32,29)	4.732 % FMD Standard Deviation 1.8477	6.363 % FMD Standard Deviation 8.0370	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Change at Month 12 (n=32,29)	-0.952 % FMD Standard Deviation 3.6796	-0.778 % FMD Standard Deviation 9.4743	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Month 18 (n=33,28)	4.942 % FMD Standard Deviation 2.6740	4.668 % FMD Standard Deviation 3.8874	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Change at Month 18 (n=33,28)	-0.762 % FMD Standard Deviation 3.7374	-2.556 % FMD Standard Deviation 6.3123	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Month 24 (n=33,28)	4.538 % FMD Standard Deviation 2.4239	5.679 % FMD Standard Deviation 4.3224	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Change at Month 24 (n=33,28)	-1.166 % FMD Standard Deviation 3.2524	-1.545 % FMD Standard Deviation 7.2325	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Month 30 (n=33,28)	5.571 % FMD Standard Deviation 2.7198	5.191 % FMD Standard Deviation 2.5120	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Change at Month 30 (n=33,28)	-0.134 % FMD Standard Deviation 3.3399	-2.033 % FMD Standard Deviation 5.8591	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Month 36/ET (n=34,33)	4.987 % FMD Standard Deviation 2.2540	5.360 % FMD Standard Deviation 2.9873	—	—	—
Flow-Mediated Dilatation (FMD) During the Study Change at Month 36/ET (n=34,33)	-0.550 % FMD Standard Deviation 3.6625	-1.563 % FMD Standard Deviation 4.8355	—	—	—

PRIMARY outcome

Timeframe: Months 6, 12, 18, 24, 30 and 36/ET

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

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=34 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=33 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percent Change From Baseline in FMD Month 6 (n=27,23)	14.867 percent change Standard Deviation 67.6028	-0.205 percent change Standard Deviation 60.7192	—	—	—
Percent Change From Baseline in FMD Month 12 (n=32,29)	-3.880 percent change Standard Deviation 56.1910	15.444 percent change Standard Deviation 207.6932	—	—	—
Percent Change From Baseline in FMD Month 18 (n=33,28)	-4.598 percent change Standard Deviation 68.0267	-24.387 percent change Standard Deviation 81.5683	—	—	—
Percent Change From Baseline in FMD Month 24 (n=33,28)	-9.992 percent change Standard Deviation 57.3868	3.850 percent change Standard Deviation 102.2001	—	—	—
Percent Change From Baseline in FMD Month 30 (n=33,28)	7.000 percent change Standard Deviation 63.0894	-18.804 percent change Standard Deviation 42.2259	—	—	—
Percent Change From Baseline in FMD Month 36/ET (n=34,33)	0.648 percent change Standard Deviation 62.5814	-7.506 percent change Standard Deviation 61.2361	—	—	—

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Baseline (n=139,132)	99.3 percentage of participants	100.0 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 1 (n=118,113)	100.0 percentage of participants	100.0 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 2 (n=116,109)	100.0 percentage of participants	100.0 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 3 (n=130,118)	100.0 percentage of participants	100.0 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 6 (n=127,115)	100.0 percentage of participants	99.1 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 12 (n=121,109)	100.0 percentage of participants	99.1 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 18 (n=115,102)	100.0 percentage of participants	100.0 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 24 (n=113,95)	100.0 percentage of participants	100.0 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 30 (n=111,94)	100.0 percentage of participants	98.9 percentage of participants	—	—	—
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Month 36/Early Termination (n=128,127)	99.2 percentage of participants	99.2 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)

Population: 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.

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

Outcome measures

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=135 Participants 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 Participants 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 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.	Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 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.
Percentage of Participants by Study Drug Compliance Category Month 36/ET, <80% (n=129,129)	11.6 percentage of participants	16.3 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 1, <80% (n=135,132)	3.0 percentage of participants	6.8 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 1, 80%-120% (n=135,132)	97.0 percentage of participants	93.2 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 1, >120% (n=135,132)	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 2, <80% (n=132,126)	6.8 percentage of participants	7.9 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 2, 80%-120% (n=132,126)	92.4 percentage of participants	92.1 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 2, >120% (n=132,126)	0.8 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 3, <80% (n=130,118)	3.8 percentage of participants	7.6 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 3, 80%-120% (n=130,118)	95.4 percentage of participants	92.4 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 3, >120% (n=130,118)	0.8 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 6, <80% (n=127,115)	7.9 percentage of participants	9.6 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 6, 80%-120% (n=127,115)	92.1 percentage of participants	90.4 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 6, >120% (n=127,115)	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 12, <80% (n=121,109)	7.4 percentage of participants	7.3 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 12, 80%-120% (n=121,109)	92.6 percentage of participants	92.7 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 12, >120% (n=121,109)	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 18, <80% (n=116,102)	4.3 percentage of participants	5.9 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 18, 80%-120% (n=116,102)	94.0 percentage of participants	94.1 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 18, >120% (n=116,102)	1.7 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 24, <80% (n=113,95)	8.8 percentage of participants	9.5 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 24, 80%-120% (n=113,95)	91.2 percentage of participants	89.5 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 24, >120% (n=113,95)	0 percentage of participants	1.1 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 30, <80% (n=112,94)	8.0 percentage of participants	6.4 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 30, 80%-120% (n=112,94)	92.0 percentage of participants	92.6 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 30, >120% (n=112,94)	0 percentage of participants	1.1 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 36/ET, 80%-120% (n=129,129)	86.8 percentage of participants	83.7 percentage of participants	—	—	—
Percentage of Participants by Study Drug Compliance Category Month 36/ET, >120% (n=129,129)	1.6 percentage of participants	0 percentage of participants	—	—	—

Adverse Events

Atorvastatin (5-80 mg): Tanner_Stage 1

Serious events: 14 serious events

Other events: 93 other events

Deaths: 0 deaths

Atorvastatin (10-80 mg): Tanner_Stage 2+

Serious events: 7 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 participants at risk 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 participants at risk 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.
Gastrointestinal disorders Abdominal pain	0.72% 1/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Gastrointestinal disorders Appendix disorder	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Gastrointestinal disorders Haemorrhoids	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Gastrointestinal disorders Vomiting	0.00% 0/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
General disorders Feeling abnormal	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Infections and infestations Appendicitis	1.4% 2/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Infections and infestations Viral infection	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Injury, poisoning and procedural complications Concussion	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Injury, poisoning and procedural complications Limb injury	0.00% 0/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Injury, poisoning and procedural complications Ulna fracture	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Metabolism and nutrition disorders Obesity	0.00% 0/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Metabolism and nutrition disorders Type I diabetes mellitus	0.00% 0/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Musculoskeletal and connective tissue disorders Myositis	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ewing's sarcoma	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intravascular papillary endothelial hyperplasia	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Nervous system disorders Syncope	0.72% 1/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Psychiatric disorders Bipolar disorder	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Psychiatric disorders Suicide attempt	0.00% 0/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Reproductive system and breast disorders Testsicular appendage torsion	0.72% 1/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.

Other adverse events

Measure	Atorvastatin (5-80 mg): Tanner_Stage 1 n=139 participants at risk 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.	Atorvastatin (10-80 mg): Tanner_Stage 2+ n=132 participants at risk 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.
Gastrointestinal disorders Abdominal pain	15.1% 21/139 • Baseline up through Month 36 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.	7.6% 10/132 • Baseline up through Month 36 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.
Infections and infestations Nasopharyngitis	18.7% 26/139 • Baseline up through Month 36 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.	19.7% 26/132 • Baseline up through Month 36 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.
Musculoskeletal and connective tissue disorders Arthralgia	7.2% 10/139 • Baseline up through Month 36 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.	3.8% 5/132 • Baseline up through Month 36 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.
Musculoskeletal and connective tissue disorders Myalgia	2.9% 4/139 • Baseline up through Month 36 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.	7.6% 10/132 • Baseline up through Month 36 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.
Nervous system disorders Headache	18.0% 25/139 • Baseline up through Month 36 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.	18.9% 25/132 • Baseline up through Month 36 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.
Gastrointestinal disorders Abdominal pain upper	5.0% 7/139 • Baseline up through Month 36 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.	2.3% 3/132 • Baseline up through Month 36 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.
Gastrointestinal disorders Diarrhoea	5.8% 8/139 • Baseline up through Month 36 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.	6.8% 9/132 • Baseline up through Month 36 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.
Gastrointestinal disorders Nausea	2.2% 3/139 • Baseline up through Month 36 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.	6.1% 8/132 • Baseline up through Month 36 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.
Gastrointestinal disorders Vomiting	10.8% 15/139 • Baseline up through Month 36 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.	5.3% 7/132 • Baseline up through Month 36 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.
General disorders Pyrexia	10.8% 15/139 • Baseline up through Month 36 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.	9.8% 13/132 • Baseline up through Month 36 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.
Infections and infestations Bronchitis	6.5% 9/139 • Baseline up through Month 36 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.	0.76% 1/132 • Baseline up through Month 36 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.
Infections and infestations Ear infection	6.5% 9/139 • Baseline up through Month 36 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.	4.5% 6/132 • Baseline up through Month 36 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.
Infections and infestations Gastroenteritis	12.2% 17/139 • Baseline up through Month 36 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.	9.1% 12/132 • Baseline up through Month 36 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.
Infections and infestations Influenza	9.4% 13/139 • Baseline up through Month 36 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.	10.6% 14/132 • Baseline up through Month 36 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.
Infections and infestations Pharyngitis	6.5% 9/139 • Baseline up through Month 36 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.	6.1% 8/132 • Baseline up through Month 36 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.
Infections and infestations Respiratory tract infection	5.0% 7/139 • Baseline up through Month 36 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.	0.00% 0/132 • Baseline up through Month 36 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.
Infections and infestations Rhinitis	9.4% 13/139 • Baseline up through Month 36 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.	6.8% 9/132 • Baseline up through Month 36 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.
Infections and infestations Tonsillitis	7.2% 10/139 • Baseline up through Month 36 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.	4.5% 6/132 • Baseline up through Month 36 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.
Infections and infestations Upper respiratory tract infection	14.4% 20/139 • Baseline up through Month 36 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.	7.6% 10/132 • Baseline up through Month 36 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.
Infections and infestations Viral upper respiratory tract infection	9.4% 13/139 • Baseline up through Month 36 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.	2.3% 3/132 • Baseline up through Month 36 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.
Investigations Blood creatine phosphokinase increased	2.2% 3/139 • Baseline up through Month 36 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.	6.8% 9/132 • Baseline up through Month 36 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.
Musculoskeletal and connective tissue disorders Pain in extremity	10.1% 14/139 • Baseline up through Month 36 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.	3.8% 5/132 • Baseline up through Month 36 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.
Respiratory, thoracic and mediastinal disorders Cough	10.1% 14/139 • Baseline up through Month 36 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.	8.3% 11/132 • Baseline up through Month 36 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.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER