Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02055976

Collaborator

(none)

218

Enrollment

Locations

Arms

10.1

Actual Duration (Months)

24.2

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Bococizumab (PF-04950615;RN316) Drug: Bococizumab (PF-04950615;RN316) Drug: Bococizumab (PF-04950615;RN316) Drug: Placebo Drug: Ezetimibe Drug: Bococizumab (PF-04950615;RN316) Drug: Bococizumab (PF-04950615;RN316) Drug: Bococizumab (PF-04950615;RN316) Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

218 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Double Blind, Parallel Group, Placebo Controlled, Randomized, Dose Ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Twice Monthly Subcutaneous Doses In Hypercholesterolemic Japanese Subjects Who Are Receiving A Stable Dose Of Atorvastatin Or Treatment Naïve.

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Population A A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups.	Drug: Bococizumab (PF-04950615;RN316) Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week Drug: Bococizumab (PF-04950615;RN316) Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week Drug: Bococizumab (PF-04950615;RN316) Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week Drug: Placebo Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week Drug: Ezetimibe Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)
Experimental: Population B A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups.	Drug: Bococizumab (PF-04950615;RN316) 50 mg Q14D SC for 16 week Drug: Bococizumab (PF-04950615;RN316) 100 mg Q14D SC for 16 week Drug: Bococizumab (PF-04950615;RN316) 150 mg Q14D SC for 16 week Drug: Placebo Placebo Q14D SC for 16 week

Arm

Intervention/Treatment

Experimental: Population A

A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups.

Drug: Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week

Drug: Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week

Drug: Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week

Drug: Placebo

Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week

Drug: Ezetimibe

Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)

Experimental: Population B

A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups.

Drug: Bococizumab (PF-04950615;RN316)

50 mg Q14D SC for 16 week

Drug: Bococizumab (PF-04950615;RN316)

100 mg Q14D SC for 16 week

Drug: Bococizumab (PF-04950615;RN316)

150 mg Q14D SC for 16 week

Drug: Placebo

Placebo Q14D SC for 16 week

Outcome Measures

Primary Outcome Measures

Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 [Baseline, Day 85]
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113 [Baseline, Day 113]
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.

Secondary Outcome Measures

Low Density Lipoprotein-Cholesterol (LDL-C) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113 [Baseline, Day 85, 113]
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Total Cholesterol (TC) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113 [Baseline, Day 85, 113]
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113 [Baseline, Day 85, 113]
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Apolipoprotein B (ApoB) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113 [Baseline, Day 85, 113]
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113 [Baseline, Day 85, 113]
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Apolipoprotein A-I (ApoA-I) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113 [Baseline, Day 85, 113]
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113 [Baseline, Day 85, 113]
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Apolipoprotein A-II (ApoA-II) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113 [Baseline, Day 85, 113]
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113 [Baseline, Day 85, 113]
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Lipoprotein (a) (Lp[a]) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113 [Baseline, Day 85, 113]
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113 [Baseline, Day 85, 113]
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
High Density Lipoprotein- Cholesterol (HDL-C) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113 [Baseline, Day 85, 113]
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113 [Baseline, Day 85, 113]
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Very Low Density Lipoprotein-Cholesterol (VLDL-C) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113 [Baseline, Day 85, 113]
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113 [Baseline, Day 85, 113]
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Triglyceride (TG) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Triglyceride (TG) at Day 85 and Day 113 [Baseline, Day 85, 113]
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113 [Baseline, Day 85, 113]
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113 [Baseline, Day 85, 113]
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113 [Baseline, Day 85, 113]
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113 [Baseline, Day 85, 113]
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113 [Baseline, Day 85, 113]
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio [Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169]
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113 [Baseline, Day 85, 113]
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113 [Baseline, Day 85, 113]
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter [Baseline up to Day 113]
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) [Baseline up to Day 169]
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value.
Number of Participants With Anti-Drug Antibody (ADA) Response [Baseline up to Day 169]
Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=6.23 for PF-04950615 were considered ADA positive.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 [Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)]
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615 [Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)]
Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 [Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)]
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Maximum Observed Plasma Concentration (Cmax) of PF-04950615 [Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)]
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615 [Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)]
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 [Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)]
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Terminal Elimination Half-Life (t1/2) of PF-04950615 [Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)]
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) [Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141]
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A).
Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B).

Exclusion Criteria:

Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
Subjects who were administered or prior exposed to PF-04950615 and/or anti-body targeting PCSK9.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maebashi Hirosegawa Clinic	Maebashi	Gunma	Japan	371-0022
2	Yokohama Minoru Clinic	Yokohama	Kanagawa	Japan	232-0064
3	Heishinkai Medical Group Incorporated OCROM Clinic	Suita	Osaka	Japan	565-0853
4	Meiwa Hospital	Chiyoda-ku	Tokyo	Japan	101-0041
5	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo	Japan	103-0027
6	Heishinkai Medical Group Incorporated ToCROM Clinic	Shinjuku-ku	Tokyo	Japan	160-0022
7	Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo	Japan	162-0053
8	Oda Clinic	Shinjuku-ku	Tokyo	Japan	169-0072
9	Sekino Hospital	Toshima-ku	Tokyo	Japan	171-0014

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT02055976

Other Study ID Numbers:

B1481036

First Posted:

Feb 5, 2014

Last Update Posted:

Feb 8, 2019

Last Verified:

Sep 1, 2018

Keywords provided by Pfizer

PF-04950615

Japan

Additional relevant MeSH terms:

Hypercholesterolemia

Ezetimibe

Bococizumab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Period Title: Overall Study
STARTED	25	24	24	26	22	25	25	24	23
COMPLETED	25	24	23	25	22	24	23	24	23
NOT COMPLETED	0	0	1	1	0	1	2	0	0

Baseline Characteristics

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo	Total
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.	Total of all reporting groups
Overall Participants	25	24	24	26	22	25	25	24	23	218
Age, Customized (Count of Participants)
Less than (<) 18 years	0 (8.9) 0%	0 (12.2) 0%	0 (8.6) 0%	0 (11.2) 0%	0 (10.7) 0%	0 (8.4) 0%	0 (10.6) 0%	0 (8.1) 0%	0 (11.7) 0%	0 0%
18-44 years	1 4%	3 12.5%	1 4.2%	3 11.5%	2 9.1%	1 4%	3 12%	3 12.5%	2 8.7%	19 8.7%
45-64 years	18 72%	10 41.7%	16 66.7%	14 53.8%	14 63.6%	16 64%	14 56%	20 83.3%	12 52.2%	134 61.5%
Greater than or equal to (>=) 65 years	6 24%	11 45.8%	7 29.2%	9 34.6%	6 27.3%	8 32%	8 32%	1 4.2%	9 39.1%	65 29.8%
Sex: Female, Male (Count of Participants)
Female	8 32%	10 41.7%	12 50%	13 50%	10 45.5%	13 52%	15 60%	9 37.5%	10 43.5%	100 45.9%
Male	17 68%	14 58.3%	12 50%	13 50%	12 54.5%	12 48%	10 40%	15 62.5%	13 56.5%	118 54.1%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85
Description	LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS) included all the participants who were randomized and administered at least 1 dose of study treatment.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	23	26	22	25	23	24	23
Mean (Standard Deviation) [percent change]	-55.65 (15.748)	-68.25 (18.769)	-74.00 (13.848)	-5.91 (14.323)	-18.56 (15.968)	-47.25 (17.699)	-62.24 (16.097)	-65.89 (10.779)	-1.21 (14.815)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-49.838
	Confidence Interval	(2-Sided) 95% -57.335 to -42.340
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.775
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-66.754
	Confidence Interval	(2-Sided) 95% -74.523 to -58.986
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.912
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-71.534
	Confidence Interval	(2-Sided) 95% -79.284 to -63.784
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.903
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-47.531
	Confidence Interval	(2-Sided) 95% -55.511 to -39.551
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.016
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-62.624
	Confidence Interval	(2-Sided) 95% -70.557 to -54.691
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.993
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-64.268
	Confidence Interval	(2-Sided) 95% -72.128 to -56.409
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.955
	Estimation Comments

2. Primary Outcome

Title	Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113
Description	LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	24	24	23	25	22	25	23	23	23
Mean (Standard Deviation) [percent change]	-54.41 (12.062)	-64.46 (19.149)	-69.98 (19.074)	-12.10 (12.727)	-20.55 (18.682)	-44.94 (19.641)	-61.79 (15.476)	-66.98 (12.396)	0.39 (16.246)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-42.293
	Confidence Interval	(2-Sided) 95% -49.417 to -35.168
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.587
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-56.262
	Confidence Interval	(2-Sided) 95% -63.603 to -48.921
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.696
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-61.384
	Confidence Interval	(2-Sided) 95% -68.733 to -54.035
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.700
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-47.578
	Confidence Interval	(2-Sided) 95% -56.067 to -39.088
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.273
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-63.346
	Confidence Interval	(2-Sided) 95% -71.776 to -54.915
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.244
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-66.691
	Confidence Interval	(2-Sided) 95% -75.088 to -58.295
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.226
	Estimation Comments

3. Secondary Outcome

Title	Low Density Lipoprotein-Cholesterol (LDL-C)
Description	LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	135.36 (23.652)	123.85 (20.585)	129.19 (17.769)	135.90 (24.697)	135.36 (24.745)	164.22 (25.839)	158.00 (20.004)	159.90 (19.800)	155.22 (23.096)
Day 5	86.72 (24.917)	71.83 (26.020)	76.04 (17.111)	130.35 (22.280)	111.50 (23.118)	128.68 (30.905)	120.20 (21.352)	114.63 (30.177)	165.09 (22.880)
Day 8	70.36 (18.932)	55.38 (28.309)	57.71 (16.433)	132.08 (21.244)	105.86 (21.070)	118.20 (33.823)	102.63 (26.577)	96.50 (36.130)	167.22 (23.537)
Day 15	73.76 (18.807)	51.96 (23.921)	39.00 (16.395)	132.50 (19.449)	102.64 (19.458)	113.28 (36.371)	80.44 (25.366)	77.08 (25.943)	165.39 (21.148)
Day 22	49.08 (19.577)	37.58 (20.011)	31.00 (11.176)	133.27 (19.359)	101.68 (21.825)	90.32 (34.956)	67.29 (26.527)	67.71 (32.399)	166.04 (15.741)
Day 29	61.56 (24.316)	48.29 (21.814)	34.26 (13.965)	129.60 (23.381)	107.50 (23.299)	93.36 (36.718)	65.20 (17.970)	63.58 (23.404)	168.14 (24.032)
Day 36	44.40 (19.967)	35.13 (17.306)	29.52 (11.233)	128.50 (23.930)	103.05 (26.462)	80.64 (34.744)	60.67 (19.257)	60.75 (27.619)	154.00 (22.815)
Day 43	58.24 (21.357)	39.63 (20.342)	31.83 (11.750)	126.23 (14.356)	104.95 (23.941)	87.76 (36.555)	64.84 (19.882)	61.83 (29.732)	167.30 (21.850)
Day 50	39.76 (16.042)	32.33 (16.578)	29.96 (11.400)	127.92 (20.392)	106.23 (21.728)	76.96 (32.194)	57.91 (20.889)	59.29 (28.406)	158.83 (17.031)
Day 57	56.88 (18.306)	37.21 (18.352)	29.61 (11.053)	125.27 (20.330)	99.27 (26.705)	81.32 (33.628)	63.54 (25.072)	55.75 (26.272)	152.91 (15.395)
Day 71	61.50 (22.683)	36.29 (18.196)	33.13 (13.384)	130.31 (21.031)	109.18 (26.412)	90.96 (34.188)	60.63 (24.315)	57.33 (25.237)	156.70 (25.663)
Day 85	58.96 (19.650)	38.00 (19.077)	33.91 (19.400)	126.38 (21.478)	110.64 (33.530)	86.64 (30.447)	59.83 (27.495)	54.71 (18.388)	151.30 (21.137)
Day 99	66.48 (23.208)	41.96 (18.995)	38.09 (25.183)	125.80 (15.992)	106.14 (31.001)	93.80 (29.672)	61.67 (31.175)	54.25 (20.339)	163.70 (17.778)
Day 106	45.16 (20.874)	32.13 (18.059)	37.36 (24.849)	127.76 (17.973)	104.14 (25.496)	84.52 (29.679)	57.00 (25.719)	57.42 (22.654)	155.57 (17.010)
Day 113	62.17 (20.417)	42.88 (19.427)	38.48 (24.346)	118.88 (22.883)	107.32 (30.459)	89.44 (29.798)	61.48 (28.511)	53.39 (20.954)	153.30 (16.255)
Day 127	108.16 (21.893)	86.71 (27.414)	61.87 (33.267)	131.92 (21.922)	132.73 (29.660)	137.00 (36.894)	87.22 (42.031)	78.96 (25.696)	161.17 (24.383)
Day 141	126.13 (26.555)	111.38 (24.588)	95.30 (37.497)	129.32 (20.860)	139.14 (38.095)	160.80 (37.487)	130.22 (40.707)	103.08 (34.759)	163.52 (22.224)
Day 155	126.52 (23.631)	113.75 (19.236)	110.57 (26.678)	133.92 (23.240)	139.45 (35.880)	165.17 (31.251)	140.78 (29.645)	119.54 (32.896)	158.17 (15.135)
Day 169	131.28 (25.988)	123.42 (25.782)	124.04 (24.453)	129.28 (24.576)	140.91 (39.309)	168.50 (28.657)	154.52 (21.715)	137.13 (32.817)	168.55 (19.767)

4. Secondary Outcome

Title	Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113
Description	LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-76.40 (26.447)	-85.85 (28.977)	-95.11 (21.145)	-9.52 (21.041)	-24.73 (23.125)	-77.58 (29.943)	-99.28 (32.550)	-105.19 (19.833)	-3.91 (23.632)
Change at Day 113	-73.33 (18.047)	-80.98 (28.902)	-90.54 (28.496)	-17.48 (20.767)	-28.05 (23.663)	-74.78 (34.970)	-97.63 (25.545)	-107.57 (21.765)	-1.91 (20.147)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-67.254
	Confidence Interval	(2-Sided) 95% -76.757 to -57.752
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.785
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-87.122
	Confidence Interval	(2-Sided) 95% -96.969 to -77.275
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.959
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-93.327
	Confidence Interval	(2-Sided) 95% -103.153 to -83.501
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.949
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-71.724
	Confidence Interval	(2-Sided) 95% -84.128 to -59.321
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.243
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-96.206
	Confidence Interval	(2-Sided) 95% -108.541 to -83.872
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.209
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-98.533
	Confidence Interval	(2-Sided) 95% -110.743 to -86.323
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.145
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-56.225
	Confidence Interval	(2-Sided) 95% -65.630 to -46.819
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.736
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-73.813
	Confidence Interval	(2-Sided) 95% -83.507 to -64.119
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.881
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-81.239
	Confidence Interval	(2-Sided) 95% -90.939 to -71.538
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.885
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-72.573
	Confidence Interval	(2-Sided) 95% -84.461 to -60.684
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.983
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-96.222
	Confidence Interval	(2-Sided) 95% -108.039 to -84.405
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.948
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-102.184
	Confidence Interval	(2-Sided) 95% -113.945 to -90.424
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.919
	Estimation Comments

5. Secondary Outcome

Title	Total Cholesterol (TC)
Description	Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	214.16 (30.658)	210.29 (21.594)	211.71 (23.065)	222.44 (31.317)	222.84 (25.395)	245.94 (30.425)	243.26 (21.967)	244.19 (29.987)	242.04 (22.956)
Day 5	169.20 (28.586)	154.83 (30.045)	156.91 (22.240)	219.42 (24.861)	197.77 (25.487)	211.56 (37.176)	203.56 (28.777)	199.58 (41.618)	249.09 (24.156)
Day 8	149.72 (24.979)	137.71 (31.992)	136.50 (21.364)	222.68 (28.253)	190.19 (20.856)	202.44 (37.095)	184.58 (30.935)	186.73 (44.905)	254.26 (22.481)
Day 15	154.20 (26.011)	137.83 (27.241)	120.75 (25.589)	221.69 (23.988)	190.50 (20.964)	198.64 (39.145)	165.48 (30.456)	165.71 (37.735)	251.91 (24.830)
Day 22	129.28 (22.856)	119.00 (26.462)	112.78 (19.247)	218.12 (24.006)	190.64 (23.768)	176.28 (36.510)	152.63 (29.854)	153.67 (43.213)	253.57 (15.716)
Day 29	141.04 (27.355)	133.54 (25.507)	114.91 (24.487)	217.12 (24.280)	192.41 (31.173)	176.36 (41.260)	153.20 (25.762)	150.42 (34.557)	256.73 (22.391)
Day 36	124.12 (22.380)	113.88 (25.000)	107.35 (19.590)	217.08 (26.204)	187.55 (30.803)	163.48 (39.528)	147.08 (25.568)	144.63 (40.577)	244.65 (24.356)
Day 43	139.40 (23.944)	128.83 (30.724)	113.75 (23.167)	214.62 (19.179)	190.86 (28.734)	171.96 (40.287)	151.80 (23.638)	147.25 (41.429)	254.04 (19.793)
Day 50	120.04 (20.687)	112.63 (23.585)	107.74 (22.471)	215.42 (23.262)	189.18 (24.209)	161.00 (37.653)	145.22 (24.814)	144.17 (40.223)	246.09 (17.776)
Day 57	134.16 (25.826)	116.96 (24.489)	104.61 (20.045)	208.04 (23.282)	184.14 (31.148)	158.96 (39.046)	148.00 (30.107)	135.83 (39.794)	236.78 (16.105)
Day 71	142.13 (29.489)	121.04 (28.608)	113.48 (25.056)	218.38 (23.474)	192.91 (31.288)	174.64 (37.758)	146.17 (29.736)	142.42 (37.326)	243.74 (24.849)
Day 85	135.52 (25.161)	119.58 (24.959)	109.57 (27.611)	208.88 (24.747)	198.82 (36.000)	165.44 (32.651)	141.09 (31.318)	134.17 (30.972)	231.52 (22.701)
Day 99	151.24 (31.139)	128.58 (28.864)	122.36 (36.702)	216.28 (19.250)	194.05 (33.230)	178.36 (33.103)	149.83 (33.780)	139.13 (32.510)	249.83 (19.277)
Day 106	126.40 (29.017)	114.75 (26.967)	118.55 (29.987)	212.36 (22.002)	190.27 (28.352)	167.84 (32.859)	142.26 (32.265)	139.92 (35.003)	241.65 (18.982)
Day 113	140.63 (26.650)	124.58 (27.910)	115.17 (30.293)	201.64 (26.967)	191.73 (34.189)	169.72 (31.052)	146.00 (33.889)	134.17 (31.400)	236.83 (16.808)
Day 127	193.96 (26.253)	176.88 (32.328)	147.87 (37.486)	219.32 (26.684)	221.18 (32.444)	223.16 (39.032)	176.74 (46.917)	166.63 (34.144)	249.78 (25.598)
Day 141	209.75 (32.446)	202.71 (26.989)	184.09 (38.141)	216.48 (22.450)	229.50 (38.480)	247.36 (40.025)	217.43 (43.351)	192.96 (37.406)	253.48 (21.494)
Day 155	208.32 (28.912)	203.83 (24.533)	195.26 (31.865)	221.28 (24.455)	228.86 (37.640)	250.00 (34.453)	227.83 (31.438)	208.25 (33.069)	246.35 (15.171)
Day 169	212.96 (29.508)	212.79 (25.267)	211.00 (31.348)	221.00 (26.091)	234.95 (43.216)	254.17 (32.859)	245.57 (34.103)	227.65 (39.088)	258.64 (20.537)

6. Secondary Outcome

Title	Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Description	Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-78.64 (28.525)	-90.71 (31.705)	-101.43 (25.436)	-13.56 (22.346)	-24.02 (26.166)	-80.50 (31.851)	-102.80 (34.603)	-110.02 (24.119)	-10.52 (26.111)
Change at Day 113	-73.44 (21.242)	-85.71 (30.263)	-95.83 (27.765)	-21.68 (23.686)	-31.11 (24.992)	-76.22 (36.301)	-97.89 (29.274)	-111.96 (24.871)	-5.22 (20.333)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-value (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-69.537
	Confidence Interval	(2-Sided) 95% -80.900 to -58.175
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.721
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-86.446
	Confidence Interval	(2-Sided) 95% -98.074 to -74.818
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.855
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-98.273
	Confidence Interval	(2-Sided) 95% -109.983 to -86.563
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.898
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-71.435
	Confidence Interval	(2-Sided) 95% -85.757 to -57.112
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.209
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-94.959
	Confidence Interval	(2-Sided) 95% -109.333 to -80.585
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.236
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-98.519
	Confidence Interval	(2-Sided) 95% -112.727 to -84.311
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.150
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-55.191
	Confidence Interval	(2-Sided) 95% -66.592 to -43.791
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.741
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-72.211
	Confidence Interval	(2-Sided) 95% -83.825 to -60.597
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.848
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-83.065
	Confidence Interval	(2-Sided) 95% -94.807 to -71.323
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.913
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-73.879
	Confidence Interval	(2-Sided) 95% -87.147 to -60.612
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.678
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-95.428
	Confidence Interval	(2-Sided) 95% -108.732 to -82.124
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.697
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-104.859
	Confidence Interval	(2-Sided) 95% -118.079 to -91.639
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.654
	Estimation Comments

7. Secondary Outcome

Title	Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Description	Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-36.26 (11.313)	-42.64 (13.310)	-48.22 (11.066)	-5.47 (9.038)	-10.85 (11.295)	-32.56 (12.011)	-41.98 (12.224)	-45.28 (9.539)	-3.82 (10.484)
Change at Day 113	-34.28 (8.799)	-40.55 (13.471)	-45.58 (12.422)	-9.18 (9.204)	-14.02 (10.900)	-30.50 (13.212)	-40.27 (11.798)	-45.71 (9.786)	-1.62 (8.941)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-31.642
	Confidence Interval	(2-Sided) 95% -37.039 to -26.246
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.717
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-39.880
	Confidence Interval	(2-Sided) 95% -45.403 to -34.358
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.781
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-45.889
	Confidence Interval	(2-Sided) 95% -51.450 to -40.329
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.800
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-30.137
	Confidence Interval	(2-Sided) 95% -36.110 to -24.164
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.006
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-39.525
	Confidence Interval	(2-Sided) 95% -45.520 to -33.531
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.018
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-41.372
	Confidence Interval	(2-Sided) 95% -47.299 to -35.445
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.983
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-25.374
	Confidence Interval	(2-Sided) 95% -30.717 to -20.032
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.690
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-33.490
	Confidence Interval	(2-Sided) 95% -38.934 to -28.047
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.741
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-38.760
	Confidence Interval	(2-Sided) 95% -44.262 to -33.258
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.770
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-30.847
	Confidence Interval	(2-Sided) 95% -36.568 to -25.127
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.879
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-40.019
	Confidence Interval	(2-Sided) 95% -45.754 to -34.285
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.887
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-43.947
	Confidence Interval	(2-Sided) 95% -49.647 to -38.247
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.869
	Estimation Comments

8. Secondary Outcome

Title	Apolipoprotein B (ApoB)
Description	ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	92.76 (14.383)	92.54 (12.362)	90.40 (12.732)	95.65 (13.229)	96.70 (13.382)	106.54 (15.800)	104.02 (14.652)	101.88 (11.494)	103.13 (13.608)
Day 5	67.72 (15.175)	59.83 (14.269)	60.26 (8.853)	94.62 (12.847)	84.68 (13.570)	88.40 (18.777)	82.88 (13.179)	78.00 (14.025)	104.86 (11.902)
Day 8	56.12 (12.245)	49.04 (15.982)	47.42 (9.050)	95.72 (16.395)	80.38 (13.113)	82.52 (19.402)	71.71 (13.614)	70.27 (16.237)	107.61 (11.357)
Day 15	60.20 (15.658)	49.38 (15.528)	36.50 (8.703)	96.65 (13.069)	79.36 (9.639)	82.24 (21.127)	62.28 (16.403)	58.08 (12.265)	107.39 (12.052)
Day 22	44.28 (13.227)	36.83 (12.923)	31.09 (5.938)	96.35 (10.954)	79.77 (12.976)	68.76 (20.949)	53.46 (14.700)	50.54 (15.300)	108.35 (10.530)
Day 29	52.08 (16.595)	46.42 (16.264)	32.83 (8.611)	96.00 (11.800)	80.73 (12.691)	69.32 (20.613)	54.20 (12.285)	50.25 (11.752)	107.23 (12.134)
Day 36	41.04 (11.998)	35.50 (13.603)	29.43 (6.036)	96.27 (14.717)	80.18 (13.828)	62.40 (19.885)	49.25 (8.115)	46.92 (14.191)	103.74 (13.363)
Day 43	51.36 (14.494)	42.50 (17.942)	31.96 (7.538)	94.31 (9.216)	82.68 (12.797)	67.24 (19.959)	53.60 (14.283)	48.50 (14.301)	110.39 (11.645)
Day 50	38.48 (10.759)	34.08 (12.728)	30.52 (6.660)	95.69 (12.802)	82.86 (12.822)	62.28 (19.932)	49.43 (11.469)	47.58 (14.443)	107.22 (11.062)
Day 57	49.44 (14.077)	38.29 (16.236)	29.48 (6.052)	93.81 (12.316)	79.68 (15.490)	62.00 (19.660)	53.25 (17.745)	45.79 (12.322)	104.13 (9.057)
Day 71	52.83 (16.903)	38.71 (16.648)	32.00 (7.634)	97.23 (11.884)	85.18 (14.378)	69.96 (19.673)	50.63 (11.568)	47.79 (12.112)	107.78 (16.082)
Day 85	51.32 (15.258)	39.21 (15.291)	33.65 (14.717)	93.46 (12.666)	86.77 (16.934)	68.68 (17.409)	49.35 (15.183)	45.13 (10.678)	102.09 (12.387)
Day 99	57.36 (17.291)	44.29 (17.853)	37.55 (18.913)	95.08 (12.165)	84.05 (16.247)	72.56 (18.063)	53.63 (17.272)	45.88 (11.211)	110.91 (11.049)
Day 106	42.12 (13.233)	34.71 (15.029)	35.55 (15.987)	94.36 (12.192)	83.32 (14.965)	66.72 (17.111)	48.87 (13.168)	47.00 (12.332)	107.48 (10.117)
Day 113	53.50 (13.593)	42.83 (16.612)	36.48 (15.111)	88.40 (13.438)	82.77 (15.593)	69.08 (17.007)	52.52 (15.774)	45.87 (11.530)	105.61 (9.940)
Day 127	82.00 (13.871)	73.04 (21.566)	54.61 (24.203)	95.16 (12.216)	98.50 (16.280)	97.20 (20.827)	69.91 (28.257)	62.75 (19.525)	111.35 (14.288)
Day 141	89.50 (14.611)	87.71 (18.112)	74.87 (25.118)	95.08 (12.024)	100.45 (19.043)	108.96 (21.279)	92.70 (27.420)	77.67 (25.466)	110.09 (12.109)
Day 155	90.16 (14.291)	89.00 (15.836)	81.87 (16.652)	96.00 (11.832)	101.23 (18.619)	111.39 (17.758)	98.26 (19.262)	86.04 (23.451)	108.43 (10.422)
Day 169	93.36 (16.176)	93.63 (14.455)	91.57 (15.147)	96.88 (13.532)	103.09 (20.718)	112.46 (16.005)	105.91 (17.661)	95.74 (21.764)	111.41 (9.879)

9. Secondary Outcome

Title	Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Description	ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-41.44 (16.385)	-53.33 (19.097)	-56.43 (17.650)	-2.19 (10.703)	-9.93 (14.350)	-37.86 (18.125)	-54.33 (21.080)	-56.75 (14.506)	-1.04 (13.020)
Change at Day 113	-39.56 (12.011)	-49.71 (18.699)	-53.61 (16.526)	-7.70 (12.436)	-13.93 (12.650)	-37.46 (18.504)	-51.15 (16.855)	-56.83 (15.501)	2.48 (11.107)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-41.118
	Confidence Interval	(2-Sided) 95% -47.760 to -34.476
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.344
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-54.787
	Confidence Interval	(2-Sided) 95% -61.543 to -48.032
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.402
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-60.549
	Confidence Interval	(2-Sided) 95% -67.403 to -53.694
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.453
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-36.589
	Confidence Interval	(2-Sided) 95% -43.999 to -29.178
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.730
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-54.683
	Confidence Interval	(2-Sided) 95% -62.102 to -47.265
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.734
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-56.517
	Confidence Interval	(2-Sided) 95% -63.845 to -49.189
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.688
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-33.262
	Confidence Interval	(2-Sided) 95% -39.608 to -26.915
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.196
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-45.956
	Confidence Interval	(2-Sided) 95% -52.388 to -39.523
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.239
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-51.500
	Confidence Interval	(2-Sided) 95% -58.063 to -44.937
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.305
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-40.474
	Confidence Interval	(2-Sided) 95% -47.523 to -33.426
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.547
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-54.634
	Confidence Interval	(2-Sided) 95% -61.685 to -47.583
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.549
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-59.608
	Confidence Interval	(2-Sided) 95% -66.602 to -52.614
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.520
	Estimation Comments

10. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Description	ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-44.30 (15.675)	-57.02 (17.985)	-62.31 (15.684)	-1.77 (10.567)	-9.97 (14.426)	-35.16 (15.906)	-51.62 (16.289)	-55.31 (11.060)	-0.13 (12.144)
Change at Day 113	-42.64 (11.864)	-53.45 (18.449)	-59.48 (15.320)	-7.54 (11.662)	-14.17 (12.713)	-34.66 (16.214)	-49.10 (14.474)	-54.88 (12.109)	3.43 (12.038)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-43.265
	Confidence Interval	(2-Sided) 95% -50.347 to -36.183
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.566
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-57.962
	Confidence Interval	(2-Sided) 95% -65.167 to -50.758
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.628
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-64.729
	Confidence Interval	(2-Sided) 95% -72.039 to -57.419
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.682
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-36.428
	Confidence Interval	(2-Sided) 95% -43.451 to -29.405
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.535
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-53.296
	Confidence Interval	(2-Sided) 95% -60.325 to -46.267
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.538
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-55.489
	Confidence Interval	(2-Sided) 95% -62.436 to -48.542
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.496
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-35.288
	Confidence Interval	(2-Sided) 95% -42.059 to -28.516
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.410
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-48.845
	Confidence Interval	(2-Sided) 95% -55.709 to -41.982
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.456
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-55.114
	Confidence Interval	(2-Sided) 95% -62.116 to -48.112
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.526
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-40.045
	Confidence Interval	(2-Sided) 95% -47.118 to -32.971
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.560
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-53.810
	Confidence Interval	(2-Sided) 95% -60.883 to -46.737
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.560
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-58.620
	Confidence Interval	(2-Sided) 95% -65.640 to -51.600
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.533
	Estimation Comments

11. Secondary Outcome

Title	Apolipoprotein A-I (ApoA-I)
Description	ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	137.02 (13.235)	142.60 (16.507)	140.31 (18.813)	145.65 (21.908)	145.34 (16.171)	138.90 (21.808)	145.38 (19.260)	146.75 (25.587)	150.13 (16.834)
Day 5	140.72 (14.644)	146.65 (16.773)	144.48 (19.943)	146.08 (21.505)	144.68 (16.193)	142.12 (22.260)	145.12 (18.485)	149.79 (24.285)	150.09 (17.989)
Day 8	140.44 (14.972)	147.46 (16.707)	146.88 (19.200)	147.00 (21.527)	145.57 (16.351)	146.76 (25.406)	145.79 (19.260)	152.45 (28.118)	150.48 (16.782)
Day 15	141.56 (13.811)	153.00 (16.325)	150.46 (20.479)	147.04 (22.704)	148.50 (18.918)	145.76 (23.197)	150.08 (20.762)	157.04 (25.154)	151.00 (19.214)
Day 22	143.20 (15.554)	152.88 (18.473)	151.78 (20.576)	145.31 (21.481)	146.41 (17.012)	145.96 (22.354)	150.08 (19.019)	155.17 (23.265)	151.65 (17.185)
Day 29	144.32 (15.118)	155.79 (19.598)	151.78 (22.913)	144.28 (20.633)	146.23 (17.221)	146.36 (22.503)	150.04 (21.763)	155.96 (23.143)	154.32 (15.304)
Day 36	143.48 (15.273)	149.88 (17.957)	150.13 (21.102)	143.46 (20.609)	145.91 (18.652)	145.08 (22.953)	153.33 (19.417)	155.08 (24.063)	149.30 (18.639)
Day 43	144.52 (12.842)	153.88 (18.262)	150.33 (22.584)	142.42 (21.495)	144.64 (16.105)	146.00 (21.050)	152.32 (21.059)	155.75 (32.193)	149.04 (16.932)
Day 50	145.80 (15.042)	151.25 (19.157)	149.13 (19.008)	143.46 (20.397)	141.95 (15.807)	142.84 (21.885)	152.52 (19.739)	153.92 (25.100)	145.70 (14.348)
Day 57	138.40 (14.919)	149.46 (19.509)	145.83 (18.930)	137.62 (18.206)	142.18 (15.445)	136.32 (20.010)	145.96 (22.029)	144.96 (25.049)	138.87 (16.491)
Day 71	145.50 (16.192)	152.92 (21.086)	150.43 (21.002)	142.62 (19.150)	144.18 (15.383)	143.88 (21.896)	151.88 (17.523)	154.25 (23.130)	146.17 (14.981)
Day 85	138.04 (14.968)	148.17 (16.818)	144.04 (15.933)	136.00 (20.229)	144.23 (14.498)	132.88 (19.303)	145.13 (17.168)	146.58 (23.006)	136.30 (16.753)
Day 99	147.40 (18.771)	154.54 (17.840)	150.86 (21.108)	147.48 (20.799)	145.91 (16.798)	143.88 (19.577)	151.29 (21.612)	149.83 (20.750)	144.65 (19.812)
Day 106	145.92 (18.773)	154.96 (19.282)	150.23 (18.341)	143.12 (17.822)	144.64 (15.413)	142.56 (21.143)	149.26 (19.909)	150.46 (21.444)	141.17 (15.497)
Day 113	139.21 (15.731)	149.17 (18.719)	144.13 (18.587)	137.72 (21.454)	145.00 (14.690)	138.40 (19.581)	149.09 (18.033)	143.96 (21.353)	140.04 (16.767)
Day 127	144.08 (18.630)	148.75 (17.738)	150.04 (23.145)	145.60 (22.763)	144.27 (14.701)	141.68 (20.412)	148.48 (18.012)	149.17 (23.566)	144.48 (15.237)
Day 141	145.46 (19.006)	151.21 (18.990)	154.17 (22.321)	148.52 (23.261)	144.45 (16.721)	141.36 (20.968)	148.74 (17.324)	151.29 (22.831)	149.13 (19.328)
Day 155	143.52 (17.564)	148.83 (20.267)	149.52 (21.848)	147.60 (23.076)	147.09 (16.446)	140.96 (23.437)	148.09 (21.037)	149.13 (23.899)	148.83 (18.077)
Day 169	142.96 (20.387)	151.54 (19.010)	150.96 (19.025)	154.88 (23.938)	153.64 (21.367)	144.13 (24.746)	151.70 (21.699)	151.13 (29.425)	154.36 (19.742)

12. Secondary Outcome

Title	Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Description	ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	1.02 (9.479)	5.56 (10.575)	3.63 (11.155)	-9.65 (9.495)	-1.11 (11.118)	-6.02 (11.069)	-2.09 (12.040)	-0.17 (11.897)	-13.83 (10.602)
Change at Day 113	2.52 (9.226)	6.56 (12.310)	3.72 (11.977)	-7.86 (13.052)	-0.34 (10.783)	-0.50 (9.512)	1.87 (9.328)	-3.54 (8.982)	-10.09 (11.236)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	8.896
	Confidence Interval	(2-Sided) 95% 3.646 to 14.145
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.643
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	15.429
	Confidence Interval	(2-Sided) 95% 10.141 to 20.717
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.662
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	12.321
	Confidence Interval	(2-Sided) 95% 6.959 to 17.683
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.700
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	6.804
	Confidence Interval	(2-Sided) 95% 0.761 to 12.847
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.041
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	10.565
	Confidence Interval	(2-Sided) 95% 4.556 to 16.573
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.023
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	12.895
	Confidence Interval	(2-Sided) 95% 6.993 to 18.796
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.969
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	8.644
	Confidence Interval	(2-Sided) 95% 2.157 to 15.130
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.266
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	14.708
	Confidence Interval	(2-Sided) 95% 8.208 to 21.208
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.272
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	11.168
	Confidence Interval	(2-Sided) 95% 4.580 to 17.757
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.317
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	8.132
	Confidence Interval	(2-Sided) 95% 2.947 to 13.316
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.609
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	10.230
	Confidence Interval	(2-Sided) 95% 5.079 to 15.381
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.592
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.767
	Confidence Interval	(2-Sided) 95% 0.670 to 10.864
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.565
	Estimation Comments

13. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Description	ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	0.87 (7.002)	4.20 (7.438)	3.26 (8.418)	-6.44 (6.252)	-0.34 (7.749)	-3.82 (8.033)	-1.00 (8.245)	0.44 (8.673)	-9.10 (6.738)
Change at Day 113	1.93 (6.789)	4.82 (8.766)	3.13 (8.663)	-5.16 (8.106)	0.15 (7.819)	0.13 (7.013)	1.53 (6.572)	-1.84 (5.923)	-6.55 (6.903)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	6.079
	Confidence Interval	(2-Sided) 95% 2.296 to 9.863
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.905
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	10.786
	Confidence Interval	(2-Sided) 95% 6.976 to 14.597
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.918
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	9.069
	Confidence Interval	(2-Sided) 95% 5.206 to 12.932
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.945
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	4.859
	Confidence Interval	(2-Sided) 95% 0.541 to 9.178
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.173
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	7.331
	Confidence Interval	(2-Sided) 95% 3.037 to 11.624
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.161
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	9.075
	Confidence Interval	(2-Sided) 95% 4.856 to 13.293
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.122
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.936
	Confidence Interval	(2-Sided) 95% 1.435 to 10.437
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.266
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	10.213
	Confidence Interval	(2-Sided) 95% 5.702 to 14.724
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.271
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	8.056
	Confidence Interval	(2-Sided) 95% 3.484 to 12.629
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.302
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.846
	Confidence Interval	(2-Sided) 95% 2.312 to 9.380
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.778
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	6.910
	Confidence Interval	(2-Sided) 95% 3.400 to 10.421
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.766
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	4.168
	Confidence Interval	(2-Sided) 95% 0.693 to 7.642
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.748
	Estimation Comments

14. Secondary Outcome

Title	Apolipoprotein A-II (ApoA-II)
Description	ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	30.700 (3.6817)	30.223 (2.8992)	30.471 (2.8918)	31.515 (3.8373)	32.189 (3.2855)	29.940 (3.3630)	31.232 (3.9681)	30.294 (3.0541)	31.354 (3.9552)
Day 5	30.884 (3.6551)	30.161 (2.9004)	30.443 (3.4057)	31.608 (3.6099)	32.709 (3.4130)	30.088 (3.4784)	30.972 (4.2462)	30.558 (3.0567)	31.473 (4.1750)
Day 8	30.224 (2.8736)	30.675 (3.1077)	30.738 (2.9137)	32.036 (3.2261)	32.495 (3.0372)	30.760 (3.3363)	30.608 (3.8492)	30.664 (3.2942)	31.635 (3.6272)
Day 15	30.528 (3.7034)	31.129 (2.9304)	31.304 (3.0309)	32.062 (3.2968)	33.136 (3.6822)	30.568 (3.3308)	31.516 (3.9116)	31.275 (3.4925)	31.530 (4.6451)
Day 22	31.232 (3.1787)	30.667 (3.4561)	31.183 (3.8763)	31.846 (3.0899)	32.273 (3.2310)	30.620 (3.3448)	31.125 (4.0921)	30.896 (3.0900)	32.200 (3.6940)
Day 29	31.608 (3.2712)	32.279 (4.1331)	31.035 (3.7585)	32.096 (3.6363)	32.395 (3.1748)	30.740 (3.0899)	31.100 (3.6272)	31.071 (2.8639)	31.882 (3.6960)
Day 36	31.208 (3.5747)	30.838 (3.3920)	30.622 (3.3870)	31.150 (3.3011)	32.091 (4.0243)	29.768 (3.2825)	31.404 (4.0581)	30.975 (3.3526)	31.478 (3.7066)
Day 43	31.600 (3.8155)	31.908 (4.2809)	31.004 (3.6090)	31.685 (3.6743)	32.636 (3.1568)	30.720 (3.6371)	32.408 (4.0300)	31.138 (3.4691)	31.922 (3.8381)
Day 50	31.772 (3.9676)	31.117 (3.5511)	30.991 (2.9264)	31.900 (3.5621)	32.282 (3.5327)	29.760 (3.8077)	32.704 (3.8668)	31.083 (3.8423)	30.830 (3.7644)
Day 57	30.708 (5.1285)	30.271 (4.0390)	29.987 (3.2086)	30.773 (3.4292)	32.405 (3.0798)	28.548 (3.8710)	31.454 (4.3687)	30.033 (3.9031)	29.861 (3.3007)
Day 71	32.600 (4.3091)	31.554 (4.3823)	31.148 (2.8016)	32.092 (3.5748)	33.127 (3.3208)	30.260 (3.9125)	32.658 (3.9677)	31.804 (3.5119)	31.317 (4.0283)
Day 85	30.484 (4.5441)	30.296 (4.2019)	29.974 (3.3766)	30.577 (4.1019)	33.095 (3.4642)	29.036 (3.6811)	31.957 (4.8917)	30.533 (4.0376)	29.657 (3.6082)
Day 99	32.868 (4.2145)	32.054 (4.3729)	31.436 (3.7821)	32.500 (4.3987)	33.155 (3.9087)	31.352 (3.8161)	32.925 (5.9562)	31.229 (2.9670)	31.570 (4.3204)
Day 106	31.908 (4.1181)	31.850 (3.8284)	31.073 (3.3504)	31.724 (3.5444)	32.432 (3.6429)	30.520 (3.9332)	32.552 (4.3131)	31.438 (3.7623)	30.865 (3.7092)
Day 113	30.442 (4.1097)	30.313 (4.1545)	29.787 (3.3975)	30.388 (3.3572)	32.559 (3.0055)	29.300 (3.3821)	32.361 (4.1480)	30.239 (3.2747)	30.126 (3.5101)
Day 127	32.068 (3.9869)	31.358 (3.9263)	31.370 (3.4158)	31.824 (3.4922)	32.905 (3.2614)	30.904 (3.1115)	32.374 (3.7973)	31.242 (3.5215)	31.839 (3.7256)
Day 141	32.704 (4.5005)	32.325 (4.2787)	32.835 (3.3582)	32.044 (4.2146)	32.818 (3.4188)	31.412 (3.6261)	33.287 (3.0694)	32.029 (3.4970)	32.178 (3.1213)
Day 155	32.164 (3.9476)	31.629 (4.4463)	31.878 (3.3637)	31.956 (4.1374)	32.877 (3.7858)	31.061 (3.8024)	32.891 (4.0870)	31.867 (3.6487)	31.439 (3.4050)
Day 169	31.848 (4.1778)	32.033 (3.8588)	32.352 (3.8903)	33.120 (4.2339)	33.623 (4.2722)	31.433 (3.8678)	33.578 (4.4671)	32.070 (3.9987)	32.345 (3.6908)

15. Secondary Outcome

Title	Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Description	ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-0.216 (2.2274)	0.073 (2.6605)	-0.450 (2.3906)	-0.938 (1.8339)	0.907 (2.6785)	-0.904 (2.3894)	0.354 (3.3769)	0.240 (3.1812)	-1.698 (2.9589)
Change at Day 113	-0.073 (2.0937)	0.090 (2.3882)	-0.637 (2.2412)	-1.104 (4.0438)	0.370 (2.2388)	-0.640 (2.0394)	0.759 (2.2739)	0.002 (2.8256)	-1.228 (3.4404)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.127
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.7208
	Confidence Interval	(2-Sided) 95% -0.5283 to 1.9700
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.6289
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.053
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	1.0574
	Confidence Interval	(2-Sided) 95% -0.2259 to 2.3406
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.6461
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.354
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.2445
	Confidence Interval	(2-Sided) 95% -1.0486 to 1.5375
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.6511
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.176
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.8055
	Confidence Interval	(2-Sided) 95% -0.9066 to 2.5177
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.8615
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	2.0071
	Confidence Interval	(2-Sided) 95% 0.2899 to 3.7242
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.8641
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	1.7116
	Confidence Interval	(2-Sided) 95% 0.0184 to 3.4049
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.8520
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.138
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.8585
	Confidence Interval	(2-Sided) 95% -0.6992 to 2.4163
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7844
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.137
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.8807
	Confidence Interval	(2-Sided) 95% -0.7064 to 2.4678
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7990
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.373
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.2624
	Confidence Interval	(2-Sided) 95% -1.3370 to 1.8618
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.8053
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.333
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.3239
	Confidence Interval	(2-Sided) 95% -1.1611 to 1.8089
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7472
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	1.9322
	Confidence Interval	(2-Sided) 95% 0.4441 to 3.4203
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7488
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.133
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.8340
	Confidence Interval	(2-Sided) 95% -0.6451 to 2.3130
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7442
	Estimation Comments

16. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Description	ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-0.85 (7.387)	0.17 (8.699)	-1.34 (7.672)	-2.93 (5.741)	3.13 (8.288)	-2.87 (7.788)	1.34 (10.779)	0.98 (10.565)	-4.97 (9.262)
Change at Day 113	-0.21 (6.972)	0.13 (7.974)	-1.99 (7.403)	-2.77 (11.234)	1.48 (6.776)	-1.94 (6.337)	2.64 (7.315)	0.39 (9.526)	-3.29 (10.137)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.155
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	2.0813
	Confidence Interval	(2-Sided) 95% -1.9730 to 6.1356
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.0411
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.062
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	3.2608
	Confidence Interval	(2-Sided) 95% -0.9035 to 7.4250
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.0965
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.349
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.8224
	Confidence Interval	(2-Sided) 95% -3.3733 to 5.0182
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.1126
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.202
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	2.3254
	Confidence Interval	(2-Sided) 95% -3.1801 to 7.8310
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.7702
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	6.1048
	Confidence Interval	(2-Sided) 95% 0.5833 to 11.6263
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.7784
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.2393
	Confidence Interval	(2-Sided) 95% -0.2058 to 10.6845
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.7396
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.185
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	2.1827
	Confidence Interval	(2-Sided) 95% -2.6334 to 6.9988
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.4251
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.195
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	2.1376
	Confidence Interval	(2-Sided) 95% -2.7718 to 7.0469
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.4716
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.450
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.3113
	Confidence Interval	(2-Sided) 95% -4.6358 to 5.2584
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.4909
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.397
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.6078
	Confidence Interval	(2-Sided) 95% -4.0274 to 5.2431
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.3322
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.7096
	Confidence Interval	(2-Sided) 95% 1.0659 to 10.3532
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.3367
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.147
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	2.4558
	Confidence Interval	(2-Sided) 95% -2.1608 to 7.0724
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.3230
	Estimation Comments

17. Secondary Outcome

Title	Lipoprotein (a) (Lp[a])
Description	Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	18.452 (13.1792)	20.998 (17.2111)	18.840 (16.7289)	19.265 (14.3646)	19.468 (18.4181)	14.080 (11.9369)	15.458 (12.6296)	13.400 (9.0719)	16.239 (10.1883)
Day 5	16.224 (13.4935)	18.348 (17.7316)	16.204 (16.6072)	18.523 (15.2512)	20.450 (18.8904)	12.464 (10.5751)	14.580 (12.2541)	11.783 (9.3506)	15.859 (10.9932)
Day 8	14.892 (13.2944)	15.333 (18.3499)	14.167 (15.5022)	19.184 (14.7461)	17.243 (15.7353)	12.000 (11.8358)	12.617 (10.4189)	12.768 (8.9168)	16.443 (12.1793)
Day 15	14.208 (12.9280)	14.129 (17.8567)	11.392 (14.1251)	19.258 (16.0484)	18.982 (20.4348)	10.140 (10.0017)	12.548 (10.9860)	9.996 (8.1113)	16.443 (11.4594)
Day 22	12.628 (12.4393)	12.446 (16.1397)	10.765 (13.3504)	18.785 (16.0604)	17.800 (18.6499)	10.936 (10.1920)	11.583 (11.3914)	8.800 (7.1835)	16.026 (11.0080)
Day 29	12.832 (12.3874)	13.379 (16.2405)	10.552 (12.7986)	18.304 (15.6050)	17.873 (18.0678)	10.424 (10.6085)	10.888 (9.8450)	9.312 (7.3675)	17.423 (11.1746)
Day 36	11.152 (11.9088)	12.833 (16.0418)	10.409 (12.7145)	17.046 (14.4893)	18.050 (19.5448)	9.484 (10.6692)	10.329 (9.7943)	8.067 (6.7186)	15.843 (10.8050)
Day 43	11.648 (12.2798)	12.525 (16.1360)	9.633 (12.4360)	16.912 (14.1356)	17.214 (18.6825)	9.380 (9.6416)	9.944 (9.7431)	8.821 (7.6426)	15.961 (10.3890)
Day 50	10.344 (11.3684)	11.675 (14.8818)	9.039 (12.0250)	16.835 (14.2068)	17.314 (19.6439)	10.040 (10.4835)	10.191 (9.2630)	7.621 (6.5659)	15.078 (9.7608)
Day 57	10.708 (10.3883)	10.871 (13.5224)	8.578 (11.2275)	15.892 (14.0990)	17.573 (21.9401)	9.392 (10.2457)	9.487 (8.2801)	6.858 (6.2894)	14.313 (9.3930)
Day 71	11.358 (12.3793)	11.354 (14.0492)	9.009 (11.7733)	16.542 (13.5029)	16.991 (20.0151)	9.248 (11.4972)	9.529 (8.6412)	6.979 (6.5414)	13.500 (9.4333)
Day 85	10.960 (11.6806)	10.879 (14.1289)	9.239 (11.1448)	16.519 (14.5691)	17.609 (19.7001)	8.808 (10.3417)	9.261 (7.6804)	6.637 (5.6695)	12.726 (8.9598)
Day 99	12.232 (12.5326)	11.837 (15.6082)	8.855 (13.9399)	15.764 (14.4527)	16.868 (19.6709)	7.940 (9.6343)	8.537 (7.6094)	6.792 (5.6212)	13.691 (9.5937)
Day 106	10.756 (11.7377)	11.079 (14.2590)	9.123 (14.1064)	15.396 (12.8944)	16.682 (18.8434)	8.608 (9.5662)	8.296 (7.3410)	6.858 (6.1058)	12.800 (8.9601)
Day 113	12.108 (12.3479)	11.183 (14.5312)	9.565 (14.0691)	14.492 (12.9060)	16.814 (17.8976)	8.020 (9.0412)	8.287 (7.6439)	6.787 (5.8743)	12.913 (9.7212)
Day 127	15.476 (14.6308)	15.112 (16.5781)	11.961 (15.6073)	15.500 (13.0255)	16.618 (19.1791)	9.864 (10.2016)	10.543 (9.2205)	7.642 (6.9977)	13.596 (9.3340)
Day 141	16.842 (15.6809)	17.329 (18.9837)	14.422 (17.3620)	15.828 (13.7114)	17.236 (18.8525)	10.100 (10.9325)	11.996 (10.0494)	8.442 (6.7945)	13.139 (9.2951)
Day 155	17.264 (15.4506)	17.483 (19.9385)	16.052 (16.9174)	16.004 (13.7418)	17.382 (19.8297)	10.204 (11.2720)	13.465 (10.8114)	9.600 (7.5028)	13.183 (9.1710)
Day 169	17.824 (15.1879)	17.404 (18.0405)	16.635 (17.8211)	15.384 (13.7150)	17.059 (20.8409)	11.271 (11.4561)	13.613 (11.5074)	10.626 (8.0902)	14.741 (10.3647)

18. Secondary Outcome

Title	Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Description	Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-7.492 (5.1400)	-10.119 (5.4374)	-10.239 (8.2471)	-2.746 (3.1292)	-1.859 (3.0759)	-5.272 (5.1528)	-7.100 (5.9402)	-6.763 (5.3474)	-3.513 (3.6550)
Change at Day 113	-6.815 (4.6182)	-9.815 (5.0568)	-9.913 (6.6763)	-3.574 (4.0251)	-2.655 (3.1725)	-6.060 (4.5477)	-8.074 (6.0886)	-7.098 (4.5025)	-3.326 (3.4975)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-4.9203
	Confidence Interval	(2-Sided) 95% -7.5504 to -2.2901
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.3242
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-7.1983
	Confidence Interval	(2-Sided) 95% -9.8718 to -4.5249
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.3462
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-7.3118
	Confidence Interval	(2-Sided) 95% -9.9935 to -4.6301
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.3505
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-3.0629
	Confidence Interval	(2-Sided) 95% -5.1132 to -1.0125
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0320
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-3.6209
	Confidence Interval	(2-Sided) 95% -5.6804 to -1.5614
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0367
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-4.1778
	Confidence Interval	(2-Sided) 95% -6.2184 to -2.1372
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0269
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-3.2914
	Confidence Interval	(2-Sided) 95% -5.8649 to -0.7178
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.2954
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-6.3569
	Confidence Interval	(2-Sided) 95% -8.9706 to -3.7432
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.3157
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-6.3962
	Confidence Interval	(2-Sided) 95% -9.0247 to -3.7677
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.3233
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-3.9228
	Confidence Interval	(2-Sided) 95% -5.7506 to -2.0950
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.9199
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-4.7094
	Confidence Interval	(2-Sided) 95% -6.5459 to -2.8729
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.9244
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-4.4374
	Confidence Interval	(2-Sided) 95% -6.2630 to -2.6118
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.9187
	Estimation Comments

19. Secondary Outcome

Title	Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Description	Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-47.11 (20.802)	-58.53 (22.181)	-46.51 (63.192)	-19.37 (25.160)	-15.22 (23.532)	-37.85 (27.223)	-37.29 (24.552)	-43.37 (39.755)	-18.40 (30.139)
Change at Day 113	-42.30 (19.223)	-57.94 (22.317)	-59.42 (21.689)	-24.35 (21.348)	-18.64 (18.300)	-45.26 (22.490)	-47.60 (19.448)	-49.77 (25.417)	-15.89 (36.642)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-27.4492
	Confidence Interval	(2-Sided) 95% -47.7872 to -7.1112
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.2401
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-40.5908
	Confidence Interval	(2-Sided) 95% -61.3577 to -19.8240
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.4568
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-27.1630
	Confidence Interval	(2-Sided) 95% -48.0927 to -6.2332
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.5402
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-24.1677
	Confidence Interval	(2-Sided) 95% -41.8023 to -6.5332
	Parameter Dispersion	Type: Standard Error of the Mean Value: 8.8755
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-19.2255
	Confidence Interval	(2-Sided) 95% -36.9471 to -1.5038
	Parameter Dispersion	Type: Standard Error of the Mean Value: 8.9203
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-26.5155
	Confidence Interval	(2-Sided) 95% -44.0795 to -8.9515
	Parameter Dispersion	Type: Standard Error of the Mean Value: 8.8387
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-18.3898
	Confidence Interval	(2-Sided) 95% -28.6698 to -8.1097
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.1768
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-36.7882
	Confidence Interval	(2-Sided) 95% -47.2423 to -26.3341
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.2640
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-36.8453
	Confidence Interval	(2-Sided) 95% -47.3864 to -26.3041
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.3084
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-32.9411
	Confidence Interval	(2-Sided) 95% -48.5748 to -17.3075
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.8656
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-31.3176
	Confidence Interval	(2-Sided) 95% -47.0238 to -15.6114
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.9032
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-32.8470
	Confidence Interval	(2-Sided) 95% -48.4650 to -17.2289
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.8576
	Estimation Comments

20. Secondary Outcome

Title	High Density Lipoprotein- Cholesterol (HDL-C)
Description	HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	54.58 (9.048)	54.75 (11.789)	57.00 (12.858)	58.54 (14.683)	56.98 (9.607)	57.22 (14.146)	60.40 (13.228)	62.02 (21.455)	60.87 (10.606)
Day 5	55.68 (11.131)	57.04 (12.532)	58.43 (13.480)	58.19 (14.403)	57.00 (9.866)	57.20 (15.785)	60.32 (13.643)	62.08 (21.354)	59.73 (11.344)
Day 8	56.48 (11.266)	58.38 (12.700)	60.33 (13.017)	60.52 (14.234)	58.67 (10.136)	59.60 (15.729)	61.33 (14.230)	64.00 (23.420)	60.57 (11.289)
Day 15	58.52 (8.637)	59.96 (11.925)	62.79 (15.562)	59.35 (15.179)	60.23 (12.208)	60.24 (16.048)	62.32 (15.513)	66.58 (22.085)	60.30 (11.117)
Day 22	59.36 (11.158)	60.08 (12.176)	64.52 (14.585)	58.08 (12.743)	60.05 (10.017)	60.92 (16.253)	63.92 (13.529)	65.38 (17.358)	61.48 (11.233)
Day 29	59.96 (10.486)	61.75 (13.553)	63.83 (15.948)	57.96 (13.192)	59.00 (9.587)	60.84 (16.222)	62.52 (15.196)	67.96 (20.412)	64.14 (9.896)
Day 36	57.92 (10.622)	60.50 (13.112)	62.39 (14.151)	57.62 (13.518)	58.23 (10.314)	59.76 (14.521)	65.25 (14.411)	65.21 (19.489)	59.91 (10.833)
Day 43	59.76 (8.724)	62.21 (13.266)	62.29 (15.415)	57.31 (13.936)	58.82 (10.450)	59.36 (14.950)	63.64 (15.435)	65.17 (18.846)	59.74 (10.558)
Day 50	60.12 (10.248)	60.04 (12.185)	62.09 (14.058)	57.81 (14.525)	58.55 (10.835)	59.40 (14.955)	64.91 (13.651)	65.21 (19.669)	59.39 (10.586)
Day 57	58.40 (8.221)	58.83 (13.830)	60.35 (13.231)	54.88 (12.745)	57.45 (10.804)	57.16 (12.589)	61.92 (14.374)	62.63 (20.549)	56.61 (10.782)
Day 71	60.29 (9.438)	62.96 (14.0492)	64.83 (16.854)	56.85 (12.069)	58.00 (9.798)	59.16 (13.539)	63.92 (14.185)	66.29 (20.354)	57.78 (9.662)
Day 85	58.24 (9.926)	59.54 (12.827)	59.70 (11.315)	53.96 (12.981)	59.77 (10.438)	55.04 (13.421)	63.09 (13.211)	62.00 (17.619)	56.35 (10.075)
Day 99	62.68 (11.926)	62.54 (13.462)	62.32 (14.496)	59.92 (12.812)	60.36 (10.472)	60.00 (13.051)	64.54 (15.453)	64.63 (18.946)	59.30 (12.430)
Day 106	62.36 (11.489)	63.25 (15.118)	64.41 (13.355)	58.28 (12.651)	59.45 (10.117)	60.08 (15.231)	64.39 (15.718)	65.17 (18.897)	58.30 (11.703)
Day 113	58.13 (11.395)	61.04 (14.245)	59.39 (12.565)	55.28 (13.145)	60.32 (10.049)	57.92 (14.617)	63.00 (14.331)	61.83 (18.218)	56.17 (10.421)
Day 127	59.16 (12.212)	59.46 (13.552)	62.78 (14.013)	60.72 (15.118)	57.82 (9.272)	58.56 (13.818)	63.61 (16.160)	63.88 (19.161)	58.00 (10.838)
Day 141	60.58 (11.960)	60.63 (13.682)	64.26 (14.530)	60.96 (15.970)	59.09 (10.766)	59.40 (16.081)	63.26 (14.229)	64.00 (20.167)	62.39 (14.138)
Day 155	58.72 (10.620)	59.00 (14.341)	61.96 (14.455)	59.48 (14.535)	59.45 (9.179)	59.04 (16.425)	63.00 (15.021)	63.67 (20.550)	61.87 (13.602)
Day 169	57.48 (11.794)	59.04 (12.726)	62.48 (14.441)	61.88 (15.078)	60.50 (11.827)	60.29 (16.206)	62.04 (15.155)	65.00 (24.355)	65.05 (13.584)

21. Secondary Outcome

Title	Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Description	HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	3.66 (6.216)	4.79 (5.568)	2.63 (5.394)	-4.58 (4.573)	2.80 (6.223)	-2.18 (6.065)	1.46 (7.408)	-0.02 (7.575)	-4.52 (5.191)
Change at Day 113	3.90 (6.437)	6.29 (7.003)	2.33 (8.053)	-3.28 (7.264)	3.34 (5.702)	0.70 (6.489)	1.37 (7.799)	-0.63 (6.995)	-4.70 (5.045)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	7.663
	Confidence Interval	(2-Sided) 95% 4.820 to 10.506
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.431
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	9.290
	Confidence Interval	(2-Sided) 95% 6.389 to 12.190
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.460
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	7.255
	Confidence Interval	(2-Sided) 95% 4.336 to 10.175
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.470
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.110
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	2.228
	Confidence Interval	(2-Sided) 95% -1.361 to 5.818
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.806
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.578
	Confidence Interval	(2-Sided) 95% 1.972 to 9.185
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.815
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	4.712
	Confidence Interval	(2-Sided) 95% 1.156 to 8.268
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.789
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.888
	Confidence Interval	(2-Sided) 95% 1.844 to 9.932
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.035
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	9.251
	Confidence Interval	(2-Sided) 95% 5.153 to 13.349
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.062
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.264
	Confidence Interval	(2-Sided) 95% 1.147 to 9.380
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.072
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.065
	Confidence Interval	(2-Sided) 95% 1.402 to 8.728
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.843
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	5.096
	Confidence Interval	(2-Sided) 95% 1.413 to 8.780
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.853
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	4.301
	Confidence Interval	(2-Sided) 95% 0.658 to 7.943
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.832
	Estimation Comments

22. Secondary Outcome

Title	Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Description	HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	7.26 (10.914)	9.46 (11.132)	5.86 (9.988)	-7.31 (7.254)	5.42 (10.501)	-3.10 (10.471)	2.93 (11.259)	2.35 (12.101)	-7.16 (8.271)
Change at Day 113	7.39 (11.623)	11.97 (13.385)	5.27 (12.612)	-4.83 (9.919)	6.31 (9.989)	1.86 (11.617)	2.35 (10.959)	1.05 (10.017)	-7.53 (7.966)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	13.389
	Confidence Interval	(2-Sided) 95% 8.373 to 18.405
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.525
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	16.546
	Confidence Interval	(2-Sided) 95% 11.430 to 21.663
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.576
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	13.288
	Confidence Interval	(2-Sided) 95% 8.137 to 18.438
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.593
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.081
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	4.112
	Confidence Interval	(2-Sided) 95% -1.671 to 9.895
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.909
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	9.560
	Confidence Interval	(2-Sided) 95% 3.743 to 15.377
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.927
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	9.826
	Confidence Interval	(2-Sided) 95% 4.103 to 15.548
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.878
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	10.004
	Confidence Interval	(2-Sided) 95% 3.395 to 16.612
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.326
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	16.252
	Confidence Interval	(2-Sided) 95% 9.560 to 22.943
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.367
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	9.571
	Confidence Interval	(2-Sided) 95% 2.847 to 16.295
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.384
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	9.029
	Confidence Interval	(2-Sided) 95% 3.348 to 14.710
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.858
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	8.543
	Confidence Interval	(2-Sided) 95% 2.827 to 14.260
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.876
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	8.898
	Confidence Interval	(2-Sided) 95% 3.252 to 14.544
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.840
	Estimation Comments

23. Secondary Outcome

Title	Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Description	VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	19.92 (9.312)	23.79 (11.286)	20.92 (7.651)	21.42 (6.858)	22.48 (7.869)	17.44 (7.509)	17.66 (9.090)	16.63 (6.273)	17.50 (8.549)
Day 5	21.36 (9.999)	19.70 (8.249)	17.22 (5.977)	23.85 (10.657)	21.95 (8.249)	19.80 (11.927)	16.08 (8.356)	18.00 (10.065)	20.68 (10.035)
Day 8	19.64 (13.073)	18.00 (6.574)	15.58 (6.192)	21.72 (10.577)	20.29 (7.100)	18.64 (9.995)	16.25 (6.661)	18.95 (9.810)	22.48 (13.737)
Day 15	17.20 (8.921)	20.42 (9.930)	16.50 (9.869)	23.04 (9.035)	22.68 (9.712)	18.52 (9.265)	16.28 (8.735)	16.25 (10.605)	20.43 (10.612)
Day 22	17.04 (6.761)	19.04 (7.410)	14.65 (6.786)	21.65 (7.573)	21.59 (7.866)	17.20 (7.984)	16.42 (6.580)	17.17 (14.199)	18.13 (9.416)
Day 29	15.76 (7.253)	19.88 (9.967)	15.39 (4.717)	21.88 (9.523)	22.73 (10.552)	17.00 (7.746)	19.68 (16.106)	13.04 (6.753)	19.00 (8.258)
Day 36	18.96 (9.361)	15.33 (4.984)	14.04 (5.842)	21.92 (9.587)	21.59 (9.169)	17.28 (6.901)	16.46 (6.129)	15.50 (5.905)	24.22 (17.231)
Day 43	16.56 (6.246)	21.33 (13.770)	18.04 (10.813)	23.65 (12.547)	20.95 (7.712)	20.00 (7.708)	18.12 (7.316)	16.96 (6.734)	22.78 (11.631)
Day 50	16.36 (9.269)	17.67 (6.787)	14.39 (6.966)	21.69 (11.235)	19.23 (6.718)	17.48 (8.186)	17.04 (7.151)	15.54 (7.818)	22.26 (13.685)
Day 57	14.36 (6.034)	17.46 (8.939)	13.87 (4.674)	20.88 (7.957)	21.55 (5.878)	15.44 (5.108)	16.83 (12.437)	13.54 (4.222)	20.13 (10.092)
Day 71	15.92 (7.064)	17.50 (9.212)	13.83 (3.950)	21.77 (9.868)	20.82 (8.151)	19.04 (6.846)	16.79 (6.840)	14.63 (6.337)	22.61 (9.014)
Day 85	14.24 (6.247)	17.63 (8.816)	14.04 (6.745)	22.58 (7.991)	19.77 (5.936)	16.68 (7.040)	14.09 (6.735)	14.04 (4.639)	16.43 (8.877)
Day 99	16.20 (6.371)	18.04 (10.378)	18.68 (17.700)	21.72 (11.085)	20.14 (7.298)	17.84 (6.756)	16.46 (9.514)	16.21 (8.490)	21.13 (8.981)
Day 106	14.44 (6.545)	15.96 (6.328)	14.59 (5.981)	19.32 (7.330)	18.64 (6.499)	17.76 (7.573)	16.09 (5.672)	13.13 (5.788)	20.00 (9.376)
Day 113	15.83 (8.726)	16.54 (7.863)	15.26 (5.056)	21.88 (14.701)	18.50 (7.951)	15.92 (8.246)	15.96 (8.466)	13.87 (6.107)	19.39 (8.322)
Day 127	20.48 (11.594)	23.21 (14.231)	16.61 (7.686)	19.32 (9.534)	21.59 (7.992)	19.72 (8.091)	17.91 (11.445)	17.38 (12.631)	21.61 (13.121)
Day 141	18.13 (7.279)	22.25 (15.109)	17.39 (5.007)	19.16 (9.573)	23.68 (9.564)	19.52 (10.627)	17.61 (7.518)	18.54 (9.913)	20.09 (9.409)
Day 155	17.00 (3.905)	22.21 (11.858)	16.52 (7.141)	20.56 (9.319)	21.41 (7.028)	19.30 (9.632)	16.17 (8.144)	18.92 (10.738)	18.57 (9.110)
Day 169	18.88 (7.732)	21.42 (7.442)	17.30 (6.292)	19.60 (7.286)	24.55 (11.931)	19.13 (8.644)	23.00 (23.279)	18.00 (10.167)	19.68 (8.306)

24. Secondary Outcome

Title	Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Description	VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-5.68 (6.973)	-6.17 (7.171)	-6.57 (6.726)	1.15 (4.841)	-2.70 (7.069)	-0.76 (5.114)	-2.63 (9.497)	-2.58 (7.290)	-1.07 (4.989)
Change at Day 113	-4.29 (8.538)	-7.25 (9.067)	-5.35 (6.619)	0.34 (10.957)	-3.98 (8.873)	-1.52 (5.771)	-0.76 (9.276)	-2.98 (6.998)	1.89 (5.762)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-7.462
	Confidence Interval	(2-Sided) 95% -10.311 to -4.614
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.434
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-6.693
	Confidence Interval	(2-Sided) 95% -9.610 to -3.776
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.469
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-8.755
	Confidence Interval	(2-Sided) 95% -11.692 to -5.817
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.479
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.484
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.072
	Confidence Interval	(2-Sided) 95% -3.596 to 3.451
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.773
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.173
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-1.701
	Confidence Interval	(2-Sided) 95% -5.264 to 1.862
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.793
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.135
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-1.953
	Confidence Interval	(2-Sided) 95% -5.452 to 1.546
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.761
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.034
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-4.447
	Confidence Interval	(2-Sided) 95% -9.230 to 0.335
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.406
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-6.764
	Confidence Interval	(2-Sided) 95% -11.617 to -1.910
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.442
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-5.951
	Confidence Interval	(2-Sided) 95% -10.836 to -1.066
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.458
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.056
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-3.070
	Confidence Interval	(2-Sided) 95% -6.876 to 0.736
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.915
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.095
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.557
	Confidence Interval	(2-Sided) 95% -6.408 to 1.293
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.937
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-5.271
	Confidence Interval	(2-Sided) 95% -9.074 to -1.469
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.913
	Estimation Comments

25. Secondary Outcome

Title	Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Description	VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-23.42 (30.458)	-22.99 (25.647)	-28.96 (25.281)	7.08 (26.054)	-6.48 (27.276)	-7.61 (23.163)	5.66 (76.931)	-3.54 (45.821)	-3.63 (39.826)
Change at Day 113	-17.23 (35.083)	-26.62 (28.464)	-19.28 (33.794)	-1.89 (43.239)	-10.80 (38.288)	-9.72 (29.006)	10.72 (65.297)	-10.36 (36.732)	18.73 (48.065)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-31.880
	Confidence Interval	(2-Sided) 95% -45.925 to -17.836
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.071
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-29.187
	Confidence Interval	(2-Sided) 95% -43.571 to -14.803
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.242
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-39.657
	Confidence Interval	(2-Sided) 95% -54.136 to -25.178
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.290
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.366
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-4.681
	Confidence Interval	(2-Sided) 95% -31.713 to 22.350
	Parameter Dispersion	Type: Standard Error of the Mean Value: 13.601
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.773
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	10.227
	Confidence Interval	(2-Sided) 95% -16.774 to 37.228
	Parameter Dispersion	Type: Standard Error of the Mean Value: 13.586
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.422
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.646
	Confidence Interval	(2-Sided) 95% -29.206 to 23.915
	Parameter Dispersion	Type: Standard Error of the Mean Value: 13.362
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.107
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-12.911
	Confidence Interval	(2-Sided) 95% -33.411 to 7.589
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.309
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-23.119
	Confidence Interval	(2-Sided) 95% -43.923 to -2.315
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.461
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.054
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-17.159
	Confidence Interval	(2-Sided) 95% -38.108 to 3.789
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.535
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-24.416
	Confidence Interval	(2-Sided) 95% -49.696 to 0.865
	Parameter Dispersion	Type: Standard Error of the Mean Value: 12.718
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.311
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-6.287
	Confidence Interval	(2-Sided) 95% -31.541 to 18.968
	Parameter Dispersion	Type: Standard Error of the Mean Value: 12.705
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-32.443
	Confidence Interval	(2-Sided) 95% -57.400 to -7.485
	Parameter Dispersion	Type: Standard Error of the Mean Value: 12.555
	Estimation Comments

26. Secondary Outcome

Title	Triglyceride (TG)
Description	Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	121.04 (56.152)	158.21 (71.477)	127.65 (59.878)	140.23 (51.283)	152.59 (50.105)	122.40 (50.578)	124.40 (59.717)	111.58 (42.354)	130.39 (49.826)
Day 5	134.20 (78.692)	130.30 (58.718)	112.17 (47.884)	154.27 (74.707)	146.41 (76.274)	128.20 (79.256)	115.40 (52.401)	114.25 (61.969)	121.09 (48.602)
Day 8	126.44 (123.041)	124.58 (49.786)	95.71 (42.796)	150.40 (76.908)	128.43 (50.155)	122.72 (66.459)	103.50 (48.515)	130.91 (75.156)	136.91 (91.378)
Day 15	109.52 (65.672)	143.96 (70.871)	123.96 (108.066)	149.31 (64.392)	145.91 (79.420)	125.64 (55.667)	113.52 (60.601)	114.25 (54.003)	130.65 (53.724)
Day 22	105.56 (45.283)	119.17 (55.800)	101.96 (54.725)	133.65 (48.535)	144.64 (68.531)	125.00 (54.636)	109.04 (49.088)	113.79 (106.198)	130.26 (59.246)
Day 29	97.84 (49.164)	133.38 (74.370)	100.04 (39.343)	147.92 (68.536)	130.00 (52.743)	111.24 (46.683)	142.84 (141.763)	94.29 (37.698)	122.09 (49.749)
Day 36	113.68 (71.769)	111.25 (45.529)	96.52 (56.535)	154.65 (59.929)	139.95 (79.796)	115.12 (54.424)	109.17 (54.052)	105.67 (38.421)	158.30 (102.642)
Day 43	108.16 (56.609)	161.75 (134.409)	130.71 (124.380)	159.19 (85.270)	135.23 (70.762)	123.80 (52.925)	119.44 (53.110)	109.29 (54.365)	140.61 (73.706)
Day 50	108.12 (65.442)	126.58 (56.883)	100.57 (52.553)	148.50 (77.558)	121.64 (51.406)	123.48 (61.199)	114.22 (53.090)	113.29 (53.870)	142.30 (83.014)
Day 57	94.40 (49.048)	124.25 (69.357)	92.52 (45.106)	139.50 (56.099)	137.55 (53.502)	102.28 (33.512)	117.21 (84.666)	90.67 (28.925)	136.78 (67.987)
Day 71	103.13 (51.243)	125.50 (74.428)	93.91 (39.340)	156.27 (65.687)	139.27 (85.017)	122.68 (52.192)	112.13 (56.034)	103.13 (47.534)	146.43 (64.368)
Day 85	92.36 (47.872)	130.25 (78.800)	95.00 (54.102)	142.81 (57.891)	142.45 (60.126)	118.64 (46.593)	100.04 (53.185)	99.92 (40.798)	119.17 (57.046)
Day 99	110.56 (57.944)	128.25 (70.840)	131.32 (118.340)	156.84 (70.931)	137.82 (60.866)	122.96 (55.697)	118.17 (63.727)	115.08 (63.629)	133.91 (49.879)
Day 106	97.80 (46.662)	116.29 (50.480)	102.59 (50.880)	131.68 (55.816)	133.41 (68.902)	116.16 (55.618)	109.91 (45.304)	93.54 (38.520)	139.00 (53.142)
Day 113	101.58 (51.130)	112.88 (60.824)	94.39 (34.093)	141.64 (96.032)	129.14 (73.031)	111.72 (53.875)	116.26 (69.771)	101.43 (52.274)	136.61 (64.291)
Day 127	133.40 (71.046)	159.25 (101.582)	115.96 (63.954)	133.40 (66.304)	153.14 (62.304)	138.08 (60.533)	139.83 (103.182)	124.50 (86.402)	159.43 (89.130)
Day 141	115.13 (51.964)	164.79 (129.257)	123.39 (35.150)	131.08 (56.266)	156.27 (76.965)	135.80 (75.159)	119.91 (59.343)	129.13 (70.190)	137.35 (56.775)
Day 155	115.44 (39.459)	164.13 (102.919)	113.83 (43.209)	139.44 (65.901)	149.23 (68.510)	129.00 (70.010)	119.91 (61.088)	133.33 (81.100)	131.74 (62.736)
Day 169	120.76 (56.962)	151.63 (59.252)	122.43 (65.091)	149.40 (58.176)	167.91 (79.436)	126.67 (60.290)	166.22 (176.973)	128.26 (71.260)	125.41 (36.439)

27. Secondary Outcome

Title	Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Description	Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-28.68 (41.898)	-27.96 (49.754)	-29.52 (40.669)	2.58 (35.796)	-10.14 (43.129)	-3.76 (37.502)	-15.87 (48.341)	-11.67 (42.519)	-11.22 (23.797)
Change at Day 113	-20.02 (41.197)	-45.33 (53.285)	-30.13 (48.592)	-0.58 (63.896)	-23.45 (51.443)	-10.68 (27.488)	0.35 (48.858)	-12.46 (44.128)	6.22 (32.888)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-35.967
	Confidence Interval	(2-Sided) 95% -57.463 to -14.472
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.822
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-29.186
	Confidence Interval	(2-Sided) 95% -51.123 to -7.249
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.044
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-40.010
	Confidence Interval	(2-Sided) 95% -62.175 to -17.845
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.160
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.614
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	3.170
	Confidence Interval	(2-Sided) 95% -18.502 to 24.842
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.906
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.221
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-8.563
	Confidence Interval	(2-Sided) 95% -30.554 to 13.427
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.067
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.303
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-5.649
	Confidence Interval	(2-Sided) 95% -27.376 to 16.079
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.933
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.067
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-22.003
	Confidence Interval	(2-Sided) 95% -50.882 to 6.875
	Parameter Dispersion	Type: Standard Error of the Mean Value: 14.530
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-41.761
	Confidence Interval	(2-Sided) 95% -70.934 to -12.588
	Parameter Dispersion	Type: Standard Error of the Mean Value: 14.676
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-34.933
	Confidence Interval	(2-Sided) 95% -64.410 to -5.456
	Parameter Dispersion	Type: Standard Error of the Mean Value: 14.832
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.064
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-17.978
	Confidence Interval	(2-Sided) 95% -41.282 to 5.326
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.725
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.318
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-5.654
	Confidence Interval	(2-Sided) 95% -29.311 to 18.004
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.903
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.052
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-19.435
	Confidence Interval	(2-Sided) 95% -42.902 to 4.032
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.807
	Estimation Comments

28. Secondary Outcome

Title	Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Description	Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-21.00 (31.109)	-16.85 (28.672)	-23.38 (24.421)	3.74 (27.803)	-5.20 (23.919)	2.62 (33.715)	-9.40 (42.868)	-5.21 (35.698)	-9.33 (19.235)
Change at Day 113	-14.44 (26.916)	-27.65 (26.827)	-17.70 (29.263)	-3.82 (36.247)	-15.23 (24.917)	-8.31 (19.500)	1.32 (37.694)	-8.47 (35.865)	4.57 (29.077)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-25.974
	Confidence Interval	(2-Sided) 95% -41.217 to -10.731
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.674
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-21.110
	Confidence Interval	(2-Sided) 95% -36.665 to -5.555
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.831
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-31.034
	Confidence Interval	(2-Sided) 95% -46.758 to -15.310
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.917
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.799
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	8.034
	Confidence Interval	(2-Sided) 95% -10.948 to 27.015
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.553
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.398
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.511
	Confidence Interval	(2-Sided) 95% -21.748 to 16.727
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.682
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.515
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	0.369
	Confidence Interval	(2-Sided) 95% -18.668 to 19.407
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.580
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.128
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-10.056
	Confidence Interval	(2-Sided) 95% -27.549 to 7.437
	Parameter Dispersion	Type: Standard Error of the Mean Value: 8.801
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-24.352
	Confidence Interval	(2-Sided) 95% -42.008 to -6.695
	Parameter Dispersion	Type: Standard Error of the Mean Value: 8.882
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.049
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-14.994
	Confidence Interval	(2-Sided) 95% -32.858 to 2.870
	Parameter Dispersion	Type: Standard Error of the Mean Value: 8.987
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.071
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-13.830
	Confidence Interval	(2-Sided) 95% -32.368 to 4.709
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.326
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.361
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-3.378
	Confidence Interval	(2-Sided) 95% -22.191 to 15.435
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.464
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.056
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-15.035
	Confidence Interval	(2-Sided) 95% -33.698 to 3.629
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.389
	Estimation Comments

29. Secondary Outcome

Title	Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Description	Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	159.58 (29.033)	155.54 (20.706)	154.71 (22.511)	163.90 (25.271)	165.86 (26.655)	188.72 (30.222)	182.86 (22.842)	182.17 (21.217)	181.17 (23.577)
Day 5	113.52 (28.259)	97.78 (25.034)	98.48 (15.003)	161.23 (22.059)	140.77 (26.324)	154.36 (35.666)	143.24 (23.520)	137.50 (28.770)	189.36 (24.432)
Day 8	93.24 (22.966)	79.33 (27.140)	76.17 (15.222)	162.16 (29.067)	131.52 (23.712)	142.84 (36.478)	123.25 (25.378)	122.73 (29.183)	193.70 (20.424)
Day 15	95.68 (27.248)	77.88 (27.299)	57.96 (16.134)	162.35 (20.558)	130.27 (19.489)	138.40 (38.794)	103.16 (26.742)	99.13 (22.099)	191.61 (22.845)
Day 22	69.92 (23.315)	58.92 (23.638)	48.26 (10.037)	160.04 (19.838)	130.59 (24.595)	115.36 (37.861)	88.71 (24.172)	88.29 (28.964)	192.09 (18.757)
Day 29	81.08 (26.644)	71.79 (26.662)	51.09 (14.820)	159.16 (20.163)	133.41 (30.589)	115.52 (38.434)	90.68 (25.610)	82.46 (20.659)	192.59 (23.425)
Day 36	66.20 (21.848)	53.38 (22.329)	44.96 (10.598)	159.46 (25.221)	129.32 (29.451)	103.72 (37.651)	81.83 (15.898)	79.42 (26.345)	184.74 (25.913)
Day 43	79.64 (23.937)	66.63 (30.685)	51.46 (14.926)	157.31 (16.790)	132.05 (29.005)	112.60 (37.446)	88.16 (23.005)	82.08 (27.547)	194.30 (22.876)
Day 50	59.92 (17.814)	52.58 (21.847)	45.65 (11.276)	157.62 (22.608)	130.64 (25.964)	101.60 (36.427)	80.30 (20.448)	78.96 (27.207)	186.70 (20.220)
Day 57	75.76 (23.552)	58.13 (23.709)	44.26 (9.186)	153.15 (19.601)	126.68 (28.919)	101.80 (35.249)	86.08 (30.679)	73.21 (24.568)	180.17 (17.167)
Day 71	81.83 (28.164)	58.08 (26.357)	48.65 (13.110)	161.54 (22.089)	134.91 (30.239)	115.48 (36.001)	82.25 (22.283)	76.13 (22.793)	185.96 (28.798)
Day 85	77.28 (25.268)	60.04 (23.665)	49.87 (24.464)	154.92 (22.289)	139.05 (36.247)	110.40 (30.783)	78.00 (27.144)	72.17 (18.874)	175.17 (24.398)
Day 99	88.56 (28.234)	66.04 (29.895)	60.05 (35.754)	156.36 (18.830)	133.68 (34.790)	118.36 (32.875)	85.29 (30.599)	74.50 (19.496)	190.52 (20.551)
Day 106	64.04 (24.315)	51.50 (23.178)	54.14 (28.648)	154.08 (19.378)	130.82 (29.301)	107.76 (31.232)	77.87 (23.470)	74.75 (22.115)	183.35 (19.664)
Day 113	82.50 (24.128)	63.54 (25.086)	55.78 (27.153)	146.36 (23.787)	131.41 (32.515)	111.80 (30.993)	83.00 (27.632)	72.35 (20.232)	180.65 (16.489)
Day 127	134.80 (24.100)	117.42 (37.408)	85.09 (41.318)	158.60 (22.504)	163.36 (33.835)	164.60 (38.791)	113.13 (46.332)	102.75 (33.666)	191.78 (28.623)
Day 141	149.17 (29.556)	142.08 (32.188)	119.83 (42.083)	155.52 (20.490)	170.41 (37.185)	187.96 (41.528)	154.17 (45.140)	128.96 (44.304)	191.09 (24.978)
Day 155	149.60 (26.876)	144.83 (26.836)	133.30 (30.526)	161.80 (21.960)	169.41 (37.377)	190.96 (34.453)	164.83 (34.193)	144.58 (40.902)	184.48 (18.030)
Day 169	155.48 (28.791)	153.75 (25.535)	148.52 (27.770)	159.12 (20.961)	174.45 (41.877)	193.88 (33.789)	183.52 (37.346)	162.65 (40.341)	193.59 (17.816)

30. Secondary Outcome

Title	Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Description	Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-82.30 (30.323)	-95.50 (32.345)	-104.07 (27.573)	-8.98 (20.888)	-26.82 (28.796)	-78.32 (33.436)	-104.26 (34.056)	-110.00 (24.274)	-6.00 (24.009)
Change at Day 113	-77.33 (22.371)	-92.00 (32.099)	-98.15 (28.798)	-18.40 (22.784)	-34.45 (26.242)	-76.92 (35.588)	-99.26 (27.347)	-111.33 (24.646)	-0.52 (20.267)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-76.189
	Confidence Interval	(2-Sided) 95% -86.975 to -65.403
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.431
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-95.205
	Confidence Interval	(2-Sided) 95% -106.238 to -84.172
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.556
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-106.077
	Confidence Interval	(2-Sided) 95% -117.239 to -94.915
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.622
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-71.234
	Confidence Interval	(2-Sided) 95% -84.390 to -58.077
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.622
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-100.638
	Confidence Interval	(2-Sided) 95% -113.768 to -87.508
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.609
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-103.386
	Confidence Interval	(2-Sided) 95% -116.353 to -90.420
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.525
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-61.124
	Confidence Interval	(2-Sided) 95% -71.813 to -50.435
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.382
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-81.837
	Confidence Interval	(2-Sided) 95% -92.721 to -70.954
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.480
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-89.683
	Confidence Interval	(2-Sided) 95% -100.740 to -78.627
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.567
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-76.747
	Confidence Interval	(2-Sided) 95% -88.902 to -64.593
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.118
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-100.666
	Confidence Interval	(2-Sided) 95% -112.781 to -88.551
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.098
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-109.490
	Confidence Interval	(2-Sided) 95% -121.519 to -97.462
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.054
	Estimation Comments

31. Secondary Outcome

Title	Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Description	Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-50.98 (15.662)	-60.62 (17.746)	-67.69 (14.462)	-4.77 (11.716)	-16.20 (16.334)	-41.11 (16.193)	-56.87 (14.745)	-60.17 (10.493)	-2.49 (12.951)
Change at Day 113	-48.56 (12.284)	-58.57 (17.970)	-63.92 (15.872)	-10.59 (11.977)	-20.67 (15.155)	-40.19 (17.244)	-54.54 (13.671)	-60.43 (11.070)	0.88 (13.236)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-46.772
	Confidence Interval	(2-Sided) 95% -53.671 to -39.874
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.473
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-59.200
	Confidence Interval	(2-Sided) 95% -66.257 to -52.143
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.554
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-66.868
	Confidence Interval	(2-Sided) 95% -74.007 to -59.730
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.595
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-40.051
	Confidence Interval	(2-Sided) 95% -47.195 to -32.908
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.595
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-56.009
	Confidence Interval	(2-Sided) 95% -63.135 to -48.882
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.587
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-57.576
	Confidence Interval	(2-Sided) 95% -64.618 to -50.533
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.544
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-37.991
	Confidence Interval	(2-Sided) 95% -44.721 to -31.260
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.389
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-50.856
	Confidence Interval	(2-Sided) 95% -57.709 to -44.002
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.451
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-56.354
	Confidence Interval	(2-Sided) 95% -63.315 to -49.393
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.505
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-43.172
	Confidence Interval	(2-Sided) 95% -50.417 to -35.926
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.647
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-56.698
	Confidence Interval	(2-Sided) 95% -63.916 to -49.480
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.633
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-61.305
	Confidence Interval	(2-Sided) 95% -68.477 to -54.134
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.609
	Estimation Comments

32. Secondary Outcome

Title	Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Description	Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	4.0118 (0.82813)	4.0154 (0.92478)	3.8500 (0.72414)	3.9629 (0.77435)	4.0223 (0.81145)	4.5408 (1.11809)	4.2558 (1.15512)	4.2610 (1.08481)	4.1076 (0.88524)
Day 5	3.1372 (0.81529)	2.7861 (0.57451)	2.7500 (0.38981)	3.9465 (0.83527)	3.5668 (0.77085)	3.9264 (1.11497)	3.5036 (0.76250)	3.4029 (0.86267)	4.3259 (0.99932)
Day 8	2.7252 (0.63762)	2.4100 (0.53023)	2.3083 (0.33483)	3.8588 (0.92894)	3.3510 (0.79979)	3.6024 (1.07004)	3.1367 (0.80233)	3.0941 (0.80907)	4.3374 (0.88617)
Day 15	2.6884 (0.58429)	2.3754 (0.62550)	1.9658 (0.33815)	3.9308 (0.89274)	3.2700 (0.68229)	3.4940 (1.02033)	2.7772 (0.71059)	2.6050 (0.53948)	4.3017 (0.84316)
Day 22	2.2428 (0.53640)	2.0258 (0.49301)	1.7730 (0.18504)	3.8915 (0.75155)	3.2550 (0.66627)	3.0676 (0.92151)	2.4338 (0.43218)	2.3617 (0.35946)	4.2822 (0.97569)
Day 29	2.4020 (0.54386)	2.2533 (0.64125)	1.8296 (0.26896)	3.8852 (0.73498)	3.3318 (0.70099)	3.0260 (0.77510)	2.5780 (0.75738)	2.2800 (0.37240)	4.1023 (0.81890)
Day 36	2.1924 (0.45842)	1.9300 (0.46830)	1.7404 (0.18627)	3.9496 (0.92977)	3.2882 (0.68375)	2.8452 (0.78785)	2.3000 (0.31095)	2.2529 (0.39114)	4.2222 (0.97022)
Day 43	2.3688 (0.48338)	2.1396 (0.61972)	1.8754 (0.39255)	3.9338 (0.87409)	3.3259 (0.70739)	3.0044 (0.77172)	2.5124 (0.80082)	2.3004 (0.42044)	4.4074 (1.03394)
Day 50	2.0280 (0.36876)	1.9254 (0.48864)	1.7443 (0.15406)	3.9419 (0.98670)	3.3277 (0.71213)	2.8300 (0.81738)	2.2883 (0.38697)	2.2658 (0.43915)	4.2909 (0.97014)
Day 57	2.3148 (0.44657)	2.0758 (0.63508)	1.7448 (0.12638)	3.9596 (0.84943)	3.2632 (0.60608)	2.8436 (0.67094)	2.5708 (1.24941)	2.2225 (0.37721)	4.3361 (0.97295)
Day 71	2.3925 (0.57023)	1.9988 (0.56686)	1.7709 (0.19489)	4.0085 (0.93120)	3.3855 (0.64850)	3.0528 (0.77095)	2.3258 (0.34951)	2.1988 (0.36789)	4.3791 (1.15180)
Day 85	2.3724 (0.52972)	2.0721 (0.54913)	1.8561 (0.49386)	4.0508 (0.91154)	3.3986 (0.73940)	3.1204 (0.72628)	2.2796 (0.46691)	2.2142 (0.37394)	4.2613 (1.08945)
Day 99	2.4564 (0.54658)	2.1417 (0.70783)	2.0305 (0.76914)	3.7648 (0.83515)	3.3073 (0.81497)	3.0868 (0.75654)	2.4075 (0.70042)	2.2121 (0.37358)	4.4200 (1.15874)
Day 106	2.0476 (0.40004)	1.8650 (0.50620)	1.8814 (0.56847)	3.7912 (0.78337)	3.2832 (0.72097)	2.9176 (0.75101)	2.2517 (0.37291)	2.1896 (0.37808)	4.3157 (1.01377)
Day 113	2.4688 (0.50001)	2.1042 (0.55015)	1.9691 (0.52016)	3.8248 (0.91875)	3.2359 (0.65683)	3.0760 (0.78321)	2.3639 (0.45213)	2.2335 (0.42128)	4.3570 (0.88681)
Day 127	3.3776 (0.67839)	3.1533 (0.98795)	2.4822 (0.91213)	3.7984 (0.90030)	3.9132 (0.79683)	3.9896 (0.99046)	2.9087 (0.92317)	2.8208 (1.08222)	4.4717 (1.06069)
Day 141	3.5433 (0.67339)	3.5242 (0.96281)	3.0078 (0.91134)	3.7508 (0.88092)	3.9841 (0.87530)	4.4256 (1.20555)	3.6070 (1.06034)	3.3500 (1.37776)	4.2843 (1.17378)
Day 155	3.6240 (0.63587)	3.6392 (0.92468)	3.2748 (0.76307)	3.9100 (0.92453)	3.9205 (0.79163)	4.5057 (1.18175)	3.8126 (0.99748)	3.6450 (1.45582)	4.1804 (1.03516)
Day 169	3.8140 (0.77275)	3.7471 (0.82852)	3.4830 (0.67010)	3.7436 (0.86236)	4.0036 (0.99761)	4.4975 (1.25117)	4.2000 (1.23292)	3.8970 (1.40230)	4.1182 (0.81436)

33. Secondary Outcome

Title	Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Description	Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-1.6394 (0.69058)	-1.9433 (0.90358)	-1.9835 (0.78766)	0.0879 (0.43755)	-0.6236 (0.66072)	-1.4204 (0.91892)	-1.8407 (0.85260)	-2.0469 (0.96230)	0.1537 (0.47755)
Change at Day 113	-1.5671 (0.65875)	-1.9113 (0.93385)	-1.8704 (0.73630)	-0.1560 (0.53286)	-0.7864 (0.60966)	-1.4648 (0.83864)	-1.7563 (0.74752)	-2.0461 (0.92038)	0.2493 (0.43772)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-1.69928
	Confidence Interval	(2-Sided) 95% -1.96175 to -1.43682
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13216
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.07922
	Confidence Interval	(2-Sided) 95% -2.34622 to -1.81223
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13446
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.23886
	Confidence Interval	(2-Sided) 95% -2.50795 to -1.96978
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13553
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-1.43281
	Confidence Interval	(2-Sided) 95% -1.75689 to -1.10872
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.16311
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.01501
	Confidence Interval	(2-Sided) 95% -2.33718 to -1.69283
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.16217
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.11359
	Confidence Interval	(2-Sided) 95% -2.43230 to -1.79489
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.16038
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-1.35298
	Confidence Interval	(2-Sided) 95% -1.62324 to -1.08271
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13609
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-1.79615
	Confidence Interval	(2-Sided) 95% -2.07001 to -1.52229
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13790
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-1.86921
	Confidence Interval	(2-Sided) 95% -2.14575 to -1.59266
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13927
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-1.57311
	Confidence Interval	(2-Sided) 95% -1.85788 to -1.28834
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14333
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.00256
	Confidence Interval	(2-Sided) 95% -2.28521 to -1.71990
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14228
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-2.20298
	Confidence Interval	(2-Sided) 95% -2.48399 to -1.92197
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14142
	Estimation Comments

34. Secondary Outcome

Title	Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Description	Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-39.99 (12.892)	-47.06 (15.152)	-50.43 (13.358)	2.19 (10.328)	-14.65 (14.740)	-29.51 (16.200)	-43.25 (12.569)	-45.74 (11.961)	3.81 (10.643)
Change at Day 113	-38.20 (10.463)	-46.04 (15.705)	-47.68 (13.195)	-3.81 (12.537)	-18.57 (13.541)	-31.07 (14.770)	-41.49 (10.520)	-45.65 (12.114)	6.98 (12.436)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-41.92915
	Confidence Interval	(2-Sided) 95% -47.55052 to -36.30778
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.83037
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-51.08604
	Confidence Interval	(2-Sided) 95% -56.81235 to -45.35973
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.88356
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-55.51600
	Confidence Interval	(2-Sided) 95% -61.29424 to -49.73777
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.91014
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-33.30375
	Confidence Interval	(2-Sided) 95% -39.41376 to -27.19373
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.07498
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-47.85210
	Confidence Interval	(2-Sided) 95% -53.92668 to -41.77751
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.05746
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-48.65686
	Confidence Interval	(2-Sided) 95% -54.66060 to -42.65313
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.02097
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-33.52920
	Confidence Interval	(2-Sided) 95% -39.42015 to -27.63826
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.96599
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-43.85680
	Confidence Interval	(2-Sided) 95% -49.82617 to -37.88744
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.00531
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-46.36865
	Confidence Interval	(2-Sided) 95% -52.40589 to -40.33142
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.03981
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-38.06019
	Confidence Interval	(2-Sided) 95% -44.29176 to -31.82863
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.13610
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-48.57807
	Confidence Interval	(2-Sided) 95% -54.76397 to -42.39217
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.11350
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-51.87214
	Confidence Interval	(2-Sided) 95% -58.01968 to -45.72460
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.09363
	Estimation Comments

35. Secondary Outcome

Title	Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Description	Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame	Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Baseline	0.6846 (0.14145)	0.6606 (0.13665)	0.6567 (0.12772)	0.6687 (0.12269)	0.6775 (0.14076)	0.7890 (0.17841)	0.7324 (0.16556)	0.7167 (0.16058)	0.6980 (0.13867)
Day 5	0.4896 (0.14794)	0.4135 (0.11264)	0.4222 (0.07116)	0.6612 (0.12682)	0.5968 (0.14211)	0.6428 (0.18885)	0.5792 (0.11372)	0.5300 (0.11967)	0.7100 (0.12642)
Day 8	0.4044 (0.09862)	0.3363 (0.11305)	0.3271 (0.06760)	0.6660 (0.14947)	0.5657 (0.14552)	0.5844 (0.18410)	0.5017 (0.12310)	0.4718 (0.13900)	0.7230 (0.11227)
Day 15	0.4308 (0.12426)	0.3300 (0.12322)	0.2450 (0.05649)	0.6712 (0.13137)	0.5445 (0.11164)	0.5776 (0.16885)	0.4216 (0.11929)	0.3763 (0.08293)	0.7226 (0.13404)
Day 22	0.3136 (0.10610)	0.2463 (0.09668)	0.2078 (0.04572)	0.6773 (0.13012)	0.5564 (0.13347)	0.4868 (0.17148)	0.3629 (0.10897)	0.3283 (0.09220)	0.7248 (0.12409)
Day 29	0.3656 (0.12076)	0.3058 (0.12721)	0.2196 (0.05943)	0.6776 (0.12337)	0.5609 (0.11924)	0.4820 (0.14437)	0.3720 (0.11247)	0.3254 (0.07524)	0.7023 (0.11439)
Day 36	0.2900 (0.09278)	0.2421 (0.10206)	0.1983 (0.04376)	0.6873 (0.15278)	0.5600 (0.13551)	0.4428 (0.15255)	0.3250 (0.06093)	0.3050 (0.08900)	0.7048 (0.13413)
Day 43	0.3592 (0.10723)	0.2800 (0.12399)	0.2142 (0.05012)	0.6788 (0.12944)	0.5805 (0.11978)	0.4696 (0.15115)	0.3632 (0.14522)	0.3188 (0.09124)	0.7548 (0.16351)
Day 50	0.2668 (0.07669)	0.2313 (0.10182)	0.2048 (0.04088)	0.6804 (0.13489)	0.5959 (0.13893)	0.4472 (0.16198)	0.3283 (0.08917)	0.3133 (0.09234)	0.7465 (0.13878)
Day 57	0.3584 (0.09715)	0.2642 (0.13319)	0.2026 (0.04081)	0.6938 (0.12747)	0.5682 (0.13297)	0.4616 (0.15220)	0.3804 (0.18286)	0.3196 (0.07765)	0.7630 (0.13394)
Day 71	0.3692 (0.12402)	0.2592 (0.11602)	0.2157 (0.05281)	0.6958 (0.13840)	0.5986 (0.12434)	0.4976 (0.15592)	0.3358 (0.07678)	0.3146 (0.08086)	0.7500 (0.17328)
Day 85	0.3768 (0.11546)	0.2696 (0.11705)	0.2335 (0.10170)	0.7023 (0.13946)	0.6132 (0.16069)	0.5264 (0.14405)	0.3435 (0.11007)	0.3125 (0.08125)	0.7665 (0.18376)
Day 99	0.3928 (0.12458)	0.2904 (0.12791)	0.2491 (0.12432)	0.6584 (0.13120)	0.5882 (0.15930)	0.5164 (0.15168)	0.3650 (0.15223)	0.3075 (0.07170)	0.7883 (0.18622)
Day 106	0.2908 (0.08450)	0.2267 (0.10925)	0.2405 (0.12187)	0.6716 (0.12925)	0.5877 (0.15253)	0.4796 (0.14386)	0.3322 (0.09130)	0.3142 (0.08230)	0.7730 (0.14455)
Day 113	0.3888 (0.10343)	0.2908 (0.11858)	0.2548 (0.10845)	0.6556 (0.14192)	0.5777 (0.12976)	0.5140 (0.15398)	0.3557 (0.10710)	0.3235 (0.08804)	0.7683 (0.14272)
Day 127	0.5772 (0.11473)	0.5029 (0.17571)	0.3778 (0.19064)	0.6692 (0.13546)	0.6950 (0.15732)	0.7024 (0.18033)	0.4730 (0.18425)	0.4325 (0.16469)	0.7830 (0.15893)
Day 141	0.6233 (0.12107)	0.5938 (0.15786)	0.5004 (0.19354)	0.6580 (0.13916)	0.7082 (0.17595)	0.7916 (0.20262)	0.6352 (0.20727)	0.5375 (0.23022)	0.7570 (0.17219)
Day 155	0.6368 (0.11957)	0.6125 (0.15224)	0.5574 (0.13288)	0.6664 (0.13225)	0.6991 (0.17124)	0.8148 (0.20102)	0.6839 (0.19315)	0.6075 (0.24120)	0.7452 (0.16318)
Day 169	0.6640 (0.14350)	0.6321 (0.14774)	0.6161 (0.12493)	0.6424 (0.14621)	0.6845 (0.17986)	0.8088 (0.20105)	0.7178 (0.18178)	0.6639 (0.22661)	0.7359 (0.13397)

36. Secondary Outcome

Title	Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Description	Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-0.3078 (0.13144)	-0.3910 (0.15635)	-0.4211 (0.16147)	0.0337 (0.09054)	-0.0643 (0.11318)	-0.2626 (0.16341)	-0.3748 (0.17224)	-0.4042 (0.14894)	0.0685 (0.10818)
Change at Day 113	-0.2998 (0.12105)	-0.3698 (0.16194)	-0.3998 (0.15163)	-0.0170 (0.10303)	-0.0998 (0.09487)	-0.2750 (0.15604)	-0.3626 (0.14553)	-0.3965 (0.15431)	0.0702 (0.09306)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.33157
	Confidence Interval	(2-Sided) 95% -0.38399 to -0.27916
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02639
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.44402
	Confidence Interval	(2-Sided) 95% -0.49727 to -0.39077
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02682
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.48314
	Confidence Interval	(2-Sided) 95% -0.53671 to -0.42956
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02698
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.30542
	Confidence Interval	(2-Sided) 95% -0.36960 to -0.24124
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.03230
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.44143
	Confidence Interval	(2-Sided) 95% -0.50466 to -0.37821
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.03183
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.46235
	Confidence Interval	(2-Sided) 95% -0.52491 to -0.39980
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.03148
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.26949
	Confidence Interval	(2-Sided) 95% -0.32142 to -0.21755
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02615
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.37493
	Confidence Interval	(2-Sided) 95% -0.42754 to -0.32231
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02649
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.41199
	Confidence Interval	(2-Sided) 95% -0.46512 to -0.35886
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02676
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.31806
	Confidence Interval	(2-Sided) 95% -0.37723 to -0.25888
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02979
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.42583
	Confidence Interval	(2-Sided) 95% -0.48409 to -0.36758
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02932
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-0.45501
	Confidence Interval	(2-Sided) 95% -0.51287 to -0.39715
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02912
	Estimation Comments

37. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Description	Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame	Baseline, Day 85, 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
Change at Day 85	-44.37 (16.358)	-58.47 (19.271)	-63.09 (16.240)	5.51 (12.823)	-9.13 (16.695)	-32.09 (18.463)	-50.97 (16.380)	-55.16 (11.927)	10.41 (15.319)
Change at Day 113	-43.21 (13.147)	-55.05 (19.756)	-60.32 (15.924)	-2.03 (14.326)	-14.00 (14.205)	-34.11 (18.505)	-49.84 (13.744)	-53.65 (13.386)	11.47 (16.250)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-49.42411
	Confidence Interval	(2-Sided) 95% -56.83019 to -42.01803
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.72907
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-66.63383
	Confidence Interval	(2-Sided) 95% -74.16086 to -59.10681
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.79050
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-71.72901
	Confidence Interval	(2-Sided) 95% -79.30431 to -64.15371
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.81541
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-43.56596
	Confidence Interval	(2-Sided) 95% -51.35899 to -35.77293
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.92236
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-62.34926
	Confidence Interval	(2-Sided) 95% -70.02607 to -54.67245
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.86432
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-65.06617
	Confidence Interval	(2-Sided) 95% -72.65818 to -57.47415
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.82052
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-40.52435
	Confidence Interval	(2-Sided) 95% -47.81299 to -33.23571
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.66973
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-56.14495
	Confidence Interval	(2-Sided) 95% -63.52668 to -48.76322
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.71641
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-61.56370
	Confidence Interval	(2-Sided) 95% -69.02510 to -54.10230
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.75690
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 50 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-46.34109
	Confidence Interval	(2-Sided) 95% -54.61427 to -38.06792
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.16385
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 100 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-61.37890
	Confidence Interval	(2-Sided) 95% -69.52338 to -53.23443
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.09957
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-04950615 150 mg, PF-04950615 Placebo
	Comments	Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.

Method of Estimation	Estimation Parameter	Adjusted Mean Difference
	Estimated Value	-64.67274
	Confidence Interval	(2-Sided) 95% -72.75728 to -56.58820
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.06866
	Estimation Comments

38. Secondary Outcome

Title	Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
Description	LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection.
Time Frame	Baseline up to Day 113

Outcome Measure Data

Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. The outcome measure was planned to be analyzed for all the reporting groups except Atorvastatin + Ezetimibe 10 mg.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	25	25	24	23
LDL-C <10 mg/dL	0.0 0%	4.2 17.5%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%
LDL-C <25 mg/dL	12.0 48%	66.7 277.9%	58.3 242.9%	0.0 0%	0.0 0%	0.0 0%	20.8 83.2%	0.0 0%
LDL-C <40 mg/dL	84.0 336%	91.7 382.1%	95.8 399.2%	0.0 0%	12.0 54.5%	36.0 144%	41.7 166.8%	0.0 0%
LDL-C <70 mg/dL	96.0 384%	100.0 416.7%	100.0 416.7%	0.0 0%	64.0 290.9%	92.0 368%	87.5 350%	0.0 0%
LDL-C <100 mg/dL	100.0 400%	100.0 416.7%	100.0 416.7%	23.1 88.8%	92.0 418.2%	100.0 400%	100.0 400%	4.3 17.9%

39. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value.
Time Frame	Baseline up to Day 169

Outcome Measure Data

Analysis Population Description
Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	Atorvastatin + Ezetimibe 10 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	22	25	25	24	23
AEs	17 68%	16 66.7%	13 54.2%	13 50%	5 22.7%	16 64%	16 64%	15 62.5%	11 47.8%
SAEs	1 4%	0 0%	0 0%	1 3.8%	0 0%	0 0%	1 4%	0 0%	0 0%

40. Secondary Outcome

Title	Number of Participants With Anti-Drug Antibody (ADA) Response
Description	Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=6.23 for PF-04950615 were considered ADA positive.
Time Frame	Baseline up to Day 169

Outcome Measure Data

Analysis Population Description
Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	0	25	25	24	0
Number [participants]	14 56%	6 25%	14 58.3%	13 50%	16 72.7%	11 44%

41. Secondary Outcome

Title	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Description	Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame	Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)

Outcome Measure Data

Analysis Population Description
The pharmacokinetic (PK) parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Measure Participants	12	12	13	11	12	12
Single dose	32.98 (57)	52.33 (49)	77.11 (43)	32.97 (42)	51.49 (46)	82.05 (45)
Multiple dose	63.54 (40)	92.46 (127)	242.5 (81)	63.74 (57)	136.6 (32)	273.5 (100)

42. Secondary Outcome

Title	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615
Description	Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame	Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)

Outcome Measure Data

Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Measure Participants	10	7	8	9	11	7
Geometric Mean (Geometric Coefficient of Variation) [mcg*day/mL]	94.83 (46)	176.9 (144)	469.5 (90)	111.7 (63)	237.4 (41)	248.4 (76)

43. Secondary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
Description	Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame	Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)

Outcome Measure Data

Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Measure Participants	10	8	8	10	11	12
Geometric Mean (Geometric Coefficient of Variation) [mcg*day/mL]	87.86 (49)	140.3 (145)	434.2 (91)	96.32 (65)	220.9 (39)	486.7 (143)

44. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Description	This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame	Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)

Outcome Measure Data

Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Measure Participants	12	12	13	11	12	12
Single dose	3.173 (61)	5.074 (50)	7.382 (45)	2.994 (44)	4.744 (47)	7.726 (42)
Multiple dose	6.197 (36)	8.343 (119)	21.91 (76)	5.874 (55)	12.22 (29)	23.64 (88)

45. Secondary Outcome

Title	Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615
Description	This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame	Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)

Outcome Measure Data

Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Measure Participants	10	8	8	10	11	12
Geometric Mean (Geometric Coefficient of Variation) [mcg/mL]	2.176 (65)	4.041 (147)	12.95 (94)	2.858 (64)	6.571 (40)	13.47 (139)

46. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Description	This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame	Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)

Outcome Measure Data

Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Measure Participants	12	12	13	11	12	12
Single dose	4.01	4.97	5.94	5.94	5.45	6.94
Multiple dose	3.03	2.98	2.97	2.99	2.98	4.98

47. Secondary Outcome

Title	Terminal Elimination Half-Life (t1/2) of PF-04950615
Description	Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame	Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)

Outcome Measure Data

Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Measure Participants	10	7	8	9	11	7
Mean (Standard Deviation) [day]	7.716 (1.7594)	9.471 (2.2889)	10.56 (1.5934)	9.404 (2.1454)	9.570 (2.2338)	9.333 (2.7535)

48. Secondary Outcome

Title	Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Description	Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Time Frame	Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141

Outcome Measure Data

Analysis Population Description
PK concentration population included participants in FAS who have at least 1 concentration of either PF-04950615, PCSK9 or atorvastatin or its active metabolites. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg.

Arm/Group Title	Atorvastatin + PF-04950615 50 mg	Atorvastatin + PF-04950615 100 mg	Atorvastatin + PF-04950615 150 mg	Atorvastatin + PF-04950615 Placebo	PF-04950615 50 mg	PF-04950615 100 mg	PF-04950615 150 mg	PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.	Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Measure Participants	25	24	24	26	25	25	24	23
Day 1	266.64 (61.5494)	261.23 (72.3625)	285.96 (75.7940)	269.19 (66.8377)	228.80 (49.9983)	215.50 (43.0086)	234.42 (77.5410)	210.22 (48.5536)
Day 5	2292.2 (676.414)	2152.6 (451.749)	1997.7 (563.722)	291.77 (65.8011)	1952.5 (527.661)	1775.4 (531.225)	1712.0 (458.574)	240.41 (63.093)
Day 8	2711.2 (614.649)	2701.9 (568.958)	2539.5 (587.196)	292.19 (62.5108)	2490.4 (573.777)	2297.7 (521.003)	2306.7 (594.409)	240.22 (53.5842)
Day 15	2539.8 (558.369)	3198.1 (897.565)	3291.9 (624.935)	303.42 (47.9418)	2590.6 (601.052)	3030.8 (715.193)	2966.7 (713.934)	224.43 (57.6903)
Day 22	3451.7 (872.597)	3297.3 (701.137)	3166.5 (663.295)	295 (71.6996)	3117.4 (582.258)	2971.6 (669.215)	2726.7 (616.409)	218.82 (41.2647)
Day 29	2844.2 (684.693)	3224.8 (868.760)	3419.8 (715.001)	275 (57.6888)	3050.0 (534.176)	3095.5 (647.481)	2955.6 (678.703)	230.09 (44.1742)
Day 36	3446.2 (825.704)	3310.7 (732.706)	3248.5 (660.213)	304.75 (48.529)	3237.0 (694.727)	3011.2 (578.469)	2761.4 (601.567)	233.09 (56.7693)
Day 43	2900.9 (653.572)	3406.3 (765.437)	3391.9 (717.922)	303.54 (81.0823)	3278.9 (693.207)	3302.5 (584.658)	3016.9 (772.615)	239.13 (43.8782)
Day 50	3394.8 (750.557)	3297.2 (654.384)	3230.9 (716.416)	293.38 (66.9138)	3148.5 (541.230)	3001.3 (696.256)	2820.3 (693.130)	237.40 (68.2421)
Day 57	2779.2 (698.727)	3204.8 (699.490)	3390.6 (1149.17)	277.69 (70.6132)	2910.6 (531.493)	3026.4 (708.490)	2791.9 (633.717)	220.13 (66.99)
Day 71	2889.6 (542.831)	3241.2 (724.363)	3280.5 (727.932)	285.81 (45.5315)	3066.8 (693.445)	3197.1 (575.162)	2887.6 (684.734)	355.17 (556.079)
Day 85	2727.0 (635.595)	3166.3 (736.216)	3198.9 (827.313)	276.31 (72.3396)	2898.7 (551.114)	2934.1 (548.311)	2787.9 (812.792)	269.61 (201.161)
Day 99	2915.1 (711.932)	3242.9 (684.758)	3259.6 (754.730)	326.08 (78.8759)	3119.2 (665.408)	3149.3 (590.228)	2918.9 (752.647)	252.13 (72.1011)
Day 106	3326.7 (611.790)	3138.9 (604.177)	2864.0 (596.757)	283.67 (58.9079)	3165.7 (786.665)	2755.7 (549.755)	2566.5 (483.133)	242.23 (59.4266)
Day 113	2727.3 (710.746)	2919.0 (511.959)	2910.3 (609.380)	267.71 (68.1498)	2908.4 (639.771)	3009.8 (685.462)	2683.9 (574.842)	222.05 (46.0574)
Day 127	1429.8 (599.406)	2148.7 (1062.32)	3030.7 (607.610)	281.40 (95.7562)	1778.9 (872.368)	2556.0 (772.015)	2769.7 (736.453)	249.87 (63.2113)
Day 141	736.63 (297.087)	1382.8 (892.457)	2851.0 (1373.69)	290.16 (84.2168)	1056.5 (545.337)	1477.0 (816.342)	2368.7 (1106.62)	20.043 (68.7012)

Adverse Events

	Atorvastatin + PF-04950615 50 mg		Atorvastatin + PF-04950615 100 mg		Atorvastatin + PF-04950615 150 mg		Atorvastatin + PF-04950615 Placebo		Atorvastatin + Ezetimibe 10 mg QD PO		PF-04950615 50 mg		PF-04950615 100 mg		PF-04950615 150 mg		PF-04950615 Placebo
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Atorvastatin + PF-04950615 50 mg		Atorvastatin + PF-04950615 100 mg		Atorvastatin + PF-04950615 150 mg		Atorvastatin + PF-04950615 Placebo		Atorvastatin + Ezetimibe 10 mg QD PO		PF-04950615 50 mg		PF-04950615 100 mg		PF-04950615 150 mg		PF-04950615 Placebo
Arm/Group Description	Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.		Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.		Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.		Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.		Participants received Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open).		Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.		Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.		Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.		Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Atorvastatin + PF-04950615 50 mg		Atorvastatin + PF-04950615 100 mg		Atorvastatin + PF-04950615 150 mg		Atorvastatin + PF-04950615 Placebo		Atorvastatin + Ezetimibe 10 mg QD PO		PF-04950615 50 mg		PF-04950615 100 mg		PF-04950615 150 mg		PF-04950615 Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		0/24 (0%)		0/24 (0%)		1/26 (3.8%)		0/22 (0%)		0/25 (0%)		1/25 (4%)		0/24 (0%)		0/23 (0%)
Cardiac disorders
Angina pectoris	0/25 (0%)		0/24 (0%)		0/24 (0%)		1/26 (3.8%)		0/22 (0%)		0/25 (0%)		0/25 (0%)		0/24 (0%)		0/23 (0%)
Infections and infestations
Cellulitis	1/25 (4%)		0/24 (0%)		0/24 (0%)		0/26 (0%)		0/22 (0%)		0/25 (0%)		0/25 (0%)		0/24 (0%)		0/23 (0%)
Injury, poisoning and procedural complications
Spinal compression fracture	0/25 (0%)		0/24 (0%)		0/24 (0%)		0/26 (0%)		0/22 (0%)		0/25 (0%)		1/25 (4%)		0/24 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Atorvastatin + PF-04950615 50 mg		Atorvastatin + PF-04950615 100 mg		Atorvastatin + PF-04950615 150 mg		Atorvastatin + PF-04950615 Placebo		Atorvastatin + Ezetimibe 10 mg QD PO		PF-04950615 50 mg		PF-04950615 100 mg		PF-04950615 150 mg		PF-04950615 Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/25 (40%)		12/24 (50%)		12/24 (50%)		10/26 (38.5%)		2/22 (9.1%)		11/25 (44%)		11/25 (44%)		11/24 (45.8%)		9/23 (39.1%)
General disorders
Injection site erythema	2/25 (8%)		6/24 (25%)		8/24 (33.3%)		0/26 (0%)		0/22 (0%)		4/25 (16%)		7/25 (28%)		6/24 (25%)		1/23 (4.3%)
Injection site haemorrhage	0/25 (0%)		0/24 (0%)		1/24 (4.2%)		2/26 (7.7%)		0/22 (0%)		1/25 (4%)		1/25 (4%)		0/24 (0%)		0/23 (0%)
Injection site pain	0/25 (0%)		1/24 (4.2%)		0/24 (0%)		0/26 (0%)		0/22 (0%)		0/25 (0%)		0/25 (0%)		3/24 (12.5%)		0/23 (0%)
Injection site pruritus	2/25 (8%)		4/24 (16.7%)		7/24 (29.2%)		0/26 (0%)		0/22 (0%)		4/25 (16%)		6/25 (24%)		5/24 (20.8%)		0/23 (0%)
Injection site swelling	0/25 (0%)		0/24 (0%)		2/24 (8.3%)		0/26 (0%)		0/22 (0%)		0/25 (0%)		0/25 (0%)		1/24 (4.2%)		0/23 (0%)
Infections and infestations
Nasopharyngitis	5/25 (20%)		1/24 (4.2%)		1/24 (4.2%)		5/26 (19.2%)		1/22 (4.5%)		3/25 (12%)		4/25 (16%)		2/24 (8.3%)		4/23 (17.4%)
Pharyngitis	1/25 (4%)		0/24 (0%)		1/24 (4.2%)		0/26 (0%)		0/22 (0%)		0/25 (0%)		0/25 (0%)		5/24 (20.8%)		0/23 (0%)
Injury, poisoning and procedural complications
Contusion	0/25 (0%)		1/24 (4.2%)		0/24 (0%)		0/26 (0%)		0/22 (0%)		0/25 (0%)		1/25 (4%)		0/24 (0%)		2/23 (8.7%)
Fall	1/25 (4%)		1/24 (4.2%)		0/24 (0%)		1/26 (3.8%)		0/22 (0%)		0/25 (0%)		3/25 (12%)		0/24 (0%)		1/23 (4.3%)
Investigations
Blood alkaline phosphatase increased	1/25 (4%)		0/24 (0%)		0/24 (0%)		0/26 (0%)		0/22 (0%)		0/25 (0%)		0/25 (0%)		2/24 (8.3%)		0/23 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/25 (0%)		0/24 (0%)		0/24 (0%)		2/26 (7.7%)		0/22 (0%)		0/25 (0%)		1/25 (4%)		0/24 (0%)		0/23 (0%)
Myalgia	1/25 (4%)		1/24 (4.2%)		0/24 (0%)		1/26 (3.8%)		0/22 (0%)		3/25 (12%)		0/25 (0%)		0/24 (0%)		1/23 (4.3%)
Nervous system disorders
Dizziness	0/25 (0%)		0/24 (0%)		2/24 (8.3%)		0/26 (0%)		0/22 (0%)		0/25 (0%)		0/25 (0%)		0/24 (0%)		0/23 (0%)
Headache	1/25 (4%)		2/24 (8.3%)		0/24 (0%)		0/26 (0%)		0/22 (0%)		1/25 (4%)		0/25 (0%)		1/24 (4.2%)		2/23 (8.7%)
Reproductive system and breast disorders
Ejaculation disorder	0/17 (0%)		0/14 (0%)		1/12 (8.3%)		0/13 (0%)		0/12 (0%)		0/10 (0%)		0/15 (0%)		0/13 (0%)		0/18 (0%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	2/25 (8%)		3/24 (12.5%)		0/24 (0%)		2/26 (7.7%)		0/22 (0%)		0/25 (0%)		0/25 (0%)		0/24 (0%)		0/23 (0%)
Skin and subcutaneous tissue disorders
Eczema	1/25 (4%)		0/24 (0%)		0/24 (0%)		0/26 (0%)		1/22 (4.5%)		3/25 (12%)		0/25 (0%)		0/24 (0%)		1/23 (4.3%)
Pruritus	0/25 (0%)		2/24 (8.3%)		0/24 (0%)		0/26 (0%)		0/22 (0%)		1/25 (4%)		0/25 (0%)		0/24 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT02055976

Other Study ID Numbers:

B1481036

First Posted:

Feb 5, 2014

Last Update Posted:

Feb 8, 2019

Last Verified:

Sep 1, 2018