Trial Outcomes & Findings for A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128) (NCT NCT00535405)

NCT ID: NCT00535405

Last Updated: 2024-05-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1289 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2024-05-16

Participant Flow

Phase III First Patient In 08-Nov-2007; Last Patient Last Visit 23-Mar-2009 Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease 65 years and older.

The study evaluated patients ≥ 65 years of age at moderately high or high risk for Coronary Heart Disease (CHD), with or without atherosclerotic vascular disease. The study was a 3-week single-blind placebo run-in period and a 12-week active treatment period where patients were equally randomized to one of 5 treatment groups for 12 weeks

Participant milestones

Measure	Atorvastatin 10 mg Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg Atorvastatin 40 mg once daily for 12 weeks
Overall Study STARTED	257	259	259	257	257
Overall Study COMPLETED	240	233	241	235	241
Overall Study NOT COMPLETED	17	26	18	22	16

Reasons for withdrawal

Measure	Atorvastatin 10 mg Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg Atorvastatin 40 mg once daily for 12 weeks
Overall Study Adverse Event	6	8	3	8	6
Overall Study Lost to Follow-up	1	3	3	2	1
Overall Study Physician Decision	3	2	0	1	1
Overall Study Protocol Violation	2	2	2	1	0
Overall Study Withdrawal by Subject	5	11	10	10	8

Baseline Characteristics

A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

Baseline characteristics by cohort

Measure	Atorvastatin 10 mg n=257 Participants Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=259 Participants Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=259 Participants Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=257 Participants Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg n=257 Participants Atorvastatin 40 mg once daily for 12 weeks	Total n=1289 Participants Total of all reporting groups
Age, Continuous	72.1 years n=5 Participants	71.8 years n=7 Participants	71.7 years n=5 Participants	72.2 years n=4 Participants	72.1 years n=21 Participants	72.0 years n=10 Participants
Sex: Female, Male Female	172 Participants n=5 Participants	146 Participants n=7 Participants	175 Participants n=5 Participants	153 Participants n=4 Participants	163 Participants n=21 Participants	809 Participants n=10 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	113 Participants n=7 Participants	84 Participants n=5 Participants	104 Participants n=4 Participants	94 Participants n=21 Participants	480 Participants n=10 Participants
Race/Ethnicity, Customized Asian	10 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants	8 participants n=4 Participants	10 participants n=21 Participants	46 participants n=10 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants	6 participants n=4 Participants	9 participants n=21 Participants	27 participants n=10 Participants
Race/Ethnicity, Customized Other	21 participants n=5 Participants	27 participants n=7 Participants	30 participants n=5 Participants	29 participants n=4 Participants	28 participants n=21 Participants	135 participants n=10 Participants
Race/Ethnicity, Customized White	224 participants n=5 Participants	224 participants n=7 Participants	209 participants n=5 Participants	214 participants n=4 Participants	210 participants n=21 Participants	1081 participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorvastatin 10 mg n=242 Participants Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=232 Participants Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=238 Participants Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=236 Participants Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg n=239 Participants Atorvastatin 40 mg once daily for 12 weeks
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12	-39.5 Percent change in LDL-C Interval -41.4 to -37.5	-54.2 Percent change in LDL-C Interval -56.1 to -52.2	-46.6 Percent change in LDL-C Interval -48.6 to -44.7	-59.1 Percent change in LDL-C Interval -61.0 to -57.1	-50.8 Percent change in LDL-C Interval -52.8 to -48.9

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorvastatin 10 mg n=242 Participants Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=232 Participants Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=238 Participants Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=236 Participants Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg n=239 Participants Atorvastatin 40 mg once daily for 12 weeks
Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12	9.9 Percent of Patients Standard Error 1.92	51.3 Percent of Patients Standard Error 3.28	26.1 Percent of Patients Standard Error 2.85	68.2 Percent of Patients Standard Error 3.03	38.1 Percent of Patients Standard Error 3.14

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

Outcome measures

Measure	Atorvastatin 10 mg n=242 Participants Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=232 Participants Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=238 Participants Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=236 Participants Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg n=239 Participants Atorvastatin 40 mg once daily for 12 weeks
Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12	45.0 Percent of Patients Standard Error 3.20	69.0 Percent of Patients Standard Error 3.04	61.3 Percent of Patients Standard Error 3.16	82.1 Percent of Patients Standard Error 2.50	69.9 Percent of Patients Standard Error 2.97

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorvastatin 10 mg n=242 Participants Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=232 Participants Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=238 Participants Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=236 Participants Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg n=239 Participants Atorvastatin 40 mg once daily for 12 weeks
Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12	58.7 Percent of Patients Standard Error 3.17	83.6 Percent of Patients Standard Error 2.43	76.9 Percent of Patients Standard Error 2.73	90.3 Percent of Patients Standard Error 1.93	79.5 Percent of Patients Standard Error 2.61

SECONDARY outcome

Timeframe: 12 Weeks

Population: Patients with High Risk for CHD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.

Outcome measures

Measure	Atorvastatin 10 mg n=138 Participants Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=138 Participants Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=128 Participants Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=130 Participants Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg n=136 Participants Atorvastatin 40 mg once daily for 12 weeks
Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12	10.9 Percent of Patients Standard Error 2.65	54.3 Percent of Patients Standard Error 4.24	28.9 Percent of Patients Standard Error 4.01	69.2 Percent of Patients Standard Error 4.05	38.2 Percent of Patients Standard Error 4.17

SECONDARY outcome

Timeframe: 12 Weeks

Population: Patients with AVD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

Outcome measures

Measure	Atorvastatin 10 mg n=70 Participants Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=81 Participants Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=79 Participants Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=79 Participants Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorva 40 mg n=72 Participants Atorvastatin 40 mg once daily for 12 weeks
Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12	10.0 Percent of Patients Standard Error 3.59	44.4 Percent of Patients Standard Error 5.52	31.6 Percent of Patients Standard Error 5.23	65.8 Percent of Patients Standard Error 5.34	44.4 Percent of Patients Standard Error 5.86

Adverse Events

Atorvastatin 10 mg

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Ezetimibe 10 mg/Simvastatin 20 mg

Serious events: 8 serious events

Other events: 32 other events

Deaths: 0 deaths

Atorvastatin 20 mg

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Ezetimibe 10 mg/Simvastatin 40 mg

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Atorvastatin 40 mg

Serious events: 5 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atorvastatin 10 mg n=257 participants at risk Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=256 participants at risk Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=258 participants at risk Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=257 participants at risk Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorvastatin 40 mg n=256 participants at risk Atorvastatin 40 mg once daily for 12 weeks
Cardiac disorders AV dissociation	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Cardiac disorders Acute myocardial infarction	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Cardiac disorders Myocardial infarction	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Cardiac disorders Ventricular fibrillation	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Gastrointestinal disorders Abdominal pain	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Gastrointestinal disorders Colitis ischaemic	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
General disorders Mechanical complication of implant	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
General disorders Oedema peripheral	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Infections and infestations Pneumonia	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Infections and infestations Urinary tract infection	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Injury, poisoning and procedural complications Head injury	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Respiratory, thoracic and mediastinal disorders Intervertebral disc protrusion	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Psychiatric disorders Panic attack	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).

Other adverse events

Measure	Atorvastatin 10 mg n=257 participants at risk Atorvastatin (Atorva) 10 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 20 mg n=256 participants at risk Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks	Atorvastatin 20 mg n=258 participants at risk Atorvastatin 20 mg once daily for 12 weeks	Ezetimibe 10 mg/Simvastatin 40 mg n=257 participants at risk Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks	Atorvastatin 40 mg n=256 participants at risk Atorvastatin 40 mg once daily for 12 weeks
Gastrointestinal disorders Constipation	1.2% 3/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	2.0% 5/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Gastrointestinal disorders Diarrhoea	1.2% 3/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Infections and infestations Bronchitis	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Infections and infestations Nasopharyngitis	0.78% 2/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	2.0% 5/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Infections and infestations Urinary tract infection	0.78% 2/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Investigations Aspartate aminotransferase increased	0.00% 0/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Musculoskeletal and connective tissue disorders Arthralgia	1.2% 3/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Musculoskeletal and connective tissue disorders Back pain	1.9% 5/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Musculoskeletal and connective tissue disorders Muscle spasms	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.6% 4/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Musculoskeletal and connective tissue disorders Myalgia	1.9% 5/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Nervous system disorders Dizziness	0.78% 2/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	2.3% 6/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.00% 0/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Nervous system disorders Headache	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	2.0% 5/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.78% 2/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Vascular disorders Hypertension	0.39% 1/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/258 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	1.2% 3/257 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).	0.39% 1/256 AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER