Trial Outcomes & Findings for MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162) (NCT NCT01154036)

Results Overview

LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)\<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1547 participants

Primary outcome timeframe

Baseline and Week 6 (end of Phase I )

Results posted on

2022-02-09

Participant Flow

Participants in the Atorvastatin 20mg and Rosuvastatin 10mg arms who did not meet low density lipoprotein-cholesterol goals during Phase I were eligible for Phase II. Approximately 25% of participants in the ezetimibe 10mg+atorvastatin10mg arm continued to Phase II regardless of LDL-C control but were not included in any of the statistical analyses

Participant milestones

Participant milestones
Measure	Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks	Phase I: Atorvastatin 20 mg Atorvastatin 20 mg tablet once daily for 6 weeks	Phase I: Rosuvastatin 10 mg Rosuvastatin 10 mg tablet once daily for 6 weeks;	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.	Phase II: EZ 10mg + Atorva 20mg [A] Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
Phase I STARTED	120	483	944	0	0	0	0	0
Phase I COMPLETED	117	455	888	0	0	0	0	0
Phase I NOT COMPLETED	3	28	56	0	0	0	0	0
Phase II STARTED	0	0	0	28	124	126	234	206
Phase II COMPLETED	0	0	0	27	116	121	225	200
Phase II NOT COMPLETED	0	0	0	1	8	5	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks	Phase I: Atorvastatin 20 mg Atorvastatin 20 mg tablet once daily for 6 weeks	Phase I: Rosuvastatin 10 mg Rosuvastatin 10 mg tablet once daily for 6 weeks;	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.	Phase II: EZ 10mg + Atorva 20mg [A] Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
Phase I Physician Decision	0	1	0	0	0	0	0	0
Phase I Lost to Follow-up	0	3	6	0	0	0	0	0
Phase I Protocol Violation	0	3	9	0	0	0	0	0
Phase I Withdrawal by Subject	2	10	29	0	0	0	0	0
Phase I Adverse Event	1	11	12	0	0	0	0	0
Phase II Adverse Event	0	0	0	0	1	1	1	1
Phase II Physician Decision	0	0	0	0	0	0	1	0
Phase II Lost to Follow-up	0	0	0	1	2	0	2	1
Phase II Protocol Violation	0	0	0	0	1	2	0	0
Phase II Withdrawal by Subject	0	0	0	0	4	2	5	4

Baseline Characteristics

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg n=120 Participants Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks	Phase I: Atorvastatin 20 mg n=483 Participants Atorvastatin 20 mg tablet once daily for 6 weeks	Phase I: Rosuvastatin 10 mg n=944 Participants Rosuvastatin 10 mg tablet once daily for 6 weeks	Total n=1547 Participants Total of all reporting groups
Age, Customized <20 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Customized 20 to 29 years	0 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Age, Customized 30 to 39 years	1 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants	39 Participants n=4 Participants
Age, Customized 40 to 49 years	16 Participants n=5 Participants	50 Participants n=7 Participants	99 Participants n=5 Participants	165 Participants n=4 Participants
Age, Customized 50 to 59 years	37 Participants n=5 Participants	170 Participants n=7 Participants	324 Participants n=5 Participants	531 Participants n=4 Participants
Age, Customized 60 to 64 years	27 Participants n=5 Participants	87 Participants n=7 Participants	183 Participants n=5 Participants	297 Participants n=4 Participants
Age, Customized ≥65 years	39 Participants n=5 Participants	159 Participants n=7 Participants	310 Participants n=5 Participants	508 Participants n=4 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	253 Participants n=7 Participants	489 Participants n=5 Participants	813 Participants n=4 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	230 Participants n=7 Participants	455 Participants n=5 Participants	734 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6 (end of Phase I )

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participant who received at least one dose of study drug during Phase I and had a baseline or at least one measurement available during Phase I

LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)\<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=480 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=939 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)	-24.8 Percentage Change Standard Deviation 23.6	-10.1 Percentage Change Standard Deviation 20.8	-13.8 Percentage Change Standard Deviation 22.8	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6) and Week 12

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)\<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).	-16.4 Percentage Change Standard Deviation 31.1	-8.1 Percentage Change Standard Deviation 23.3	-19.3 Percentage Change Standard Deviation 32.1	-8.4 Percentage Change Standard Deviation 20.8	2.4 Percentage Change Standard Deviation 27.4

SECONDARY outcome

Timeframe: Week 6 (End of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=119 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=471 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=915 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)	56.3 Percentage of Participants 4.55	37.4 Percentage of Participants 2.23	43.6 Percentage of Participants 1.64	—	—

SECONDARY outcome

Timeframe: Week 12 (End of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=123 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=228 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=201 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)	55.8 Percentage of Participants 4.53	34.1 Percentage of Participants 4.28	53.5 Percentage of Participants 3.30	35.8 Percentage of Participants 3.38	NA Percentage of Participants Study plan did not include the collection of data for this arm for this Phase II endpoint; data not obtained or recorded

SECONDARY outcome

Timeframe: Week 6 (End of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=119 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=471 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=915 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)	19.3 Percentage of Participants 3.62	3.0 Percentage of Participants 0.78	6.6 Percentage of Participants 0.82	—	—

SECONDARY outcome

Timeframe: Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=123 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=228 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=201 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)	18.3 Percentage of Participants 3.53	0.8 Percentage of Participants 0.81	15.4 Percentage of Participants 2.39	3.0 Percentage of Participants 1.20	NA Percentage of Participants Study plan did not include the collection of data for this arm for this Phase II endpoint; data not obtained or recorded

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=480 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=939 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Total Cholesterol (TC) (Phase I)	-13.6 Percentage Change Standard Deviation 17.0	-6.3 Percentage Change Standard Deviation 14.1	-8.2 Percentage Change Standard Deviation 14.7	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Total Cholesterol (TC) (Phase II)	-10.2 Percentage Change Standard Deviation 19.9	-2.9 Percentage Change Standard Deviation 15.7	-13.1 Percentage Change Standard Deviation 22.8	-5.0 Percentage Change Standard Deviation 14.0	2.2 Percentage Change Standard Deviation 15.4

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.

TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=119 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=471 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=915 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Triglycerides (TG) (Phase I)	-6.0 Percentage Change Interval -10.9 to -0.8	-3.9 Percentage Change Interval -6.5 to -1.2	-1.1 Percentage Change Interval -3.1 to 0.9	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II

TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=123 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=228 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=201 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Triglycerides (TG) (Phase II)	-5.9 Percentage Change Interval -11.0 to -0.4	-3.1 Percentage Change Interval -8.4 to 2.4	-10.2 Percentage Change Interval -13.9 to -6.4	-3.2 Percentage Change Interval -7.3 to 1.2	NA Percentage Change Study plan did not include the calculation of these values

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=480 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=939 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)	0.9 Percentage Change Standard Deviation 11.9	-1.3 Percentage Change Standard Deviation 11.6	1.0 Percentage Change Standard Deviation 13.1	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in HDL-C (Phase II)	0.9 Percentage Change Standard Deviation 14.1	1.0 Percentage Change Standard Deviation 16.0	-0.8 Percentage Change Standard Deviation 13.7	0.0 Percentage Change Standard Deviation 15.2	0.0 Percentage Change Standard Deviation 11.7

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=479 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=938 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)	-12.1 Percentage Change Standard Deviation 20.7	-6.1 Percentage Change Standard Deviation 20.7	-7.6 Percentage Change Standard Deviation 20.1	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=27 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Apo B (Phase II)	-12.0 Percentage Change Standard Deviation 26.5	-6.3 Percentage Change Standard Deviation 19.6	-14.0 Percentage Change Standard Deviation 25.1	-4.9 Percentage Change Standard Deviation 21.8	-4.0 Percentage Change Standard Deviation 16.8

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=479 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=938 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)	-0.6 Percentage Change Standard Deviation 13.1	-1.9 Percentage Change Standard Deviation 12.5	1.4 Percentage Change Standard Deviation 13.0	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=27 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Apo A-I (Phase II)	1.6 Percentage Change Standard Deviation 11.9	1.4 Percentage Change Standard Deviation 14.1	-0.6 Percentage Change Standard Deviation 14.4	0.0 Percentage Change Standard Deviation 16.0	-0.7 Percentage Change Standard Deviation 14.3

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=480 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=939 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Non-HDL-C (Phase I)	-18.0 Percentage Change Standard Deviation 22.3	-7.9 Percentage Change Standard Deviation 17.6	-11.1 Percentage Change Standard Deviation 19.8	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Non-HDL-C (Phase II)	-17.5 Percentage Change Standard Deviation 26.1	-5.5 Percentage Change Standard Deviation 16.6	-18.1 Percentage Change Standard Deviation 29.4	-6.3 Percentage Change Standard Deviation 18.5	-0.5 Percentage Change Standard Deviation 17.7

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=480 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=939 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in TC/HDL-C Ratio (Phase I)	-14.3 Percentage Change Standard Deviation 17.9	-4.5 Percentage Change Standard Deviation 16.8	-9.0 Percentage Change Standard Deviation 19.1	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in TC/HDL-C Ratio (Phase II)	-13.5 Percentage Change Standard Deviation 21.7	-6.5 Percentage Change Standard Deviation 13.9	-11.7 Percentage Change Standard Deviation 23.3	-4.0 Percentage Change Standard Deviation 17.8	-1.0 Percentage Change Standard Deviation 9.6

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=480 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=939 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)	-23.9 Percentage Change Standard Deviation 23.6	-7.1 Percentage Change Standard Deviation 23.2	-14.7 Percentage Change Standard Deviation 26.9	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)	-20.6 Percentage Change Standard Deviation 31.4	-8.2 Percentage Change Standard Deviation 20.6	-18.2 Percentage Change Standard Deviation 31.6	-7.5 Percentage Change Standard Deviation 21.5	-4.5 Percentage Change Standard Deviation 22.9

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=479 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=938 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)	-13.0 Percentage Change Standard Deviation 22.3	-4.8 Percentage Change Standard Deviation 18.9	-8.8 Percentage Change Standard Deviation 23.0	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=27 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)	-11.2 Percentage Change Standard Deviation 26.2	-6.4 Percentage Change Standard Deviation 19.4	-11.2 Percentage Change Standard Deviation 27.5	-5.4 Percentage Change Standard Deviation 21.5	-6.7 Percentage Change Standard Deviation 11.3

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.

Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=120 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=480 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=939 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)	-18.9 Percentage Change Standard Deviation 23.9	-6.3 Percentage Change Standard Deviation 22.8	-12.2 Percentage Change Standard Deviation 25.9	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II

Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=28 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)	-18.2 Percentage Change Standard Deviation 29.5	-8.8 Percentage Change Standard Deviation 18.8	-16.3 Percentage Change Standard Deviation 32.3	-5.9 Percentage Change Standard Deviation 23.4	-1.9 Percentage Change Standard Deviation 12.9

SECONDARY outcome

Timeframe: Baseline and Week 6 (end of Phase I)

Population: Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.

hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=117 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=458 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=899 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)	-10.5 Percentage Change Interval -23.0 to 4.0	-6.6 Percentage Change Interval -13.6 to 1.0	-9.0 Percentage Change Interval -14.0 to -3.6	—	—

SECONDARY outcome

Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

Population: Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II

hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Phase II: EZ 10mg + Atorva 20mg [A] n=119 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=121 Participants Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=226 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=200 Participants Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg+Atorva 10mg n=27 Participants Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Percent Change From Baseline in Hs-CRP (Phase II)	-19.5 Percentage Change Interval -31.5 to -5.3	-6.4 Percentage Change Interval -20.2 to 9.8	-10.9 Percentage Change Interval -20.9 to 0.3	0.7 Percentage Change Interval -11.2 to 14.2	NA Percentage Change Study plan did not include the calculation of these values

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg n=120 participants at risk Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks	Phase I: Atorvastatin 20 mg n=480 participants at risk Atorvastatin 20 mg tablet once daily for 6 weeks	Phase I: Rosuvastatin 10 mg n=939 participants at risk Rosuvastatin 10 mg tablet once daily for 6 weeks	Phase II: EZ 10mg+Atorva 10mg n=28 participants at risk Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.	Phase II: EZ 10mg + Atorva 20mg [A] n=124 participants at risk Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Atorva 40mg n=124 participants at risk Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II	Phase II: EZ 10mg + Atorva 20mg [R] n=231 participants at risk Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II	Phase II: Rosuvastatin 20mg n=205 participants at risk Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
Cardiac disorders Ventricular extrasystoles	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Coronary artery disease	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.21% 1/480 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.43% 1/231 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial infarction	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.81% 1/124 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Transient ischaemic attack	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.21% 1/480 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.21% 1/480 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.21% 1/480 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.21% 1/480 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Mental status changes	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.21% 1/480 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal failure acute	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.21% 1/480 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.11% 1/939 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.21% 1/480 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.43% 1/231 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Angina unstable	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.81% 1/124 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Eye disorders Vitreous haemorrhage	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.81% 1/124 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
General disorders Chest pain	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.81% 1/124 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.43% 1/231 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.43% 1/231 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Cerebral infarction	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/231 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.49% 1/205 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Calculus urinary	0.00% 0/120 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/480 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/939 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/28 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/124 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.43% 1/231 • Number of events 1 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.	0.00% 0/205 • up to 12 weeks Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER