Trial Outcomes & Findings for Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events (NCT NCT01968954)

NCT ID: NCT01968954

Last Updated: 2017-05-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 711 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2017-05-17

Participant Flow

Participant milestones

Measure	Placebo Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Study STARTED	354	357
Overall Study Treated	353	356
Overall Study COMPLETED	314	314
Overall Study NOT COMPLETED	40	43

Reasons for withdrawal

Measure	Placebo Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Study Adverse Event	6	3
Overall Study Death	1	2
Overall Study Lost to Follow-up	6	4
Overall Study Withdrawal by Subject	20	23
Overall Study Other	7	8
Overall Study Protocol Violation	0	1
Overall Study Did not met inclusion criteria	0	2

Baseline Characteristics

Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Baseline characteristics by cohort

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Total n=711 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 9.7 • n=5 Participants	61.1 years STANDARD_DEVIATION 10.2 • n=7 Participants	61.3 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	136 Participants n=7 Participants	266 Participants n=5 Participants
Sex: Female, Male Male	224 Participants n=5 Participants	221 Participants n=7 Participants	445 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo n=329 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=336 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12	1.0 percent change Standard Deviation 20.89	-55.6 percent change Standard Deviation 29.17

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Week 12 (n =330, 340)	1.0 percent change Standard Deviation 14.85	-35.1 percent change Standard Deviation 19.23
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Week 24 (n =331, 337)	3.2 percent change Standard Deviation 19.35	-31.7 percent change Standard Deviation 20.47
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Week 52 (n =313, 315)	1.8 percent change Standard Deviation 18.50	-27.3 percent change Standard Deviation 23.57

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52 Week 12 (n =330, 339)	1.3 percent change Standard Deviation 19.53	-50.0 percent change Standard Deviation 26.28
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52 Week 24 (n =329, 336)	4.7 percent change Standard Deviation 27.81	-46.2 percent change Standard Deviation 28.52
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52 Week 52 (n =312, 314)	2.3 percent change Standard Deviation 25.22	-38.9 percent change Standard Deviation 33.32

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Week 12 (n =330, 339)	0.3 percent change Standard Deviation 19.10	-51.1 percent change Standard Deviation 27.62
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Week 24 (n =331, 335)	3.5 percent change Standard Deviation 22.39	-47.3 percent change Standard Deviation 30.43
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Week 52 (n =313, 313)	1.9 percent change Standard Deviation 22.25	-39.1 percent change Standard Deviation 33.39

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Week 12 (n =330, 339)	4.7 percent change Standard Deviation 84.86	1.9 percent change Standard Deviation 508.44
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Week 24 (n =331, 336)	1.9 percent change Standard Deviation 51.82	4.4 percent change Standard Deviation 465.24
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Week 52 (n =311, 311)	1.1 percent change Standard Deviation 42.47	17.3 percent change Standard Deviation 562.63

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 Week 12 (n= 330, 339)	1.9 percent change Standard Deviation 17.24	6.6 percent change Standard Deviation 14.24
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 Week 24 (n =329, 336)	1.0 percent change Standard Deviation 15.78	7.8 percent change Standard Deviation 15.91
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 Week 52 (n =312, 314)	2.0 percent change Standard Deviation 15.73	5.3 percent change Standard Deviation 16.59

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.

Outcome measures

Measure	Placebo n=262 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=266 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia	1.5 percent change Standard Deviation 20.89	-56.8 percent change Standard Deviation 27.78

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.

Outcome measures

Measure	Placebo n=67 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=70 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia	-1.0 percent change Standard Deviation 20.95	-50.9 percent change Standard Deviation 33.78

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52 Week 24 (n =331, 336)	6.3 percent change Standard Deviation 32.52	-50.0 percent change Standard Deviation 31.36
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52 Week 52 (n =311, 313)	5.2 percent change Standard Deviation 29.69	-40.9 percent change Standard Deviation 38.02

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off TG <200 mg/dL: Week 24 (n =261, 265)	7.2 percent change Standard Deviation 34.38	-50.8 percent change Standard Deviation 30.90
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off TG <200 mg/dL: Week 52(n =243, 248)	6.2 percent change Standard Deviation 29.95	-41.1 percent change Standard Deviation 38.35
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off TG >=200 mg/dL: Week 24(n =70, 71)	3.0 percent change Standard Deviation 24.30	-46.9 percent change Standard Deviation 33.05
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off TG >=200 mg/dL: Week 52(n =68, 65)	2.0 percent change Standard Deviation 28.74	-40.1 percent change Standard Deviation 37.01

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52 Week 12 (n =330, 340)	5.9 percent change Standard Deviation 34.90	-9.4 percent change Standard Deviation 42.00
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52 Week 24 (n =331, 336)	7.0 percent change Standard Deviation 37.79	-13.8 percent change Standard Deviation 33.24
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52 Week 52 (n =313, 315)	0.6 percent change Standard Deviation 38.33	-9.3 percent change Standard Deviation 48.47

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 Week 12 (n =330, 339)	-0.3 percent change Standard Deviation 14.05	3.7 percent change Standard Deviation 12.56
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 Week 24 (n =331, 336)	-0.8 percent change Standard Deviation 12.77	4.3 percent change Standard Deviation 12.25
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 Week 52 (n =313, 313)	0.4 percent change Standard Deviation 13.13	3.3 percent change Standard Deviation 13.00

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 Week 12 (n =327, 339)	-1.8 percent change Standard Deviation 12.92	-1.9 percent change Standard Deviation 12.10
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 Week 24 (n =331, 335)	-3.7 percent change Standard Deviation 14.40	-1.9 percent change Standard Deviation 13.25
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 Week 52 (n =310, 310)	-3.0 percent change Standard Deviation 14.76	-1.6 percent change Standard Deviation 12.91

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 12 (n =330, 340)	5.9 percent change Standard Deviation 34.90	-9.4 percent change Standard Deviation 42.00
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 24 (n =331, 336)	7.0 percent change Standard Deviation 37.79	-13.8 percent change Standard Deviation 33.24
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 52 (n =313, 315)	0.6 percent change Standard Deviation 38.33	-9.3 percent change Standard Deviation 48.47

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized.'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm.

Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.

Outcome measures

Measure	Placebo n=353 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off TG <200 mg/dL: Baseline (n =282, 282)	111.2 mg/dL Standard Deviation 31.28	112.8 mg/dL Standard Deviation 36.42
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off TG <200 mg/dL: Change at Week12 (n =262, 266)	0.4 mg/dL Standard Deviation 22.60	-63.4 mg/dL Standard Deviation 37.38
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off TG >=200 mg/dL: Baseline (n =71, 75)	126.5 mg/dL Standard Deviation 42.07	125.7 mg/dL Standard Deviation 42.10
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off TG >=200 mg/dL: Change at Week 12 (n =67, 70)	-2.6 mg/dL Standard Deviation 26.98	-63.1 mg/dL Standard Deviation 44.91

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52 Baseline (n =353, 357)	114.3 mg/dL Standard Deviation 34.22	115.5 mg/dL Standard Deviation 37.99
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52 Change at Week 12 (n =329, 336)	-0.2 mg/dL Standard Deviation 23.55	-63.3 mg/dL Standard Deviation 39.00
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52 Change at Week 24 (n =331, 336)	5.5 mg/dL Standard Deviation 33.14	-56.0 mg/dL Standard Deviation 39.34
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52 Change at Week 52 (n =311, 313)	3.9 mg/dL Standard Deviation 32.17	-45.9 mg/dL Standard Deviation 46.43

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Baseline (n =354, 357)	186.0 mg/dL Standard Deviation 40.04	189.0 mg/dL Standard Deviation 44.68
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Change at Week 12 (n =330, 340)	0.6 mg/dL Standard Deviation 27.64	-66.8 mg/dL Standard Deviation 42.38
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Change at Week 24 (n =331, 337)	5.1 mg/dL Standard Deviation 35.83	-60.1 mg/dL Standard Deviation 43.33
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Change at Week 52 (n =313, 315)	1.8 mg/dL Standard Deviation 35.18	-51.9 mg/dL Standard Deviation 49.68

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52 Baseline (n =354, 357)	137.2 mg/dL Standard Deviation 37.38	140.1 mg/dL Standard Deviation 43.48
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52 Change at Week 12 (n =330, 339)	0.3 mg/dL Standard Deviation 26.53	-69.8 mg/dL Standard Deviation 43.53
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52 Change at Week 24 (n =329, 336)	5.2 mg/dL Standard Deviation 35.91	-63.6 mg/dL Standard Deviation 44.37
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52 Change at Week 52 (n =312, 314)	1.3 mg/dL Standard Deviation 33.93	-53.9 mg/dL Standard Deviation 51.10

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Baseline (n =354, 357)	94.0 mg/dL Standard Deviation 21.51	95.1 mg/dL Standard Deviation 25.57
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Change at Week 12 (n =330, 339)	-0.5 mg/dL Standard Deviation 17.32	-47.9 mg/dL Standard Deviation 28.40
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Change at Week 24 (n =331, 335)	2.5 mg/dL Standard Deviation 19.87	-43.9 mg/dL Standard Deviation 29.95
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Change at Week 52 (n =313, 313)	0.9 mg/dL Standard Deviation 20.59	-36.4 mg/dL Standard Deviation 32.23

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Baseline (n =353, 356)	44.0 mg/dL Standard Deviation 45.93	45.1 mg/dL Standard Deviation 52.30
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Change at Week 12 (n =330, 339)	-0.6 mg/dL Standard Deviation 10.42	-11.4 mg/dL Standard Deviation 22.19
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Change at Week 24 (n =331, 336)	-1.2 mg/dL Standard Deviation 12.62	-10.6 mg/dL Standard Deviation 20.16
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Change at Week 52 (n =311, 311)	-1.0 mg/dL Standard Deviation 10.71	-8.6 mg/dL Standard Deviation 23.78

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 Baseline (n =354, 357)	48.7 mg/dL Standard Deviation 12.52	49.0 mg/dL Standard Deviation 13.23
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 Change at Week 12 (n =330, 339)	0.4 mg/dL Standard Deviation 7.50	2.9 mg/dL Standard Deviation 6.92
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 Change at Week 24 (n =329, 336)	-0.0 mg/dL Standard Deviation 7.90	3.3 mg/dL Standard Deviation 7.41
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 Change at Week 52 (n =312, 314)	0.6 mg/dL Standard Deviation 7.59	2.1 mg/dL Standard Deviation 8.32

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Baseline (n =354, 357)	4.0 ratio Standard Deviation 1.10	4.1 ratio Standard Deviation 1.26
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Change at Week 12 (n =330, 339)	-0.0 ratio Standard Deviation 0.71	-1.6 ratio Standard Deviation 1.17
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Change at Week 24 (n =329, 336)	0.1 ratio Standard Deviation 0.93	-1.5 ratio Standard Deviation 1.21
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Change at Week 52 (n =312, 314)	0.0 ratio Standard Deviation 0.85	-1.2 ratio Standard Deviation 1.35

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Baseline (n =354, 357)	0.7 ratio Standard Deviation 0.18	0.7 ratio Standard Deviation 0.21
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Change at Week 12 (n =330, 339)	0.0 ratio Standard Deviation 0.12	-0.3 ratio Standard Deviation 0.21
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Change at Week 24 (n =331, 335)	0.0 ratio Standard Deviation 0.16	-0.3 ratio Standard Deviation 0.24
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Change at Week 52 (n =313, 313)	0.0 ratio Standard Deviation 0.14	-0.3 ratio Standard Deviation 0.25

SECONDARY outcome

Timeframe: Week 12, 24 and 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52 Week 12 (n =330, 336)	41.5 percentage of participants	87.5 percentage of participants
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52 Week 24 (n =332, 336)	37.3 percentage of participants	82.1 percentage of participants
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52 Week 52 (n =312, 313)	36.9 percentage of participants	77.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12, 24 and 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52 Week 12 (n =330, 336)	5.5 percentage of participants	76.8 percentage of participants
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52 Week 24 (n =332, 336)	3.3 percentage of participants	69.6 percentage of participants
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52 Week 52 (n =312, 313)	6.4 percentage of participants	61.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12, 24, 52

Population: Analysis set included participants who received at least 1 dose of PF-04950615. Here, 'n' signifies those participants who were evaluable at specified time points.

Outcome measures

Measure	Placebo n=356 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Plasma PF-04950615 Concentrations at Week 12, 24 and 52 Week 24 (n =327)	5.36 microgram per milliliter Standard Deviation 6.029	—
Plasma PF-04950615 Concentrations at Week 12, 24 and 52 Week 12 (n =332)	5.53 microgram per milliliter Standard Deviation 5.666	—
Plasma PF-04950615 Concentrations at Week 12, 24 and 52 Week 52 (n =306)	4.07 microgram per milliliter Standard Deviation 4.947	—

SECONDARY outcome

Timeframe: Baseline up to the end of study (up to 58 weeks)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment.

Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.

Outcome measures

Measure	Placebo n=353 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=356 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions Type 1 or 3 hypersensitivity reactions	2 participants	1 participants
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions Injection site reactions	5 participants	42 participants

SECONDARY outcome

Timeframe: Baseline up to the end of study (up to 58 weeks)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of PF-04950615 were evaluable for this outcome measure. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.

Outcome measures

Measure	Placebo n=352 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) ADA	44 percentage of participants	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) nAb	27 percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52 Baseline (n =354, 357)	149.5 mg/dL Standard Deviation 66.83	156.2 mg/dL Standard Deviation 78.75
Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52 Change at Week 12 (n =330, 340)	3.8 mg/dL Standard Deviation 57.04	-23.0 mg/dL Standard Deviation 71.52
Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52 Change at Week 24 (n =331, 336)	5.0 mg/dL Standard Deviation 64.34	-28.9 mg/dL Standard Deviation 68.41
Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52 Change at Week 52 (n =313, 315)	-7.7 mg/dL Standard Deviation 64.14	-24.3 mg/dL Standard Deviation 82.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 Change at Week 12 (n =330, 339)	-1.2 mg/dL Standard Deviation 19.46	4.6 mg/dL Standard Deviation 18.32
Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 Baseline (n =354, 357)	147.5 mg/dL Standard Deviation 24.25	147.2 mg/dL Standard Deviation 24.96
Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 Change at Week 24 (n =331, 336)	-2.3 mg/dL Standard Deviation 19.33	5.6 mg/dL Standard Deviation 17.53
Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 Change at Week 52 (n =313, 313)	-0.2 mg/dL Standard Deviation 19.56	3.8 mg/dL Standard Deviation 18.86

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Outcome measures

Measure	Placebo n=354 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=357 Participants Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 Baseline (n =353, 356)	38.1 mg/dL Standard Deviation 6.46	38.2 mg/dL Standard Deviation 6.58
Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 Change at Week 12 (n =327, 339)	-0.9 mg/dL Standard Deviation 4.95	-0.9 mg/dL Standard Deviation 4.63
Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 Change at Week 24 (n =331, 335)	-1.7 mg/dL Standard Deviation 5.65	-1.0 mg/dL Standard Deviation 5.07
Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 Change at Week 52 (n =310, 310)	-1.5 mg/dL Standard Deviation 5.54	-0.9 mg/dL Standard Deviation 5.15

Adverse Events

Placebo

Serious events: 40 serious events

Other events: 185 other events

Deaths: 0 deaths

PF-04950615 150 mg

Serious events: 45 serious events

Other events: 205 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=353 participants at risk Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=356 participants at risk Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Acute coronary syndrome	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Angina pectoris	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Angina unstable	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.84% 3/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Atrial fibrillation	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Bradycardia	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Cardiac failure	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Cardiac failure congestive	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Coronary artery disease	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.56% 2/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Left ventricular failure	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Myocardial infarction	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Myocardial ischaemia	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Silent myocardial infarction	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Ventricular extrasystoles	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Eye disorders Retinal aneurysm	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Eye disorders Retinal haemorrhage	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Faecaloma	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Gastritis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Inguinal hernia	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Intestinal ischaemia	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Large intestine polyp	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Mesenteric artery stenosis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Small intestinal obstruction	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Chest pain	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Non-cardiac chest pain	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.56% 2/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Pyrexia	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Appendicitis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Appendicitis perforated	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Arthritis bacterial	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Bursitis infective	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Cellulitis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.56% 2/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Diverticulitis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Encephalitis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Endocarditis staphylococcal	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Gastroenteritis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Gastroenteritis viral	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Hepatitis B	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Pneumonia	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Sepsis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Urinary tract infection	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Urosepsis	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.56% 2/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Femur fracture	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Humerus fracture	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Patella fracture	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Subdural haematoma	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Vascular graft complication	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Wound	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Metabolism and nutrition disorders Dehydration	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.56% 2/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma of sites other than skin	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.45% 1/224 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/221 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Intracranial aneurysm	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Lethargy	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Nerve root compression	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Presyncope	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Syncope	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Transient ischaemic attack	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Psychiatric disorders Completed suicide	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Psychiatric disorders Suicidal behaviour	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Renal and urinary disorders Acute kidney injury	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Skin and subcutaneous tissue disorders Angioedema	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Skin and subcutaneous tissue disorders Psoriasis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Vascular disorders Aortic aneurysm rupture	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Vascular disorders Aortic stenosis	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Vascular disorders Orthostatic hypotension	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Vascular disorders Peripheral arterial occlusive disease	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Vascular disorders Peripheral vascular disorder	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.

Other adverse events

Measure	Placebo n=353 participants at risk Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF-04950615 150 mg n=356 participants at risk Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Cardiac disorders Angina pectoris	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Cardiac disorders Palpitations	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Abdominal pain	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Constipation	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.2% 8/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Diarrhoea	1.7% 6/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	3.4% 12/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Dyspepsia	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.84% 3/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Nausea	2.0% 7/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.0% 7/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Gastrointestinal disorders Vomiting	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Chest pain	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.56% 2/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Fatigue	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.0% 7/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Injection site bruising	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Injection site erythema	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.5% 9/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Injection site haemorrhage	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Injection site pain	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.7% 6/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Injection site pruritus	0.00% 0/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Injection site reaction	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	11.8% 42/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Non-cardiac chest pain	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
General disorders Pain	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Acute sinusitis	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Bronchitis	4.0% 14/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	3.7% 13/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Cellulitis	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.56% 2/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Gastroenteritis	2.3% 8/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.56% 2/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Herpes zoster	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Influenza	2.0% 7/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.8% 10/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Nasopharyngitis	7.6% 27/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	7.3% 26/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Pharyngitis	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.7% 6/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Pneumonia	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.2% 8/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Rhinitis	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Sinusitis	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.8% 10/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Upper respiratory tract infection	5.4% 19/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	3.9% 14/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Infections and infestations Urinary tract infection	1.7% 6/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	3.1% 11/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Contusion	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Fall	3.7% 13/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.8% 10/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Injury, poisoning and procedural complications Muscle strain	0.28% 1/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Investigations Alanine aminotransferase increased	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.00% 0/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Investigations Blood cortisol decreased	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.7% 6/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Investigations Blood creatine phosphokinase increased	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.84% 3/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Investigations Gamma-glutamyltransferase increased	1.7% 6/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Investigations Vitamin D decreased	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Metabolism and nutrition disorders Diabetes mellitus	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Metabolism and nutrition disorders Hypoglycaemia	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Metabolism and nutrition disorders Vitamin D deficiency	10.2% 36/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	5.3% 19/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 7/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	3.7% 13/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Back pain	2.3% 8/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	4.2% 15/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	2.3% 8/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.0% 7/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Myalgia	2.5% 9/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.2% 8/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	3.1% 11/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.4% 5/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Dizziness	3.4% 12/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Headache	4.0% 14/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.2% 8/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Nervous system disorders Hypoaesthesia	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Psychiatric disorders Anxiety	1.4% 5/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.28% 1/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Psychiatric disorders Depression	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.7% 6/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.3% 3/224 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.45% 1/221 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.85% 3/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.7% 6/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 9/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	2.2% 8/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 6/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.84% 3/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.57% 2/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	1.1% 4/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Skin and subcutaneous tissue disorders Rash	1.1% 4/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	0.84% 3/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Vascular disorders Hypertension	3.1% 11/353 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.	3.4% 12/356 • Baseline up to the end of study (up to 58 weeks) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER