Trial Outcomes & Findings for Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events (NCT NCT02100514)

NCT ID: NCT02100514

Last Updated: 2018-07-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 746 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2018-07-31

Participant Flow

This study was conducted at multiple sites from 28 October 2014 to 15 July 2016 for the treatment period and up to 10 July 2017 for the extension period.

Participant milestones

Measure	Treatment Period: Placebo Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg Participants received Bococizumab (PF-04950615) 150 milligram (mg) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Placebo Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.	Extension Period: Bococizumab ADA Positive Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Treatment Period STARTED	247	499	0	0	0
Treatment Period COMPLETED	218	425	0	0	0
Treatment Period NOT COMPLETED	29	74	0	0	0
Extension Period STARTED	0	0	44	33	56
Extension Period COMPLETED	0	0	42	33	56
Extension Period NOT COMPLETED	0	0	2	0	0

Reasons for withdrawal

Measure	Treatment Period: Placebo Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg Participants received Bococizumab (PF-04950615) 150 milligram (mg) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Placebo Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.	Extension Period: Bococizumab ADA Positive Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Treatment Period Adverse Event	0	5	0	0	0
Treatment Period Death	2	2	0	0	0
Treatment Period Lost to Follow-up	5	17	0	0	0
Treatment Period Did Not Meet Entrance Criteria	0	1	0	0	0
Treatment Period Protocol Violation	1	1	0	0	0
Treatment Period Withdrawal by Subject	12	37	0	0	0
Treatment Period Other	9	11	0	0	0
Extension Period Withdrew consent	0	0	2	0	0

Baseline Characteristics

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Baseline characteristics by cohort

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Total n=746 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 10.0 • n=5 Participants	61.5 years STANDARD_DEVIATION 9.9 • n=7 Participants	61.6 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	223 Participants n=7 Participants	330 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants	276 Participants n=7 Participants	416 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

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

Outcome measures

Measure	Treatment Period: Placebo n=235 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=468 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	-0.8 percent change Standard Deviation 17.61	-50.8 percent change Standard Deviation 29.81	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 Week 12	-2.2 percent change Standard Deviation 13.41	-35.4 percent change Standard Deviation 20.93	—
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 Week 24	-3.1 percent change Standard Deviation 15.79	-32.9 percent change Standard Deviation 23.06	—
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 Week 52	-5.0 percent change Standard Deviation 17.22	-29.0 percent change Standard Deviation 22.08	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 Week 12	-0.6 percent change Standard Deviation 16.70	-46.5 percent change Standard Deviation 28.87	—
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 Week 24	-2.1 percent change Standard Deviation 18.66	-43.5 percent change Standard Deviation 32.26	—
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 Week 52	-4.4 percent change Standard Deviation 20.77	-37.3 percent change Standard Deviation 29.59	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52 Week 12	-2.6 percent change Standard Deviation 17.57	-47.6 percent change Standard Deviation 28.36	—
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52 Week 24	-3.8 percent change Standard Deviation 20.63	-44.7 percent change Standard Deviation 30.83	—
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52 Week 52	-6.4 percent change Standard Deviation 22.70	-39.5 percent change Standard Deviation 29.36	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: A subset of FAS included all participants who were randomized and had TG \<200 mg/dL at pre-randomization. Here, "n" signifies number of participants who were evaluable at the specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=164 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=331 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 12	0.5 percent change Standard Deviation 16.61	-51.1 percent change Standard Deviation 30.43	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 24	-1.6 percent change Standard Deviation 21.68	-48.4 percent change Standard Deviation 33.67	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 52	-4.2 percent change Standard Deviation 24.11	-42.2 percent change Standard Deviation 33.75	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: A subset of FAS included all participants who were randomized and had TG \>=200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=83 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=168 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 24	-5.7 percent change Standard Deviation 21.67	-45.8 percent change Standard Deviation 33.13	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 52	-5.7 percent change Standard Deviation 23.78	-40.9 percent change Standard Deviation 30.25	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52 Week 12	4.9 percent change Standard Deviation 54.24	-25.7 percent change Standard Deviation 29.45	—
Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52 Week 24	5.9 percent change Standard Deviation 50.52	-21.3 percent change Standard Deviation 34.42	—
Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52 Week 52	27.9 percent change Standard Deviation 374.64	-21.5 percent change Standard Deviation 32.61	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 Week 12	0.6 percent change Standard Deviation 13.93	6.3 percent change Standard Deviation 13.86	—
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 Week 24	0.6 percent change Standard Deviation 14.88	6.3 percent change Standard Deviation 14.49	—
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 Week 52	0.7 percent change Standard Deviation 14.24	7.0 percent change Standard Deviation 15.60	—

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period Week 24	-2.9 percent change Standard Deviation 21.72	-47.5 percent change Standard Deviation 33.48	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period Week 52	-4.7 percent change Standard Deviation 23.96	-41.8 percent change Standard Deviation 32.67	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52 Week 12	-6.2 percent change Standard Deviation 32.92	-16.2 percent change Standard Deviation 32.86	—
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52 Week 24	-8.9 percent change Standard Deviation 35.60	-18.2 percent change Standard Deviation 65.13	—
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52 Week 52	-8.0 percent change Standard Deviation 41.46	-15.8 percent change Standard Deviation 35.57	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Week 12	-0.9 percent change Standard Deviation 11.09	3.4 percent change Standard Deviation 11.43	—
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Week 24	-1.6 percent change Standard Deviation 10.81	2.5 percent change Standard Deviation 11.61	—
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Week 52	-1.0 percent change Standard Deviation 13.12	3.4 percent change Standard Deviation 11.77	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 Week 12	2.0 percent change Standard Deviation 11.94	3.0 percent change Standard Deviation 11.94	—
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 Week 24	2.6 percent change Standard Deviation 12.12	3.7 percent change Standard Deviation 14.12	—
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 Week 52	0.7 percent change Standard Deviation 12.46	1.9 percent change Standard Deviation 12.22	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 12	-6.2 percent change Standard Deviation 32.92	-16.2 percent change Standard Deviation 32.86	—
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 24	-8.9 percent change Standard Deviation 35.60	-18.2 percent change Standard Deviation 65.13	—
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 52	-8.0 percent change Standard Deviation 41.46	-15.8 percent change Standard Deviation 35.57	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: A subset of FAS included all participants who were randomized and had TG \<200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=164 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=331 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12 Baseline	130.1 mg/dL Standard Deviation 25.22	130.2 mg/dL Standard Deviation 28.72	—
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12 Change at Week 12	-0.5 mg/dL Standard Deviation 22.37	-67.3 mg/dL Standard Deviation 40.14	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: A subset of FAS included all participants who were randomized and had TG \>=200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=83 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=168 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12 Baseline	143.7 mg/dL Standard Deviation 35.49	147.2 mg/dL Standard Deviation 39.48	—
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12 Change at Week 12	-6.6 mg/dL Standard Deviation 29.61	-74.1 mg/dL Standard Deviation 48.04	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline	134.7 mg/dL Standard Deviation 29.71	135.9 mg/dL Standard Deviation 33.67	—
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Change at Week 12	-2.5 mg/dL Standard Deviation 25.07	-69.6 mg/dL Standard Deviation 42.98	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 Baseline	209.4 mg/dL Standard Deviation 33.84	210.3 mg/dL Standard Deviation 37.97	—
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 Change at Week 12	-5.9 mg/dL Standard Deviation 29.61	-75.4 mg/dL Standard Deviation 46.91	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Baseline	160.2 mg/dL Standard Deviation 33.49	162.1 mg/dL Standard Deviation 37.78	—
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Change at Week 12	-5.8 mg/dL Standard Deviation 29.59	-77.9 mg/dL Standard Deviation 48.28	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12 Baseline	106.1 mg/dL Standard Deviation 20.43	107.1 mg/dL Standard Deviation 23.33	—
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12 Change at Week 12	-1.6 mg/dL Standard Deviation 18.09	-49.8 mg/dL Standard Deviation 31.81	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12 Baseline	48.5 mg/dL Standard Deviation 54.04	47.3 mg/dL Standard Deviation 53.55	—
Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12 Change at Week 12	0.1 mg/dL Standard Deviation 10.91	-10.3 mg/dL Standard Deviation 17.01	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Change at Week 12	-0.1 mg/dL Standard Deviation 6.75	2.5 mg/dL Standard Deviation 6.64	—
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Baseline	49.2 mg/dL Standard Deviation 13.20	48.3 mg/dL Standard Deviation 11.60	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 Baseline	4.6 ratio Standard Deviation 1.90	4.6 ratio Standard Deviation 1.31	—
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 Change at Week 12	-0.2 ratio Standard Deviation 1.27	-1.8 ratio Standard Deviation 1.29	—
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 Change at Week 24	-0.2 ratio Standard Deviation 1.42	-1.6 ratio Standard Deviation 1.38	—
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 Change at Week 52	-0.2 ratio Standard Deviation 1.62	-1.5 ratio Standard Deviation 1.32	—

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, "n" signifies number of participants evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Baseline	0.7 ratio Standard Deviation 0.25	0.8 ratio Standard Deviation 0.22	—
Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Change at Week 12	0.0 ratio Standard Deviation 0.14	-0.4 ratio Standard Deviation 0.25	—
Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Change at Week 24	-0.0 ratio Standard Deviation 0.16	-0.3 ratio Standard Deviation 0.27	—
Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Change at Week 52	0.0 ratio Standard Deviation 0.66	-0.3 ratio Standard Deviation 0.25	—

SECONDARY outcome

Timeframe: 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 respectively.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 12	10.2 percentage of participants	81.6 percentage of participants	—
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 24	19.9 percentage of participants	75.1 percentage of participants	—
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 52	25.2 percentage of participants	72.7 percentage of participants	—

SECONDARY outcome

Timeframe: 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 respectively.

Outcome measures

Measure	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 12	1.3 percentage of participants	62.2 percentage of participants	—
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 24	1.7 percentage of participants	60.1 percentage of participants	—
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 Week 52	3.2 percentage of participants	53.4 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12, 24, 52

Population: Analysis set included participants who received at least 1 dose of PF-04950615. This outcome measure was planned not to be analysed for placebo reporting arm. Here, "n" signifies those participants who were evaluable at specified time points.

Outcome measures

Measure	Treatment Period: Placebo n=499 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Plasma Concentration Versus Time Summary of PF-04950615 Week 12	5.37 microgram per milliliter Standard Deviation 5.327	—	—
Plasma Concentration Versus Time Summary of PF-04950615 Week 24	5.28 microgram per milliliter Standard Deviation 5.888	—	—
Plasma Concentration Versus Time Summary of PF-04950615 Week 52	4.01 microgram per milliliter Standard Deviation 4.652	—	—

SECONDARY outcome

Timeframe: Baseline up to end of study (up to 110 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. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab 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	Treatment Period: Placebo n=247 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions With type 1 or 3 hypersensitivity reactions	0.0 Percentage of participants	0.2 Percentage of participants	—
Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions With injection site reactions	0.8 Percentage of participants	13.4 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 58

Population: Analysis set included all participants who received at least 1 dose of PF-04950615 150 mg. This outcome measure was planned not to be analysed for placebo reporting arm. Here "N" signifies number of subjects who were evaluable for this outcome measure.

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) unit was considered to be nAb positive.

Outcome measures

Measure	Treatment Period: Placebo n=491 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period Baseline up to Week 58: ADA positive	54.8 Percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period Baseline up to Week 58: nAb positive	37.9 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 58 follow-up to Week 110

Population: All participants who consented for extension period.

In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.

Outcome measures

Measure	Treatment Period: Placebo n=44 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=33 Participants Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative n=56 Participants Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Number of Participants Who Changed Concomitant Medication During Extension Period	2 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 58 (follow up), 71, 84, 97, 110

Population: All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period).

Outcome measures

Measure	Treatment Period: Placebo n=33 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period Week 58 (follow up)	6.7 percent change Standard Deviation 27.70	—	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period Week 71	8.7 percent change Standard Deviation 34.83	—	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period Week 84	7.0 percent change Standard Deviation 30.34	—	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period Week 97	2.6 percent change Standard Deviation 31.43	—	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period Week 110	15.5 percent change Standard Deviation 36.17	—	—

SECONDARY outcome

Timeframe: Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110

Population: All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, "n" signifies number of participants who were evaluable at specified time points.

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 log2 unit was considered to be ADA positive and nAb titer >=1.58 log2 unit was considered to be nAb positive.

Outcome measures

Measure	Treatment Period: Placebo n=33 Participants Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Bococizumab ADA Negative Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 58 (follow up): ADA positive	100.0 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 58 (follow up): nAB positive	60.6 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 71: ADA positive	87.1 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 71: nAB positive	35.5 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 84: ADA positive	82.1 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 84: nAB positive	25.0 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 97: ADA positive	86.4 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 97: nAB positive	18.2 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 110: ADA positive	100.0 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 110: nAB positive	11.8 percentage of participants	—	—

Adverse Events

Treatment Period: Placebo

Serious events: 32 serious events

Other events: 29 other events

Deaths: 2 deaths

Treatment Period: Bococizumab 150 mg

Serious events: 44 serious events

Other events: 97 other events

Deaths: 2 deaths

Extension Period: Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Extension Period: Bococizumab ADA Positive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Extension Period: Bococizumab ADA Negative

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Period: Placebo n=247 participants at risk Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 participants at risk Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Placebo n=44 participants at risk Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.	Extension Period: Bococizumab ADA Positive n=33 participants at risk Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.	Extension Period: Bococizumab ADA Negative n=56 participants at risk Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
General disorders POSSIBLE SEIZURE DISORDER SECONDARY TO AMPHETAMINE ABUSE	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Blood and lymphatic system disorders Anaemia	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Acute myocardial infarction	0.81% 2/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Angina pectoris	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.60% 3/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Angina unstable	0.81% 2/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.80% 4/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Arrhythmia	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Atrial fibrillation	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	2.3% 1/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Cardiac failure	0.81% 2/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Coronary artery disease	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Coronary artery occlusion	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Left ventricular failure	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Myocardial infarction	1.2% 3/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Sinus bradycardia	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Sinus node dysfunction	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Ventricular tachycardia	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Eye disorders Cataract	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Gastrointestinal disorders Abdominal hernia	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Gastrointestinal disorders Gastric ulcer	0.81% 2/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Gastrointestinal disorders Oesophageal perforation	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
General disorders Asthenia	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
General disorders Chest pain	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
General disorders Complication associated with device	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
General disorders Death	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
General disorders Non-cardiac chest pain	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	1.0% 5/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
General disorders Pyrexia	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
General disorders Vascular stent occlusion	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Hepatobiliary disorders Cholecystitis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Arthritis bacterial	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Diverticulitis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Gangrene	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Infected skin ulcer	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Klebsiella sepsis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Pneumonia	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.40% 2/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Postoperative wound infection	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Sepsis	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Urinary tract infection	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Urosepsis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Injury, poisoning and procedural complications Arterial injury	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Investigations Gamma-glutamyltransferase increased	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Musculoskeletal and connective tissue disorders Arthritis	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Cerebral haematoma	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Cerebral haemorrhage	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Cerebrovascular accident	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.60% 3/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Ischaemic stroke	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Miller Fisher syndrome	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Radiculopathy	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Subarachnoid haemorrhage	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Syncope	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.40% 2/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Nervous system disorders Transient ischaemic attack	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Psychiatric disorders Depression	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Psychiatric disorders Depression suicidal	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Psychiatric disorders Paranoia	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Psychiatric disorders Psychiatric decompensation	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Psychiatric disorders Suicidal behaviour	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Renal and urinary disorders Acute kidney injury	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Renal and urinary disorders Chronic kidney disease	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Renal and urinary disorders Nephrolithiasis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Renal and urinary disorders Renal failure	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Renal and urinary disorders Urinary retention	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Respiratory, thoracic and mediastinal disorders Asthma	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.40% 2/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.20% 1/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Vascular disorders Aortic aneurysm	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Vascular disorders Peripheral artery dissection	0.40% 1/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	1.8% 1/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Respiratory, thoracic and mediastinal disorders Chest pain	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	1.8% 1/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Cardiac disorders Myocardial ischaemia	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	2.3% 1/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	0.00% 0/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	2.3% 1/44 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/33 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	0.00% 0/56 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.

Other adverse events

Measure	Treatment Period: Placebo n=247 participants at risk Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Treatment Period: Bococizumab 150 mg n=499 participants at risk Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	Extension Period: Placebo n=44 participants at risk Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.	Extension Period: Bococizumab ADA Positive n=33 participants at risk Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.	Extension Period: Bococizumab ADA Negative n=56 participants at risk Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
General disorders Injection site reaction	0.81% 2/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	13.4% 67/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Nasopharyngitis	5.7% 14/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	3.4% 17/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
Infections and infestations Upper respiratory tract infection	5.7% 14/247 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	3.6% 18/499 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.	— 0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58 Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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